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What changed in Neuronetics, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Neuronetics, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+501 added−474 removedSource: 10-K (2026-03-17) vs 10-K (2025-03-27)

Top changes in Neuronetics, Inc.'s 2025 10-K

501 paragraphs added · 474 removed · 430 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

105 edited+10 added−13 removed129 unchanged
Biggest changeAs a result of the Arrangement, the Company may be subject to additional federal, state and foreign laws. ​ ● Our ability to obtain SPRAVATO from our suppliers on a timely basis at competitive costs could suffer as a result of events that adversely affect our suppliers or cause disruptions in their businesses. ​ ● Our revenue may be negatively impacted if third-party payors impose additional requirements or reduce reimbursement rates. ​ ● Tariffs implemented by the new presidential administration could adversely affect our business and financial results, if we are not able to sufficiently offset increased supply prices caused by any such tariffs. ​ ● Regulatory and compliance requirements associated with our billing and collections system could have a material adverse effect on our revenues, cash flows and operating results. ​ ● We may become subject to professional malpractice liability, which could be costly and negatively impact our business. ​ ● There is a concentration of ownership of our common stock by Madryn Asset Management, LP, or Madryn, and Madryn may exert substantial influence over the Company’s business, and the interest of Madryn may conflict with those interests of other stockholders. ​
Biggest changeOur business may be subject to additional federal, state and foreign laws. ​ ● Our ability to obtain SPRAVATO from our suppliers on a timely basis at competitive costs could suffer as a result of events that adversely affect our suppliers or cause disruptions in their businesses. ​ ● Our revenue may be negatively impacted if third-party payors impose additional requirements or reduce reimbursement rates. ​ ● Our products and services and operations are subject to extensive government regulation and oversight both in the United States and abroad, and our failure to comply with applicable requirements could harm our business.
However, it is possible that such initiatives could have an adverse effect on our ability to obtain approval and/or successfully commercialize products in the United States in the future. For example, U.S. federal government and state legislatures have continued to implement cost containment programs, including price controls and restrictions on coverage and reimbursement.
However, it is possible that such initiatives could have an adverse effect on our ability to obtain approval or successfully commercialize products in the United States in the future. For example, U.S. federal government and state legislatures have continued to implement cost containment programs, including price controls and restrictions on coverage and reimbursement.
These include: ● establishment registration and device listing with the FDA; 12 Table of Contents ● QSR requirements, which require manufacturers, including third-party manufacturers and contract manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the design and, manufacturing, and distribution process; ● labeling and marketing regulations, which require that promotion is truthful, not misleading, fairly balanced and provide adequate directions for use and that all claims are substantiated, and also prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling; FDA guidance on off-label dissemination of information and responding to unsolicited requests for information; ● clearance or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or efficacy or that would constitute a major change in intended use of one of our cleared devices; ● medical device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury or serious adverse events, if the malfunction were to recur; ● correction, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; ● complying with regulations requiring Unique Device Identifiers on devices and also requiring the submission of certain information about each device to the FDA’s Global Unique Device Identification Database; ● the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations; and ● post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and efficacy data for the device.
These include: ● establishment registration and device listing with the FDA; ● QSR requirements, which require manufacturers, including third-party manufacturers and contract manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the design and, manufacturing, and distribution process; ● labeling and marketing regulations, which require that promotion is truthful, not misleading, fairly balanced and provide adequate directions for use and that all claims are substantiated, and also prohibit the promotion of products for unapproved or “off-label” uses and impose other restrictions on labeling; FDA guidance on off-label dissemination of information and responding to unsolicited requests for information; ● clearance or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or efficacy or that would constitute a major change in intended use of one of our cleared devices; ● medical device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury or serious adverse events, if the malfunction were to recur; ● correction, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health; ● complying with regulations requiring Unique Device Identifiers on devices and also requiring the submission of certain information about each device to the FDA’s Global Unique Device Identification Database; ● the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations; and 14 Table of Contents ● post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and efficacy data for the device.
NeuroStar Advanced Therapy System is safe, clinically effective, reproducible and precise and we believe is supported by the largest clinical data set of any competing TMS system. Greenbrook Treatment Centers also obtain SPRAVATO® to treat adults with treatment-resistant depression or depressive symptoms in adults suffering from MDD with acute suicidal ideation or behavior.
The NeuroStar Advanced Therapy System is safe, clinically effective, reproducible and precise and we believe is supported by the largest clinical data set of any competing TMS system. Treatment Centers also obtain SPRAVATO® to treat adults with treatment-resistant depression or depressive symptoms in adults suffering from MDD with acute suicidal ideation or behavior.
Notably, however, the Stark Law is a strict liability statute and compliance is difficult to assure; ● HIPAA, among other things, established various criminal health care fraud laws, which impose criminal liability for executing or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and creates federal criminal laws that prohibit knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services.
Notably, however, the Stark Law is a strict liability statute and compliance with the Stark Law or analogous state law is difficult to assure; ● HIPAA, among other things, established various criminal health care fraud laws, which impose criminal liability for executing or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and creates federal criminal laws that prohibit knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services.
We believe that the NeuroStar Advanced Therapy System coupled with these advantages offer significant improvement over competing TMS, which lack the ability to reproduce consistent treatments, significant clinical data from randomized outcome trials, practice development resources, and a cloud-based practice management system.
We believe that the NeuroStar Advanced Therapy System coupled with these advantages offer significant improvement over competing TMS systems, which lack the ability to reproduce consistent treatments, significant clinical data from randomized outcome trials, practice development resources, and a cloud-based practice management system.
We have identified the following key opportunity drivers for Greenbrook’s business: •the safety and efficacy of TMS as a treatment option for patients suffering from MDD and OCD; •the growing societal awareness and acceptance of depression as a treatable disease and a corresponding reduction in stigma surrounding depression, seeking treatment and mental health issues generally; •the growing acceptance, but under-adoption, of TMS; 4 Table of Contents •the poor alignment of TMS treatment with traditional practices of psychiatry which created an opportunity for a new, differentiated service channel; •the fragmented competitive landscape for TMS, which provides an opportunity for consolidation; and •the track record of success by the Greenbrook management team in multi-location, center-based healthcare service companies.
We have identified the following key opportunity drivers for Greenbrook’s business: •the safety and efficacy of TMS as a treatment option for patients suffering from MDD and OCD; 5 Table of Contents •the growing societal awareness and acceptance of depression as a treatable disease and a corresponding reduction in stigma surrounding depression, seeking treatment and mental health issues generally; •the growing acceptance, but under-adoption, of TMS; •the poor alignment of TMS treatment with traditional practices of psychiatry which created an opportunity for a new, differentiated service channel; •the fragmented competitive landscape for TMS, which provides an opportunity for consolidation; and •the track record of success by the Greenbrook management team in multi-location, center-based healthcare service companies.
If the FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or request the recall of the modified device until 510(k) marketing clearance or PMA is obtained. Also, in these circumstances, we may be subject to significant regulatory fines or penalties.
If the FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing or request the recall of the modified device until 510(k) marketing clearance or PMA is obtained. Also, in these circumstances, we may be subject to significant regulatory fines or penalties.
It is also cleared by the FDA, as an adjunct for adults with obsessive-compulsive disorder (“OCD”) and for adolescent patients aged 15-21 with MDD. It is also cleared by the FDA as an adjunct for adults with OCD, and to decrease anxiety symptoms in adult patients with MDD that may exhibit comorbid anxiety symptoms (anxious depression).
It is also cleared by the FDA as an adjunct for adults with obsessive-compulsive disorder (“OCD”) and for adolescent patients aged 15-21 with MDD. It is also cleared by the FDA to decrease anxiety symptoms in adult patients with MDD that may exhibit comorbid anxiety symptoms (anxious depression).
Among other ways in which it may impact a medical device manufacturer’s business, the PPACA: ● established a Patient-Centered Outcomes Research Institute to oversee and identify priorities in comparative clinical efficacy research in an effort to coordinate and develop such research; ● required manufacturers to report certain payments and other transfers of value pursuant to the Physician Payments Sunshine Act, described above; ● implemented payment system reforms including a national pilot program on payment bundling to encourage hospitals, physicians and other providers to improve the coordination, quality and efficiency of certain healthcare services through bundled payment models; and ● expanded the eligibility criteria for Medicaid programs and, originally, required certain employers to provide, and all individuals to obtain, health insurance .
Among other ways in which it may impact a medical device manufacturer’s business, the PPACA: ● established a Patient-Centered Outcomes Research Institute to oversee and identify priorities in comparative clinical efficacy research in an effort to coordinate and develop such research; ● required manufacturers to report certain payments and other transfers of value pursuant to the Physician Payments Sunshine Act, described above; 18 Table of Contents ● implemented payment system reforms including a national pilot program on payment bundling to encourage hospitals, physicians and other providers to improve the coordination, quality and efficiency of certain healthcare services through bundled payment models; and ● expanded the eligibility criteria for Medicaid programs and, originally, required certain employers to provide, and all individuals to obtain, health insurance .
If a medical device manufacturer’s operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to it, it may be subject to penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement, substantial monetary penalties, individual imprisonment, exclusion from governmental funded healthcare programs, such as Medicare and Medicaid, additional reporting obligations and oversight if it becomes 16 Table of Contents subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of operations, any of which could adversely affect the ability of a medical device manufacturer to operate its business and the results of its operations.
If a medical device manufacturer’s operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to it, it may be subject to penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement, substantial monetary penalties, individual imprisonment, exclusion from governmental funded healthcare programs, such as Medicare and Medicaid, additional reporting obligations and oversight if it becomes subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of operations, any of which could adversely affect the ability of a medical device manufacturer to operate its business and the results of its operations.
If the FDA determines that we failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions: ● warning letters, untitled letters, fines, injunctions, consent decrees and civil penalties; 13 Table of Contents ● recalls, withdrawals, or administrative detention or seizure of our products; ● operating restrictions or partial suspension or total shutdown of production; ● refusing or delaying requests for 510(k) marketing clearance or PMAs of new products or modified products; ● withdrawing 510(k) clearances or PMAs that have already been authorized; ● refusal to authorize export or import approvals for our products; or ● criminal prosecution.
If the FDA determines that we failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions: ● warning letters, untitled letters, fines, injunctions, consent decrees and civil penalties; ● recalls, withdrawals, or administrative detention or seizure of our products; ● operating restrictions or partial suspension or total shutdown of production; ● refusing or delaying requests for 510(k) marketing clearance or PMAs of new products or modified products; ● withdrawing 510(k) clearances or PMAs that have already been authorized; ● refusal to authorize export or import approvals for our products; or ● criminal prosecution.
Moreover, there are no safe harbors for many common practices, such as reimbursement support programs, educational or research grants, or charitable donations; ● the federal civil and criminal false claims laws and civil monetary penalty laws, such as the FCA, which can be enforced by private citizens through civil qui tam actions, prohibits individuals or entities from, among other things, knowingly presenting, or causing to be presented, false, fictitious or 14 Table of Contents fraudulent claims for payment of federal funds, and knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government.
Moreover, there are no safe harbors for many common practices, such as reimbursement support programs, educational or research grants, or charitable donations; ● the federal civil and criminal false claims laws and civil monetary penalty laws, such as the FCA, which can be enforced by private citizens through civil qui tam actions, prohibits individuals or entities from, among other things, knowingly presenting, or causing to be presented, false, fictitious or fraudulent claims for payment of federal funds, and knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government.
Based on our commercial data, we believe psychiatrists can recoup their initial capital investment in our system by providing a standard course of treatment to approximately 12 patients, assuming these patients receive reimbursement from federal healthcare programs or commercial insurance at rates that are similar to what our customers have observed for existing and prior patients.
Based on our commercial data, we believe providers can recoup their initial capital investment in our system by providing a standard course of treatment to approximately 12 patients, assuming these patients receive reimbursement from federal healthcare programs or commercial insurance at rates that are similar to what our customers have observed for existing and prior patients.
We believe our NeuroStar Advanced Therapy System provides our psychiatrist customers and their patients with several benefits, including clinically demonstrated response and remission with durable results, a demonstrated safety profile with limited treatment-emergent side effects and high patient adherence. Additionally, NeuroStar Advanced Therapy System was designed to provide a precise and reproducible office-based therapy that is efficient and convenient.
We believe our NeuroStar Advanced Therapy System provides our provider customers and their patients with several benefits, including clinically demonstrated response and remission with durable results, a demonstrated safety profile with limited treatment-emergent side effects and high patient adherence. Additionally, NeuroStar Advanced Therapy System was designed to provide a precise and reproducible office-based therapy that is efficient and convenient.
To capture new psychiatrist customers, we plan to optimize our specialized, direct sales organization that targets MDD treating psychiatric practices that accept reimbursement from private insurance and Medicare. Symphony Health estimates that there are approximately 26,300 group and solo practice sites in the United States with psychiatrists that prescribe antidepressant medications.
To capture new provider customers, we plan to optimize our specialized, direct sales organization that targets MDD treating psychiatric practices that accept reimbursement from private insurance and Medicare. Symphony Health estimates that there are approximately 26,300 group and solo practice sites in the United States with psychiatrists that prescribe antidepressant medications.
Beginning in 2021, Greenbrook commenced its roll-out of SPRAVATO therapy in Treatment Centers to treat treatment-resistant depression in adults and depressive symptoms in adults with MDD with acute suicidal ideation or behavior. Currently, Greenbrook offers SPRAVATO at 69 Treatment Centers within its operating network as of the date of this Annual Report on Form 10-K.
Beginning in 2021, Greenbrook commenced its roll-out of SPRAVATO therapy in Treatment Centers to treat treatment-resistant depression in adults and depressive symptoms in adults with MDD with acute suicidal ideation or behavior. Currently, Greenbrook offers SPRAVATO at 83 Treatment Centers within its operating network as of the date of this Annual Report on Form 10-K.
Reimbursement, Payor Relations and Customer Support Based on our estimates, over 65 major private insurers in the United States, including the top 25 largest private insurers and federal healthcare programs, have coverage policies for reimbursement of TMS, including NeuroStar Advanced Therapy System, representing over 300 million covered lives or about 95% of the total payor covered lives in the United States.
Reimbursement, Payor Relations and Customer Support Based on our estimates, over 104 major private insurers in the United States, including the top 25 largest private insurers and federal healthcare programs, have coverage policies for reimbursement of TMS, including NeuroStar Advanced Therapy System, representing over 300 million covered lives or about 95% of the total payor covered lives in the United States.
Although a variety of antidepressant medications are available, drug therapy has at least two 2 Table of Contents primary limitations: limited effectiveness and treatment-emergent side effects. These limitations were demonstrated in the STAR*D Study, a large clinical trial funded by the U.S.
Although a variety of antidepressant medications are available, drug therapy has at least two 3 Table of Contents primary limitations: limited effectiveness and treatment-emergent side effects. These limitations were demonstrated in the STAR*D Study, a large clinical trial funded by the U.S.
Additionally, the effect of the uncertainty relating to potential future changes to government regulation may increase our costs. ● Modifications to our products may require new 510(k) clearances, de novo classification or PMAs, and may require us to cease marketing or recall the modified products until clearances are obtained. ● Our products must be manufactured in accordance with federal and state regulations, and we could be forced to recall our installed systems or terminate production if we fail to comply with these regulations. ● Our products may cause or contribute to adverse medical events that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations.
Additionally, the effect of the uncertainty relating to potential future changes to government regulation may increase our costs. ● Modifications to our products may require new 510(k) clearances, de novo classification or PMAs, and may require us to cease marketing or recall the modified products until clearances are obtained. ● Our products must be manufactured in accordance with federal and state regulations, and we could be forced to recall our installed systems or terminate production if we fail to comply with these regulations. ● Our products and services may cause or contribute to adverse medical events that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our 23 Table of Contents reputation, business, financial condition and results of operations.
Greenbrook Currently operating through 95 company-operated Treatment Centers and company-supported healthcare provider practice groups, Greenbrook is a leading provider of TMS and SPRAVATO (esketamine nasal spray), FDA-cleared, non-invasive therapies for the treatment of MDD and other mental health disorders, in the United States.
Greenbrook Currently operating through 93 company-operated Treatment Centers and company-supported healthcare provider practice groups, Greenbrook is a leading provider of TMS and SPRAVATO (esketamine nasal spray), FDA-cleared, non-invasive therapies for the treatment of MDD and other mental health disorders, in the United States.
As of the date of this Annual report on Form 10-K, Greenbrook owns and operates 95 Treatment Centers in the states of Alaska, California, Connecticut, Florida, Illinois, Maryland, Massachusetts, Michigan, Missouri, North Carolina, Ohio, Oregon, South Carolina, Texas and Virginia.
As of the date of this Annual Report on Form 10-K, Greenbrook owns and operates 93 Treatment Centers in the states of Alaska, California, Connecticut, Florida, Illinois, Maryland, Massachusetts, Michigan, Missouri, North Carolina, Ohio, Oregon, South Carolina, Texas and Virginia.
The FDA regulates the development, design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling, packaging, 9 Table of Contents storage, installation, servicing, recordkeeping, premarket clearance or approval, import, export, adverse event reporting, advertising, promotion, marketing and distribution, and import and export of medical devices to ensure that medical devices distributed domestically are safe and effective for their intended uses and otherwise meet the requirements of the FDCA.
The FDA regulates the development, design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling, packaging, storage, installation, servicing, recordkeeping, premarket clearance or approval, import, export, adverse event reporting, advertising, promotion, marketing and distribution, and import and export of medical devices to ensure that medical devices distributed domestically are safe and effective for their intended uses and otherwise meet the requirements of the FDCA.
Our international commercial focus is on Japan, which has the third largest healthcare spend globally. 3 Table of Contents We are also evaluating the use of enhancements to our NeuroStar Advanced Therapy System to treat additional indications.
Our international commercial focus is on Japan, which has the third largest healthcare spend globally. 4 Table of Contents We are also evaluating the use of enhancements to our NeuroStar Advanced Therapy System to treat additional indications.
Culture A diverse and welcoming culture that provides equal opportunities helps the Company remain competitive, advance its innovation culture, and serve customers. The Company focuses on attracting and advancing top talent as well as advancing initiatives that enhance belonging and broad representation.
Culture A diverse and welcoming culture that provides equal opportunities helps the Company remain competitive, advance its innovative culture, and serve customers. The Company focuses on attracting and advancing top talent as well as advancing initiatives that enhance belonging and broad representation.
Our therapy is delivered without general anesthesia or sedation, enabling the patient to drive and resume normal activities immediately following each treatment session. We couple our product’s clinical benefits with significant practice development resources, on-site clinical training and reimbursement and service support to help our psychiatrist customers develop a successful NeuroStar Advanced Therapy System practice.
Our therapy is delivered without general anesthesia or sedation, enabling the patient to drive and resume normal activities immediately following each treatment session. We couple our product’s clinical benefits with practice development resources, on-site clinical training and reimbursement and service support to help our provider customers develop a successful NeuroStar Advanced Therapy System practice.
In this case, the review time is shorter (approximately 30 days), compared to the review time of approximately 90 days for the traditional 510(k) pathway. Alternatively, the abbreviated 510(k) pathway may be used when the submission relies on FDA guidance documents, demonstration of compliance with special controls for the device type, and voluntary consensus standards.
In this case, the review time is shorter (approximately 30 days), compared to the review time of approximately 90 days for the traditional 510(k) pathway. Alternatively, the abbreviated 510(k) pathway may be used when the submission relies on FDA guidance documents, demonstration of compliance with special controls for the 13 Table of Contents device type, and voluntary consensus standards.
Our area sales managers are responsible for identifying key customer prospects, educating them on the value of NeuroStar Advanced Therapy System, gaining their commitment for capital placement and introducing them to our PDMs. Our PDMs enhance the operational experience for providers and drive implementation of the NeuroStar Advanced Therapy System into our customers’ practices.
Our area sales managers are responsible for identifying key customer prospects, educating them on the value of NeuroStar Advanced Therapy System, gaining their commitment 8 Table of Contents for capital placement and introducing them to our PDMs. Our PDMs enhance the operational experience for providers and drive implementation of the NeuroStar Advanced Therapy System into our customers’ practices.
Through consistent messaging and outreach, our team builds strong referral pathways, connecting thousands of patients to the care they need and helping them take the next step toward remission. ● Increase utilization of our new and existing active customer sites of NeuroStar Advanced Therapy Systems.
Through consistent messaging and outreach, our team builds strong referral pathways, connecting thousands of patients to the care they need and helping them take the next step toward remission. 7 Table of Contents ● Increase utilization of our new and existing active customer sites of NeuroStar Advanced Therapy Systems.
PMA supplements often require submission of the same type of information as an original PMA application, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA application, and may not require as extensive clinical data or the convening of an advisory panel.
PMA supplements often require submission of the same type of information as an original PMA 12 Table of Contents application, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA application and may not require as extensive clinical data or the convening of an advisory panel.
In addition to earning a base salary, eligible employees are compensated for their contributions to the Company’s goals with cash incentives and long-term equity-based incentives. The Company is committed to providing fair and equitable pay for employees. Eligible full-time 20 Table of Contents employees also have access to medical, dental, and vision plans; savings and retirement plans; and other benefits.
In addition to earning a base salary, eligible employees are compensated for their contributions to the Company’s goals with cash incentives and long-term equity-based incentives. The Company is committed to providing fair and equitable pay for employees. Eligible full-time employees also have access to medical, dental, and vision plans; savings and retirement plans; and other benefits.
The device sponsor must then fulfill more rigorous 10 Table of Contents PMA requirements, or can request a risk-based classification determination for the device in accordance with the “de novo” classification process, which is a route to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device.
The device sponsor must then fulfill more rigorous PMA requirements or can request a risk-based classification determination for the device in accordance with the “de novo” classification process, which is a route to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device.
At the state level, individual states in the United States are also increasingly passing legislation and implementing regulations designed to control product pricing or manufacturer interactions with healthcare providers, including price or patient 17 Table of Contents reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures.
At the state level, individual states in the United States are also increasingly passing legislation and implementing regulations designed to control product pricing or manufacturer interactions with healthcare providers, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures.
We cannot predict the impact that health care reform under the former Biden administration will have on our business, and there is uncertainty as to what healthcare programs and regulations may be implemented or changed at the federal and/or state level in the United States, or the effect of any future legislation or regulation.
We cannot predict the impact that health care reform will have on our business, and there is uncertainty as to what healthcare programs and regulations may be implemented or changed at the federal or state level in the United States, or the effect of any future legislation or regulation.
While most Class I devices are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a premarket notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device.
While most Class I devices are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a premarket notification under Section 510(k) of the FDCA 11 Table of Contents requesting permission to commercially distribute the device.
Similar to the federal healthcare Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the applicable statute or specific intent to violate it or to have committed a violation; 15 Table of Contents ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their implementing regulations, which imposes privacy, security, transmission and breach reporting obligations with respect to individually identifiable health information upon “covered entities” subject to the law, including health plans, healthcare clearinghouses and certain healthcare providers and their respective business associates that perform services on their behalf that involve individually identifiable health information.
Similar to the AKS, a person or entity does not need to have actual knowledge of the applicable statute or specific intent to violate it or to have committed a violation; ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their implementing regulations, which imposes privacy, security, transmission and breach reporting obligations with respect to individually identifiable health information upon “covered entities” subject to the law, including health plans, healthcare clearinghouses and certain healthcare providers and their respective business associates that perform services on their behalf that involve individually identifiable health information.
The laws that may affect a medical device manufacturer’s ability to operate include, but are not limited to: ● the federal Anti-Kickback Statute, which prohibits any person or entity from, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of an item or service reimbursable, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs.
The laws that may affect a medical device manufacturer’s ability to operate include, but are not limited to: ● the federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b) (the “AKS”), which prohibits any person or entity from, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of an item or service reimbursable, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs.
Human Capital Employees As of December 31, 2024, we had 716 full time employees working collaboratively across our sales and customer support team, in research and development, including clinical, regulatory and certain quality functions, operations and in general and administrative. All of our employees are employed full time.
Human Capital Employees As of December 31, 2025, we had 658 full-time employees working collaboratively across our sales and customer support team, in research and development, including clinical, regulatory and certain quality functions, operations and in general and administrative. All of our employees are employed full-time.
In addition, a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA. As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes “any request or demand” for money or property presented to the U.S. government.
In addition, a claim including items or services resulting from a violation of the AKS constitutes a false or fraudulent claim for purposes of the FCA. As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes “any request or demand” for money or property presented to the U.S. government.
HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions; ● the federal physician payment transparency requirements, sometimes referred to as the “Physician Payments Sunshine Act,” created under the Patient Protection and Affordable Care Act (“PPACA”), which requires, among other things, certain manufacturers of drugs, devices, biologics and medical supplies reimbursed under Medicare, Medicaid, or the Children’s Health Insurance Program (with certain exceptions) to report annually to the United States Department of Health and Human Services, Centers for Medicare and Medicare Services,(“CMS”), information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other professionals (physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and ● foreign and state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, that may impose similar or more prohibitive restrictions, and may apply to items or services reimbursed by any non-governmental third-party payors, including private insurers; state laws that require device manufacturers to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information; and other federal and state laws that govern the privacy and security of health information or personally identifiable information in certain circumstances, including state health information privacy and data breach notification laws which govern the collection, use, disclosure, and protection of health-related and other personal information, many of which differ from each other in significant ways and often are not pre-empted by HIPAA, thus requiring additional compliance efforts and data privacy and security laws and regulations in foreign jurisdictions that may be more stringent than those in the United States (such as the European Union, which adopted the GDPR, which became effective in May 2018).
HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions; ● federal and state antitrust law may limit contracting relationships or the sharing of cost or pricing data amongst healthcare providers, and may prohibit or limit healthcare providers from acting collectively to jointly contract with payors or negotiate reimbursement rates, depending upon whether certain network or joint ventures maintain sufficient financial or clinical integration; ● the federal physician payment transparency requirements, sometimes referred to as the “Physician Payments Sunshine Act,” created under the Patient Protection and Affordable Care Act (“PPACA”), which requires, among other things, certain manufacturers of drugs, devices, biologics and medical supplies reimbursed under Medicare, Medicaid, or the Children’s Health Insurance Program (with certain exceptions) to report annually to the United States Department of Health and Human Services, Centers for Medicare and Medicare Services,(“CMS”), information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other professionals (physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and 17 Table of Contents ● foreign and state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, that may impose similar or more prohibitive restrictions, and may apply to items or services reimbursed by any non-governmental third-party payors, including private insurers; state laws that require device manufacturers to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and pricing information; and other federal and state laws that govern the privacy and security of health information or personally identifiable information in certain circumstances, including state health information privacy and data breach notification laws which govern the collection, use, disclosure, and protection of health-related and other personal information, many of which differ from each other in significant ways and often are not pre-empted by HIPAA, thus requiring additional compliance efforts and data privacy and security laws and regulations in foreign jurisdictions that may be more stringent than those in the United States (such as the European Union, which adopted the GDPR, which became effective in May 2018).
We also provide cloud-based practice management solutions that enhance convenience for both psychiatrists and patients.
We also provide cloud-based practice management solutions that enhance convenience for both providers and patients.
The term “remuneration” has been broadly interpreted to include anything of value. The government can establish a violation of the Anti-Kickback Statute without proving that a person or entity had actual knowledge of the law or a specific intent to violate.
The term “remuneration” has been broadly interpreted to include anything of value. The government can establish a violation of the AKS without proving that a person or entity had actual knowledge of the law or a specific intent to violate.
We currently sell our NeuroStar Advanced Therapy System and recurring treatment sessions in the United States with the collaborative support of our 716 employees as of December 31, 2024. We generate Neurostar revenues from initial capital sales of our systems, sales of our recurring treatment sessions, service and repair and extended warranty contracts and clinic revenue.
We currently sell our NeuroStar Advanced Therapy System and recurring treatment sessions in the United States with the collaborative support of our 658 employees as of December 31, 2025. We generate NeuroStar revenues from clinic revenue, capital sales of our systems, sales of our recurring treatment sessions, service and repair and extended warranty contracts.
There are also criminal penalties, including imprisonment and criminal fines, for making or presenting false, fictitious or fraudulent claims to the federal government; ● the federal physician self-referral law (“Stark Law”) prohibits, subject to exceptions, referring Medicare patients for “designated health services” (including “durable medical equipment and supplies” and “outpatient hospital services”) (“DHS”) to entities with which a referring physician (or immediate family member) maintains a “financial relationship.” States (as required in order to maintain Medicaid funding) have further enacted similar prohibitions that apply to Medicaid, as well as other insurance programs, and which may be more restrictive than the Stark Law.
There are also criminal penalties, including imprisonment and criminal fines, for making or presenting false, fictitious or fraudulent claims to the federal government; ● the federal physician self-referral law (“Stark Law”) prohibits, subject to exceptions, referring Medicare patients for “designated health services” (“DHS”) to entities with which a referring physician (or immediate family member) maintains a “financial relationship.” States (as required in order to 16 Table of Contents maintain Medicaid funding) have further enacted similar prohibitions that apply to Medicaid, as well as other insurance programs, and which may be more restrictive than the Stark Law.
On a worldwide basis, as of December 31, 2024, our patent estate included 82 issued or allowed patents and 20 pending patent applications for our products and novel design methods, manufacturing processes, novel TMS devices and systems and future combination products that are mainly designed to treat psychiatric conditions or perform diagnostic procedures.
On a worldwide basis, as of December 31, 2025, our patent estate included 62 issued or allowed patents and 17 pending patent applications for our products and novel design methods, manufacturing processes, novel TMS devices and systems and future combination products that are mainly designed to treat psychiatric conditions or perform diagnostic procedures.
Our first commercial product, the NeuroStar Advanced Therapy System, is a non-invasive and non-systemic office-based treatment that uses transcranial magnetic stimulation (“TMS”) to create a pulsed, MRI-strength magnetic field that induces electrical currents designed to stimulate specific areas of the brain associated with mood.
The Company’s first commercial product, the NeuroStar Advanced Therapy System, is a non-invasive and non-systemic office-based treatment that uses transcranial magnetic stimulation (“TMS”), to create a pulsed, magnetic resonance imaging (“MRI”)-strength magnetic field that induces electrical currents designed to stimulate specific areas of the brain associated with mood.
We created the role of clinical training manager to partner with our customers to conduct initial and ongoing on-site clinical training to ensure clinical and practice success. Practice Management Support and Psychiatrist Training—United States Our PDMs play a pivotal role in ensuring the success of our customers as they implement a new service line into their practice.
We created the role of clinical training manager to partner with our customers to conduct initial and ongoing on-site clinical training to ensure clinical and practice success. Practice Management Support and Provider Training—United States Our PDMs can play an important role in ensuring the success of our customers as they implement a new service line into their practice.
NeuroStar is a market leader in transcranial magnetic stimulation with expertise in the following areas: • Unrivalled Clinical Results: Long-Term Relief for Depression, 5 Table of Contents • Widely Reimbursed • Proven Formula for Practice Success • Top Tier Training and Best Practices • Comprehensive Direct Sales and Support Team • As a leading mental health provider Greenbrook’s expertise includes: • Large Network of Clinics • Offer New Paradigms for Treating Depression • Established and Growing Network of Referring Physicians • Centralized, Scalable Business Infrastructure • Patient Focused Service ​ ● Improve customer targeting and optimize our direct sales and customer support team to accelerate growth.
NeuroStar is a market leader in transcranial magnetic stimulation with expertise in the following areas: • unrivalled Clinical Results: Long-Term Relief for Depression, • widely Reimbursed • proven Formula for Practice Success • top Tier Training and Best Practices • comprehensive Direct Sales and Support Team • extensive database of real world outcomes ​ As a leading mental health provider Greenbrook’s expertise includes: • Large Network of Clinics • Offer in-office treatments for Treating Depression • Established and Growing Network of Referring Physicians • Centralized, Scalable Business Infrastructure • Patient Focused Service ​ ● Improve customer targeting and optimize our direct sales and customer support team to accelerate growth.
The system is cleared by the United States Food and Drug Administration (the “FDA”) to treat adult patients with major depressive disorder (“MDD”) who have failed to achieve satisfactory improvement from at least one prior antidepressant medication in the current MDD episode.
The system is cleared by the United States (“U.S.”) Food and Drug Administration (the “FDA”) to treat adult patients with major depressive disorder (“MDD”) who have failed to achieve satisfactory improvement from prior antidepressant medication in the current MDD episode.
We have had difficulty processing claims. ​ 22 Table of Contents ● We may be subject to fines, penalties, and other sanctions if we fail to comply with laws governing our business.
We have had difficulty processing claims. ​ ● We may be subject to fines, penalties, and other sanctions if we fail to comply with laws governing our business.
Response and remission rates at 12 months were 68% and 45% respectively as measured by CGI-S. Our growth strategy includes expanding our commercialization efforts in the United States, expanding international opportunities and pursuing pipeline development of our therapy for additional indications. Outside the United States, our products have received marketing authorizations in the European Union and Japan.
Response and remission rates at 12 months were 68% and 45% respectively as measured by Clinical Global Impression-Severity (“CGI-S”). Our growth strategy includes expanding our commercialization efforts in the United States, expanding international opportunities and pursuing pipeline development of our therapy for additional indications. Outside the United States, our products have received marketing authorizations in the European Union and Japan.
Throughout our history, we have provided material support to more than 65 investigator-initiated trials and are currently considering a number of new indications for the use of the NeuroStar Advanced Therapy System related to neurohealth disorders.
Research and Development We invest in research and development for the use of the NeuroStar Advanced Therapy System in neurohealth disorders. Throughout our history, we have provided material support to more than 104 investigator-initiated trials and are currently considering a number of new indications for the use of the NeuroStar Advanced Therapy System related to neurohealth disorders.
We intend to make further investments in marketing resources, such as our marketing portal, which consists of customizable practice development and advertising materials, and digital patient outreach tools all of which are designed to drive patient awareness and help identify 6 Table of Contents patients who can benefit from NeuroStar TMS within an existing practice and in the local community.
We intend to continue to optimize marketing resources, such as our marketing portal, which consists of customizable practice development and advertising materials, and digital patient outreach tools, all of which are designed to drive patient awareness and help identify patients who can benefit from NeuroStar TMS within an existing practice and in the local community.
Our patents and patent applications mainly relate to iron core technology, including materials, manufacturing methods, geometries, applications, and open core technologies, TMS design patents, including coil position, motor threshold level determination, contact sensing, and articulation arm designs, patient comfort, TMS support technologies and pulse monitoring, and potential next generation technologies.
Our patents and patent applications mainly relate to iron core technology, including materials, manufacturing methods, geometries, applications, and open core technologies, coil positioning, motor threshold level determination and monitoring, contact sensing, , patient comfort, TMS support technologies and pulse monitoring, and potential next generation technologies as well as design patents.
We also plan to invest further in our direct to consumer marketing programs, which is comprised of paid search, display advertising, social media, billboards, radio and public relations. ● Pursue enhancements of our NeuroStar Advanced Therapy System and pipeline development for additional indications.
We also plan to continue to optimize our direct to consumer marketing programs, which are comprised of paid search, display advertising, social media, billboards, radio and public relations. ● Pursue enhancements of our NeuroStar Advanced Therapy System and pipeline development for additional indications.
Once the practice begins treating patients, our PDMs will educate the psychiatrist on how to track clinical outcomes, interpret data and effectively convey results to existing and potential patients and referring physicians. Our 7 Table of Contents PDMs also work with our customers to increase awareness with referring physicians and develop external marketing tactics.
Once the practice begins treating patients, our PDMs will educate the provider on how to track clinical outcomes, interpret data and effectively convey results to existing and potential patients and referring providers. Our PDMs also work with our customers to increase awareness with referring providers and develop external marketing tactics.
Although there are a number of statutory exceptions and regulatory safe harbors to the federal healthcare Anti-Kickback Statute protecting certain common business arrangements and activities from prosecution or regulatory sanctions, the exceptions and safe harbors are drawn narrowly.
Although there are a number of statutory exceptions and regulatory safe harbors to the AKS protecting certain common business arrangements and activities from prosecution or regulatory sanctions, the exceptions and safe harbors are drawn narrowly.
We target approximately 53,000 psychiatrists across 26,000 psychiatric practices, We target these practices by the number of psychiatrists within their practices, the number of patients they treat and their acceptance of commercial insurance and Medicare. We believe that our psychiatrist targeting strategy makes for a well-defined customer base that is accessible by our direct sales organization.
We target these practices by the number of providers within their practices, the number of patients they treat and their acceptance of commercial insurance and Medicare. We believe that our customer targeting strategy makes for a well-defined customer base that is accessible by our direct sales organization.
For the year ended December 31, 2024, our U.S. revenues were $72.5 million, compared to $69.3 million for the year ended December 31, 2023, which represented an increase of 5% compared to the prior period.
For the year ended December 31, 2025, our U.S. revenues were $146.0 million, compared to $72.5 million for the year ended December 31, 2024, which represented an increase of 101% compared to the prior period.
Importantly, we do not provide DHS and do not bill payors for DHS (or any other items or services). While we manufacture and sell equipment and supplies to our customers, we are not a Medicare supplier.
Importantly, we do not provide DHS and do not bill payors for DHS (or any other items or services). While we manufacture and sell equipment and supplies to our customers, we are not a Medicare supplier. TMS furnished outside of a hospital typically does not constitute DHS.
As a business associate, we are also directly liable for compliance with HIPAA.
As a business associate, we are also 15 Table of Contents directly liable for compliance with HIPAA.
Item 1. Business Overview We believe that mental health is as important as physical health. As a global leader in neuroscience, we are delivering more treatment options to patients and healthcare providers by offering exceptional in-office treatments that produce extraordinary results.
Item 1. Business Overview Neuronetics, Inc. (the “Company” or “Neuronetics” or the “Registrant”) believes that mental health is as important as physical health. As a global leader in neuroscience, the Company is delivering more treatment options to patients and healthcare providers by offering exceptional in-office treatments that produce extraordinary results.
Development Developing employees contributes to growing our business. The Company has leadership development programs which bring a consistent approach to leadership development that all managers and directors are required to attend. The Company also provides learning opportunities for all employees to continue to progress their development and career at the Company.
The Company has leadership development programs which bring a consistent approach to leadership development that all managers and directors are 21 Table of Contents encouraged to attend. The Company also provides learning opportunities for all employees to continue to progress their development and career at the Company.
Our dedicated reimbursement managers help practices navigate issues regarding the reimbursement process including investigation of benefits, prior authorizations and claims documentation. This group has assisted our customers to conduct over 83,815 benefit investigations. Psychiatrists and staff training on the NeuroStar Advanced Therapy System is a key to success within each practice.
Our dedicated reimbursement managers help practices navigate issues regarding the reimbursement process including investigation of benefits, prior authorizations and claims documentation. Providers and staff training on the NeuroStar Advanced Therapy System is a key to success within each practice.
In 2025, we expect that 11 U.S. patents will expire and 14 non-U.S. patents will expire. Our worldwide intellectual property portfolio includes multiple pending patent applications relating to methods and apparatuses for the treatment of psychiatric health conditions in Australia, Canada, selected European Union countries, Japan and the United States.
Our worldwide intellectual property portfolio includes multiple pending patent applications relating to methods and apparatuses for the treatment of psychiatric health conditions in Australia, Canada, selected European Union countries, Japan and the United States.
Moreover, the government may assert that a claim for reimbursement that includes items resulting from a violation of the federal healthcare Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act (“FCA”).
Moreover, the government may assert that a claim for reimbursement that includes items resulting from a violation of the AKS constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act, 31 U.S.C. § 3729 (the “FCA”).
Some countries may not require any special registration process prior to importing and marketing the device. Whether or not we have obtained FDA approval, our NeuroStar Advanced Therapy System may be subject to different regulatory requirements in other jurisdictions. The foreign regulatory approval process includes all the risks associated with FDA regulation, as well as country-specific regulations. Other Regulations Import-export.
Some countries may not require any special registration process prior to importing and marketing the device. Whether or not we have obtained FDA approval, our NeuroStar Advanced Therapy System may be subject to different regulatory requirements in other jurisdictions.
We own trade secrets relating to our technology, and we maintain the confidentiality of proprietary information to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection.
We are currently assessing the long-term value proposition in maintaining patents outside of the United States. We own trade secrets relating to our technology, and we maintain the confidentiality of proprietary information to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection.
We rely on third parties to acquire the raw materials and provide components used in existing products and we expect to continue to do so for future products. We establish our relationships with our third-party manufacturers and suppliers through supplier contracts and purchase orders. In most cases, these supplier relationships may be terminated by either party upon short notice.
We rely on third parties to acquire the raw materials and provide components used in existing products and we expect to continue to do so for future products. 10 Table of Contents We establish our relationships with our third-party manufacturers and suppliers through supplier contracts and purchase orders.
During 2025, we intend to integrate the Neuronetics and Greenbrook benefit plans. Corporate Information We were incorporated in Delaware in April of 2003. Our principal executive offices are located at 3222 Phoenixville Pike, Malvern, Pennsylvania 19355, and our telephone number is (610) 640-4202. Our website address is https://neurostar.com/neuronetics/ .
During 2025, we integrated the US Neuronetics and Greenbrook health benefit plans for equal coverage and company contributions. Corporate Information We were incorporated in Delaware in April of 2003. Our principal executive offices are located at 3222 Phoenixville Pike, Malvern, Pennsylvania 19355, and our telephone number is (877) 600-7555. Our website address is https://neurostar.com/neuronetics/ .
These risks include, among others: ● We have incurred losses in the past and may be unable to achieve or sustain profitability in the future. ● If insurance coverage is unavailable or reimbursement from third-party payors for treatments using our products significantly declines, psychiatrists may be reluctant to use our products and our revenues, earnings and cash flows at our Treatment Centers would be substantially reduced. ● Our revenue has been concentrated among a small number of customers, and if we lose any of these customers and fail to replace them, or if any of these customers fail to perform their obligations to us, our revenue may decrease substantially. ● Our success depends upon patient satisfaction with the effectiveness of our NeuroStar Advanced Therapy System. ● We operate in a very competitive environment and if we are unable to compete successfully against our existing or potential competitors, our sales and operating results may be negatively affected. ● The loss of certain members of our senior management or our inability to attract and retain highly skilled executives, salespeople, product development, clinicians in our Treatment Centers and other personnel could negatively impact our business. ● We rely on single-source suppliers for some components used in our NeuroStar Advanced Therapy System and on a single manufacturer for the assembly of our NeuroStar Advanced Therapy System, and we may be unable to find replacements or immediately transition to alternative parties for these components. ● We rely on a network of third-party distributors to market and distribute our products internationally, and if we are unable to maintain and expand this network, we may be unable to generate anticipated sales. 21 Table of Contents ● If we are not able to obtain and enforce patent protection for our technologies, products, or product candidates, development and commercialization of our products and product candidates may be adversely affected. ● Our products and operations are subject to extensive government regulation and oversight both in the United States and abroad, and our failure to comply with applicable requirements could harm our business.
These risks include, among others: ● We have incurred losses in the past and may be unable to achieve or sustain profitability in the future. ● If insurance coverage is unavailable or reimbursement from third-party payors for treatments using our products and services significantly declines, providers may be reluctant to use our products and services and our revenues, earnings and cash flows at our Treatment Centers would be substantially reduced. ● Our success depends upon patient satisfaction with the effectiveness of our NeuroStar Advanced Therapy System. ● We operate in a very competitive environment and if we are unable to compete successfully against our existing or potential competitors, our sales and operating results may be negatively affected. 22 Table of Contents ● The loss of certain members of our senior management or our inability to attract and retain highly skilled executives, salespeople, product development, clinicians in our Treatment Centers and other personnel could negatively impact our business. ● We rely on single-source suppliers for some components used in our NeuroStar Advanced Therapy System and on a single manufacturer for the assembly of our NeuroStar Advanced Therapy System, and we may be unable to find replacements or immediately transition to alternative parties for these components. ● We rely on a network of third-party distributors to market and distribute our products internationally, and if we are unable to maintain and expand this network, we may be unable to generate anticipated sales. ● We are subject to certain federal, state and foreign fraud and abuse laws, health information privacy and security laws and transparency laws, which, if violated, could subject us to substantial penalties.
We derive the majority of our revenues from recurring treatment sessions. For the year ended December 31, 2024, we generated revenues of $74.9 million and had a net loss of $43.7 million. Our revenues increased 5% during the year ended December 31, 2024 compared to the year ended December 31, 2023.
We derive the majority of our revenues from clinic and recurring treatment sessions. For the year ended December 31, 2025, we generated revenues of $149.2 million and had a net loss of $39.1 million. Our revenues increased 99% during the year ended December 31, 2025 compared to the year ended December 31, 2024.
We believe we are the market leader in TMS therapy based on the estimated 195,356 global patients treated with over 7.1 million of our treatment sessions through December 31, 2024. We generated revenues of $74.9 million for the year ended December 31, 2024.
We believe we are the market leader in TMS therapy based on the estimated 237,574 global patients treated with over 8.5 million of our treatment sessions through December 31, 2025. We generated revenues of $149.2 million for the year ended December 31, 2025.
Clinical trials for significant risk devices generally require submission of an application for an Investigational Device Exemption (“IDE”) to the FDA. The IDE application must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test the device in humans and that the investigational protocol is scientifically sound.
The IDE application must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test the device in humans and that the investigational protocol is scientifically sound.
Revenues from treatment sessions represented 70% of our U.S. revenues for the year ended December 31, 2024 compared to 73% of our U.S. revenues for the prior year.
Clinic revenues represented 59% of our U.S. revenues for the year ended December 31, 2025 compared to 6% of our U.S. revenues in the prior year. Revenue from treatment sessions represented 30% of our U.S. revenues for the year ended December 31, 2025, compared to 70% in the prior year.
The MHLW is also responsible for creating policies, regulations, guidance documents, and laws, and governs safe use of medical products as well as for social insurance, reimbursement policies, and pricing. 18 Table of Contents After a device is approved for importation and commercial sale in Japan, the MHLW continues to monitor sales of approved products for compliance with labeling regulations, which prohibit promotion of devices for unapproved uses, and reporting regulations, which require reporting of product malfunctions, including serious injury or death caused by any approved device.
After a device is approved for importation and commercial sale in Japan, the MHLW continues to monitor sales of approved products for compliance with labeling regulations, which prohibit promotion of devices for unapproved uses, and reporting regulations, which require reporting of product malfunctions, including serious injury or death caused by any approved device.
Each Greenbrook Share issued and outstanding immediately prior to the effective time of the Arrangement was exchanged for 0.01149 of a share of common stock of Neuronetics (the “Exchange Ratio”) upon closing of the Arrangement.
The results of operations and financial position of Greenbrook are included in the Company’s consolidated financial statements from the date of acquisition. Each Greenbrook Share issued and outstanding immediately prior to the effective time of the Arrangement was exchanged for 0.01149 of a share of common stock of Neuronetics (the “Exchange Ratio”) upon closing of the Arrangement.
In the United States, as of December 31, 2024, we owned or licensed 33 issued or 8 Table of Contents allowed patents and 10 pending patent applications that are directed to our TMS technology.
In the United States, as of December 31, 2025, we owned or licensed 26 issued or allowed patents and 8 pending patent applications that are directed to our TMS technology. Outside the United States, as of December 31, 2025, we owned or licensed 36 issued or allowed patents, 8 pending patent applications and one pending Patent Cooperation Treaty application.
As a result, based on our expected revenues for a standard course of treatment, we believe our total annual addressable market opportunity for treatment sessions in the United States is approximately $8.9 billion. We intend to continue to expand our team of business development managers that are responsible for driving new customer acquisitions.
As a result, based on our expected revenues for a standard course of treatment, we believe our total annual addressable market opportunity for treatment sessions in the United States is approximately $8.9 billion.
Field Support—United States Our field service engineers are responsible for maintenance, repairs and installation. We provide a support hotline to respond to inquiries and technical questions that arise in all time zones. International We market our products in a few select markets outside the United States through independent distributors.
We provide a support hotline to respond to inquiries and technical questions that arise in all time zones. International We market our products in a few select markets outside the United States through independent distributors. In Japan, we have an exclusive distribution agreement for the commercialization of our products.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIn this event, failure to comply could lead to adverse judicial or administrative action against the Company and/or the Company’s healthcare provider practices, overpayment demands, civil or criminal penalties, receipt of cease and desist orders from state regulators, loss of provider licenses, and/or the need to make changes to the terms of engagement of the Company’s healthcare provider practices that interfere with the Company’s business, each of which could have a material adverse impact on the Company’s business, results of operations and financial condition. ● The federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), or the Anti-Kickback Statute, is a criminal statute that prohibits healthcare providers and others from directly or indirectly soliciting, receiving, offering or paying any remuneration, in cash or in kind, as an inducement or reward for using, referring, ordering, recommending or arranging for referrals or orders of services or other items paid in whole or in part by a government healthcare program.
Biggest changeThe Company’s inability to find a suitable replacement for this relationship could have a material adverse effect on the Company’s business, results of operations and financial condition. ● The AKS is a criminal statute that prohibits healthcare providers and others from directly or indirectly soliciting, receiving, offering or paying any remuneration, in cash or in kind, as an inducement or reward for using, referring, ordering, recommending or arranging for referrals or orders of services or other items paid in whole or in part by a government healthcare program.
We also compete with our competitors in acquiring technologies and technology licenses complementary to our products or advantageous to our business. In addition, we compete with our competitors to engage the services of independent distributors outside the United States, both those presently working with us and those with whom we hope to work as we expand.
We also compete with our competitors in acquiring technologies and technology licenses complementary to our products and services or advantageous to our business. In addition, we compete with our competitors to engage the services of independent distributors outside the United States, both those presently working with us and those with whom we hope to work as we expand.
Our business prospects depend in part on our ability to develop and commercialize new products, services and applications for our technology, including in new markets that develop as a result of technological, pharmaceutical and scientific advances, while improving the performance and cost-effectiveness of our products.
Our business prospects depend in part on our ability to develop and commercialize new products, services and applications for our technology, including in new markets that develop as a result of technological, pharmaceutical and scientific advances, while improving the performance and cost-effectiveness of our products and services.
Medicare and Medicaid reimbursement rules impose extensive requirements upon healthcare providers that furnish services to Medicare and/or Medicaid beneficiaries, including our healthcare provider practices. Moreover, additional laws and regulations potentially affecting healthcare providers participating in the Medicare and Medicaid programs continue to be promulgated that may impact us in the future.
Medicare and Medicaid reimbursement rules impose extensive requirements upon healthcare providers that furnish services to Medicare or Medicaid beneficiaries, including our healthcare provider practices. Moreover, additional laws and regulations potentially affecting healthcare providers participating in the Medicare and Medicaid programs continue to be promulgated that may impact us in the future.
Certain insurance companies only provide reimbursement for SPRAVATO under what is referred to as the Buy & Bill model, as opposed to the Administer & Observe model. Under the Administer & Observe model, SPRAVATO is acquired under the patient’s pharmacy benefit without cost to us, and we receive payment for administering the drug and observing the patient.
Certain insurance companies provide reimbursement for SPRAVATO only under what is referred to as the Buy & Bill model, as opposed to the Administer & Observe model. Under the Administer & Observe model, SPRAVATO is acquired under the patient’s pharmacy benefit without cost to us, and we receive payment for administering the drug and observing the patient.
The imposition of additional requirements related to the provision of TMS and/or esketamine nasal spray therapy by commercial insurance plans, Medicare and other non-Medicare government insurance plans that increase the cost or complexity of furnishing these therapies to patients may result in increased costs.
The imposition of additional requirements related to the provision of TMS or esketamine nasal spray therapy by commercial insurance plans, Medicare and other non-Medicare government insurance plans that increase the cost or complexity of furnishing these therapies to patients may result in increased costs.
The United States faces a shortage of psychiatrists and the number of licensed psychiatrists is shrinking. The lack of available properly licensed medical professionals could limit our growth opportunities and negatively impact our financial results. These issues also affect other NeuroStar providers and may affect our ability to sell NeuroStar devices and/or Treatment Sessions.
The United States faces a shortage of psychiatrists and the number of licensed psychiatrists is shrinking. The lack of available properly licensed medical professionals could limit our growth opportunities and negatively impact our financial results. These issues also affect other NeuroStar providers and may affect our ability to sell NeuroStar devices or treatment sessions.
Though these license agreements may provide guidelines for how our trademarks and trade names may be used, a breach of these agreements or misuse of our trademarks and tradenames by our licensees may jeopardize our rights in or diminish the goodwill associated with our trademarks and trade names.
Though these license agreements provide guidelines for how our trademarks and trade names may be used, a breach of these agreements or misuse of our trademarks and tradenames by our licensees may jeopardize our rights in or diminish the goodwill associated with our trademarks and trade names.
While the Company believes that the Company, including via its contractual relationships with supported physician groups, is in substantial compliance with state laws prohibiting the corporate practice of medicine and fee-splitting, other parties may assert that, despite the way the Company will be structured, the Company could be engaged in the corporate practice of medicine and/or unlawful fee-splitting.
While the Company believes that the Company, including via its contractual relationships with supported physician groups, is in substantial compliance with state laws prohibiting the corporate practice of medicine and fee-splitting, other parties may assert that, despite the way the Company will be structured, the Company could be engaged in the corporate practice of medicine or unlawful fee-splitting.
A violation of the Stark Law, including schemes to circumvent the Stark Law, may result in a denial of Medicare or Medicaid payment, required refunds to the Medicare or Medicaid programs and/or the imposition of civil monetary penalties for each claim knowingly submitted in violation of the Stark Law.
A violation of the Stark Law, including schemes to circumvent the Stark Law, may result in a denial of Medicare or Medicaid payment, required refunds to the Medicare or Medicaid programs and the imposition of civil monetary penalties for each claim knowingly submitted in violation of the Stark Law.
On February 10, 2025, the Company issued and sold 9,200,000 shares of the its common stock at a price to the public of $2.25 per share which represented a significant discount to the closing price of our common stock on February 7, 2025.
On February 10, 2025, the Company issued and sold 9,200,000 shares of its common stock at a price to the public of $2.25 per share which represented a significant discount to the closing price of our common stock on February 7, 2025.
Collaborations are subject to numerous risks, which may include that: ● collaborators have significant discretion in determining the efforts and resources that they will apply to collaborations; ● collaborators may not pursue development and commercialization of our products or may elect not to continue or renew development or commercialization programs based on trial or test results, changes in their strategic focus due to the acquisition of competitive products, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities; ● collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates; ● a collaborator with marketing, manufacturing and distribution rights to one or more products may not commit sufficient resources to or otherwise not perform satisfactorily in carrying out these activities; ● we could grant exclusive rights to our collaborators that would prevent us from collaborating with others; ● collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability; ● disputes may arise between us and a collaborator that causes the delay or termination of the research, development or commercialization of our current or future products or that results in costly litigation or arbitration that diverts management attention and resources; ● collaborations may be terminated, and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable current or future products; ● collaborators may own or co-own intellectual property covering our products that results from our collaborating with them, and in such cases, we would not have the exclusive right to develop or commercialize such intellectual property; and 53 Table of Contents ● a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings.
Collaborations are subject to numerous risks, which may include that: ● collaborators have significant discretion in determining the efforts and resources that they will apply to collaborations; ● collaborators may not pursue development and commercialization of our products or may elect not to continue or renew development or commercialization programs based on trial or test results, changes in their strategic focus due to the acquisition of competitive products, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities; ● collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates; ● a collaborator with marketing, manufacturing and distribution rights to one or more products may not commit sufficient resources to or otherwise not perform satisfactorily in carrying out these activities; ● we could grant exclusive rights to our collaborators that would prevent us from collaborating with others; ● collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability; ● disputes may arise between us and a collaborator that causes the delay or termination of the research, development or commercialization of our current or future products or that results in costly litigation or arbitration that diverts management attention and resources; ● collaborations may be terminated, and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable current or future products; ● collaborators may own or co-own intellectual property covering our products that results from our collaborating with them, and in such cases, we would not have the exclusive right to develop or commercialize such intellectual property; and 68 Table of Contents ● a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings.
If our available cash balances, potential future borrowing capacity, and anticipated cash flow from operations are insufficient to satisfy our liquidity requirements, including because of lower demand for our products as a result of the risks described in this Annual Report on Form 10-K, we may seek to sell common or preferred equity or debt securities, enter into an additional credit facility or another form of third-party funding or seek other debt financing.
If our available cash balances, potential future borrowing capacity, and anticipated cash flow from operations are insufficient to satisfy our liquidity requirements, including because of lower demand for our products and services as a result of the risks described in this Annual Report on Form 10-K, we may seek to sell common or preferred equity or debt securities, enter into an additional credit facility or another form of third-party funding or seek other debt financing.
The degree of future protection for our proprietary rights is uncertain, and we cannot ensure that: ● any of our patents, or any of our pending patent applications, if issued, or those of our licensors, will include claims having a scope sufficient to protect our products; ● any of our pending patent applications or those of our licensors may issue as patents; ● others will not or may not be able to make, use, offer to sell, or sell products that are the same as or similar to our own but that are not covered by the claims of the patents that we own or license; 46 Table of Contents ● we will be able to successfully commercialize our products on a substantial scale, if approved, before the relevant patents that we own or license expire; ● we were the first to make the inventions covered by each of the patents and pending patent applications that we own or license; ● we or our licensors were the first to file patent applications for these inventions; ● others will not develop similar or alternative technologies that do not infringe the patents we own or license; ● any of the patents we own or license will be found to ultimately be valid and enforceable; ● any patents issued to us or our licensors will provide a basis for an exclusive market for our commercially viable products or will provide us with any competitive advantages; ● a third party may not challenge the patents we own or license and, if challenged, a court would hold that such patents are valid, enforceable and infringed; ● we may develop or in-license additional proprietary technologies that are patentable; ● the patents of others will not have an adverse effect on our business; ● our competitors do not conduct research and development activities in countries where we do not have enforceable patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; ● we will develop additional proprietary technologies or products that are separately patentable; or ● our commercial activities or products will not infringe upon the patents of others.
The degree of future protection for our proprietary rights is uncertain, and we cannot ensure that: ● any of our patents, or any of our pending patent applications, if issued, or those of our licensors, will include claims having a scope sufficient to protect our products; ● any of our pending patent applications or those of our licensors may issue as patents; 61 Table of Contents ● others will not or may not be able to make, use, offer to sell, or sell products that are the same as or similar to our own but that are not covered by the claims of the patents that we own or license; ● we will be able to successfully commercialize our products on a substantial scale, if approved, before the relevant patents that we own or license expire; ● we were the first to make the inventions covered by each of the patents and pending patent applications that we own or license; ● we or our licensors were the first to file patent applications for these inventions; ● others will not develop similar or alternative technologies that do not infringe the patents we own or license; ● any of the patents we own or license will be found to ultimately be valid and enforceable; ● any patents issued to us or our licensors will provide a basis for an exclusive market for our commercially viable products or will provide us with any competitive advantages; ● a third party may not challenge the patents we own or license and, if challenged, a court would hold that such patents are valid, enforceable and infringed; ● we may develop or in-license additional proprietary technologies that are patentable; ● the patents of others will not have an adverse effect on our business; ● our competitors do not conduct research and development activities in countries where we do not have enforceable patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; ● we will develop additional proprietary technologies or products that are separately patentable; or ● our commercial activities or products will not infringe upon the patents of others.
Additional factors that we expect may contribute to variability in our sales and gross profit over the course of the year include: ● the growth or decline of our installed system base; ● the unpredictability of future sales by our international distributors, including through our exclusive distributor in Japan; ● the demand for, and pricing of, our products and the products of our competitors; ● the timing of or failure to obtain regulatory clearances or approvals for other products, indications or treatments; or ● the costs, benefits and timing of new product introductions.
Additional factors that we expect may contribute to variability in our sales and gross profit over the course of the year include: ● the growth or decline of our installed system base; ● the unpredictability of future sales by our international distributors, including through our exclusive distributor in Japan; ● the demand for, and pricing of, our products and services and the products of our competitors; ● the timing of or failure to obtain regulatory clearances or approvals for other products, indications or treatments; or ● the costs, benefits and timing of new product introductions.
Failure to comply with applicable regulations could jeopardize our ability to sell our products and result in enforcement actions such as: warning letters; fines; injunctions; civil penalties; termination of distribution; recalls or seizures of products; delays in the introduction of products into the market; total or partial suspension of production; refusal to grant future clearances or approvals; withdrawals or suspensions of current clearances or approvals, resulting in prohibitions on sales of our products; and in the most serious cases, criminal penalties.
Failure to comply with applicable regulations could jeopardize our ability to sell our products and services and result in enforcement actions such as: warning letters; fines; injunctions; civil penalties; termination of distribution; recalls or seizures of products; delays in the introduction of products into the market; total or partial suspension of production; refusal to grant future clearances or approvals; withdrawals or suspensions of current clearances or approvals, resulting in prohibitions on sales of our products and services; and in the most serious cases, criminal penalties.
We are subject to the FDA’s medical device reporting regulations and similar foreign regulations, which require us to report to the FDA when we receive or become aware of information that reasonably suggests that one or more of our products may have caused or contributed to a death or serious injury or malfunctioned in a way that, if the malfunction were to recur, it could cause or contribute to a death or serious injury.
We are subject to the FDA’s medical device reporting regulations and similar foreign regulations, which require us to report to the FDA when we receive or become aware of information that reasonably suggests that one or more of our products and services may have caused or contributed to a death or serious injury or malfunctioned in a way that, if the malfunction were to recur, it could cause or contribute to a death or serious injury.
Factors that could cause volatility in the market price of our common stock include, but are not limited to: ● the actual or anticipated fluctuations in our financial condition and operating results; ● the actual or anticipated changes in our growth rate; ● the commercial success and market acceptance of our products; ● the success of our competitors in developing or commercializing products; ● media exposure of our products or of those of others in our industry; ● our ability to commercialize or obtain regulatory approvals for our products, or delays in commercializing or obtaining regulatory approvals; ● announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments; ● the addition or departure of key personnel; ● product liability claims; ● general prevailing economic, industry and market conditions, including factors unrelated to our operating performance or the operating performance of our competitors; 70 Table of Contents ● business disruptions caused by earthquakes, fires, pandemic diseases (such as from coronavirus), or other natural disasters; ● disputes or other developments concerning our intellectual property or other proprietary rights, including litigation; ● the FDA or other U.S. or foreign regulatory actions affecting us or the healthcare or medical device industry; ● healthcare reform measures in the United States; ● third-party payor developments in the United States and other countries; ● sales of our common stock by our directors, officers, or stockholders; ● the timing and amount of our investments in the growth of our business; ● inability to obtain additional funding; ● future sales or issuances of equity or debt securities by us; ● failure to meet or exceed financial estimates and projections of the investment community or that we provide to the public; and ● the issuance of new or changed securities analysts’ reports or recommendations regarding us .
Factors that could cause volatility in the market price of our common stock include, but are not limited to: ● the actual or anticipated fluctuations in our financial condition and operating results; ● the actual or anticipated changes in our growth rate; ● the commercial success and market acceptance of our products and services; ● the success of our competitors in developing or commercializing products; ● media exposure of our products and services or of those of others in our industry; ● our ability to commercialize or obtain regulatory approvals for our products and services, or delays in commercializing or obtaining regulatory approvals; ● announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments; ● the addition or departure of key personnel; ● product liability claims; ● general prevailing economic, industry and market conditions, including factors unrelated to our operating performance or the operating performance of our competitors; ● business disruptions caused by earthquakes, fires, pandemic diseases (such as from coronavirus), or other natural disasters; ● disputes or other developments concerning our intellectual property or other proprietary rights, including litigation; ● the FDA or other U.S. or foreign regulatory actions affecting us or the healthcare or medical device industry; ● healthcare reform measures in the United States; ● third-party payor developments in the United States and other countries; ● sales of our common stock by our directors, officers, or stockholders; ● the timing and amount of our investments in the growth of our business; ● inability to obtain additional funding; ● future sales or issuances of equity or debt securities by us; 72 Table of Contents ● failure to meet or exceed financial estimates and projections of the investment community or that we provide to the public; and ● the issuance of new or changed securities analysts’ reports or recommendations regarding us .
For example, certain commercial payors are increasing the levels of clinician supervision that must be provided to patients receiving TMS therapy, thereby restraining our ability to provide patient care when these increased levels of clinician supervision are not available and/or resulting in the incurrence of additional clinician compensation costs for ensuring the requisite level of supervision as a result of these increased requirements.
For example, certain commercial payors are increasing the levels of clinician supervision that must be provided to patients receiving TMS therapy, thereby restraining our ability to provide patient care when these increased levels of clinician supervision are not available or resulting in the incurrence of additional clinician compensation costs for ensuring the requisite level of supervision as a result of these increased requirements.
These provisions include: ● a prohibition on stockholder action through written consent; ● no cumulative voting in the election of directors; ● the exclusive right of our board of directors to elect a director to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director; ● a requirement that special meetings of stockholders be called only by the board of directors, the chairman of the board of directors, the chief executive officer or, in the absence of a chief executive officer, the president; 72 Table of Contents ● an advance notice requirement for stockholder proposals and nominations; ● the authority of our board of directors to issue blank-check preferred stock with such terms as our board of directors may determine; and ● a requirement of approval of not less than 66 2/3% of all outstanding shares of our capital stock entitled to vote to amend any bylaws by stockholder action, or to amend specific provisions of our amended and restated certificate of incorporation.
These provisions include: ● a prohibition on stockholder action through written consent; ● no cumulative voting in the election of directors; ● the exclusive right of our board of directors to elect a director to fill a vacancy created by the expansion of the board of directors or the resignation, death or removal of a director; ● a requirement that special meetings of stockholders be called only by the board of directors, the chairman of the board of directors, the chief executive officer or, in the absence of a chief executive officer, the president; ● an advance notice requirement for stockholder proposals and nominations; ● the authority of our board of directors to issue blank-check preferred stock with such terms as our board of directors may determine; and 74 Table of Contents ● a requirement of approval of not less than 66 2/3% of all outstanding shares of our capital stock entitled to vote to amend any bylaws by stockholder action, or to amend specific provisions of our amended and restated certificate of incorporation.
We expect to continue to incur significant integration, sales and marketing, product development, regulatory and other expenses as we continue to expand our marketing efforts to increase adoption of our products and expand existing relationships with our customers, to obtain regulatory clearances or approvals for our products in additional countries and for additional indications, integrate the Greenbrook business, and to develop new products or add new features to our existing products.
We expect to continue to incur significant integration, sales and marketing, product development, regulatory and other expenses as we continue to expand our marketing efforts to increase adoption of our products and services and expand existing relationships with our customers, to obtain regulatory clearances or approvals for our products in additional countries and for additional indications, integrate the Greenbrook business, and to develop new products or add new features to our existing products.
If we are unable to expand our sales and marketing capabilities domestically and internationally, we may be unable to effectively commercialize our products. The loss of any member of our senior management or our inability to attract and retain highly skilled executives, salespeople, product development and other personnel could negatively impact our business.
If we are unable to expand our sales and marketing capabilities domestically and internationally, we may be unable to effectively commercialize our products and services. The loss of any member of our senior management or our inability to attract and retain highly skilled executives, salespeople, product development and other personnel could negatively impact our business.
However, our customers may not select appropriate patient candidates for NeuroStar Advanced Therapy System treatment, which may produce results that may not meet patients’ expectations. In addition, the efficacy of treatment is dependent on proper patient set up at the initial treatment session and duplication of that set up at future treatment sessions.
However, our customers and Treatment Centers may not select appropriate patient candidates for NeuroStar Advanced Therapy System treatment, which may produce results that may not meet patients’ expectations. In addition, the efficacy of treatment is dependent on proper patient set up at the initial treatment session and duplication of that set up at future treatment sessions.
In order to sell our products in member countries of the European Economic Area, or (EEA) or in countries that also rely on the CE Mark outside the EEA, our products must comply with the essential requirements of the EU Medical Devices Directive (Council Directive 93/42/EEC), and with the Medical Device Regulation (Regulation 2017/745).
In order to sell our products in member countries of the European Economic Area (the “EEA”) or in countries that also rely on the CE Mark outside the EEA, our products must comply with the essential requirements of the EU Medical Devices Directive (Council Directive 93/42/EEC), and with the Medical Device Regulation (Regulation 2017/745).
We train our customers to select the appropriate patient candidates for treatment using the NeuroStar Advanced Therapy System, explain to their patients the time-period over which the results from a treatment course can be expected to occur, and measure the success of treatments using medical guidelines.
We train our customers and our Treatment Centers to select the appropriate patient candidates for treatment using the NeuroStar Advanced Therapy System, explain to their patients the time-period over which the results from a treatment course can be expected to occur, and measure the success of treatments using medical guidelines.
Our clinical trials are managed by our own staff and personnel, but we rely in part upon certain third parties, including clinical trial sites, medical institutions, clinical research organizations, (“CROs”), and private practices, for, among other things, site monitoring, statistical work and electronic data capture in our clinical trials.
Our clinical trials are managed by our own staff and personnel, but we rely in part upon certain third parties, including clinical trial sites, medical institutions, clinical research organizations, and private practices, for, among other things, site monitoring, statistical work and electronic data capture in our clinical trials.
Our business practices and relationships with providers, patients and third-party payors are subject to scrutiny under these laws. We may also be subject to patient information privacy and security regulation by both the federal government in addition to the states and foreign jurisdictions in which we conduct our business.
Our business practices and relationships with providers, patients, vendors and third-party payors are subject to scrutiny under these laws. We may also be subject to patient information privacy and security regulation by both the federal government in addition to the states and foreign jurisdictions in which we conduct our business.
These factors could also reduce the number of procedures performed using our NeuroStar Advanced Therapy System, and if we do not facilitate the utilization of our products by our customers, our revenues and results of operations could be harmed. Our success depends upon patient satisfaction with the effectiveness of our NeuroStar Advanced Therapy System.
These factors could also reduce the number of procedures performed using our NeuroStar Advanced Therapy System, and if we do not facilitate the utilization of our products and services by our customers, our revenues and results of operations could be harmed. Our success depends upon patient satisfaction with the effectiveness of our NeuroStar Advanced Therapy System.
Foreign Corrupt Practices Act of 1977, (the “FCPA”), and anti-money laundering laws; ● differing regulatory requirements for obtaining clearances or approvals to market our products; ● changes in, or uncertainties relating to, foreign rules and regulations that may impact our ability to sell our products, perform services or repatriate profits to the United States; ● tariffs and trade barriers, export regulations, sanctions and other regulatory and contractual limitations on our ability to sell our products in certain foreign markets; ● potential adverse tax consequences, including imposition of limitations on or increases of withholding and other taxes on remittances and other payments by foreign subsidiaries or joint ventures; ● imposition of differing labor laws and standards; ● armed conflicts or economic, political, health (including pandemic diseases) or social instability in foreign countries and regions; ● fluctuations in foreign currency exchange rates; ● an inability, or reduced ability, to protect our intellectual property, including any effect of compulsory licensing imposed by government action; ● availability of government subsidies or other incentives that benefit competitors in their local markets that are not available to us; and ● conducting post-market surveillance on product performance.
Foreign Corrupt Practices Act of 1977, (the “FCPA”), and anti-money laundering laws; ● differing regulatory requirements for obtaining clearances or approvals to market our products; ● changes in, or uncertainties relating to, foreign rules and regulations that may impact our ability to sell our products, perform services or repatriate profits to the United States; ● tariffs and trade barriers, export regulations, sanctions and other regulatory and contractual limitations on our ability to sell our products in certain foreign markets; ● potential adverse tax consequences, including imposition of limitations on or increases of withholding and other taxes on remittances and other payments by foreign subsidiaries or joint ventures; 33 Table of Contents ● imposition of differing labor laws and standards; ● armed conflicts or economic, political, health (including pandemic diseases) or social instability in foreign countries and regions; ● fluctuations in foreign currency exchange rates; ● an inability, or reduced ability, to protect our intellectual property, including any effect of compulsory licensing imposed by government action; ● availability of government subsidies or other incentives that benefit competitors in their local markets that are not available to us; and ● conducting post-market surveillance on product performance.
If our employees or our independent distributors fail to adequately promote, market and sell our products, our sales could significantly decrease. If we launch new products, expand our product offerings to new indications or increase our marketing efforts with respect to existing products, we will need to expand the reach of our marketing and sales networks.
If our employees or our independent distributors fail to adequately promote, market and sell our products and services, our sales could significantly decrease. If we launch new products, expand our product offerings to new indications or increase our marketing efforts with respect to existing products, we will need to expand the reach of our marketing and sales networks.
Our currently marketed products are, and any future products we develop and commercialize will be, subject to intense competition. The industry in which we operate is subject to rapid change and is highly sensitive to the introduction of new products or other market activities of current or new industry participants.
Our currently marketed products and services are, and any future products and services we develop and commercialize will be, subject to intense competition. The industry in which we operate is subject to rapid change and is highly sensitive to the introduction of new products and services or other market activities of current or new industry participants.
Our products may cause or contribute to adverse medical events that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations.
Our products and services may cause or contribute to adverse medical events that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations.
Perceptive could declare a default upon the occurrence of any event that it interprets as a material adverse effect as defined under the credit facility, thereby requiring us to repay the loan immediately or to attempt to reverse the declaration of default through negotiation or litigation.
Perceptive could declare a default upon the occurrence of any event that it interprets as a material adverse effect as defined under the Perceptive facility, thereby requiring us to repay the loan immediately or to attempt to reverse the declaration of default through negotiation or litigation.
At any time, these and other potential market entrants may develop treatment alternatives that may render our products uncompetitive. In addition, our competitors may have more established distribution networks than we do, or may be acquired by enterprises that have more established distribution networks than we do.
At any time, these and other potential market entrants may develop treatment alternatives that may render our products and services uncompetitive. In addition, our competitors may have more established distribution networks than we do, or may be acquired by enterprises that have more established distribution networks than we do.
Our products and operations are subject to extensive government regulation and oversight both in the United States and abroad, and our failure to comply with applicable requirements could harm our business. We and our products are subject to extensive regulation in the United States and elsewhere, including by the FDA, FTC, and their foreign counterparts.
Our products and services and operations are subject to extensive government regulation and oversight both in the United States and abroad, and our failure to comply with applicable requirements could harm our business. We and our products and services are subject to extensive regulation in the United States and elsewhere, including by the FDA, FTC, and their foreign counterparts.
If we are not successful in convincing others of the merits of our products, including in comparison to those of our competitors, or educating them on the use of our products, they may not use our products or use them effectively and we may be unable to increase our sales.
If we are not successful in convincing others of the merits of our products and services, including in comparison to those of our competitors, or educating them on the use of our products and services, they may not use our products and services or use them effectively and we may be unable to increase our sales.
Our success depends on the skills, experience and performance of the members of our senior management team. The individual and collective efforts of these employees will be important as we continue to develop our products and as we expand our commercial activities.
Our success depends on the skills, experience and performance of the members of our senior management team. The individual and collective efforts of these employees will be important as we continue to develop our products and services and as we expand our commercial activities.
We may not receive the necessary regulatory clearances or approvals to market our future products or other proposed indications for our products in the future, and failure to timely obtain necessary clearances or approvals for such future products or indications would adversely affect our ability to grow our business.
We may not receive the necessary regulatory clearances or approvals to market our future products or other proposed indications for our products and services in the future, and failure to timely obtain necessary clearances or approvals for such future products or indications would adversely affect our ability to grow our business.
If our facilities or those of our manufacturers or suppliers are found to be in violation of applicable laws and regulations, or if we or 61 Table of Contents our manufacturers or suppliers fail to take satisfactory corrective action in response to an adverse inspection, the regulatory authority could take enforcement action, including any of the following sanctions: untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties; customer notifications or repair, replacement, refunds, recalls, detention or seizure of our products; operating restrictions or partial suspension or total shutdown of production; refusing or delaying requests for 510(k) marketing clearance or PMA of new products or modified products; withdrawing 510(k) marketing clearances or PMAs that have already been granted; refusing to provide Certificates for Foreign Government; refusing to grant export approval for our products; or pursuing criminal prosecution.
If our facilities or those of our manufacturers or suppliers are found to be in violation of applicable laws and regulations, or if we or our manufacturers or suppliers fail to take satisfactory corrective action in response to an adverse inspection, the regulatory authority could take enforcement action, including any of the following sanctions: untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties; customer notifications or repair, replacement, refunds, recalls, detention or seizure of our products; operating restrictions or partial suspension or total shutdown of production; refusing or delaying requests for 510(k) marketing clearance or PMA of new products or modified products; withdrawing 510(k) marketing clearances or PMAs that have already been granted; refusing to provide Certificates for Foreign Government; refusing to grant export approval for our products; or pursuing criminal prosecution.
If we are unable to adequately address our customers’ needs, it could negatively impact sales and market acceptance of our products and we may never generate sufficient revenues to achieve or sustain profitability.
If we are unable to adequately address our customers’ needs, it could negatively impact sales and market acceptance of our products and services and we may never generate sufficient revenues to achieve or sustain profitability.
Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to be paid to the USPTO and various governmental patent agencies outside of the US in several stages over the lifetime of the patents and/or applications.
Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and applications will be due to be paid to the USPTO and various governmental patent agencies outside of the US in several stages over the lifetime of the patents and applications.
Technological change in our industry or novel drug treatments for MDD could reduce the demand for our services or require us to incur significant cost to incorporate new technology into our centers.
Technological change in our industry or novel drug treatments for MDD could reduce the demand for our services or require us to incur significant cost to incorporate new technology into our Treatment Centers.
The significance of the impact of a global pandemic on our operations depends on numerous evolving factors that we may not be able to accurately predict or effectively respond to, including, among others: ​ ● the effect on global economic activity, financial markets and the resulting impact on our customer’s businesses, their credit and liquidity, and their demand for our solutions and services, as well as their ability to pay; ● our ability to deliver and implement our solutions in a timely manner, including as a result of supply chain disruptions and related cost increases; and ● actions taken by U.S., foreign, state, and local governments, suppliers, and individuals in response to the outbreak (including the extent of travel restrictions and business closures). ​ If insurance coverage is unavailable or reimbursement from third-party payors for treatments using our products significantly declines, psychiatrists may be reluctant to use our products and our revenues, earnings and cash flows at our Treatment Centers would be substantially reduced.
The significance of the impact of a global pandemic on our operations depends on numerous evolving factors that we may not be able to accurately predict or effectively respond to, including, among others: ​ ● the effect on global economic activity, financial markets and the resulting impact on our customers’ businesses, their credit and liquidity, and their demand for our solutions and services, as well as their ability to pay; ● our ability to deliver and implement our solutions in a timely manner, including as a result of supply chain disruptions and related cost increases; and ● actions taken by U.S., foreign, state, and local governments, suppliers, and individuals in response to the outbreak (including the extent of travel restrictions and business closures). ​ If insurance coverage is unavailable or reimbursement from third-party payors for treatments using our products or services significantly declines, providers may be reluctant to use our products or services and our revenues, earnings and cash flows at our Treatment Centers would be substantially reduced.
Further, while we do not submit claims to any payor and our customers make the ultimate decision on how to submit claims, we may provide reimbursement guidance and support regarding our products.
Further, while we do not submit claims to any payor and our customers make the ultimate decision on how to submit claims, we may provide reimbursement guidance and support regarding our products and services.
Our products must be manufactured in accordance with federal and state regulations, and we could be forced to recall our installed systems or terminate production if we fail to comply with these regulations.
Our products and services must be manufactured in accordance with federal and state regulations, and we could be forced to recall our installed systems or terminate production if we fail to comply with these regulations.
These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.
These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs, referral and other business arrangements.
In the first quarter, our results can be impacted by the resetting of annual U.S. patient healthcare insurance plan deductibles, which may cause delays in patients seeking NeuroStar Advanced Therapy System treatments. Historically, we have seen a sequential decline in third quarter revenues, which we believe is attributable to summer vacation plans of psychiatrists and patients.
In the first quarter, our results can be impacted by the resetting of annual U.S. patient healthcare insurance plan deductibles, which may cause delays in patients seeking NeuroStar Advanced Therapy System treatments. Historically, we have seen a sequential decline in third quarter revenues, which we believe is attributable to summer vacation plans of providers and patients.
In such an event, competitors might be able to enter the market earlier than would otherwise have been the case. 52 Table of Contents If we fail to comply with our obligations under license or technology agreements with third parties, we may be required to pay damages and we could lose license rights that are critical to our business.
In such an event, competitors might be able to enter the market earlier than would otherwise have been the case. 67 Table of Contents If we fail to comply with our obligations under license or technology agreements with third parties, we may be required to pay damages and we could lose license rights that are critical to our business.
While we currently qualify as a smaller reporting company under SEC regulations, we cannot be certain whether taking advantage of the reduced disclosure requirements applicable to these companies will not make our common stock less attractive to investors. Once we lose smaller reporting company status, the costs and demands placed upon our management are expected to increase.
While we currently qualify as a smaller reporting company (“SRC”) under SEC regulations, we cannot be certain whether taking advantage of the reduced disclosure requirements applicable to these companies will not make our common stock less attractive to investors. Once we lose SRC status, the costs and demands placed upon our management are expected to increase.
These risks include our ability to: ● manage rapidly changing and expanding operations; ● increase awareness of our brand and strengthen customer loyalty; ● successfully execute our business and marketing strategy; ● respond effectively to competitive pressures and developments; ● continue to develop and enhance our products and products in development; ● obtain regulatory clearance or approval to commercialize new products and enhance our existing products; ● refrain from infringing on the intellectual property rights of others, and maintaining appropriate legal policies and procedures; 27 Table of Contents ● expand our presence in existing and commence operations in new international markets; and ● attract, retain and motivate qualified personnel.
These risks include our ability to: ● manage rapidly changing and expanding operations; ● increase awareness of our brand and strengthen customer loyalty; ● successfully execute our business and marketing strategy; ● respond effectively to competitive pressures and developments; ● continue to develop and enhance our products and services and products and services in development; ● obtain regulatory clearance or approval to commercialize new products and enhance our existing products; 28 Table of Contents ● refrain from infringing on the intellectual property rights of others, and maintaining appropriate legal policies and procedures; ● expand our presence in existing and commence operations in new international markets; and ● attract, retain and motivate qualified personnel.
Although various extensions may be available, the life of a patent, and the protection it affords, is limited. Even if patents covering our technologies, products, or product candidates are obtained, once the patent life has expired, we may be open to competition. Patents covering some of our core technology have expired or will expire within the next five years.
Although various extensions may be available, the life of a patent, and the protection it affords, is limited. Even if patents covering our technologies, products, or product candidates are obtained, once the patent life has expired, we may be open to competition. Patents covering some of our core technology have expired or will expire within the next four years.
These laws and regulations, among other impacts, constrain our business, marketing and other promotional activities by limiting the kinds of financial arrangements, including sales programs and provider directory services, we may have with psychiatrists, other healthcare providers, or other potential purchasers of our products. We have also entered into consulting agreements with physicians, which are subject to these laws.
These laws and regulations, among other impacts, constrain our business, marketing and other promotional activities by limiting the kinds of financial arrangements, including sales programs and provider directory services, we may have with providers or other potential purchasers of our products and services. We have also entered into consulting agreements with physicians, which are subject to these laws.
Any such determination could adversely impact our ability to operate in one or more jurisdictions. For instance as described above, we are subject to ongoing audits that have designated approximately $1.2 million in reimbursements from CMS as potentially subject to recoupment, which if adversely determined could have an adverse effect on our operations.
Any such determination could adversely impact our ability to operate in one or more jurisdictions. For instance as described above, we are subject to ongoing audits that have designated approximately $1.3 million in reimbursements from CMS as potentially subject to recoupment, which if adversely determined could have an adverse effect on our operations.
Additionally, any challenge to or investigation into our practices under these laws could cause adverse publicity and be costly to respond to, and thus could harm our business. There are numerous U.S. federal and state, as well as foreign, laws pertaining to healthcare fraud and abuse, including anti-kickback, false claims and physician transparency laws.
Additionally, any challenge to or investigation into our practices under these laws could cause adverse publicity and be costly to respond to, and thus could harm our business. There are numerous U.S. federal and state, as well as foreign, laws pertaining to healthcare fraud and abuse, including anti-kickback, self-referral, false claims and physician transparency laws.
An element of our strategy is to continue to upgrade our products, add new enhancements and features and expand clearance or approval of our current products to include new indications.
An element of our strategy is to continue to upgrade our products and services, add new enhancements and features and expand clearance or approval of our current products to include new indications.
If patients are not satisfied with the results of our NeuroStar Advanced Therapy System, our reputation and future sales will suffer. 26 Table of Contents We operate in a very competitive environment and if we are unable to compete successfully against our existing or potential competitors, our sales and operating results may be negatively affected.
If patients are not satisfied with the results of our NeuroStar Advanced Therapy System, our reputation and future sales will suffer. 27 Table of Contents We operate in a very competitive environment and if we are unable to compete successfully against our existing or potential competitors, our sales and operating results may be negatively affected.
This training process may also take longer than expected or be more complicated than the psychiatrists or their personnel are comfortable with and may therefore affect our ability to increase sales. Convincing psychiatrists to dedicate the time and energy necessary for adequate training is challenging, and we may not be successful in these efforts.
This training process may also take longer than expected or be more complicated than the providers or their personnel are comfortable with and may therefore affect our ability to increase sales. Convincing providers to dedicate the time and energy necessary for adequate training is challenging, and we may not be successful in these efforts.
Any failure of our clinicians to maintain credentials and licenses could result in delays in our ability to deliver care to patients, and therefore adversely affect our reputation and our business. Most insurance companies require that TMS be prescribed and performed by psychiatrists. Certain insurance companies also impose this requirement on the administration of SPRAVATO.
Any failure of our clinicians to maintain credentials and licenses could result in delays in our ability to deliver care to patients, and therefore adversely affect our reputation and our business. Many insurance companies require that TMS be prescribed and performed by psychiatrists. Certain insurance companies also impose this requirement on the administration of SPRAVATO.
New pharmaceutical products, technologies, techniques or other products could emerge that might offer better combinations of price and performance than our products.
New pharmaceutical products, technologies, techniques or other products could emerge that might offer better combinations of price and performance than our products and services.
It is important that we anticipate changes in technology and market demand, as well as psychiatrist practices to successfully develop, obtain clearance or approval, if required, and successfully introduce new, enhanced and competitive technologies to meet our prospective customers’ needs on a timely and cost-effective basis.
It is important that we anticipate changes in technology and market demand, as well as provider practices to successfully develop, obtain clearance or approval, if required, and successfully introduce new, enhanced and competitive technologies to meet our prospective customers’ needs on a timely and cost-effective basis.
We are also subject to payment card association operating rules, including data security and management rules, certification requirements and rules governing electronic funds transfers and if we fail to comply with these rules or requirements, or if our data security systems are breached or compromised, we may be liable for card issuing banks’ costs, subject to fines and higher transaction fees and/or lose our ability to accept credit and debit card payments from our 66 Table of Contents patients and process electronic funds transfers or facilitate other types of payments, and our business and operating results may be adversely affected.
We are also subject to payment card association operating rules, including data security and management rules, certification requirements and rules governing electronic funds transfers and if we fail to comply with these rules or requirements, or if our data security systems are breached or compromised, we may be liable for card issuing banks’ costs, subject to fines and higher transaction fees and lose our ability to accept credit and debit card payments from our patients and process electronic funds transfers or facilitate other types of payments, and our business and operating results may be adversely affected.
Additionally, if patients undergoing treatment with a NeuroStar Advanced Therapy System perceive the benefits to be inadequate or adverse events too numerous or severe compared to the relevant rates of alternative TMS therapies or pharmaceutical options, it will be difficult to demonstrate the value of our NeuroStar Advanced Therapy System to patients and psychiatrists.
Additionally, if patients undergoing treatment with a NeuroStar Advanced Therapy System perceive the benefits to be inadequate or adverse events too numerous or severe compared to the relevant rates of alternative TMS therapies or pharmaceutical options, it will be difficult to demonstrate the value of our NeuroStar Advanced Therapy System to patients and providers.
Additionally, to the extent SPRAVATO constitutes a “designated health service,” arrangements between any physician (or family member) making a referral to an entity in which the physician (or family member) maintains a financial relationship, including Company, must comply the Stark Law and state analogues, if any, in applicable jurisdictions.
Additionally, to the extent any activity involving SPRAVATO constitutes a “designated health service,” arrangements between any physician (or family member) making a referral to an entity in which the physician (or family member) maintains a financial relationship, including Company, must comply the Stark Law and state analogues, if any, in applicable jurisdictions.
One payor’s determination to provide coverage for a specific treatment does not assure that other payors will also provide coverage, and adequate reimbursement. In addition, the federal government and state legislatures have continued to implement cost containment programs, including price controls and restrictions on coverage and reimbursement.
One payor’s determination to provide coverage for a specific treatment does not ensure that other payors will also provide coverage, and adequate reimbursement. In addition, the federal government and state legislatures have continued to implement cost containment programs, including price controls and restrictions on coverage and reimbursement.
Our international business operations are subject to a variety of risks, including: ● difficulties in staffing and managing foreign and geographically dispersed operations, to the extent we establish non-U.S. operations; ● attaining reimbursement under differing and multiple payor reimbursement regimes, government payors or patient self-pay systems; ● difficulties in determining and creating the proper sales pathway in new, international markets; 31 Table of Contents ● compliance with various U.S. and international laws, including export control laws and the U.S.
Our international business operations are subject to a variety of risks, including: ● difficulties in staffing and managing foreign and geographically dispersed operations, to the extent we establish non-U.S. operations; ● attaining reimbursement under differing and multiple payor reimbursement regimes, government payors or patient self-pay systems; ● difficulties in determining and creating the proper sales pathway in new, international markets; ● compliance with various U.S. and international laws, including export control laws and the U.S.
Increases in our occupancy costs and difficulty in identifying economically suitable new Treatment Centers could have significant negative consequences, which include: ● requiring that a greater portion of our available cash be applied to pay our rental obligations, thus reducing cash available for other purposes and reducing our profitability; ● increasing our vulnerability to general adverse economic and industry conditions; and ● limiting our flexibility in planning for, or reacting to changes in, our business.
Increases in our 44 Table of Contents occupancy costs and difficulty in identifying economically suitable new Treatment Centers could have significant negative consequences, which include: ● requiring that a greater portion of our available cash be applied to pay our rental obligations, thus reducing cash available for other purposes and reducing our profitability; ● increasing our vulnerability to general adverse economic and industry conditions; and ● limiting our flexibility in planning for, or reacting to changes in, our business.
We may also consider raising additional capital in the future to expand our business, to pursue strategic investments, to take advantage of financing opportunities or for other reasons, including to: ● expand our sales and marketing efforts to increase market adoption of our products and address competitive developments; ● fund new and existing Treatment Centers; ● fund development and marketing efforts of any future products or additional features to then-current products; ● acquire, license or invest in new technologies; 68 Table of Contents ● provide for supply and inventory costs associated with plans to accommodate potential increases in demand for our products. ● acquire or invest in complementary businesses or assets; and ● finance capital expenditures and general and administrative expenses.
We may also consider raising additional capital in the future to expand our business, to pursue strategic investments, to take advantage of financing opportunities or for other reasons, including to: ● expand our sales and marketing efforts to increase market adoption of our products and services and address competitive developments; ● fund new and existing Treatment Centers; ● fund development and marketing efforts of any future products or additional features to then-current products; ● acquire, license or invest in new technologies; ● provide for supply and inventory costs associated with plans to accommodate potential increases in demand for our products and services. ● acquire or invest in complementary businesses or assets; and ● finance capital expenditures and general and administrative expenses.
Reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that a treatment is neither experimental nor investigational, safe, effective, medically reasonable and necessary (which may include provision of treatment only in the absence of certain 24 Table of Contents alternatives), appropriate for the specific patient, cost-effective, supported by peer-reviewed medical journals and/or included in clinical practice guidelines.
Reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that a treatment is neither experimental nor investigational, safe, effective, medically reasonable and necessary (which may include provision of treatment only in the absence of certain alternatives), appropriate for the specific patient, cost-effective, supported by peer-reviewed medical journals or included in clinical practice guidelines.
Clinical studies demonstrate that, in order to be effective, our products must be used for a period of four to six weeks, and require a patient to return to a psychiatrist’s office five days a week during that period in order to receive the recommended course of treatment.
Clinical studies demonstrate that, in order to be effective, our products must be used for a period of four to six weeks, and require a patient to return to a providers’s office five days a week during that period in order to receive the recommended course of treatment.
Congress are considering a number of legislative and regulatory proposals that could, if passed into law, impact the healthcare system, the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010, or collectively, the ACA, and/or the Medicare and Medicaid programs.
Congress are considering a number of legislative and regulatory proposals that could, if passed into law, impact the healthcare system, the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively, the “ACA”), or the Medicare and Medicaid programs.
Even if a third-party payor covers a particular treatment that uses our products, the resulting reimbursement rate may not be adequate to cover a provider’s cost to purchase our products or ensure such purchase is profitable for the provider.
Even if a third-party payor covers a particular treatment that uses our products, the resulting reimbursement rate may not be adequate to cover a provider’s cost to purchase our products and services or ensure such purchase is profitable for the provider.
In addition, the fourth quarter has consistently been a strong revenue quarter on a sequential basis primarily due to U.S. psychiatrists’ historical timing for capital expenditures and patients’ needs to exhaust remaining balances in flexible spending accounts.
In addition, the fourth quarter has consistently been a strong revenue quarter on a sequential basis primarily due to U.S. providers’ historical timing for capital expenditures and patients’ needs to exhaust remaining balances in flexible spending accounts.
A major earthquake, fire or other disaster, such as a major flood, seasonal storms, global pandemic (such as COVID-19), or terrorist attack affecting our facilities, or those of our third-party manufacturers or suppliers, could significantly disrupt our or their operations, and delay or prevent product shipment or installation during 36 Table of Contents the time required to repair, rebuild or replace our third-party manufacturers or suppliers’ damaged manufacturing facilities.
A major earthquake, fire or other disaster, such as a major flood, seasonal storms, global pandemic (such as COVID-19), or terrorist attack affecting our facilities, or those of our third-party manufacturers or suppliers, could significantly disrupt our or their operations, and delay or prevent product shipment or installation during the time required to repair, rebuild or replace our third-party manufacturers or suppliers’ damaged manufacturing facilities.
Therefore, coverage, reimbursement and utilization guidelines for treatments may differ significantly from payor to payor. Decisions regarding the extent of coverage and amount of reimbursement to be provided for an in-office treatment is made on a plan-by-plan basis.
Therefore, coverage, reimbursement and utilization guidelines for treatments may differ significantly from payor to payor. Decisions regarding the extent of coverage and amount of reimbursement to be provided for an in-office treatment are made on a plan-by-plan basis.
In certain instances, relators have been current or former employees of companies subject to qui tam litigations, even when these employees knew of or participated in the alleged malfeasance. ​ 58 Table of Contents In addition to the FCA, the federal government may use several criminal laws, such as the federal mail fraud, wire fraud or healthcare fraud statutes, to prosecute the submission of false or fraudulent claims for payment to the federal government.
In certain instances, relators have been current or former employees of companies subject to qui tam litigations, even when these employees knew of or participated in the alleged malfeasance. ​ In addition to the FCA, the federal government may use several criminal laws, such as the federal mail fraud, wire fraud or healthcare fraud statutes, to prosecute the submission of false or fraudulent claims for payment to the federal government.
This training process generally requires psychiatrists to review and study product materials, engage in multi-day, hands-on training sessions for up to four hours per day and participate in a multi-day observational period prior to treating patients independently.
This training process generally requires providers to review and study product materials, engage in multi-day, hands-on training sessions for up to four hours per day and participate in a multi-day observational period prior to treating patients independently.
Shares of common stock that are either subject to outstanding options, or are outstanding but subject to vesting or reserved for future issuance under our 2018 Equity Incentive Plan (the “2018 Plan”), will become 71 Table of Contents eligible for sale in the public market to the extent permitted by the provisions of various vesting schedules, Rule 144 and Rule 701 under the Securities Act.
Shares of common stock that are either subject to outstanding options, or are outstanding but subject to vesting or reserved for future issuance under our 2018 Equity Incentive Plan (the “2018 Plan”), will become eligible for sale in the public market to the extent permitted by the provisions of various vesting schedules, Rule 144 and Rule 701 under the Securities Act.
Our present and future funding requirements will depend on many other factors, including: ● our ability to achieve revenue growth and improve operating margins; ● our ability to comply with financial and other restrictive covenants in our credit facility, which, among other things, requires us to maintain specified financial covenants; ● our ability to improve or maintain coverage and reimbursement arrangements with domestic third-party and government payors; ● our rate of progress in establishing coverage and reimbursement arrangements from international commercial third-party and government payors, particularly in Japan; ● the cost of expanding our operations and offerings, including our sales and marketing efforts; ● our rate of progress in, and cost of the sales and marketing activities associated with, establishing adoption of our products and maintaining or improving our sales to our current customers; ● the cost of research and development activities, including research and development relating to additional indications; ● the effect of competing technological and market developments; ● costs related to international expansion; and ● the potential cost of and delays in product development as a result of any regulatory oversight applicable to our products.
Our present and future funding requirements will depend on many other factors, including: ● our ability to achieve revenue growth and improve operating margins; ● our ability to comply with financial and other restrictive covenants in our credit facility, which, among other things, requires us to maintain specified financial covenants; ● our ability to improve or maintain coverage and reimbursement arrangements with domestic third-party and government payors; ● our rate of progress in establishing coverage and reimbursement arrangements from international commercial third-party and government payors; ● the cost of expanding our operations and offerings, including our sales and marketing efforts; ● our rate of progress in, and cost of the sales and marketing activities associated with, establishing adoption of our products and services and maintaining or improving our sales to our current customers; ● the cost of research and development activities, including research and development relating to additional indications; 69 Table of Contents ● the effect of competing technological and market developments; ● costs related to international expansion; and ● the potential cost of and delays in product development as a result of any regulatory oversight applicable to our products and services.
In particular, sales, marketing and business arrangements in the healthcare industry, including the sale of medical devices, are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices.
In particular, sales, marketing and business arrangements in the healthcare industry, including the sale of medical devices, are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-referral and other abusive practices.
Additional factors that could complicate our ability to timely or accurately bill payors include: ● complexity of procedures, and changes in procedures, for electronic processing of insurance claims; ● the complicated nature of determining patients’ insurance benefits, securing prior authorizations from third-party payors for treating patients, properly coding and providing accurate data for us to process insurance claims; ● cumbersome nature of manual processes at payors for processing claims where electronic processing is not possible; ● pricing or reimbursement differences between our fee schedules and those of the payors; ● changes in or questions about how products are to be identified in the requisitions; ● disputes between payors as to which party is responsible for payment; ● disparity in coverage among various payors; 40 Table of Contents ● difficulties of adherence to specific compliance requirements and procedures mandated by various payors, including without limitation payor delays in reviewing provider credentialing applications; ● patients’ unwillingness or inability to pay their insurance co-pays, co-insurance and deductibles; ● failure of information systems and processes to submit and collect claims in a timely manner; ● variation in coverage for similar services among various payors; ● our reliance on third parties, whom we do not control, to provide billing services; ● the difficulty of adherence to specific compliance requirements and other procedures mandated by various payors; ● failure to obtain proper provider credentialing and documentation in order to bill various payors; and ● failure to collect patient balances due to economic conditions or other unknown reasons.
Additional factors that could complicate our ability to timely or accurately bill payors include: ● complexity of procedures, and changes in procedures, for electronic processing of insurance claims; ● the complicated nature of determining patients’ insurance benefits, securing prior authorizations from third-party payors for treating patients, properly coding and providing accurate data for us to process insurance claims; ● cumbersome nature of manual processes at payors for processing claims where electronic processing is not possible; ● pricing or reimbursement differences between our fee schedules and those of the payors; ● changes in or questions about how products are to be identified in the requisitions; ● disputes between payors as to which party is responsible for payment; ● disparity in coverage or lack of agreement for coverage among various payors; ● difficulties of adherence to specific compliance requirements and procedures mandated by various payors, including without limitation payor delays in reviewing provider credentialing applications; ● patients’ unwillingness or inability to pay their insurance co-pays, co-insurance and deductibles; ● failure of information systems and processes to submit and collect claims in a timely manner; ● variation in coverage for similar services among various payors; ● our reliance on third parties, whom we do not control, to provide billing services; 42 Table of Contents ● the difficulty of adherence to specific compliance requirements and other procedures mandated by various payors; ● failure to obtain proper provider credentialing and documentation, or otherwise reach agreements for “in-network” coverage in order to bill various payors; and ● failure to collect patient balances due to economic conditions or other unknown reasons.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe collaborate with third parties to assess the effectiveness of our cybersecurity prevention and response systems and processes through various penetration testing and best practice reviews.
Biggest changeRecurring maintenance, reporting and awareness tasks are conducted and documented within our Service Management Software and Security tools for record keeping and trending. 77 Table of Contents We collaborate with third parties to assess the effectiveness of our cybersecurity prevention and response systems and processes through various penetration testing and best practice reviews.
These reports come from the Company’s Chief Information and Operations Officer (the “Head of IT”) to include our enterprise risk profile on a quarterly basis. The Audit Committee reviews our cybersecurity risk profile with management on a periodic basis using key performance and/or risk indicators.
These reports come from the Company’s Chief Information and Operations Officer (the “Head of IT”) to include our enterprise risk profile on a quarterly basis. The Audit Committee reviews our cybersecurity risk profile with management on a periodic basis using key performance or risk indicators.
These include 75 Table of Contents cybersecurity assessors, consultants, and other external cybersecurity experts to assist in the identification, verification, and validation of cybersecurity risks, as well as to support associated mitigation plans when necessary.
These include cybersecurity assessors, consultants, and other external cybersecurity experts to assist in the identification, verification, and validation of cybersecurity risks, as well as to support associated mitigation plans when necessary.
These mitigations target implementing automated tools for detection and prevention wherever possible, supplemented by training and process controls as needed. Recurring maintenance, reporting and awareness tasks are conducted and documented within our Service Management Software and Security tools for record keeping and trending.
These mitigations target implementing automated tools for detection and prevention wherever possible, supplemented by training and process controls as needed.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeItem 2. Properties. We occupy an approximately 42,500 square foot facility in Malvern, Pennsylvania, under a lease that ends in February 2028, for our corporate headquarters, which includes office and warehouse space. We have an option to extend the lease for an additional five-year term.
Biggest changeItem 2. Properties. As of December 31, 2025 we occupied approximately 42,500 square foot facility in Malvern, Pennsylvania. During the year ended December 31, 2025 the Company executed a lease modification for this facility, extending the lease term through June 2033 for only 32,000 square feet of the premises, for our corporate headquarters, which includes office and warehouse space.
We have designated TMS NeuroHealth Centers Inc. as our agent for service of process in the United States and its address is 8401 Greensboro Drive, Suite 425, Tysons Corner, Virginia, USA, 22102. ​ For our Greenbrook locations, we do not own any real estate. Instead, we lease all of our retail Treatment Center locations.
We have designated TMS NeuroHealth Centers Inc. as our agent for service of process in the United States and its address is 8401 Greensboro Drive, Suite 425, Tysons Corner, Virginia, USA, 22102. ​ 78 Table of Contents For our Greenbrook locations, we do not own any real estate. Instead, we lease all of our retail Treatment Center locations.
The entirety of the Company’s revenue is generated through treatment delivered at the Treatment Centers. 76 Table of Contents As at December 31, 2024, our Treatment Center network consisted of 95 Treatment Center locations spanning 17 management regions in the States of Alaska, California, Connecticut, Florida, Illinois, Maryland, Massachusetts, Michigan, Missouri, North Carolina, Ohio, Oregon, South Carolina, Texas and Virginia. ​
As of December 31, 2025, our Treatment Center network consisted of 93 Treatment Center locations spanning 17 management regions in the States of Alaska, California, Connecticut, Florida, Illinois, Maryland, Massachusetts, Michigan, Missouri, North Carolina, Ohio, Oregon, South Carolina, Texas and Virginia. ​
Our existing Treatment Centers are leased from third parties, with typical lease commitments ranging from “month-to-month” to seven years.
Our existing Treatment Centers are leased from third parties, with typical lease commitments ranging from “month-to-month” to seven years. The entirety of the Company’s revenue is generated through treatment delivered at the Treatment Centers.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeManagement believes that there are currently no claims or legal actions that would reasonably be expected to have a material adverse effect on the Company’s results of operations, financial condition, or cash flows. ​ Item 4. Mine Safety Disclosures. Not applicable. ​ ​ 77 Table of Contents PART II
Biggest changeManagement believes that there are currently no claims or legal actions that would reasonably be expected to have a material adverse effect on the Company’s results of operations, financial condition, or cash flows. ​ Item 4. Mine Safety Disclosures. Not applicable. ​ ​ 79 Table of Contents PART II

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeItem 4. Mine Safety Disclosures. 77 ​ ​ PART II ​ Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. 78 Item 6 . [Reserved] 79 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations . 79 Item 7A. Quantitative and Qualitative Disclosures About Market Risk. 92 Item 8.
Biggest changeItem 4. Mine Safety Disclosures. 79 ​ ​ PART II ​ Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. 80 Item 6 . [Reserved] 81 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations . 81 Item 7A. Quantitative and Qualitative Disclosures About Market Risk. 95 Item 8.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeEquity Compensation Plans The following table details information regarding our existing equity compensation plans as of December 31, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Number of ​ ​ ​ ​ ​ ​ ​ Securities ​ ​ ​ ​ ​ ​ ​ Remaining ​ ​ ​ ​ ​ ​ ​ Available for ​ ​ Number of ​ ​ ​ ​ Future ​ ​ Securities to ​ ​ ​ ​ Issuance ​ ​ be Issued ​ Weighted ​ Under Equity ​ ​ Upon ​ Average ​ Compensation ​ ​ Exercise of ​ Exercise ​ Plans ​ ​ Outstanding ​ Price of ​ (Excluding ​ ​ Options, ​ Outstanding ​ Securities ​ ​ Warrants ​ Options, ​ reflected ​ ​ and Rights ​ Warrants ​ in Column (a) ​ ​ (in thousands) ​ and Rights ​ (in thousands) Plan Category (a) (b) (c) Equity compensation plans approved by security holders 1,237 ​ $ 3.75 ​ 4,775 Equity compensation plans not approved by security holders — ​ — (1) 445 Total 1,237 ​ $ 3.75 ​ 5,220 ​ (1) This number includes 444.8 thousand shares available for issuance under the 2020 Inducement Incentive Plan as of December 31, 2024.
Biggest changeEquity Compensation Plans The following table details information regarding our existing equity compensation plans as of December 31, 2025: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Number of ​ ​ ​ ​ ​ ​ ​ Securities ​ ​ ​ ​ ​ ​ ​ Remaining ​ ​ ​ ​ ​ ​ ​ Available for ​ ​ Number of ​ ​ ​ ​ Future ​ ​ Securities to ​ ​ ​ ​ Issuance ​ ​ be Issued ​ Weighted ​ Under Equity ​ ​ Upon ​ Average ​ Compensation ​ ​ Exercise of ​ Exercise ​ Plans ​ ​ Outstanding ​ Price of ​ (Excluding ​ ​ Options, ​ Outstanding ​ Securities ​ ​ Warrants ​ Options, ​ reflected ​ ​ and Rights ​ Warrants ​ in Column (a) ​ ​ (in thousands) ​ and Rights ​ (in thousands) Plan Category ​ ​ ​ (a) ​ ​ ​ (b) ​ ​ ​ (c) Equity compensation plans approved by security holders 1,099 ​ $ 2.89 ​ 5,595 Equity compensation plans not approved by security holders — ​ — (1) 900 Total 1,099 ​ $ 2.89 ​ 6,495 ​ (1) This number includes 277.4 thousand shares available for issuance under the 2020 Inducement Incentive Plan as of December 31, 2025.
Employee Benefit Plans” for additional information on compensation plans under which equity securities of the registrant are authorized for issuance without the approval of stockholders. ​ ​ 78 Table of Contents Issuer Purchases of Equity Securities ​ None ​ ​ ​ ​
Employee Benefit Plans” for additional information on compensation plans under which equity securities of the registrant are authorized for issuance without the approval of stockholders. ​ ​ 80 Table of Contents Issuer Purchases of Equity Securities ​ None ​ ​ ​ ​
Holders of Record As of March 18, 2025, there were approximately 56 holders of record of our common stock, solely based upon the count our transfer agent provided to us as of that date. Sales of Unregistered Securities None except as disclosed on Form 8-K.
Shares sold under the ATM Program during 2025 were sold at an average price of $3.68 per share. Holders of Record As of March 10, 2026, there were approximately 57 holders of record of our common stock, solely based upon the count our transfer agent provided to us as of that date.
Added
Sales of Unregistered Securities None except as disclosed on Form 8-K.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeResults of Operations Comparison of the Years ended December 31, 2024 and 2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Years ended December 31, ​ Increase / (Decrease) ​ ​ ​ 2024 2023 Dollars Percentage ​ ​ (in thousands, except percentages) Revenues ​ $ 74,890 ​ $ 71,348 ​ $ 3,542 5 % Cost of revenues ​ 20,729 ​ 19,643 ​ 1,086 6 % Gross Profit ​ 54,161 ​ 51,705 ​ 2,456 5 % Gross Margin ​ 72.3 % 72.5 % ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Operating expenses: ​ ​ ​ ​ Sales and marketing ​ 45,631 ​ 47,318 ​ (1,687) (4) % General and administrative ​ 30,322 ​ 25,426 ​ 4,896 19 % Research and development ​ 12,771 ​ 9,515 ​ 3,256 34 % Total operating expenses ​ 88,724 ​ 82,259 ​ 6,465 8 % Loss from Operations ​ (34,563) ​ (30,554) ​ (4,009) (13) % Other (income) expense: ​ ​ ​ ​ Interest expense ​ 7,286 ​ 5,424 ​ 1,862 34 % Loss on extinguishment of debt ​ ​ 4,427 ​ ​ — ​ ​ 4,427 — % Other income, net ​ (2,549) ​ (5,789) ​ 3,240 56 % Net Loss ​ $ (43,727) ​ $ (30,189) ​ $ (13,538) (45) % ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Revenues by Geography ​ ​ Years ended December 31, ​ ​ 2024 ​ 2023 ​ ​ ​ ​ ​ % of ​ ​ ​ ​ % of ​ ​ Amount Revenues Amount Revenues ​ ​ (in thousands, except percentages) United States ​ $ 72,488 ​ 97 % $ 69,336 ​ 97 % International ​ 2,402 3 % 2,012 3 % Total revenues ​ $ 74,890 100 % $ 71,348 100 % ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ U.S.
Biggest changeResults of Operations Comparison of the Years ended December 31, 2025 and 2024 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Years ended December 31, ​ Increase / (Decrease) ​ ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ Dollars ​ ​ ​ Percentage ​ ​ (in thousands, except percentages) Revenues ​ $ 149,157 ​ $ 74,890 ​ $ 74,267 99 % Cost of revenues ​ 76,849 ​ 20,729 ​ 56,120 271 % Gross Profit ​ 72,308 ​ 54,161 ​ 18,147 34 % Gross Margin ​ 48.5 % 72.3 % ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Operating expenses: ​ ​ ​ ​ ​ ​ ​ ​ Sales and marketing ​ 47,458 ​ 45,631 ​ 1,827 4 % General and administrative ​ 49,702 ​ 30,322 ​ 19,380 64 % Research and development ​ 6,584 ​ 12,771 ​ (6,187) (48) % Total operating expenses ​ 103,744 ​ 88,724 ​ 15,020 17 % Loss from Operations ​ (31,436) ​ (34,563) ​ 3,127 9 % Other (income) expense: ​ ​ ​ ​ ​ ​ ​ ​ Interest expense ​ 8,415 ​ 7,286 ​ 1,129 15 % Loss on extinguishment of debt ​ ​ — ​ ​ 4,427 ​ ​ (4,427) (100) % Other income, net ​ (716) ​ (2,549) ​ 1,833 72 % Net Loss ​ $ (39,135) ​ $ (43,727) ​ $ 4,592 11 % ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Revenues by Geography ​ ​ Years ended December 31, ​ ​ 2025 ​ 2024 ​ ​ ​ ​ ​ % of ​ ​ ​ ​ % of ​ ​ Amount ​ ​ ​ Revenues ​ ​ ​ Amount ​ ​ ​ Revenues ​ ​ (in thousands, except percentages) United States ​ $ 146,048 ​ 98 % $ 72,488 ​ 97 % International ​ 3,109 2 % 2,402 3 % Total revenues ​ $ 149,157 100 % $ 74,890 100 % ​ ​ 85 Table of Contents ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ U.S.
If we are unable to maintain our current financing or obtain adequate additional financing when we require it, or if we obtain financing on terms which are not favorable to us, or if we expend capital on products or technologies that are unsuccessful, our ability to continue to support our business growth and to respond to business challenges could be significantly limited, or we may be required to delay the development, commercialization and marketing of our products.
If we are unable to maintain our current financing or obtain adequate additional financing when we require it, or if we obtain financing on terms which are not favorable to us, or if we expend capital on products or technologies that are unsuccessful, our ability to continue to support our business growth and to respond to business challenges could be significantly limited, or we may be required to delay the development, commercialization and marketing of our products and services.
We primarily earn revenues from the sale of NeuroStar Advanced Therapy Systems, consumable use treatment sessions, and accessory products. A contract’s transaction price is allocated to each performance obligation and recognized as revenue when, or as, the performance obligation is satisfied, which generally is the point in time when the product is shipped or control is transferred.
We primarily earn revenues from clinic revenue, the sale of NeuroStar Advanced Therapy Systems, consumable use treatment sessions, and accessory products. A contract’s transaction price is allocated to each performance obligation and recognized as revenue when, or as, the performance obligation is satisfied, which generally is the point in time when the product is shipped or control is transferred.
Our current and future funding requirements will depend on many factors, including: ● our ability to achieve revenue growth and improve operating margins; ● compliance with the terms and conditions, including covenants, set forth in our credit facility; ● the cost of expanding our operations and offerings, including our sales and marketing efforts; ● our ability to improve or maintain coverage and reimbursement arrangements with domestic third-party and government payors, particularly in Japan; ● our rate of progress in establishing coverage and reimbursement arrangements from international commercial third-party and government payors; ● our rate of progress in, and cost of the sales and marketing activities associated with, establishing adoption of our products and maintaining or improving our sales to our current customers; ● the cost of research and development activities, including research and development relating to additional indications of neurohealth disorders; ● the effect of competing technological and market developments; ● costs related to international expansion; and ● the potential cost of and delays in product development as a result of any regulatory oversight applicable to our products.
Our current and future funding requirements will depend on many factors, including: ● our ability to achieve revenue growth and improve operating margins; ● compliance with the terms and conditions, including covenants, set forth in our credit facility; ● the cost of expanding our operations and offerings, including our sales and marketing efforts; ● our ability to improve or maintain coverage and reimbursement arrangements with domestic third-party and government payors; ● our rate of progress in establishing coverage and reimbursement arrangements from international commercial third-party and government payors; ● our rate of progress in, and cost of the sales and marketing activities associated with, establishing adoption of our products and services and maintaining or improving our sales to our current customers; ● the cost of research and development activities, including research and development relating to additional indications of neurohealth disorders; ● the effect of competing technological and market developments; ● costs related to international expansion; and ● the potential cost of and delays in product development as a result of any regulatory oversight applicable to our products and services.
We cannot be assured that additional equity, equity-linked or debt financing will be available on terms favorable to us or our stockholders, or at all. It is also possible that 85 Table of Contents we may allocate significant amounts of capital towards products or technologies for which market demand is lower than expected and, as a result, abandon such efforts.
We cannot be assured that additional equity, equity-linked or debt financing will be available on terms favorable to us or our stockholders, or at all. It is also possible that 88 Table of Contents we may allocate significant amounts of capital towards products or technologies for which market demand is lower than expected and, as a result, abandon such efforts.
Net patient fees are estimated using an expected value approach where management considers such variables as the average of previous net patient fees received by the applicable payor and fees received by other patients for similar services and the Company’s best estimate leveraging industry knowledge and expectations of third-party payors’ fee schedules. We expect clinic revenue to increase in 2025.
Net patient fees are estimated using an expected value approach where management considers such variables as the average of previous net patient fees received by the applicable payor and fees received by other patients for similar services and the Company’s best estimate leveraging industry knowledge and expectations of third-party payors’ fee schedules. We expect clinic revenue to increase in 2026.
Debt in our audited financial statements and related notes thereto appearing elsewhere in this Annual Report on Form 10-K for information regarding our current Perceptive Facility. Perceptive Credit Facility The following table sets forth by year our required future principal payments under the term loan portion of the Perceptive Facility (as discussed in Note 14.
Debt in our audited financial statements and related notes thereto appearing elsewhere in this Annual Report on Form 10-K for information regarding our current Perceptive Facility. 91 Table of Contents Perceptive Credit Facility The following table sets forth by year our required future principal payments under the term loan portion of the Perceptive Facility (as discussed in Note 14.
Net Cash (Used in) Provided by Financing Activities Net cash used in financing activities for the year ended December 31, 2024 was $6.8 million and primarily consisted of the repayment of the Solar Facility, proceeds from the Perceptive Facility issuance of long-term debt and warrants and payment of debt issuance costs related to the Perceptive Facility.
Net cash used in financing activities for the year ended December 31, 2024 was $6.8 million and primarily consisted of the repayment of the Solar Facility, proceeds from the Perceptive Facility, issuance of long-term debt and warrants and payment of debt issuance costs related to the Perceptive Facility.
Net patient fees are estimated using an expected value approach where management considers such variables as the average of previous net patient fees received by the applicable payor and fees received by other patients for similar services and management’s best estimate leveraging industry knowledge and expectations of third-party payors’ fee schedules.
Net patient fees are estimated using an expected value approach where management considers such variables as the average of previous net patient fees received by the applicable payor and fees received by other patients for similar services and management’s best estimate leveraging industry knowledge and 93 Table of Contents expectations of third-party payors’ fee schedules.
The purchase price allocation process requires us to use significant estimates and assumptions, including fair value estimates, as of the business combination date. Although we believe the assumptions and 90 Table of Contents estimates we have made are reasonable and appropriate, they are based in part on historical experience and information obtained from management of the acquired company.
The purchase price allocation process requires us to use significant estimates and assumptions, including fair value estimates, as of the business combination date. Although we believe the assumptions and estimates we have made are reasonable and appropriate, they are based in part on historical experience and information obtained from management of the acquired company.
The Company continues to operate as Neuronetics, Inc., and the Neuronetics Shares continues to trade on the NASDAQ Global Market under the ticker “STIM”. We designed the NeuroStar Advanced Therapy System as a non-invasive therapeutic alternative to treat patients who suffer from MDD and to address many of the key limitations of existing treatment options.
We continue to operate as Neuronetics, Inc., and the Neuronetics Shares continue to trade on the NASDAQ Global Market under the ticker “STIM”. We designed the NeuroStar Advanced Therapy System as a non-invasive therapeutic alternative to treat patients who suffer from MDD and to address many of the key limitations of existing treatment options.
In connection with this prepayment, the Company paid Solar $64.7 million, which consisted of (i) $60.0 million of remaining principal amount outstanding, (ii) $0.5 million of accrued and unpaid interest, (iii) $3.0 million in connection with the 86 Table of Contents final payment fee, and (iv) $1.2 million in connection with the prepayment fee.
In connection with this prepayment, the Company paid Solar $64.7 million, which consisted of (i) $60.0 million of remaining principal amount outstanding, (ii) $0.5 million of accrued and unpaid interest, (iii) $3.0 million in connection with the final payment fee, and (iv) $1.2 million in connection with the prepayment fee.
Debt) (in thousands): ​ ​ ​ ​ ​ ​ Principal Year: ​ Payments 2025 ​ $ — 2026 ​ — 2027 ​ — 2028 ​ — 2029 ​ 60,000 Total principal payments ​ $ 60,000 ​ Common Stock Offering On February 10, 2025, the Company closed on a secondary public offering of its common stock in which the Company issued and sold 9,200,000 shares of its common stock, which included shares pursuant to an option granted to the underwriter to purchase additional shares, at a public offering price of $2.25 per share.
Debt) (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ Principal Year: ​ Payments 2026 ​ $ — 2027 ​ — 2028 ​ — 2029 ​ 70,000 Total principal payments ​ $ 70,000 ​ Common Stock Offering On February 10, 2025, the Company completed a secondary public offering of its common stock in which the Company issued and sold 9,200,000 shares of its common stock, which included shares pursuant to an option granted to the underwriter to purchase additional shares, at a public offering price of $2.25 per share.
Under ASC 606, we recognize revenue when control of the promised good or service is transferred to our customers in an amount that reflects the consideration to which we expect to be 89 Table of Contents entitled in exchange for those good or services.
Under ASC 606, we recognize revenue when control of the promised good or service is transferred to our customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those good or services.
Our gross margins on revenues from sales of NeuroStar Advanced Therapy Systems and clinic revenue are lower than our gross margins on revenues from sales of treatment sessions and, as a result, the 81 Table of Contents sales mix between NeuroStar Advanced Therapy Systems, clinic revenues and treatment sessions can affect the gross margin in any reporting period. ​ Sales and Marketing Expenses Sales and marketing expenses consist of market research and commercial activities related to the sale of our NeuroStar Advanced Therapy Systems and treatment sessions and salaries and related benefits, sales commissions and share-based compensation for employees focused on these efforts.
Our gross margins on revenues from sales of NeuroStar Advanced Therapy Systems and clinic revenue are lower than our gross margins on revenues from sales of treatment sessions and, as a result, the sales mix between NeuroStar Advanced Therapy Systems, clinic revenues and treatment sessions can affect the gross margin in any reporting period. ​ Sales and Marketing Expenses Sales and marketing expenses consist of market research and commercial activities related to the sale of our NeuroStar Advanced Therapy Systems and treatment sessions and personnel costs including salaries and related benefits, sales commissions and share-based compensation for employees focused on these efforts.
Net cash provided by financing activities for the year ended December 31, 2023 was $22.7 million attributable primarily to additional debt net of final payment and amendment fee paid in connection with the two amendments of the Solar Facility in 2023.
Net cash provided by financing activities for the year ended December 31, 2023 was $22.7 million attributable primarily to additional debt net of final payment and amendment fee paid in connection with the two amendments of the Solar Facility in 2023. Indebtedness Refer to Note 14.
Summary of Significant Accounting Policies in our audited consolidated financial statements and related notes thereto appearing elsewhere in this Annual Report on Form 10-K, we believe the following discussion addresses our most critical accounting policies. Revenue Recognition We account for revenue in accordance with Accounting Standards Codification (ASC) 606, Revenue from Contracts with Customers .
Summary of Significant Accounting Policies in our audited consolidated financial statements and related notes thereto appearing 92 Table of Contents elsewhere in this Annual Report on Form 10-K, we believe the following discussion addresses our most critical accounting policies. Revenue Recognition We account for revenue in accordance with Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers .
Based on our commercial data, we believe psychiatrists can recoup their initial capital investment in our system by providing a standard course of treatment to approximately 12 patients. We believe psychiatrists can generate approximately $8,500 of average revenue per patient for a standard course of treatment, which may provide meaningful incremental income to their practices.
Based on our commercial data, we believe providers can recoup their initial capital investment in our system by providing a standard course of treatment to approximately 12 patients. We believe psychiatrists can generate approximately $9,000 of average revenue per patient for a standard course of treatment, which may provide meaningful incremental income to their practices.
NeuroStar Advanced Therapy System revenues consist primarily of sales or rentals of a capital component, including equipment upgrades to the initial sale of the system. NeuroStar Advanced Therapy Systems can be purchased outright or on a rent-to-own basis by certain customers. Treatment Session Revenues . Treatment session revenues primarily include sales of NeuroStar Treatment Sessions and SenStar treatment links.
NeuroStar Advanced Therapy System Revenues . NeuroStar Advanced Therapy System revenues consist primarily of sales or rentals of a capital component, including equipment upgrades to the initial sale of the NeuroStar Advanced Therapy System. NeuroStar Advanced Therapy Systems can be purchased outright or on a rent-to-own basis by certain customers. Treatment Session Revenues .
Our gross profit is calculated by subtracting our cost of revenues from our revenues. We calculate our gross margin as our gross profit divided by our revenues. Our gross margin has been and will continue to be affected by a variety of factors, primarily product sales mix, pricing and third-party contract manufacturing costs.
We calculate our gross margin as our gross profit divided by our revenues. Our gross margin has been and will continue to be affected by a variety of factors, primarily product sales mix, pricing and third-party contract manufacturing costs.
The $1.2 million decrease in revenue was directly attributable to a decrease in the number of units sold from 204 units for year ended December 31, 2023 to 185 units for the year ended December 31, 2024. This decrease in revenue was partially offset by a marginal increase in our average selling price per unit.
The $1.0 million decrease in revenue was directly attributable to a decrease in the number of units sold from 185 units for the year ended December 31, 2024 to 159 units for the year ended December 31, 2025. This decrease in revenue was partially offset by a marginal increase in our average selling price per unit.
The increase in net operating assets was primarily due to increases in accounts receivable, prepaid expenses and other assets, prepaid commission expense and decreases in accounts payable and accrued expenses.
The 90 Table of Contents increase in net operating assets was primarily due to increases in accounts receivable, prepaid expenses and other assets, prepaid commission expense and decreases in accounts payable and accrued expenses.
Net cash used in investing activities for the year ended December 31, 2023 was due to payments received on our promissory notes offset partially by purchases of property and equipment and capitalized software.
Net cash used in investing activities for the year ended December 31, 2023 was due to payments received on our promissory notes offset partially by purchases of property and equipment and capitalized software. Net Cash Provided by (Used in) Financing Activities Net cash provided by financing activities for the year ended December 31, 2025 was $35.9 million.
Comparison of the Years ended December 31, 2023 and 2022 ​ The information required within this section is incorporated by reference to the information set forth in the section titled “Comparison of the Years ended December 31, 2023 and 2022” in “Management’s Discussion and Analysis of our Financial Condition and Results of Operations” in our 2023 Annual Report on Form 10-K filed on March 8, 2024. ​ ​ Liquidity and Capital Resources Overview As of December 31, 2024, we had cash and cash equivalents of $18.5 million and an accumulated deficit of $419.8 million, compared to cash and cash equivalents of $59.7 million and an accumulated deficit of $376.1 million as of December 31, 2023.
Comparison of the Years ended December 31, 2024 and 2023 ​ The information required within this section is incorporated by reference to the information set forth in the section titled “Comparison of the Years ended December 31, 2024 and 2023” in “Management’s Discussion and Analysis of our Financial Condition and Results of Operations” in our 2024 Annual Report on Form 10-K filed on March 27, 2025. ​ ​ Liquidity and Capital Resources Overview As of December 31, 2025, we had cash and cash equivalents of $28.1 million and an accumulated deficit of $458.8 million, compared to cash and cash equivalents of $18.5 million and an accumulated deficit of $419.8 87 Table of Contents million as of December 31, 2024.
This included $1.2 million of early prepayment fees and $3.2 million of deferred financing expense related to extinguishment of debt. As of December 31, 2024, the Company had $60.0 million of borrowings outstanding under the Perceptive Facility, which has a final maturity on July 25, 2029.
This included $1.2 million of early prepayment fees and $3.2 million of deferred financing expense related to extinguishment of debt. In July 2025 the Company borrowed an additional $10 million under the Perceptive Facility. As of December 31, 2025, the Company had $70.0 million of borrowings outstanding under the Perceptive Facility, which has a final maturity on July 25, 2029.
We incurred negative cash flows from operating activities of $31.0 million and $32.0 million for the years ended December 31, 2024 and 2023, respectively.
We incurred negative cash flows from operating activities of $20.4 million and $31.0 million for the years ended December 31, 2025 and 2024, respectively.
We typically use our employee, consultant and infrastructure resources across our research and development programs. We expect our research and development expenses to decrease during 2025 compared to our 2024 expenses.
We typically use our employee, consultant and infrastructure resources across our research and development programs. We expect our research and development expenses to remain consistent during 2026 compared to 2025 expenses.
Under the Solar Sixth Amendment, Solar (i) waived the specified events with respect to the Company’s non-compliance with the required revenue under the net product revenue covenant and (ii) amended the financial covenants to reflect current projections.
On March 7, 2024, the Company entered into the “Solar Sixth Amendment”. Under the Solar Sixth Amendment, Solar (i) waived the specified events with respect to the Company’s non-compliance with the required revenue under the net product revenue covenant and (ii) amended the financial covenants to reflect current projections.
Sales in the United States represented 97% of our total revenues for the years ending December 31, 2024 and 2023, respectively, and have been generated by our direct sales force. Outside the United States, our sales are made through local third-party distributors. International revenues were 3% for the years ended December 31, 2024 and 2023, respectively.
Sales in the United States represented 98% of our total revenues for the year ended December 31, 2025 and 97% for the year ended December 31, 2024, and have been generated by our direct sales force. Outside the United States, our sales are made through local third-party distributors.
We anticipate that our general and administrative expenses will increase in 2025 from 2024 due to an increase in the overall size of the general and administrative function within the consolidated company.
We anticipate that our general and administrative expenses will increase in 2026 from 2025 due to an increase in the overall size of the general and administrative function within the consolidated company and investments needed to streamline systems and leverage automation.
For the period ended December 31, 2024, U.S. revenue increased by 5% and international revenue increased by 19% over the comparative prior year period.
For the year ended December 31, 2025, U.S. revenue increased by 101% and international revenue increased by 29% over the comparative prior year period.
Our sales force targets an estimated 53,000 psychiatrists across 26,000 practices. We expect to continue to expand our direct sales and customer support team to further penetrate the market by demonstrating the benefits of our NeuroStar Advanced Therapy System to psychiatrists and their MDD patients. Some of our customers have and may purchase more than one NeuroStar Advanced Therapy System.
We expect to continue to expand our direct sales and customer support team to further penetrate the market by demonstrating the benefits of our NeuroStar Advanced Therapy System to providers and their MDD patients. Some of our customers have purchased or may purchase more than one NeuroStar Advanced Therapy System.
Other Revenues . Other revenues are derived primarily from service and repair extended warranty contracts with our existing customers. We refer you to the section titled “Critical Accounting Policies and Use of Estimates—Revenue Recognition” appearing elsewhere in this Annual Report on Form 10-K for additional information regarding how we account for revenues.
We refer you to the section titled “Critical Accounting Policies and Use of Estimates—Revenue Recognition” appearing elsewhere in this Annual Report on Form 10-K for additional information regarding how we account for revenues.
We generated revenues of $74.9 million and $71.3 million for the years ended December 31, 2024 and 2023, respectively. Effective as of December 9, 2024, Neuronetics and Greenbrook completed the Arrangement. Each Greenbrook Share outstanding immediately prior to the effective time of the Arrangement was exchanged for Neuronetics Shares at the Exchange Ratio upon closing of the Arrangement.
Effective as of December 9, 2024, Neuronetics and Greenbrook completed the Arrangement. Each Greenbrook Share outstanding immediately prior to the effective time of the Arrangement was exchanged for Neuronetics Shares at the Exchange Ratio upon closing of the Arrangement.
These lease agreements range from “month-to-month” to seven years in length. As of December 31, 2024, the Company had fixed lease payment obligations of $39.2 million, including $7.7 million due within the next twelve months.
Additionally the Company has lease agreements related to its treatment centers. These lease agreements range from “month-to-month” to seven years in length. As of December 31, 2025, the Company had fixed lease payment obligations of $34.8 million, including $7.9 million due within the next twelve months.
The Company’s material cash requirements include the following contractual and other obligations. Debt On March 2, 2020 the Company entered into a Loan and Security Agreement with Solar as collateral agent and other lenders as defined in the Solar Facility. On March 7, 2024, the Company entered into a sixth amendment (the “Solar Sixth Amendment”) to the Solar Facility.
The Company’s material cash requirements include the following contractual and other obligations. Debt On March 2, 2020 the Company entered into a Loan and Security Agreement with Solar as collateral agent and other lenders as defined in the Solar Facility. As of December 31, 2023 the Solar Facility was $60 million.
For the year ended December 31, 2024, our U.S. revenues were $72.5 million, compared to $69.3 million for the year ended December 31, 2023, which represented an increase of 5% period over period. As of December 31, 2024, we had an accumulated deficit of $419.8 million.
For the year ended December 31, 2025, our U.S. revenues were $146.0 million, 82 Table of Contents compared to $72.5 million for the year ended December 31, 2024, which represented an increase of 101% year over year. As of December 31, 2025, we had an accumulated deficit of $458.8 million.
On July 25, 2024 the Company entered into a Credit Agreement and Guaranty with Perceptive and used the proceeds to partially prepay in full all outstanding obligations under our Solar Facility.
The amount of borrowing affected by this noncompliance was $60 million. 89 Table of Contents On July 25, 2024, the Company entered into a Credit Agreement and Guaranty with Perceptive and used the proceeds to partially prepay in full all outstanding obligations under our Solar Facility.
Cash Flows The following table sets forth a summary of our cash flows for the years ended December 31, 2024, 2023, and 2022: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ ​ 2024 2023 2022 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Net Cash used in Operating activities ​ $ (30,997) ​ $ (32,038) ​ $ (30,739) Net Cash (used in) provided by Investing activities ​ (2,413) ​ (1,322) ​ 6,731 Net Cash (used in) provided by Financing activities ​ (6,808) ​ 22,697 ​ 207 Net (Decrease) in Cash and Cash Equivalents and Restricted cash ​ $ (40,218) ​ $ (10,663) ​ $ (23,801) ​ Net Cash Used in Operating Activities Net cash used in operating activities for 2024 was $31.0 million, consisting primarily of a net loss of $43.7 million and an increase in net operating assets of $6.8 million, partially offset by non-cash charges of $19.5 million, primarily consisting of depreciation and amortization, capitalized software impairment, allowance for credit losses, share-based compensation, non-cash interest expense and loss on extinguishment of debt.
Cash Flows The following table sets forth a summary of our cash flows for the years ended December 31, 2025, 2024, and 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ ​ 2025 ​ ​ ​ 2024 ​ ​ ​ 2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Net Cash used in Operating activities ​ $ (20,374) ​ $ (30,997) ​ $ (32,038) Net Cash used in Investing activities ​ (801) ​ (2,413) ​ (1,322) Net Cash provided by (used in) Financing activities ​ 35,850 ​ (6,808) ​ 22,697 Net increase (decrease) in Cash, Cash equivalents and Restricted cash ​ $ 14,675 ​ $ (40,218) ​ $ (10,663) ​ Net Cash Used in Operating Activities Net cash used in operating activities for 2025 was $20.4 million, consisting primarily of a net loss of $39.1 million which is partially offset with a decrease in net operating assets of $6.6 million, and non-cash charges of $12.1 million, primarily consisting of depreciation and amortization, allowance for credit losses, share-based compensation and non-cash interest expense.
We received regulatory approval for our system in Japan in September 2017. We obtained reimbursement coverage for NeuroStar Advanced Therapy System in Japan, which went into effect on June 1, 2019 and covers patients who are treated in the largest inpatient and outpatient psychiatric facilities in Japan.
We obtained reimbursement coverage for NeuroStar Advanced Therapy System in Japan, which went into effect on June 1, 2019 and covers patients who are treated in the largest inpatient and outpatient psychiatric facilities in Japan. We expect our international revenues to decrease as a percentage of our total revenue.
We expect our international revenues to decrease as a percentage of our total revenue. Our research and development efforts are focused on the following: hardware and software product developments and enhancements of our NeuroStar Advanced Therapy System and clinical development relating to additional indications.
Our research and development efforts are focused on hardware and software product developments and enhancements of our NeuroStar Advanced Therapy System and clinical development relating to additional indications.
The NeuroStar Treatment Sessions are access codes that are delivered electronically in the United States. The SenStar treatment links are disposable units containing single-use access codes that are sold and used outside the United States.
Treatment session revenues primarily include sales of treatment sessions and SenStar treatment links. The treatment sessions are access codes that are delivered electronically in the U.S. The SenStar treatment links are disposable units containing single-use access codes that are sold and used outside the U.S.
If our cash and cash equivalents and anticipated revenues from sales or our products and services are insufficient to satisfy our liquidity requirements, we may seek to sell additional common or preferred equity or debt securities or enter into a new credit facility or another form of third-party funding or seek other debt financing.
Management believes that the Company’s cash and cash equivalents as of December 31, 2025 and anticipated revenues from sales of our products and services are sufficient to fund the Company’s operations for at least the next 12 months from the issuance of these consolidated financial statements. ​ If our cash and cash equivalents and anticipated revenues from sales of our products and services are insufficient to satisfy our liquidity requirements, we may seek to sell additional common or preferred equity or debt securities or enter into a new credit facility or another form of third-party funding or seek other debt financing.
International revenues represented 3% of our total revenues for the years ended December 31, 2024 and 2023, respectively. In October 2017, we entered into an exclusive distribution agreement, for the distribution of our NeuroStar Advanced Therapy Systems and treatment sessions to customers who will treat patients with MDD in Japan.
In October 2017, we entered into an exclusive distribution agreement, for the distribution of our NeuroStar Advanced Therapy Systems and treatment sessions to customers who will treat patients with MDD in Japan. We received regulatory approval for our system in Japan in September 2017.
Revenues by Product Category ​ ​ Years ended December 31, ​ ​ 2024 ​ 2023 ​ ​ ​ ​ ​ % of ​ ​ ​ ​ % of ​ ​ Amount Revenues Amount Revenues ​ ​ (in thousands, except percentages) NeuroStar Advanced Therapy System ​ $ 15,267 ​ 21 % $ 16,460 ​ 24 % Treatment sessions ​ 50,832 70 % 50,896 73 % Clinic revenue ​ ​ 4,445 6 % — — % Other ​ 1,944 3 % 1,980 3 % Total U.S. revenues ​ $ 72,488 100 % $ 69,336 100 % ​ ​ 83 Table of Contents Revenues Total revenues increased by $3.6 million, or 5%, from $71.3 million for the year ended December 31, 2023 to $74.9 million for the year ended December 31, 2024.
Revenues by Product Category ​ ​ Years ended December 31, ​ ​ 2025 ​ 2024 ​ ​ ​ ​ ​ % of ​ ​ ​ ​ % of ​ ​ Amount ​ ​ ​ Revenues ​ ​ ​ Amount ​ ​ ​ Revenues ​ ​ (in thousands, except percentages) NeuroStar Advanced Therapy System ​ $ 14,259 ​ 10 % $ 15,267 ​ 21 % Treatment sessions ​ 43,319 30 % 50,832 70 % Clinic revenue ​ ​ 86,977 59 % 4,445 6 % Other ​ 1,493 1 % 1,944 3 % Total U.S. revenues ​ $ 146,048 100 % $ 72,488 100 % ​ ​ Revenues Total revenues increased by $74.3 million, or 99%, from $74.9 million for the year ended December 31, 2024, to $149.2 million for the year ended December 31, 2025.
Components of Our Results of Operations Revenues To date, we have generated revenues primarily from the capital portion of our business and related sales and rentals of the NeuroStar Advanced Therapy System and the recurring revenues from our sale of treatment sessions in the United States. 80 Table of Contents NeuroStar Advanced Therapy System Revenues .
Components of Our Results of Operations Revenues We have generated revenues primarily from the sale of our NeuroStar Advanced Therapy Systems and related sales and rentals of the NeuroStar Advanced Therapy System, clinic revenue and the recurring revenues from our sale of treatment sessions in the U.S. Clinic Revenues .
The interest rate on borrowings under the Perceptive Facility is the monthly SOFR rate plus 7%. Leases The Company has lease arrangements for equipment and certain facilities, including corporate headquarters and our warehouse in Malvern, Pennsylvania and a training facility in Charlotte, North Carolina. Additionally following the acquisition of Greenbrook, the Company has lease agreements related to its Treatment Centers.
The interest rate on borrowings under the Perceptive Facility is the sum of 7.00% plus the greater of (a) 4.50% and (b) One-Month Term SOFR (as defined in the Perceptive Facility). Leases The Company has lease arrangements for equipment and certain facilities, including our corporate headquarters and warehouse in Malvern, Pennsylvania and a training facility in Charlotte, North Carolina.
We expect that both our United States and international revenues will increase in the near term as we continue to expand active customer sites utilizing our NeuroStar Advanced Therapy Systems and increase the related patient utilization in the United States, as well as grow our presence in Japan.
International revenues were 2% for the years ended December 31, 2025 and 3% for the year ended December 31, 2024. We expect our United States revenue will increase in the near term as we continue to expand active customer sites utilizing our NeuroStar Advanced Therapy Systems and increase the related patient utilization in the United States.
We derive the majority of our revenues from recurring treatment sessions. For the year ended December 31, 2024, revenues from sales of our treatment sessions and NeuroStar Advanced Therapy Systems represented 70% and 21% of our U.S. revenues, respectively.
For the year ended December 31, 2024, revenues from sales of our clinic, treatment sessions and NeuroStar Advanced Therapy Systems represented 6%, 70% and 21% of our U.S. revenues, respectively. Clinic revenue consists of revenue attributable to the performance of treatments to patients in 15 states in the U.S.
Our new Treatment Center costs include direct center and patient care costs, regional employee compensation, regional marketing expenses, and depreciation. We expect our cost of revenues to increase mainly for Treatment Centers, as our product mix changes. We expect to realize efficiencies with our new contract manufacturer.
Our treatment center costs include direct center and patient care 83 Table of Contents costs, regional employee compensation and depreciation. We expect our cost of revenues to increase mainly for treatment centers, as our product mix changes. ​ Our gross profit is calculated by subtracting our cost of revenues from our revenues.
The decrease in gross margin was primarily a result of the inclusion of Greenbrook’s clinic business and reduction in Treatment session revenue. Sales and marketing Expenses Sales and marketing expenses decreased by $1.7 million, or 4%, from $47.3 million for the year ended December 31, 2023 to $45.6 million for the year ended December 31, 2024.
Gross margin was 48.5% for the year ended December 31, 2025 compared to 72.3% for the year ended December 31, 2024. The decrease in gross margin was primarily a result of the inclusion of Greenbrook’s clinic business and reduction in treatment session revenue.
Our total revenues increased by $3.6 million, or 5%, from $71.3 million for the year ended December 31, 2023 to $74.9 million for the year ended December 31, 2023.
Our total revenues increased by $74.3 million, or 99%, from $74.9 million for the year ended December 31, 2024 to $149.2 million for the year ended December 31, 2025, due to the inclusion of revenues from our Greenbrook acquisition.
Other significant sales and marketing costs include conferences and trade shows, promotional and marketing activities, including direct and online marketing, practice support programs, primarily digital media campaigns, travel and training expenses. We anticipate that our sales and marketing expenses will increase in 2025 relative to 2024 as a result of the addition of the Greenbrook sales personnel to our company.
Other significant sales and marketing costs include conferences and trade shows, promotional and marketing activities, including direct and online marketing, practice support programs, primarily digital media campaigns, travel and training expenses.
Loss on extinguishment of debt Loss on extinguishment of debt amounting to $4.4 million was recorded during the three months ended September 30, 2024, related to the Solar Facility. This included $1.2 million of early prepayment fees and $3.2 million of deferred financing expense related to extinguishment of debt.
During the year ended December 31, 2024, the Company recorded a loss on extinguishment of debt of $4.4 million related to the Solar Facility, which consisted of $1.2 million in early prepayment fees and $3.2 million related to the write-off of deferred financing costs.
Loss on extinguishment of debt Loss on debt extinguishment consists of prepayment penalties and impairment of deferred financing costs associated with the extinguishment of debt, as well as fees incurred with third parties in connection with debt extinguishment. 82 Table of Contents Other Income, Net Other income, net consists primarily of interest income earned on our money market account balances and notes receivable.
Interest Expense Interest expense consists of cash interest payable under our credit facility and the amortization of deferred financing costs related to our indebtedness. 84 Table of Contents Loss on extinguishment of debt Loss on debt extinguishment consists of prepayment penalties and impairment of deferred financing costs associated with the extinguishment of debt, as well as fees incurred with third parties in connection with debt extinguishment.
We generate revenues from initial capital sales of our systems, sales of our recurring treatment sessions and 79 Table of Contents from service and repair and extended warranty contracts. Additionally, through our acquisition of Greenbrook we now derive revenue directly from our Treatment Centers, by providing TMS and SPRAVATO therapy for MDD and other mental health disorders.
Additionally through our acquisition of Greenbrook, we now derive revenue directly from our Treatment Centers, by providing TMS therapy and SPRAVATO for MDD and other mental health disorders. We derive the majority of our revenues from clinic revenue and treatment sessions. 81 Table of Contents We currently operate under in two segments: Medicial device and Clinic services.
If the asset’s carrying value is determined to not be recoverable, the impairment to be recognized is measured by the amount by which the carrying amount exceeds the fair market value of the intangible asset. Calculating cash flows for this measurement requires is to make significant estimates and assumptions related to forecasts of futures revenues, expenses and discount rates.
Calculating cash flows for this measurement requires is to make significant estimates and assumptions related to forecasts of futures revenues, expenses and discount rates. Changes in these assumptions could have a significant impact on the fair value of the intangible asset.
We received net proceeds of approximately $18.9 million after deducting underwriting discounts, commissions and estimated offering expenses. Critical Accounting Policies and Use of Estimates The preparation of our consolidated financial statements in accordance with U.S.
Critical Accounting Policies and Use of Estimates The preparation of our consolidated financial statements in accordance with U.S.
As of December 31, 2024, the Company had $60.0 million of borrowings outstanding under the Perceptive Facility, which has a final maturity on July 25, 2029. The Perceptive Facility is subject to certain financial covenants including a minimum net revenue covenant that escalates over the term of the Perceptive Facility and a minimum liquidity covenant.
The Perceptive Facility is subject to certain financial covenants including a minimum net revenue covenant that escalates over the term of the Perceptive Facility and a minimum liquidity covenant.
Any impairment recognized could significantly impact our results of operations in the period of impairment. ​ 91 Table of Contents Recent Accounting Pronouncements We refer you to Note 4. Recent Accounting Pronouncements in our audited consolidated financial statements and related notes thereto included elsewhere in this Annual Report on Form 10-K. ​
Recent Accounting Pronouncements in our audited consolidated financial statements and related notes thereto included elsewhere in this Annual Report on Form 10-K. ​
Changes in these assumptions could have a significant impact on the fair value of the intangible asset. If such assets are determined to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount exceeds the fair value of the assets.
If such assets are determined to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount exceeds the fair value of the assets. Any impairment recognized could significantly impact our results of operations in the period of impairment. ​ Recent Accounting Pronouncements We refer you to Note 4.
Other Income, Net Other income, net decreased by $3.2 million from $5.8 million for the year ended December 31, 2023 to $2.5 million for the year ended December 31, 2024, primarily as a result of the Employee Retention Credit (the “ERC”) of $2.9 million recorded during the year ended December 31, 2023.
Other Income, Net Other income, net decreased by $1.8 million from $2.5 million for the year ended December 31, 2024 to $0.7 million for the year ended December 31, 2025, primarily as a result of decreased interest income earned on the Company’s money market accounts and notes receivable interest.
Net cash provided by investing activities for the year ended December 31, 2022 was attributable to repayment of a promissory note and purchases of property and equipment and capitalized software costs.
Net Cash Used in Investing Activities Net cash used in investing activities for the years ended December 31, 2025, 2024 and 2023 was $(0.8) million, $(2.4) million and $(1.3) million, respectively. Net cash used in investing activities for the year ended December 31, 2025 was attributable to purchases of property and equipment and capitalized software costs.
Access codes are purchased separately by our customers, primarily on an as-needed basis, and are required by the NeuroStar Advanced Therapy System in order to deliver treatment sessions. Clinic Revenue. Clinic revenue is determined based on net patient fees, which includes estimates for contractual allowances and discounts.
Access codes are purchased separately by our customers, primarily on an as-needed basis, and are required by the NeuroStar Advanced Therapy System in order to deliver treatment sessions. Other Revenues . Other revenues are derived primarily from service and repair, research collaboration agreements and extended warranty contracts with our existing customers.
The Company expects to recognize future recurring treatment session revenue related to the sale of 185 NeuroStar Advanced Therapy Systems for the year ended December 31, 2024. Treatment sessions revenues represented 70% and 73% of total revenues in the United States for the years ended December 31, 2024 and 2023, respectively.
The Company expects to recognize future recurring treatment session revenue related to the sale of 160 NeuroStar Advanced Therapy Systems for the year ended December 31, 2025 including 1 unit recognized as an operating lease for December 31, 2025.
The decrease was primarily driven by the reduction in marketing program spend due to synergies obtained on account of the acquisition of Greenbrook. General and Administrative Expenses General and administrative expenses increased by $4.9 million, or 19% from $25.4 million for the year ended December 31, 2023 to $30.3 million for the year ended December 31, 2024.
General and Administrative Expenses General and administrative expenses increased by $19.4 million, or 64% from $30.3 million for the year ended December 31, 2024 to $49.7 million for the year ended December 31, 2025.
Net cash used in operating activities for 2022 was $30.7 million, consisting primarily of a net loss of $37.2 million and an increase in net operating assets of $4.8 million, partially offset by non-cash charges of $11.2 million.
Net cash used in operating activities for 2024 was $31.0 million, consisting primarily of a net loss of $43.7 million and an increase in net operating assets of $6.8 million, partially offset by non-cash charges of $19.5 million, primarily consisting of depreciation and amortization, capitalized software impairment, allowance for credit losses, share-based compensation, non-cash interest expense and loss on extinguishment of debt.
For the year ended December 31, 2023, revenues from sales of our treatment sessions and NeuroStar Advanced Therapy Systems represented 73% and 24% of our U.S. revenues, respectively. We currently sell our NeuroStar Advanced Therapy System and recurring treatment sessions in the United States through our sales and customer support team.
We generate revenues from clinic operations, initial capital sales of our systems, sales of our recurring treatment sessions and from service and repair and extended warranty contracts. For the year ended December 31, 2025 revenues from sales of our clinic revenue, treatment sessions and NeuroStar Advanced Therapy Systems represented 59%, 30% and 10% of our U.S. revenues, respectively.
Patients are reimbursed by federal healthcare programs and the vast majority of commercial payors in the United States for treatment sessions utilizing our NeuroStar Advanced Therapy System. We market our products in a few select markets outside the United States through independent distributors.
We have a diverse customer base in the U.S. Patients are reimbursed by federal healthcare programs and the vast majority of commercial payors in the U.S. for treatment sessions utilizing our NeuroStar Advanced Therapy System. For the years ended December 31, 2024 and 2023, one customer Greenbrook, accounted for 12% and 15%, respectively, of the Company’s revenue.
The U.S. revenue growth was primarily due to the addition of U.S. clinic revenue as a result of the acquisition of Greenbrook and the international revenue growth was primarily driven by an increase in NeuroStar Advanced Therapy System revenue.
The international revenue growth was primarily driven by an increase in NeuroStar Advanced Therapy System revenue. U.S. NeuroStar Advanced Therapy System revenue for the year ended December 31, 2025 was $14.3 million, a decrease of 7% compared year ended December 31, 2024 revenue of $15.3 million.
Cost of Revenues and Gross Margin Cost of revenues increased by $1.1 million, or 6%, from $19.6 million for the year ended December 31, 2023 to $20.7 million for the year ended December 31, 2024. Gross margin was 72.3% for the year ended December 31, 2024 compared to 72.5% for the year ended December 31, 2023.
Sales and Marketing Expenses Sales and marketing expenses increased by $1.8 million, or 4%, from $45.6 million for the year ended December 31, 2024 to $47.5 million for the year ended December 31, 2025.
Treatment session revenue in United States for year ended December 31, 2024 was $50.8 million which was materially consistent with revenue for the year ended December 31, 2023 of $50.9 million.
U.S. treatment session revenue for the year ended December 31, 2025 was $43.3 million, a decrease of 15% compared to year ended December 31, 2024 revenue of $50.8 million.
NeuroStar Advanced Therapy System is safe, clinically effective, reproducible and precise and we believe is supported by the largest clinical data set of any competing TMS system. We believe we are the market leader in TMS therapy based on the estimated 195,356 global patients treated with over 7.1 million of our treatment sessions through December 31, 2024.
We believe we are the market leader in TMS therapy based on the estimated 237,574 global patients treated with over 8.5 million of our treatment sessions through December 31, 2025. We generated revenues of $149.2 million and $74.9 million for the years ended December 31, 2025 and 2024, respectively.
This increase was partially offset by savings related to project spend and personnel. 84 Table of Contents Interest Expense Interest expense increased by $1.9 million, or 34%, from $5.4 million for the year ended December 31, 2023 to $7.3 million for the year ended December 31, 2024 due to interest rates and debt balance increases.
Interest Expense Interest expense increased by $1.1 million, or 15%, from $7.3 million for the year ended December 31, 2024 to $8.4 million for the year ended December 31, 2025 primarily due to a higher outstanding debt balance. Loss on extinguishment of debt No loss on extinguishment of debt was recorded during the year ended December 31, 2025.
The increase in net operating assets was primarily due to increases in accounts receivable, inventory and prepaid commission expense, which were offset by increases in accounts payable and accrued expenses 87 Table of Contents as a result of timing and accrued 2022 compensation and commissions as of December 31, 2022.
The decrease in net operating assets was primarily due to decreases in accounts receivable, prepaid expense and other assets, partially offset with decreases in accounts payable and accrued expenses.
Our primary sources of capital to date have been from our IPO, private placements of our convertible preferred securities, borrowings under our credit facility, sales of our products and a secondary public offering of our common stock. The Company entered into a Credit Agreement and Guaranty with Perceptive as collateral agent and other lenders defined in the Perceptive Facility.
The Company’s primary sources of capital to date have been from its initial public offering (“IPO”), borrowings under its credit facility, proceeds from its secondary public offering of common stock (including, without limitation, our ATM Program), and revenues from sales of its products.
Research and Development Expenses Research and development expenses increased by $3.3 million, or 34% from $9.5 million for the year ended December 31, 2023 to $12.8 million for the year ended December 31, 2024. The Company halted development on a certain product release resulting in a software impairment charge of $4.0 million.
Research and Development Expenses Research and development expenses decreased by $6.2 million, or 48%, from $12.8 million for the year ended December 31, 2024 to $6.6 million for the year ended December 31, 2025.
Removed
In connection with and prior to closing of the Arrangement, Madryn converted (i) all of the outstanding amount owing under Greenbrook’s credit agreement into 2,056,453,835 Greenbrook Shares, representing 95.3% of the Greenbrook Shares (including the Greenbrook Shares held by Madryn prior to such conversion) immediately prior to closing of the Arrangement and (ii) all of the interim period funding provided by Madryn to Greenbrook into an additional 252,999,770 Greenbrook Shares, which Greenbrook Shares were exchanged for Neuronetics Shares at the Exchange Ratio upon closing of the Arrangement.
Added
It is also cleared by the FDA to decrease anxiety symptoms in adult patients with MDD that may exhibit comorbid anxiety symptoms (anxious depression). In addition to selling the NeuroStar Advanced Therapy System and associated treatment sessions to customers, we operate Greenbrook Treatment Centers across the U.S., offering NeuroStar Advanced Therapy.
Removed
We have a diverse customer base of psychiatrists in group psychiatric practices in the United States. For the years ended December 31, 2024, 2023 and 2022 one customer Greenbrook accounted for 12%,15% and 17% respectively, of the Company’s revenue. Following the acquisition, Greenbrook is no longer a customer.

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