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What changed in MYOMO, INC.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of MYOMO, 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.

+370 added−328 removedSource: 10-K (2026-03-09) vs 10-K (2025-03-10)

Top changes in MYOMO, INC.'s 2025 10-K

370 paragraphs added · 328 removed · 262 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

80 edited+14 added−19 removed95 unchanged
Biggest changeThe EU MDR, among other things: • strengthens the rules on placing devices on the market (e.g., reclassification of certain devices and wider scope than the EU MDD) and reinforces surveillance once they are available; • establishes explicit provisions on manufacturers’ responsibilities for the follow up of the quality, performance and safety of devices placed on the market; • establishes explicit provisions on importers’ and distributors’ obligations and responsibilities; • imposes an obligation to identify a responsible person who is ultimately responsible for all aspects of compliance with the requirements of the new regulation; 9 Table of Contents • improves the traceability of medical devices throughout the supply chain to the end user or patient through the introduction of a unique identification number, to increase the ability of manufacturers and regulatory authorities to trace specific devices through the supply chain and to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk; and • sets up a central database (EUDAMED) to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU.
Biggest changeIn the EU, medical devices are regulated under the Medical Devices Regulation (EU) No. 2017/745, or the EU MDR, which repealed and replaced the previous Medical Devices Directive 93/42/EEC, or EU MDD, on May 26, 2021. 10 Table of Contents The EU MDR, among other things: • strengthens the rules on placing devices on the market (e.g., reclassification of certain devices and wider scope than the EU MDD) and reinforces surveillance once they are available; • establishes explicit provisions on manufacturers’ responsibilities for the follow up of the quality, performance and safety of devices placed on the market; • establishes explicit provisions on importers’ and distributors’ obligations and responsibilities; • imposes an obligation to identify a responsible person who is ultimately responsible for all aspects of compliance with the requirements of the new regulation; • improves the traceability of medical devices throughout the supply chain to the end user or patient through the introduction of a unique identification number, to increase the ability of manufacturers and regulatory authorities to trace specific devices through the supply chain and to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk; and • sets up a central database referred to as the European Database of Medical Devices (“EUDAMED” to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU.
Where You Can Find More Information Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 are available through the investor relations portion of our website (www.myomo.com) free of charge as soon as reasonably practicable after we electronically file such material with, or furnish it to, the Securities and Exchange Commission, or SEC.
Where You Can Find More Information Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 are available through the investor relations portion of our website (www.myomo.com) free of charge as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.
In addition to our EU authorization as outlined above, we have a Medical Device License for Canada. In addition, Myomo has obtained certification of our Quality System, or QS, to the Medical-Device-Single-Audit-Program, or MDSAP. This certifies compliance of the QS for sales in the United States, Canada, Brazil, Australia, and Japan.
In addition to our EU and UK authorization as outlined above, we have a Medical Device License for Canada. In addition, Myomo has obtained certification of our Quality System, or QS, to the Medical-Device-Single-Audit-Program, or MDSAP. This certifies compliance of the QS for sales in the United States, Canada, Brazil, Australia, and Japan.
This research demonstrated that it is technically feasible to design a myoelectric elbow-hand orthosis; however, we believe that the product was not commercially practical until we were able to incorporate recent technological developments such as improved microprocessors and software, lightweight materials and motors, and smaller batteries to create an acceptable orthosis for users. 5 Table of Contents The MyoPro can enable individuals to self-initiate and control movements of a partially paralyzed or weakened limb using their own muscle signals.
This research demonstrated that it is technically feasible to design a myoelectric elbow-hand orthosis; however, we believe that the product was not commercially practical until we were able to incorporate recent technological developments such as improved microprocessors and software, lightweight materials and motors, and smaller batteries to create an acceptable orthosis for users. 6 Table of Contents The MyoPro can enable individuals to self-initiate and control movements of a partially paralyzed or weakened limb using their own muscle signals.
MyoPro devices are typically reimbursed by the patient’s health insurance plan, which include government health programs in the United States such as Medicare and Medicaid, commercial health insurers and managed care organizations.
MyoPro devices are typically reimbursed by the patient’s health insurance plan, which include government health programs in the United States such as Medicare, commercial health insurers and managed care organizations.
We have working relationships with rehabilitation facilities in the United States, including the Mayo Clinic, Cleveland Clinic, Spaulding Rehabilitation Hospital, Loma Linda University Medical Center, Kennedy Krieger Institute, and numerous VA Medical Centers, and we have developed an appropriate set of inclusion criteria to determine which persons that are affected by stroke would be medically qualified for the intervention.
We have working relationships with rehabilitation facilities in the United States, including Cleveland Clinic, Spaulding Rehabilitation Hospital, Loma Linda University Medical Center, Kennedy Krieger Institute, University of Utah, and numerous VA Medical Centers, and we have developed an appropriate set of inclusion criteria to determine which persons that are affected by stroke would be medically qualified for the intervention.
Importantly, the EMG-driven device requires that users are actively engaged throughout the movement; if they stop trying to move, the device stops. With our product, someone who has upper extremity paralysis from a brachial plexus injury, stroke or other neuromuscular disorder can experience improved function in performing ADLs including feeding, reaching and lifting.
Importantly, the EMG-driven device requires that users are actively engaged throughout the movement; if they stop trying to move, the device stops. With our product, someone who has upper extremity paralysis from a brachial plexus injury, stroke or other neuromuscular disorder may experience improved function in performing ADLs including feeding, reaching and lifting.
Based on the final published fees, our O&P partners, as well as others whom we do not work with today, may find the fees sufficient to cover the cost of the MyoPro device, the clinical services to evaluate and fit patients, and the other support services associated with provisioning of products to patients, which may result in higher sales volume from that channel in 2025 and beyond.
Based on the final published fees, our O&P partners, as well as others whom we do not work with today, may find the fees sufficient to cover the cost of the MyoPro device, the clinical services to evaluate and fit patients, and the other support services associated with provisioning of products to patients, which may result in higher sales volume from that channel in 2026 and beyond.
We hold 35 patents in the United States and various countries, which expire at various times from 2027 through 2042, and we have 12 pending patent applications in the United States and international markets. Our intellectual property also consists of trade secrets related to myoelectric control software and mechanical designs from over ten years of R&D and product development activity.
We hold 35 patents in the United States and various countries, which expire at various times from 2027 through 2042, and we have 14 pending patent applications in the United States and international markets. Our intellectual property also consists of trade secrets related to myoelectric control software and mechanical designs from over ten years of R&D and product development activity.
Many individuals recover from their related trauma with the exception of 4 Table of Contents the ability to control their elbow and/or hand. Nerve transfer surgery is often a solution; however, these procedures are not always restorative. In some cases, patients undergo amputation and receive myoelectric prosthetics rather than deal with a paralyzed arm.
Many individuals recover from their related trauma with the exception of the ability to control their elbow and/or hand. Nerve transfer surgery is often a solution; however, these procedures are 5 Table of Contents not always restorative. In some cases, patients undergo amputation and receive myoelectric prosthetics rather than deal with a paralyzed arm.
There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution; 11 Table of Contents • the federal civil and criminal false claims laws, including the FCA, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment or approval that are false, fictitious or fraudulent; knowingly making, using or causing to be made or used, a false statement or record material to a false or fraudulent claim or obligation to pay or transmit money or property to the federal government; or knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay money to the federal government.
There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution; • the federal civil and criminal false claims laws, including the FCA, which prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment or approval that are false, fictitious or fraudulent; knowingly making, using or causing to be made or used, a false statement or record material to a false or fraudulent claim or obligation to pay or transmit money or property to the federal government; or knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay money to the federal government.
Cerebral Palsy Based on data provided by the CDC, the prevalence of cerebral palsy, or CP, in the United States is approximately 73,000 for children ages 6-11 years old. CP is caused by brain injury or brain malformation that occurs before, during, or immediately after birth while the infant’s brain is under development.
Cerebral Palsy Based on data provided by the CDC, the prevalence of CP, in the United States is approximately 70,000 for children ages 6-11 years old. CP is caused by brain injury or brain malformation that occurs before, during, or immediately after birth while the infant’s brain is under development.
We have partnered with leading researchers to study the impact of the technology to regain function to a paralyzed joint as well as the real-world benefit that comes from being able to independently perform ADLs in the home, vocational tasks at work, and community activities such as shopping.
We have partnered with leading researchers to study the impact of the technology to regain movement to a paralyzed joint as well as the real-world benefit that comes from being able to independently perform ADLs in the home, vocational tasks at work, and community activities such as shopping.
In addition to supporting the weakened limb, the MyoPro functions as a neuro-muscular orthotic by helping regain function to the impaired limb similarly to a myoelectric prosthetic for an amputee. It is prescribed by physicians and provided by trained clinical professionals as a custom-fabricated myoelectric elbow-wrist-hand orthosis.
In addition to supporting the weakened limb, the MyoPro functions as a neuro-muscular orthotic by helping regain movement to the impaired limb similarly to a myoelectric prosthetic for an amputee. It is prescribed by physicians and provided by trained clinical professionals as a custom-fabricated myoelectric elbow-wrist-hand orthosis.
Currently funded studies include a randomized control trial by the Kessler Foundation, using the MyoPro to study the restoration of upper extremity motor function in people with spinal cord injury, and a recently initiated randomized control trial at the Cleveland VA using the MyoPro for stroke patients using motor learning in therapy and home use.
Currently funded studies include a randomized control trial by the Kessler Foundation, using the MyoPro to study the restoration of upper extremity motor function in people with spinal cord injury, and a randomized control trial at the Cleveland VA using the MyoPro for stroke patients using motor learning in therapy and home use.
We believe it is the only device commercially available in the United States that is able to help neuromuscular-impaired people who have been through therapy and have been left with partial paralysis regain function in weak arms and hands using their own muscle signals.
We believe it is the only device commercially available in the United States that is able to help neuromuscular-impaired people who have been through therapy and have been left with partial paralysis regain movement in weak arms and hands using their own muscle signals.
In addition to stroke patients, we believe our technology may be used on medically appropriate patients to improve upper extremity movement in patients with peripheral nerve injury, spinal cord injury, cerebral palsy, traumatic brain injury, and other neurological disorders, depending on the individual patient’s condition.
In addition to stroke patients, we believe our technology may be used on medically appropriate patients to improve upper extremity movement in patients with peripheral nerve injury, spinal cord injury, cerebral palsy, or CP, traumatic brain injury, and other neurological disorders, depending on the individual patient’s condition.
When the user tries to move, our patented EMG control system uses sensors to detect the weak muscle signal and to activate a motor to move the limb in the desired direction. The user is in control of their own limb; the brace amplifies their weak muscle signal to regain function to the affected joint.
When the user tries to move, our patented EMG control system uses sensors to detect the weak muscle signal and to activate a motor to move the limb in the desired direction. The user is in control of their own limb; the brace amplifies their weak muscle signal to regain movement to the affected joint.
To assess whether an individual is a medically-qualified candidate for a MyoPro, we and our channel partners utilize a variety of techniques to evaluate patients, including tele-health video conference sessions, in-person evaluations, screening days at various locations, and evaluations at clinical facilities where therapists and physicians refer patients for a MyoPro, which requires a physician’s prescription to be reimbursed by insurance.
To assess whether an individual is a medically-qualified candidate for a MyoPro, we and our channel partners utilize a variety of techniques to evaluate patients, including telehealth video conference sessions, in-person evaluations, screening days at various locations, and evaluations at clinical facilities where therapists and physicians refer patients for a MyoPro, which requires a physician’s prescription to be reimbursed by insurance.
Factors payers consider in determining reimbursement are based on whether the product is: a covered benefit under its health plan; safe, effective, and medically necessary; appropriate for the specific patient; cost effective, and neither experimental nor investigational. Our Patient Advocacy Team assists patients in developing and submitting this documentation for coverage of the prescribed MyoPro.
Factors payers consider in determining reimbursement are based on whether the product is: a covered benefit under its health plan; safe, effective, and medically necessary; appropriate for the specific patient; cost effective, and neither experimental nor investigational. Our Patient and Market Access Team assists patients in developing and submitting this documentation for coverage of the prescribed MyoPro.
HITECH also created 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 the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions; • the federal Physician Payments Sunshine Act, created under the ACA, and its implementing regulations, which require manufacturers of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to HHS, under the Open Payments Program, information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and • analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers or patients; state laws that require device companies 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 and local laws that require the licensure of sales representatives; 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; data privacy 12 Table of Contents 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 General Data Protection Regulation, which became effective in May 2018); state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; and state laws related to insurance fraud in the case of claims involving private insurers.
HITECH also created 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 the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions; • the federal Physician Payments Sunshine Act, created under the Affordable Care Act (“ACA”), and its implementing regulations, which require manufacturers of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to HHS, under the Open Payments Program, information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and • analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including 13 Table of Contents commercial insurers or patients; state laws that require device companies 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 and local laws that require the licensure of sales representatives; 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; 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’s General Data Protection Regulation, as amended and interpreted from time to time); state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; and state laws related to insurance fraud in the case of claims involving private insurers.
Once these documents are obtained and reviewed to ensure our inclusion criteria are met, we will proceed to measure the patient’s arm, manufacture and provide the device to a qualifying Medicare patient. For patients with Medicare Advantage or other commercial insurance, our patient advocacy team submits a pre-authorization request to the patient’s insurer.
Once these documents are obtained and reviewed to ensure our inclusion criteria are met, we will proceed to measure the patient’s arm, manufacture and provide the device to a qualifying Medicare patient. For patients with Medicare Advantage or other commercial insurance, our patient and market access team submits a pre-authorization request to the patient’s insurer.
A person or entity need not have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it in order to have committed a violation. Violations are subject to civil and criminal fines and penalties for each violation, plus imprisonment and exclusion from government healthcare programs.
A person or entity need not have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it in order to have committed a violation. Violations are subject to civil and criminal fines and penalties for each 12 Table of Contents violation, plus imprisonment and exclusion from government healthcare programs.
The European Commission has adopted various standards applicable to medical devices and there are additionally harmonized standards relating to the design and manufacture of medical devices (such as the international management system standard for medical systems set by the International Organization for Standardization or ISO, ISO13485:2016) which are not mandatory however, if complied with, indicate that the device satisfies the applicable element of the general safety and performance requirements.
The European Commission has adopted various harmonized standards relating to the design and manufacture of medical devices (such as the international quality management system standard for medical devices set by the International Organization for Standardization or ISO, ISO13485:2016) which are not mandatory however, if complied with, indicate that the device satisfies the applicable element of the general safety and performance requirements.
We expect to introduce the MyoPro3, which will include further improvements over the MyoPro2+, and our MyoPal device for pediatric use at a future date.
We expect to introduce the MyoPro3, which will include further improvements over the MyoPro2x, and our MyoPal device for pediatric use at a future date.
While we believe our device to be exempt from FDA premarket review, our device is subject to FDA’s post-market requirements, which include compliance with the applicable portions of the FDA’s Quality System Regulation, or QSR, facility registration and product listing, reporting of adverse medical events, and appropriate, truthful and non-misleading labeling, advertising, and promotional materials.
While we believe our device to be exempt from FDA premarket review, our device is subject to FDA’s post-market requirements, which include compliance with the applicable portions of the FDA’s Quality Management System Regulation (“QMSR”) facility registration and product listing, reporting of adverse medical events, and appropriate, truthful and non-misleading labeling, advertising, and promotional materials.
CE marks issued by EU notified bodies to place medical devices on the market in the EU will remain valid in the UK up until, at the latest, 10 Table of Contents June 30, 2028 (for CE marks issued under the EU MDD) or June 30, 2030 (for CE marks issued under the EU MDR), following which a UK Conformity Assessed, or UKCA, mark will be required to place a device on the Great Britain market.
CE marks issued by EU notified bodies to place medical devices on the market in the EU will remain valid in the UK up until, at the latest, June 30, 2028 (for CE marks issued under the EU MDD) or June 30, 2030 (for CE marks issued under the EU MDR), following which a UK Conformity Assessed, or UKCA, mark will be required to place a device on the Great Britain market.
As of December 31, 2024, 272 MyoPro units were in backlog, which we define as patients for whom we received insurance authorization, or in the case of Medicare Part B patients, those who have been qualified for delivery through receipt of required medical documentation, but revenue has not been recognized.
As of December 31, 2025, 199 MyoPro units were in backlog, which we define as patients for whom we received insurance authorization, or in the case of Medicare Part B patients, those who have been qualified for delivery through receipt of required medical documentation, but revenue has not been recognized.
Our goal is to address the need to help regain function to individuals who have suffered partial paralysis and can no longer support or move their arm or hand despite the best efforts of surgeons and rehabilitation therapists. Our solution, the MyoPro custom fabricated limb orthosis, is for the upper limbs.
Our goal is to help individuals who have suffered partial paralysis and can no longer support or move their arm or hand despite the best efforts of surgeons and rehabilitation therapists. Our solution, the MyoPro custom fabricated limb orthosis, is for the upper limbs.
Once the patient’s arm measurements are captured, the orthotic parts are 3D printed by a subcontractor based on these measurements. The fabrication of the brace is completed in-house. • Fabrication typically takes approximately 2 weeks.
Once the patient’s arm measurements are captured, the orthotic parts are 3D printed by a subcontractor based on these measurements. The fabrication of the brace is completed in-house. • Fabrication typically takes less than 2 weeks.
Similar patents have been issued in China, Hong Kong, and Japan and is validated (currently in force) in six European countries (European Patent No. 3307225). We also have 8 pending U.S. patent applications and 4 foreign applications under examination. We plan to continue to file additional patent applications over time.
Similar patents have been issued in China, Hong Kong, and Japan and is validated (currently in force) in six European countries (European Patent No. 3307225). We also have 10 pending U.S. patent applications and 5 foreign applications under examination. We plan to continue to file additional patent applications over time.
The R&D team seeks to combine innovative research conducted over the last 50 years with cutting edge innovations in robotics, machine learning, material science and artificial intelligence to 6 Table of Contents continue to enhance our products and product offerings.
The R&D team seeks to combine innovative research conducted over the last 50 years with cutting-edge innovations in robotics, machine learning, material science and artificial intelligence to continue to enhance our products and product offerings.
Manufacturers may choose to use the UKCA mark on a voluntary basis prior to such dates. UKCA marking will, however, not be recognized in the EU.
Manufacturers may choose to use the UKCA mark on a voluntary basis prior to such dates. UKCA marking is, however, not recognized in the EU.
Of that population, we estimate that up to 20% of such individuals may be medically qualified candidates for a MyoPro whose insurance may reimburse for the device, which now includes Medicare Part B beneficiaries.
Of that population, we estimate that 10% to 20% of such individuals may be medically qualified candidates for a MyoPro whose insurance may reimburse 4 Table of Contents for the device, which now includes Medicare Part B beneficiaries.
The longest term of our patents extends intellectual property rights until 2042. In terms of trademarks, the terms Myomo, MyoPro, MyoPal and MyoCare are registered as trademarks with the U.S. Patent & Trademark Office. Our trademarks were initially registered in 2013 and 2014, and we have been making the required filings to maintain our trademarks.
The longest term of our patents extends intellectual property rights until 2042. In terms of trademarks, the terms Myomo, MyoPro, MyoPal, MyoCare and MyoCoach are registered as trademarks with the U.S. Patent & Trademark Office, as well as in other countries. We have been making the required filings to maintain our trademarks.
According to the CDC, 7% of adults aged 65 and over in the United States require daily help with ADLs. For patients without caregivers, such long term, full-time support services cost approximately $62,400 annually according to The KFF. This approximates the cost to a payer for a MyoPro, which is paid once.
According to the CDC, 7% of adults aged 65 and over in the United States require daily help with ADLs. For patients without caregivers, the median annual cost of such long term, full-time support services is approximately $68,600 annually according to Kaiser Family Foundation. This approximates the cost to a payer for a MyoPro, which is paid once.
Many elements of health care reform such as comparative effectiveness research, payment system reforms including shared savings pilots and other provisions could meaningfully change the way healthcare is developed and 14 Table of Contents delivered, and may materially adversely impact numerous aspects of our business, results of operations and financial condition.
Many elements of health care reform such as comparative effectiveness research, payment system reforms including shared savings pilots and other provisions could meaningfully change the way healthcare is developed and delivered, and may materially adversely impact numerous aspects of our business, results of operations and financial condition. Manufacturing Myomo’s custom fabricated orthosis is comprised of two elements.
Some new products have 8 Table of Contents been introduced that compete with the MyoPro from companies such as Neurolutions in the United States and Vincent Systems and HKK in Germany. Intellectual Property Our intellectual property efforts have focused on improvements to the patents that we licensed from MIT, which expired in 2023.
Some new products have been introduced that compete with the MyoPro from companies such as Neurolutions in the United States and Vincent Systems and HKK Bionics in Germany. Intellectual Property Our intellectual property efforts have focused on improvements to the patents that we licensed from MIT, which expired in 2023. Myomo has 35 of its own issued patents.
If we receive a pre-authorization, we will proceed to complete the aforementioned activities resulting in the delivery of a 7 Table of Contents MyoPro to the patient. This process is what we refer to as direct billing.
If we receive a pre-authorization, we will proceed to complete the aforementioned activities resulting in the delivery of a MyoPro to the patient. This go-to-market approach is what we refer to as direct billing.
Under direct billing, we evaluate, measure and fit the MyoPro devices using our own clinical staff or as circumstances dictate, utilize the clinical consulting services of orthotics and prosthetics, or O&P, professionals, for which they are paid a fee.
Under direct billing, we evaluate, measure and fit the MyoPro devices using our own clinical staff or as circumstances dictate, utilize the clinical consulting services of orthotics and prosthetics, or O&P.
On June 9, 2017, we executed our initial public offering, and our common stock trades under the symbol “MYO.” Our principal executive offices are located at 45 Blue Sky Drive, Suite 101, Burlington, MA 01803, and our telephone number is (617) 996-9058.
Our common stock trades under the symbol “MYO.” Our principal executive offices are located at 45 Blue Sky Drive, Suite 101, Burlington, MA 01803, and our telephone number is (617) 996-9058.
If an O&P provider is responsible for working with and delivering the MyoPro to the patient, then we sell the custom-fabricated MyoPro device to the O&P provider at a wholesale price, to which they add their clinical services. In November 2018, CMS issued two billing codes for the MyoPro, L8701 and L8702.
If an O&P provider is responsible for working with and delivering the MyoPro to the patient, then we sell the custom-fabricated MyoPro device to the O&P provider at a wholesale price, to which they add their clinical services.
Sales and Marketing Our strategic goal is to develop and commercialize products that become the standard of care for individuals with paralysis who cannot be successfully treated with conventional interventions such as rehabilitation therapy.
The study is expected to enroll approximately 50 participants and follow them for six months. Sales and Marketing Our strategic goal is to develop and commercialize products that become the standard of care for individuals with paralysis who cannot be successfully treated with conventional interventions such as rehabilitation therapy.
With a first-mover advantage in the U.S. and a presence in international markets such as Germany and the United Kingdom, we believe we are well-positioned to meet the large global need that we believe exists for individuals with upper limb paralysis.
With a first-mover advantage in the U.S. and a presence in international markets such as Germany and the United Kingdom, we believe we are well-positioned to meet the large global need that we believe exists for individuals with upper limb paralysis. To generate awareness and interest in our products, we advertise on television and through social media.
As of December 31, 2024, 1,389 patients were in our reimbursement pipeline, a 33% increase compared to 1,042 patients in the pipeline at December 31, 2023.
As of December 31, 2025, 1,528 patients were in our reimbursement pipeline, a 10% increase compared to 1,389 patients in the pipeline at December 31, 2024.
Next, the patient’s medical records are collected and reviewed to make sure the device is appropriate for their condition and a prescription is typically obtained from the patient’s physician in conjunction with a face-to-face visit.
Next, the patient’s medical records are collected and reviewed to make sure the device is appropriate for their condition and 8 Table of Contents a standard written order is obtained from the patient’s physician in conjunction with a face-to-face visit.
To bring the MyoPro to what we believe is the large number of potential patients outside of the United States, in July 2017 we met the criteria to apply the CE mark under the European Union (EU) Medical Devices Directive (93/42/EEC), or EU MDD, which is a manufacturer’s declaration that the product complies with the essential requirements of such legislation, so that the MyoPro can be marketed in the EU.
To bring the MyoPro to what we believe is the large number of potential patients outside of the United States, we met the criteria to apply the CE mark under the European Union (EU) Medical Devices Directive, or EU MDD, following the applicable conformity assessment procedure and our declaration of conformity that the product complies with the essential requirements of such legislation, so that the MyoPro can be marketed in the EU.
According to the American Orthotics and Prosthetics Association, there are more than 2,000 member O&P facilities located in the United States. Additionally, the VA has been a pioneer in O&P. In fact, the design of the MyoPro Motion G powered grasp product is rooted in research conducted at the Boston-area VA in the 1990s.
There are approximately 3,000 O&P facilities located in the United States. Additionally, the VA has been a pioneer in O&P. In fact, the design of the MyoPro Motion G powered grasp product is rooted in research conducted at the Boston-area VA in the 1990s.
Since its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of the ACA, and we expect there will be additional challenges and amendments to the ACA in the future. On June 17, 2021, the U.S.
If any such changes were to be imposed, they could adversely affect the operation of our business. Since its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of the ACA, and we expect there will be additional challenges and amendments to the ACA in the future. On June 17, 2021, the U.S.
In addition, we 3 Table of Contents estimate that approximately 250,000 new patients are added to the prevalence population each year in the United States as a result of strokes, brachial plexus injuries and other afflictions. Though not all these new chronic patients are suitable for a MyoPro, we believe that between 25,000-50,000 of these patients per year could be.
In addition, we estimate that approximately 400,000 to 500,000 new patients are added to the prevalence population each year in the United States as a result of strokes. Though not all these new chronic patients are suitable for a MyoPro, we believe that between 40,000-80,000 of these patients per year could be.
Myomo has 35 of its own issued patents. These additional patents cover our MyoPro Motion G product. The Motion G product, which allows for the movement of multiple joints as compared to a single joint, which is the technology that underlies the patents previously licensed from MIT.
These additional patents cover our MyoPro Motion G product. The Motion G product, which allows for the movement of multiple joints as compared to a single joint, which is the technology that underlies the patents previously licensed from MIT. The Motion G generated 96% of our product revenue for the year ended December 31, 2025.
We have been successful in obtaining coverage for the MyoPro on a case by case basis and we continue to follow up on other cases in our reimbursement pipeline which are pending an insurance decision. As of January 1, 2019, two HCPCS codes for the MyoPro, L8701 and L8702, issued by CMS, went into effect.
We have been successful in obtaining coverage for the MyoPro on a case-by-case basis and we continue to follow up on other cases in our reimbursement pipeline which are pending an insurance decision.
The Motion G generated 98% of our product revenue for the year ended December 31, 2024. In January 2013, Myomo’s patent entitled Powered Orthotic Device was granted in Europe (European Patent No. 2079361), which is validated (currently in force) in six European countries. In June 2014, a substantially similar patent was granted in Japan (Japanese Patent No. 5557529).
In January 2013, Myomo’s patent entitled Powered Orthotic Device was granted in Europe (European Patent No. 2079361), which is validated (currently in force) in six European countries. In June 2014, a substantially similar patent was granted in Japan (Japanese Patent No. 5557529).
We, together with Cogmedix, our primary contract manufacturer, actively maintain a quality management system for product design and development, manufacturing, distribution, and customer feedback processes in accordance with FDA’s QSR and ISO 13485:2016. In February 2024, the FDA issued the Quality Management System Regulation Final Rule to amend the QSR, incorporating by reference ISO 13485:2016.
We, together with Cogmedix, our primary contract manufacturer, actively maintain a quality management system for product design and development, manufacturing, distribution, and customer feedback processes in accordance with FDA’s QMSR and ISO 13485:2016.
We have been testing our planned pediatric device on children who have suffered this nerve damage to assess its ability to improve function in upper limbs, and this new version of the MyoPro, which we refer to as MyoPal, is expected to be available to these patients in the next one to two years.
We have a planned pediatric device on children who have suffered this nerve damage to assess its ability to improve function in upper limbs, and this new version of the MyoPro, which we refer to as MyoPal, is included in our product roadmap, after release of the MyoPro 3.
Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA. It is unclear how other healthcare reform measures in Congress or through executive orders, if any, to challenge repeal or replace the ACA, will impact our business.
Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA. It is unclear how future legislative, regulatory, or administrative actions aimed at healthcare reform, if any, may impact our business.
Moreover, efforts to ensure that our business arrangements comply with applicable healthcare laws may involve substantial costs. It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations.
It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations, including evolving enforcement theories and the increased use of data analytics by enforcement authorities.
The addressable market in the United States for products directed at all individuals with upper extremity paralysis, such as our MyoPro, is based on an estimated prevalence of 1% of the population, which is the prevalence of people who have suffered a stroke in the U.S., or an estimated 3 million existing cases of upper extremity paralysis.
The addressable market in the United States for products directed at all individuals with upper extremity paralysis, such as our MyoPro, is based on an estimated prevalence of 6.3 million people in the U.S. who have suffered a stroke according to Frontiers in Neurology, with approximately 60% of those having moderate to severe upper extremity impairment that persists up to six months after a stroke, or 3.8 million people.
Information on our investor relations page and on our website is not part of this Annual Report on Form 10-K or any of our other securities filings unless specifically incorporated herein or therein by reference.
Information on our investor relations page and on our website is not part of this Annual Report on Form 10-K or any of our other securities filings unless specifically incorporated herein or therein by reference. In addition, our filings with the SEC may be accessed through the SEC's Electronic Data Gathering, Analysis and Retrieval (EDGAR) system at www.sec.gov.
Manufacturing Myomo’s custom fabricated orthosis is comprised of two elements. The first is the electromechanical kit. The kit consists of the motor units, processor, sensors, and battery. Manufacturing for the electromechanical kit is provided by our supplier Cogmedix, a wholly owned subsidiary of Coughlin Companies in Worcester, MA.
The first is the electromechanical kit. The kit consists of the motor units, processor, sensors, and battery. Manufacturing for the electromechanical kit is provided by our supplier Cogmedix, a wholly owned subsidiary of Coughlin Companies in Worcester, MA. As part of our cost reduction plans, we intend to insource a portion of the manufacturing for these items in 2026.
Companies in this space include Lifeward, Ekso Bionics, and Cyberdyne. It is possible that companies may begin to compete with solutions such as ours for the upper extremity.
Exoskeleton Suits During the last few years, a number of companies have emerged to provide exoskeleton suits that enable those with lower extremity paralysis to stand and walk again. Companies in this space include Lifeward, Ekso Bionics, and Cyberdyne. It is possible that companies may begin to compete with solutions such as ours for the upper extremity.
Our regulatory, clinical, and customer service personnel work closely with our suppliers and providers to promote compliance with quality standards and good manufacturing processes, which we believe result in a high-quality product and limited customer issues.
Our regulatory, clinical, and customer service personnel work closely with our suppliers and providers to promote compliance with quality standards and good manufacturing processes, which we believe result in a high-quality product and limited customer issues. 7 Table of Contents We have continually enhanced our product offerings by increasing functionality for users by the addition of a multi-articulated wrist and introducing a powered grasp for the hand.
The rule will become effective on February 2, 2026. Until then, manufacturers are required by the FDA to comply with the QSR. Following the introduction of a product, the FDA and comparable foreign agencies may engage in periodic audits of our quality management system, the product performance, and our advertising and promotional materials.
Following the introduction of a product, the FDA and comparable foreign agencies may engage in periodic audits of our quality management system, the product performance, and our advertising and promotional materials.
In October 2017, we obtained our medical device license for Canada, enabling us to provide the MyoPro to patients in that country. We have entered into agreements with O&P providers in the United Kingdom, Denmark, Germany, Italy and Australia, and have received a number of MyoPro orders from providers outside the United States in 2024, primarily from Germany.
We also obtained our medical device license for Canada, enabling us to provide the MyoPro to patients in that country. We have entered into agreement with O&P providers in the United Kingdom, Denmark, Germany, Italy, and Australia. Competition An individual with difficulty walking has a wide range of technological alternatives from canes and crutches to powered wheelchairs and exoskeleton suits.
In conjunction with our reclassification into the brace benefit category, on February 29, 2024, CMS published final payment determinations for the MyoPro Motion W (L8701) and for the MyoPro Motion G (L8702) which became effective April 1, 2024.
Two HCPCS codes for the MyoPro, L8701 and L8702, issued by CMS, are in effect. under the brace benefit category, which makes the MyoPro eligible to be reimbursed on a lump sum On February 29, 2024, CMS published final payment determinations for the MyoPro Motion W (L8701) and for the MyoPro Motion G (L8702) which became 14 Table of Contents effective April 1, 2024.
Until EUDAMED is fully functional, the corresponding provisions of the EU MDD continue to apply.
Until the relevant EUDAMED model is fully functional and mandatory use commences, the corresponding provisions of the EU MDD continue to apply in line with MDR transitional arrangements and guidance.
Healthcare and Privacy Laws and Regulation As an accredited Medicare provider, we are subject to broadly applicable fraud and abuse and other healthcare laws and regulations.
Healthcare and Privacy Laws and Regulation As an accredited Medicare provider, we are subject to broadly applicable fraud and abuse and other healthcare laws and regulations. CMS recently mandated that DMEPOS providers be subject to reaccreditation on an annual basis, beginning with the annual period after expiration of the current accreditation.
We plan, depending on available resources, to continually improve our system architecture and develop new product innovations based on our product roadmap and clinician feedback to increase the value and breadth of our product offerings. Clinical Research Studies Evidence of effectiveness involving myoelectric orthotics dates back to 1967.
In April 2025, we introduced the MyoPro2x, which incorporates more intuitive donning on top of other features, including 3D printed orthotics capability and software enhancements. We plan, depending on available resources, to continually improve our system architecture and develop new product innovations based on our product roadmap and clinician feedback to increase the value and breadth of our product offerings.
Employees and Human Capital As of December 31, 2024, we employed a total of 184 full time employees and 1 part time employee. All employees are subject to contractual agreements that specify requirements for confidentiality, ownership of newly developed intellectual property and restrictions on working for competitors as well as other matters.
All employees are subject to contractual agreements that specify requirements for confidentiality, ownership of newly developed intellectual property and restrictions on working for competitors as well as other matters. None of our employees are represented by labor unions or covered by collective bargaining agreements, and we have experienced no work stoppages.
Our current capacity is 120 units per month, and we have the ability to expand manufacturing capacity in this facility, as demand increases. If the volume and geographic reach of our sales expand further, we may seek additional sources for manufacturing and custom fabrication of the devices as our needs may require, or expand our manufacturing space and capacity.
If the volume and geographic reach of our sales expand further, we may seek additional sources for manufacturing and custom fabrication of the devices as our needs may require, or expand our manufacturing space and capacity. Employees and Human Capital As of December 31, 2025, we employed a total of 194 ful-time employees and 1 part-time employee.
In November 2023, CMS reclassified the MyoPro into the brace benefit category, effective January 1, 2024. Previously, CMS had classified the MyoPro as durable medical equipment, reimbursed on a rental basis. With the classification as a brace, the MyoPro is eligible to be reimbursed on a lump sum basis by CMS similar to other commercial insurance payers.
With the classification as a brace, the MyoPro is eligible to be reimbursed on a lump sum basis by CMS similar to other commercial insurance payers and on February 29, 2024, CMS published final payment determinations for these codes, which became effective April 1, 2024.
In respect of medical devices, since the end of the Brexit transitional period on January 1, 2021, new regulations require medical devices to be registered with the Medicines and Healthcare products Regulatory Agency, or MHRA (the UK medicines and medical devices regulator) before being placed on the Great Britain market.
The aforementioned EU rules are generally applicable in the European Economic Area, or EEA, which consists of the EU member states plus Norway, Liechtenstein and Iceland. 11 Table of Contents In the UK regulations require medical devices to be registered with the Medicines and Healthcare products Regulatory Agency, or MHRA (the UK medicines and medical devices regulator) before being placed on the Great Britain market.
In January 2025, we completed the move of our manufacturing operations from Boston to our new headquarters facility in Burlington, MA. We have double the manufacturing floor space compared to our prior facility in Boston, and our available manufacturing space will increase again when we take possession of an additional 7,500 square feet of manufacturing space in June 2025.
We have double the manufacturing floor space compared to our prior facility in Boston. Our available capacity further increased when we took possession of an additional 7,500 square feet of manufacturing space in July 2025. Our current capacity is 120 units per month, and we have the ability to expand manufacturing capacity in this facility as demand increases.
These fees were subsequently updated to approximately $34,300 for the Motion W and approximately $67,500 for the Motion G, effective January 1, 2025. Published fees are subject to annual inflationary adjustments.
These fees are typically updated annually to account for inflation and were recently updated to approximately $34,970 for the Motion W and approximately $68,800 for the Motion G, effective January 1, 2026, subject to annual fee schedule updates and future CMS rulemaking.
Rehabilitation Therapy Rehabilitation therapy is the standard of care for upper extremity paralysis and a prerequisite to qualifying for a myoelectric orthosis such as the MyoPro. After a stroke or other traumatic injury, a large portion of survivors regain much or all of their function.
However, those with paralysis of the arm, wrist, and hand, whose physical challenges that we seek to address, have few options to regain function. Rehabilitation Therapy Rehabilitation therapy is the standard of care for upper extremity paralysis and a prerequisite to qualifying for a myoelectric orthosis such as the MyoPro.
However, every year there are many survivors whose upper extremities remain paralyzed despite best efforts of rehabilitation therapists. Non-Powered Braces Some individuals are able to accomplish their functional goals with braces that are non-powered or use springs to offset forces of gravity or muscle tightness, referred to as spasticity.
Non-Powered Braces Some individuals are able to accomplish their functional goals with braces that are non-powered or use springs to offset forces of gravity or muscle tightness, referred to as spasticity. Medical professionals who evaluate patients for myoelectric orthotics screen out individuals who could accomplish their goals with a simpler, less costly intervention such as these braces.
The second element is the custom fabrication of the orthosis itself from measurements obtained either in person or remotely. A third-party, AB Corp, creates the orthotic parts from these measurements and the fabrication of the device is done in our facility in Burlington, Massachusetts. Coverage for the MyoPro from CMS is expected to increase sales volumes for the MyoPro.
A third-party, AB Corp, creates the orthotic parts from these measurements and the fabrication of the device is done in our facility in Burlington, Massachusetts. 15 Table of Contents In January 2025, we completed the move of our manufacturing operations from Boston to our new headquarters facility in Burlington, MA.
To generate awareness and interest in our products, we perform in-services for therapists and physicians, and we directly educate and inform those individuals who are potential candidates for our products. In addition, we utilize digital ads on various platforms as well as television ads.
In addition, our clinical teams educate therapists and physicians through in-services and other educational events, which can lead to patient referrals under a new program we refer to as MyoConnect, and we directly educate and inform those individuals who are potential candidates for our products.
None of our employees are represented by labor unions or covered by collective bargaining agreements, and we have experienced no work stoppages. We consider our relationship with our employees to be good. We believe that our future success largely depends upon our continued ability to attract and retain highly skilled employees and personnel.
We consider our relationship with our employees to be good. We believe that our future success largely depends upon our continued ability to retain highly skilled employees and personnel. Our human capital resources objectives include identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants.
Currently, the DME MACs are reimbursing claims upon submission and may conduct post-reimbursement audits in the future to determine if claims for medically appropriate patients are being submitted. 13 Table of Contents Medicare Advantage insurance plans are obligated to reimburse for the MyoPro, so long as the device is deemed to be medically necessary for their beneficiaries as well as not experimental or investigational.
Medicare Advantage insurance plans are obligated to provide coverage that is no less than that available under the original Medicare (and therefore to cover and reimburse for the MyoPro), so long as the device is deemed to be medically necessary for their beneficiaries, subject to plan-specific coverage policies, utilization management practices, and determinations, regarding whether the device is not experimental or investigational.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeThese factors include, among other things: • our ability to obtain sufficient reimbursement from third-party payers for our products; • our ability to scale the business to return to positive cash flow from operations on a quarterly basis by the fourth quarter 2025; • our revenue concentration with Medicare and with a particular insurance payer as a result of focusing our efforts on patients with insurers who have previously reimbursed for the MyoPro; • our ability to continue normal operations and patient interactions without supply chain disruption in order to deliver and fit our custom-fabricated devices; • our marketing and commercialization efforts; • our dependence upon external sources for the financing of our operations, to the extent that we do not achieve or maintain cash flow breakeven; • our ability to obtain and maintain our strategic collaborations and to realize the intended results of such collaborations; • our ability to effectively execute our business plan and scale up our operations; • our ability to remediate the material weakness in our internal control over financial reporting; • our expectations as to our product development programs, including improving our existing products and developing new products; • our ability to maintain and grow our reputation and to achieve and maintain the market acceptance of our products; • our expectations as to our clinical research program and clinical results; • our ability to maintain adequate protection of our intellectual property and to avoid violation of the intellectual property rights of others; • our ability to gain and maintain regulatory approvals; • our ability to compete and succeed in a highly competitive and evolving industry; and • general market, economic, environmental and social factors that may affect the evaluation, fitting, delivery and sale of our products to patients; and • other risks and uncertainties, including those listed under the captain “Risk Factors” in this Annual Report on Form 10-K.
Biggest changeThese factors include, among other things: • our ability to achieve or obtain sufficient reimbursement from third-party payers for our products; • our dependence on external sources for the financing of our operations; • our ability to scale the business to return to positive cash flow from operations; • our revenue concentration with Medicare Part B insurance coverage; • our ability to continue normal operations and patient interactions without supply chain disruption in order to deliver and fit our custom-fabricated devices; • our marketing and commercialization efforts; • our ability to obtain and maintain our strategic collaborations and to realize the intended results of such collaborations; • our ability to effectively execute our business plan and scale up our operations; • our expectations as to our product development programs, including improving our existing products and developing new products; • our ability to maintain and grow our reputation and to achieve and maintain the market acceptance of our products; • our expectations as to our clinical research program and clinical results; • our ability to maintain adequate protection of our intellectual property and to avoid violation of the intellectual property rights of others; • our ability to gain and maintain regulatory approvals; • our ability to compete and succeed in a highly competitive and evolving industry; and • general market, economic, environmental and social factors that may affect the evaluation, fitting, delivery and sale of our products to patients; and • other risks and uncertainties, including those listed under the captain “Risk Factors” in this Annual Report on Form 10-K.
Risks Related to Government Regulation Risks Related to Healthcare Industry We are subject to extensive governmental regulations relating to the design, development, manufacturing, labeling and marketing, delivery and billing of our products, and a failure to comply with such regulations could lead to withdrawal or recall of our products from the market.
Risks Related to Government Regulation Risks Related to Healthcare Industry We are subject to extensive governmental regulations relating to the design, development, manufacturing, labeling, marketing, delivery and billing of our products, and a failure to comply with such regulations could lead to withdrawal or recall of our products from the market.
Enforcing a claim that a third-party illegally obtained and is using our trade secrets is expensive and time consuming, and the outcome is unpredictable. We also have taken precautions to initiate reasonable safeguards to protect our information technology systems.
Enforcing a claim that a third-party illegally obtained and is using our trade secrets is expensive and time consuming, and the outcome is unpredictable. We have also taken precautions to initiate reasonable safeguards to protect our information technology systems.
Expanding market acceptance of MyoPro products could be negatively impacted by many other factors, including, but not limited to: • patient outcomes not meeting expectations; • lack of sufficient evidence supporting the benefits of MyoPro over competitive products or other available treatment, or lifestyle management to accommodate the disability; • patient resistance to wearing an external device or making required insurance co-payments; • limitations on the ability of patients to complete evaluations and fittings, including adverse changes in their health, or other environmental, social and economic barriers to patient access; • results of clinical studies relating to MyoPro or similar products; • claims that MyoPro, or any component thereof, infringes on patent or other intellectual property rights of third parties; 19 Table of Contents • perceived risks associated with the use of MyoPro or similar products or technologies; 2 • the introduction of new competitive products or greater acceptance of competitive products; • adverse regulatory or legal actions relating to MyoPro or similar products or technologies; and • problems arising from the insourcing of our manufacturing capabilities, or our existing manufacturing and supply relationships with third parties.
Expanding market acceptance of MyoPro products could be negatively impacted by many other factors, including, but not limited to: • patient outcomes not meeting expectations; 20 Table of Contents • lack of sufficient evidence supporting the benefits of MyoPro over competitive products or other available treatment, or lifestyle management to accommodate the disability; • patient resistance to wearing an external device or making required insurance co-payments; • limitations on the ability of patients to complete evaluations and fittings, including adverse changes in their health, or other environmental, social and economic barriers to patient access; • results of clinical studies relating to MyoPro or similar products; • claims that MyoPro, or any component thereof, infringes on patent or other intellectual property rights of third parties; • perceived risks associated with the use of MyoPro or similar products or technologies; 2 • the introduction of new competitive products or greater acceptance of competitive products; • adverse regulatory or legal actions relating to MyoPro or similar products or technologies; and • problems arising from the insourcing of our manufacturing capabilities, or our existing manufacturing and supply relationships with third parties.
Moreover, there are significant costs and risks inherent in selling our products, particularly in international markets, including: (a) time and difficulty in building a widespread network of distribution partners; (b) increased shipping and distribution costs, which could increase our expenses and reduce our margins; (c) potentially lower margins in some regions; (d) longer collection cycles in some regions; (e) compliance with foreign laws and regulations; (f) compliance 25 Table of Contents with anti-bribery, anti-corruption, and anti-money laundering laws, such as the Foreign Corrupt Practices Act and the Office of Foreign Assets Control regulations, by us, our employees, and our business partners; (g) currency exchange rate fluctuations and related effects on our results of operations; (h) economic weakness, including inflation, or political instability in foreign economies and markets; (i) compliance with tax, employment, immigration, and labor laws for employees living or traveling abroad; (j) workforce uncertainty in countries where labor unrest is more common than in the United States; (k) business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters, including earthquakes, typhoons, floods and fires; and (l) other costs and risks of doing business internationally, such as new tariffs which may be imposed.
Moreover, there are significant costs and risks inherent in selling our products, particularly in international markets, including: (a) time and difficulty in building a widespread network of distribution partners; (b) increased shipping and distribution costs, which could increase our expenses and reduce our margins; (c) potentially lower margins in some regions; (d) longer collection cycles in some regions; (e) compliance with foreign laws and regulations; (f) compliance with anti-bribery, anti-corruption, and anti-money laundering laws, such as the Foreign Corrupt Practices Act and the Office of Foreign Assets Control regulations, by us, our employees, and our business partners; (g) currency exchange rate fluctuations and related effects on our results of operations; (h) economic weakness, including inflation, or political instability in foreign economies and markets; (i) compliance with tax, employment, immigration, and labor laws for employees living or traveling abroad; (j) workforce uncertainty in countries where labor unrest is more common than in the United States; (k) business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters, including earthquakes, typhoons, floods and fires; and (l) other costs and risks of doing business internationally, such as new tariffs which may be imposed.
If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of noncompliance with 29 Table of Contents these laws, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business, financial condition and results of operations.
If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of noncompliance with these laws, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our 30 Table of Contents operations, any of which could adversely affect our ability to operate our business, financial condition and results of operations.
Fluctuations in our quarterly and annual financial results have resulted and will continue to result from numerous factors, including: • timing, number and dollar value of reimbursements of our products by insurance payers; • changes in the mix of products we sell; • strategic actions by us, such as acquisitions of businesses, products, or technologies; • effects of domestic and foreign economic conditions and exchange rates on our industry and/or customers; • the divestiture or discontinuation of a product line or other revenue generating activity; • the relocation and integration of manufacturing operations and other strategic restructuring; • regulatory actions which may necessitate recalls of our products or warning letters that negatively affect the markets for our products; • costs incurred by us in connection with the termination of contractual and other relationships, including distributorships; • our ability to collect outstanding accounts receivable; • the expiration or exhaustion of deferred tax assets such as net operating loss carryforwards; • increased product and price competition, due to reimbursement of our products by Medicare, the regulatory landscape, market conditions or other factors; • technology changes to enhance individual data privacy that could negatively impact our ability to market our products to prospective candidates and could result in increased advertising costs; • market reception of our new or improved product offerings; and • the loss of any significant customer.
Fluctuations in our quarterly and annual financial results have resulted and will continue to result from numerous factors, including: • timing, number and dollar value of reimbursements of our products by insurance payers; • changes in the mix of products we sell; 17 Table of Contents • strategic actions by us, such as acquisitions of businesses, products, or technologies; • effects of domestic and foreign economic conditions and exchange rates on our industry and/or customers; • the divestiture or discontinuation of a product line or other revenue generating activity; • the relocation and integration of manufacturing operations and other strategic restructuring; • regulatory actions which may necessitate recalls of our products or warning letters that negatively affect the markets for our products; • costs incurred by us in connection with the termination of contractual and other relationships, including distributorships; • our ability to collect outstanding accounts receivable; • the expiration or exhaustion of deferred tax assets such as net operating loss carryforwards; • increased product and price competition, due to reimbursement of our products by Medicare, the regulatory landscape, market conditions or other factors; • technology changes to enhance individual data privacy that could negatively impact our ability to market our products to prospective candidates and could result in increased advertising costs; • market reception of our new or improved product offerings; and • the loss of any significant customer.
Depending on the circumstances, failure to meet applicable regulatory requirements can result in civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion from participation in federal and state funded healthcare programs, contractual damages, reputational harm and the curtailment or restricting of our operations, as well as additional reporting 28 Table of Contents obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws.
Depending on the circumstances, failure to meet applicable regulatory requirements can result in civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion from participation in federal and state funded healthcare programs, contractual damages, reputational harm and the curtailment or restricting of our operations, as well as additional reporting 29 Table of Contents obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws.
If we or our third-party manufacturers or key suppliers fail to comply with the applicable good manufacturing practice requirements, including FDA’s Quality System Regulation, our manufacturing operations could be interrupted.
If we or our third-party manufacturers or key suppliers fail to comply with the applicable good manufacturing practice requirements, including FDA’s Quality Management System Regulation, our manufacturing operations could be interrupted.
Obtaining premarket clearance or approval could significantly increase our regulatory costs, including expense associated with required preclinical (animal) and clinical (human) trials, more extensive mechanical and electrical testing and other costs. We are registered with the FDA as a manufacturer for medical devices. We are also subject to regulation by foreign governmental agencies in connection with international sales.
Obtaining premarket clearance or approval could significantly increase our regulatory costs, including expenses associated with required preclinical (animal) and clinical (human) trials, more extensive mechanical and electrical testing and other costs. We are registered with the FDA as a manufacturer for medical devices. We are also subject to regulation by foreign governmental agencies in connection with international sales.
Our facilities are subject to periodic and unannounced inspection by U.S. and foreign regulatory agencies to audit compliance with the QSR, and comparable foreign regulations. The process of complying with the applicable QSR, medical device reporting, and other requirements can be costly and time consuming, and could delay or prevent the production, manufacturing or sale of the MyoPro.
Our facilities are subject to periodic and unannounced inspection by U.S. and foreign regulatory agencies to audit compliance with the QMSR, and comparable foreign regulations. The process of complying with the applicable QMSR, medical device reporting, and other requirements can be costly and time consuming, and could delay or prevent the production, manufacturing or sale of the MyoPro.
Industrial and medical robotics is characterized by intense competition and rapid technological change, and we will face competition on the basis of product features, clinical outcomes, price, services and other factors. We are experiencing competition in the United States from companies such as Neurolutions, and in Germany from companies such as Vincent Systems and HKK Bionics.
Industrial and medical robotics is characterized by intense competition and rapid technological change, and we will face competition on the basis of product features, clinical outcomes, price, services and other factors. We are experiencing competition in the United States from companies such as Neurolutions and MicroTransponder, Inc., and in Germany from companies such as Vincent Systems and HKK Bionics.
To our knowledge, from inception through December 31, 2024, fewer than 50 units have been self-paid or funded by non-profit foundations. Some commercial health insurance plans have published statements that they will not cover the cost of the MyoPro for their members.
To our knowledge, from inception through December 31, 2025, fewer than 50 units have been self-paid or funded by non-profit foundations. Some commercial health insurance plans have published statements that they will not cover the cost of the MyoPro for their members.
Any cyber-attack or security compromise or incident that 30 Table of Contents leads to unauthorized access, use, disclosure, loss, corruption or other compromise of confidential and/or proprietary information or other sensitive information could harm our reputation, cause us not to comply with federal and/or state breach notification laws and foreign law equivalents and otherwise subject us to liability under laws and regulations, including those that protect the privacy and security of personal information.
Any cyber-attack or security compromise or incident that leads to unauthorized access, use, disclosure, loss, corruption or other compromise of confidential and/or proprietary information or other sensitive information could harm our reputation, cause us not to comply with federal and/or state breach notification laws and foreign law equivalents and otherwise subject us to liability under laws and regulations, including those that protect the privacy and security of personal information.
If we do proceed with acquisitions, we do not know if we will be able to identify acquisitions we deem suitable, whether we will be able to successfully complete any such acquisitions on favorable terms or at all, or whether we will be able to successfully 26 Table of Contents integrate any acquired products or technologies.
If we do proceed with 27 Table of Contents acquisitions, we do not know if we will be able to identify acquisitions we deem suitable, whether we will be able to successfully complete any such acquisitions on favorable terms or at all, or whether we will be able to successfully integrate any acquired products or technologies.
Although the UK is regarded as a third country under the EU GDPR, the European Commission (“EC”) has now issued a decision recognizing the UK as providing adequate protection under the EU GDPR and, therefore, transfers of personal data originating in the EEA to the UK remain unrestricted.
Although the UK is regarded as a third country under the EU GDPR, the European Commission (“EC”) issued a decision recognizing the UK as providing adequate protection under the EU GDPR and, therefore, transfers of personal data originating in the EEA to the UK remain unrestricted.
There can be no assurance that the final fees will be sufficient to permit us to generate gross margin required to allow us to operate on a profitable basis. Third-party payers also may continue to deny or limit coverage, limit reimbursement or reduce their levels of payment, or our costs of production may increase faster than increases in reimbursement levels.
There can be no assurance that these fees will be sufficient to permit us to generate gross margin required to allow us to operate on a profitable basis. Third-party payers may also continue to deny or limit coverage, limit reimbursement or reduce their levels of payment, or our costs of production may increase faster than increases in reimbursement levels.
Infringement actions and other intellectual property claims brought against us, with or without merit, may cause us to incur substantial costs and could place a significant strain on our financial resources, divert the attention of management and harm our reputation. We cannot be certain that we will successfully defend against any allegations of infringement.
Infringement actions and other intellectual property claims brought against us, with or without merit, may cause us to incur substantial costs and could place a significant strain on our financial resources, divert the attention of 36 Table of Contents management and harm our reputation. We cannot be certain that we will successfully defend against any allegations of infringement.
We have benefited substantially from the leadership and performance of our senior management and other key employees. We do not carry key person insurance. Our success will depend on our ability to retain our current management and key employees.
We depend on the knowledge and skills of our senior management. We have benefited substantially from the leadership and performance of our senior management and other key employees. We do not carry key person insurance. Our success will depend on our ability to retain our current management and key employees.
If we, or Cogmedix, fail to obtain sufficient quantities of high-quality components to meet demand on a timely basis, or fail to effectively oversee the regulatory compliance of the supply chain, we could face regulatory enforcement, have to conduct recalls, lose customer orders, our reputation may be harmed, and our business could suffer.
If we, or Cogmedix, fail to obtain sufficient quantities of high-quality components to meet demand on a timely basis, or fail to effectively oversee the regulatory compliance of the supply 21 Table of Contents chain, we could face regulatory enforcement, have to conduct recalls, lose customer orders, our reputation may be harmed, and our business could suffer.
Cogmedix also may have difficulty obtaining similar components from other suppliers that are acceptable to the FDA or other regulatory agencies, and the failure of Cogmedix’s suppliers to comply with strictly enforced regulatory requirements could expose us to regulatory action including warning letters, 20 Table of Contents product recalls, termination of distribution, product seizures or civil penalties.
Cogmedix also may have difficulty obtaining similar components from other suppliers that are acceptable to the FDA or other regulatory agencies, and the failure of Cogmedix’s suppliers to comply with strictly enforced regulatory requirements could expose us to regulatory action including warning letters, product recalls, termination of distribution, product seizures or civil penalties.
We may undergo an ownership change in connection with future changes in our stock ownership (many of which are outside of our control), whereby our ability to utilize NOLs or credits could be further limited by Sections 382 and 383 of the Code or under corresponding provisions of state law.
We may undergo an ownership change in connection with future changes in our stock ownership (many of which are outside of our control), whereby our ability to utilize NOLs or credits could be further 42 Table of Contents limited by Sections 382 and 383 of the Code or under corresponding provisions of state law.
If we default on any future indebtedness, our lenders could declare all outstanding principal and interest to be due and payable and our secured lenders may foreclose on the facilities securing such indebtedness.
If we default on our existing or any future indebtedness, our lenders could declare all outstanding principal and interest to be due and payable and our secured lenders may foreclose on the facilities securing such indebtedness.
In some instances, competitors may also offer, or may attempt to develop, alternative therapies for disease states that may be delivered without a medical device. The development of new or improved products, processes or technologies by other companies may render our products or proposed products obsolete or less competitive.
In some 23 Table of Contents instances, competitors may also offer, or may attempt to develop, alternative therapies for disease states that may be delivered without a medical device. The development of new or improved products, processes or technologies by other companies may render our products or proposed products obsolete or less competitive.
This lack of clarity on future UK laws and regulations and their interaction with EU laws and regulations could add legal risk, complexity 32 Table of Contents and cost to our handling of European personal data and our privacy and data security compliance programs, and could require us to implement different compliance measures for the UK and the EEA.
This lack of clarity on future UK laws and regulations and their interaction with EU laws and regulations could add legal risk, complexity and cost to our handling of European personal data and our privacy and data security compliance programs, and could require us to implement different compliance measures for the UK and the EEA.
In addition, the cost of labor internally or at our third-party manufacturers could increase significantly due to regulation or inflationary pressures. Additionally, the cost of logistics and transportation fluctuates in large part due to the price of oil, and availability can be limited due to 17 Table of Contents political and economic issues.
In addition, the cost of labor internally or at our third-party manufacturers could increase significantly due to regulation or inflationary pressures. Additionally, the cost of logistics and transportation fluctuates in large part due to the price of oil, and availability can be limited due to political and economic issues.
We are under a continuing obligation to ensure that all applicable regulatory requirements, such as the FDA’s medical device good manufacturing practice / Quality System Regulation (“QSR”) requirements and the FDA’s medical device reporting requirements for certain device-related adverse events and malfunction, continue to be met.
We are under a continuing obligation to ensure that all applicable regulatory requirements, such as the FDA’s medical device good manufacturing practice / Quality Management System Regulation (“QMSR”) requirements and the FDA’s medical device reporting requirements for certain device-related adverse events and malfunction, continue to be met.
Our relationships with healthcare providers and physicians and third-party payers will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
Our relationships with healthcare providers and physicians and third-party payers are subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
We may not complete our analysis of our internal control over financial reporting in a timely manner, or these internal 38 Table of Contents controls may not be determined to be effective, which may harm investor confidence in our company and, as a result, the value of our common stock.
We may not complete our analysis of our internal control over financial reporting in a timely manner, or these internal controls may not be determined to be effective, which may harm investor confidence in our company and, as a result, the value of our common stock.
Adverse changes in the reimbursement policies of these payers regarding the MyoPro could have an adverse effect on our business. Revenues from providing the MyoPro directly to patients, a sales channel we refer to as direct billing, represented 78% and 71% of product revenues for the years ended December 31, 2024 and 2023, respectively.
Adverse changes in the reimbursement policies of these payers regarding the MyoPro could have an adverse effect on our business. Revenues from providing the MyoPro directly to patients, a sales channel we refer to as direct billing, represented 74% and 78% of product revenues for the years ended December 31, 2025 and 2024, respectively.
Similarly, if we fail to comply with applicable foreign regulatory requirements, 27 Table of Contents we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.
Similarly, if we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.
If other parties are able to use our proprietary technology or information, our ability 33 Table of Contents to compete in the market could be harmed. Further, unauthorized use of our intellectual property may have occurred, or may occur in the future, without our knowledge.
If other parties are able to use our proprietary technology or information, our ability to compete in the market could be harmed. Further, unauthorized use of our intellectual property may have occurred, or may occur in the future, without our knowledge.
Risks Related to Our Intellectual Property Our success depends in part on our ability to obtain and maintain protection for the intellectual property relating to or incorporated into our products. Our success depends in part on our ability to obtain and maintain protection for the intellectual property relating to or incorporated into our products.
Our success depends in part on our ability to obtain and maintain protection for the intellectual property relating to or incorporated into our products.
In addition, unauthorized parties may attempt to copy or reverse engineer certain aspects of our products that we consider proprietary or our proprietary information may otherwise become known or may be independently developed by our competitors or other third parties.
In addition, unauthorized parties may attempt to copy or reverse engineer certain aspects of our products that we consider 35 Table of Contents proprietary or our proprietary information may otherwise become known or may be independently developed by our competitors or other third parties.
Similar consumer privacy laws have passed or come into force in numerous U.S. states. Like the CCPA, these laws grant consumers rights in relation to their personal information and impose new obligations on regulated businesses, including, in some instances, broader data security requirements.
Similar consumer privacy laws have passed or come into force in numerous U.S. states. Like the CCPA, these laws grant consumers rights in relation to their personal information and impose new obligations on regulated businesses, 32 Table of Contents including, in some instances, broader data security requirements.
At the federal level, the FTC has used its authority over “unfair or deceptive acts or practices” to impose stringent requirements on the collection and disclosure of sensitive categories of personal information, including health 31 Table of Contents information.
At the federal level, the FTC has used its authority over “unfair or deceptive acts or practices” to impose stringent requirements on the collection and disclosure of sensitive categories of personal information, including health information.
Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. 39 Table of Contents Risks Related to Tax Laws We may be subject to adverse legislative or regulatory changes in tax laws that could negatively impact our financial condition.
Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. Risks Related to Tax Laws We may be subject to adverse legislative or regulatory changes in tax laws that could negatively impact our financial condition.
We undertake no obligation, other than as maybe be required by law, to re-issue this Annual Report on Form 10-K or otherwise make public statements updating our forward-looking statements. Item 1B. Unresolve d Staff Comments Not applicable.
We undertake no obligation, other than as maybe be required by law, to re-issue this Annual Report on Form 10-K or otherwise make public statements updating our forward-looking statements. 44 Table of Contents Item 1B. Unresolve d Staff Comments Not applicable.
These inquiries or letters, if not closed promptly, can result in fines, delays or suspensions of regulatory clearances, closure of manufacturing sites, seizures or recalls of products and damage to our reputation.
These inquiries or letters, if not closed promptly, can 28 Table of Contents result in fines, delays or suspensions of regulatory clearances, closure of manufacturing sites, seizures or recalls of products and damage to our reputation.
If we are found to infringe another party’s patents, we could be required to pay damages. We could also 34 Table of Contents be prevented from selling our products that infringe, unless we could obtain a license to use the technology covered by such patents or could redesign our products so that they do not infringe.
If we are found to infringe another party’s patents, we could be required to pay damages. We could also be prevented from selling our products that infringe, unless we could obtain a license to use the technology covered by such patents or could redesign our products so that they do not infringe.
Investments in advertising, R&D and clinical, reimbursement and manufacturing capacity could result in a delay in our ability to achieve cash flow breakeven on a quarterly basis. We have a history of losses since inception. For the years ended December 31, 2024 and 2023 we incurred net losses of $6.2 million and $8.1 million, respectively.
Investments in advertising, R&D and clinical, reimbursement and manufacturing capacity could result in a delay in our ability to achieve cash flow breakeven on a quarterly basis. We have a history of losses since inception. For the years ended December 31, 2025 and 2024 we incurred net losses of $15.6 million and $6.2 million, respectively.
A cyber-attack or security compromise or incident could cause interruptions in our operations and could result in a material disruption of our business operations, damage to our reputation or a loss of revenues.
A cyber-attack or security compromise or incident could cause 31 Table of Contents interruptions in our operations and could result in a material disruption of our business operations, damage to our reputation or a loss of revenues.
In December 2021, we entered into a technology license agreement and a trademark license agreement with the JV Company, under which we were entitled to receive a license fee of $2.7 million and the JV Company will commit to purchase a minimum of $10.75 million of MyoPro control units over the next ten years.
In December 2021, we entered into a technology license agreement and a trademark license agreement with the JV Company, under which we were entitled to receive a license fee of $2.7 million, which we received in 2023, and the JV Company committed to purchase a minimum of $10.75 million of MyoPro control units over the next ten years.
Often, different estimates, judgments and assumptions could reasonably be used that would have a material effect on such financial statements, and changes in these estimates, judgments and assumptions may occur from period to period over time.
Often, different estimates, judgments and assumptions could reasonably be used that would have a material effect on such financial 41 Table of Contents statements, and changes in these estimates, judgments and assumptions may occur from period to period over time.
Failure to manage our growth effectively could cause us to mis-allocate management or financial resources and result in losses or weaknesses in our infrastructure, systems, processes and controls, which could materially adversely affect our business.
Failure to manage our growth effectively could cause us to mis-allocate management or financial resources and result in losses or 26 Table of Contents weaknesses in our infrastructure, systems, processes and controls, which could materially adversely affect our business.
No assurance can be made to any investor by anyone that the expectations reflected in our forward-looking statements will be attained, or that deviations from them will not be 41 Table of Contents material and adverse.
No assurance can be made to any investor by anyone that the expectations reflected in our forward-looking statements will be attained, or that deviations from them will not be material and adverse.
Risks Related to Cybersecurity and Data Protection Our internal computer systems, or those of our customers, collaborators or other contractors, may be subject to cyber-attacks, compromises or security incidents, which could result in a material disruption of our product development programs.
Risks Related to Cybersecurity and Data Protection Our internal computer systems, or those of our customers, collaborators or other contractors, third-party service providers and vendors may be subject to cyber-attacks, compromises or security incidents, which could result in a material disruption of our product development programs.
We have registered the trademarks “MyoPro” (Registration No. 4,532,331), “MYOMO” (Registration No. 4,451,445), “MyoPal” (Registration No. 6,086,533) and “MyoCare” (Registration No. 6,579,736) in the United States. The MyoPro mark is registered in Canada and in selected EU countries with pending registration.
We have registered the trademarks “MyoPro” (Registration No. 4,532,331), “MYOMO” (Registration No. 4,451,445), “MyoPal” (Registration No. 6,086,533), “MyoCare” (Registration No. 6,579,736) and MyoCoach (Registration No. 6,867,077) in the United States. The MyoPro mark is registered in Canada and in selected EU countries.
There can be no assurance that such supplies will become less constrained in the future. Risks Related to Capital Requirements We may not have sufficient funds to meet our future capital requirements. Our cash, cash equivalents, short-term investments and restricted cash at December 31, 2024 was approximately $25.2 million.
There can be no assurance that such supplies will become less constrained in the future. Risks Related to Capital Requirements We may not have sufficient funds to meet our future capital requirements. Our cash, cash equivalents and short-term investments at December 31, 2025 was approximately $18.4 million.
Our amended and restated certificate of incorporation and bylaws include provisions that: • authorize our board of directors to issue preferred stock, without further stockholder action and with voting liquidation, dividend and other rights superior to our common stock; • establish an advance notice procedure for stockholder proposals to be brought before an annual meeting, including proposed nominations of persons for director nominees; • establish that our board of directors is divided into three classes, with directors in each class serving three-year staggered terms; • require the approval of holders of two-thirds of the shares entitled to vote at an election of directors to adopt, amend or repeal our bylaws or amend or repeal the provisions of our certificate of incorporation regarding the election and removal of directors and the ability of stockholders to take action by written consent or call a special meeting; • prohibit cumulative voting in the election of directors; and • provide that vacancies on our board of directors may be filled only by the vote of a majority of directors then in office, even though less than a quorum or by the holders of at least sixty-six and two-thirds percent (66 2/3%) of the issued and outstanding shares of common stock.
Our amended and restated certificate of incorporation and bylaws include provisions that: • authorize our board of directors to issue preferred stock, without further stockholder action and with voting liquidation, dividend and other rights superior to our common stock; • establish an advance notice procedure for stockholder proposals to be brought before an annual meeting, including proposed nominations of persons for director nominees; • establish that our board of directors is divided into three classes, with directors in each class serving three-year staggered terms; • require the approval of holders of two-thirds of the shares entitled to vote at an election of directors to adopt, amend or repeal our bylaws or amend or repeal the provisions of our certificate of incorporation regarding the election and removal of directors and the ability of stockholders to take action by written consent or call a special meeting; • prohibit cumulative voting in the election of directors; and • provide that vacancies on our board of directors may be filled only by the vote of a majority of directors then in office, even though less than a quorum or by the holders of at least sixty-six and two-thirds percent (66 2/3%) of the issued and outstanding shares of common stock. 40 Table of Contents These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors, which is responsible for appointing the members of our management.
For example, in January 2022, we announced the availability of MyoPro2+. Because MyoPro users generally do not have feeling in their upper extremities, they may not immediately notice adverse effects from updates to the MyoPro, which could exacerbate their impact.
For example, in April 2025, we announced the availability of MyoPro2x. Because MyoPro users generally do not have feeling in their upper extremities, they may not immediately notice adverse effects from updates to the MyoPro, which could exacerbate their impact.
The Federal NOLs incurred prior to 2018 of approximately $26.4 million, if not utilized, begin expiring in the year 2026. The Federal NOLs incurred after 2017 of approximately $52.6 million have an indefinite carryforward period. The state NOLs if not utilized begin to expire in 2025 through 2045.
The Federal NOLs incurred prior to 2018 of approximately $26.4 million, if not utilized, begin expiring in the year 2028. The Federal NOLs incurred after 2017 of approximately $70.8 million have an indefinite carryforward period. The state NOLs if not utilized begin to expire in 2026 through 2045.
In addition, the absence of in-network contracts with Medicare Advantage plans or commercial insurers could result in utilization management for out-of-network patients. Currently, we are almost entirely dependent on third parties to cover the cost of our products to patients and rely on their reimbursement for the cost of our products. If CMS, the U.S.
In addition, the absence of in-network contracts with Medicare Advantage plans or commercial insurers could result in heightened utilization management, prior authorization, or denials for out-of-network patients. Currently, we are almost entirely dependent on third parties to cover the cost of our products to patients and rely on their reimbursement for the cost of our products.
Further, any new contract manufacturer would need to be compliant with FDA regulations the international management system standard for medical systems set by the International Organization for Standardization (“ISO”), ISO 13485:2016. We also rely on third-party suppliers, including AB Corp, for 3D printed orthotic components. Some third-party suppliers contract directly with Cogmedix, to supply certain components of the MyoPro products.
Further, any new contract manufacturer would need to be compliant with FDA regulations and the international management system standard for medical systems set by the International Organization for Standardization (“ISO”), ISO 13485:2016. We also rely on third-party suppliers, including AB Corp, for 3D printed orthotic components.
If we fail to meet any of the NYSE American’s listing standards, our common stock may be delisted. In addition, our board may determine that the cost of maintaining our listing on a national securities exchange outweighs the benefits of such listing.
We must meet certain financial and liquidity criteria to maintain such listing. If we fail to meet any of the NYSE American’s listing standards, our common stock may be delisted. In addition, our board may determine that the cost of maintaining our listing on a national securities exchange outweighs the benefits of such listing.
Until holders of our warrants and pre-funded warrants exercise such warrants, they will have no rights with respect to the shares of our common stock underlying such warrants.
Holders of our warrants and pre-funded warrants have no rights as a common stockholder until such holders exercise their warrants and acquire our common stock. Until holders of our warrants and pre-funded warrants exercise such warrants, they will have no rights with respect to the shares of our common stock underlying such warrants.
Revenues from patients insured by this payer represented 23% and 54% of direct billing revenues (18% and 35% of total revenue) during the years ended December 31, 2024 and 2023, respectively. With a small number of exceptions, appeals filed with the payer have been successful and these claims have ultimately been paid.
Revenues from patients insured by this payer represented 7% and 18% of total revenue during the years ended December 31, 2025 and 2024, respectively. With a small number of exceptions, appeals filed with the payer have been successful and these claims have ultimately been paid.
Therefore, 36 Table of Contents holders of our common stock will not receive any return on their investment unless they sell their securities, and holders may be unable to sell their securities on favorable terms or at all.
Therefore, holders of our common stock will not receive any return on their investment unless we pay dividends in stock, or they sell their securities, and holders may be unable to sell their securities on favorable terms or at all.
During the period from January 1, 2025 to the date of the filing of this report, our stock price has ranged from $4.21 to $7.17. Our financial performance, our industry’s overall performance, changing consumer preferences, technologies, government regulatory action, tax laws and market conditions in general could have a significant impact on the future market price of our common stock.
During the period from January 1, 2026 to the date of the filing of this report, our stock price has ranged from $0.64 to $1.10. 38 Table of Contents Our financial performance, our industry’s overall performance, changing consumer preferences, technologies, government regulatory action, tax laws and market conditions in general could have a significant impact on the future market price of our common stock.
Item 1A. Risk Factors The following important factors, among others, could cause our actual operating results to differ materially from those indicated or suggested by forward-looking statements made in this Annual Report on Form 10-K or presented elsewhere by management from time to time. Investors should carefully consider the risks described below before making an investment decision.
Item 1A. Risk Factors The following important factors, among others, could cause our actual operating results to differ materially from those indicated or suggested by forward-looking statements made in this Annual Report on Form 10-K or presented elsewhere by management from time to time.
In the future, we may attempt to increase our capital resources by offering debt securities. Upon bankruptcy or liquidation, holders of our debt securities, and lenders with respect to other borrowings we may make, would receive distributions of our available assets prior to any distributions being made to holders of our common stock.
Upon bankruptcy or liquidation, holders of our debt securities, and lenders with respect to other borrowings we may make, would receive distributions of our available assets prior to any distributions being made to holders of our common stock.
Additionally, the Company has U.S. federal and state research and development tax credits of $0.7 million and $0.4 million, respectively, which begin to expire in the year 2026 and 2033, respectively. These NOL and tax credit carryforwards could expire unused and be unavailable to offset future taxable income or tax liabilities, respectively.
Additionally, the Company has U.S. federal and state research and development tax credits of $0.9 million and $0.3 million, respectively. These NOL and tax credit carryforwards could expire unused and be unavailable to offset future taxable income or tax liabilities, respectively.
If these independent O&P providers do not follow our inclusion/exclusion criteria for patient selection or do not provide adequate follow-on care, then our reputation may be harmed by patient dissatisfaction. This could also lead to product returns and adversely affect our financial condition.
If these independent O&P providers do not comply with applicable coverage or billing requirements or do not provide adequate follow-on care, then our reputation may be harmed by patient dissatisfaction. This could also lead to product returns and adversely affect our financial condition.
If our competitors are better able to develop and market products that are safer, more effective, less costly, easier to use, or are otherwise more attractive, we may be unable to compete effectively with other companies.
The publishing of fees for the HCPCS billing codes for our products may attract competition. If our competitors are better able to develop and market products that are safer, more effective, less costly, easier to use, or are otherwise more attractive, we may be unable to compete effectively with other companies.
In 2024, we began providing the MyoPro to Medicare Part B patients. Revenues from patients with Medicare Part B represented 63% of direct billing revenues (49% of total revenues) for the year ended December 31, 2024. Our historical focus on patients 16 Table of Contents with commercial insurers who have previously reimbursed for the MyoPro also impacts our payer concentration.
In 2024, we began providing the MyoPro to Medicare Part B patients. Revenues from patients with Medicare Part B represented 54% and 49% of total revenues for the years ended December 31, 2025 and 2024, respectively. Our historical focus on patients with commercial insurers who have previously reimbursed for the MyoPro also impacts our payer concentration.
At December 31, 2024, we had an accumulated deficit of approximately $103.1 million.
At December 31, 2025, we had an accumulated deficit of approximately $118.1 million.
Significant political, trade, or regulatory developments in the jurisdictions in which we may sell our products, such as those stemming from the change in U.S. federal administration, are difficult to predict and may have a material adverse effect on us. These developments may include tariffs or changes in reimbursement policies for Medicaid and Medicare.
Significant political, trade, or regulatory developments in the jurisdictions in which we may sell our products are difficult to predict and may have a material adverse effect on us. These developments may include export controls, tariffs or changes in reimbursement policies for Medicaid and Medicare.
Department of Veterans Affairs (the “VA”) health insurance companies and other third-party payers do not provide adequate coverage or reimbursement for our products, then our sales will be limited to clinical facilities and individuals who can pay for our devices without reimbursement.
If CMS, the VA, Medicare Advantage organizations, health insurance companies and other third-party payers do not provide adequate coverage or reimbursement for our products, then our sales will be limited to clinical facilities and individuals who can pay for our devices without reimbursement.
Our business strategy is based, in part, on our estimates of the number of upper extremity impaired individuals and the incidence of upper extremity injuries in our target markets and the percentage of those groups that would be able to use our current and future products. Our assumptions and estimates may be inaccurate and may change.
Our business strategy is based, in part, on our estimates of the number of upper extremity impaired individuals and the incidence of upper extremity injuries in our target markets and the percentage of those groups that would be able to use our current and future products that also carry insurance that will reimburse for the device.
There is no public market for our warrants or pre-funded warrants to purchase common stock. There is no established public trading market for our warrants or pre-funded warrants and we do not expect a market to develop. In addition, we do not intend to apply for listing of such warrants on any securities exchange.
There is no established public trading market for our warrants or pre-funded warrants and we do not expect a market to develop. In addition, we do not intend to apply for listing of such warrants on any securities exchange. Without an active market, the liquidity of such warrants will be limited.
The risks described below are not the only ones we face. Additional risks not presently known to us or that we currently believe are not material may also significantly impair our business operations. Our business could be harmed by any of these risks.
Investors should carefully consider the risks described below before 16 Table of Contents making an investment decision. The risks described below are not the only ones we face. Additional risks not presently known to us or that we currently believe are not material may also significantly impair our business operations. Our business could be harmed by any of these risks.
However, our auditors are not required to formally attest to the effectiveness of our internal control over financial reporting pursuant to Section 404 until we are no longer a “smaller reporting company” as set forth under the Exchange Act.
However, our auditors are not required to formally attest to the effectiveness of our internal control over financial reporting pursuant to Section 404 until we are no longer a “smaller reporting company” as set forth under the Exchange Act. During 2025, we undertook efforts to remediate a material weakness in information technology general controls.
Future issuances of debt securities, which would rank senior to our common stock upon our bankruptcy or liquidation, and future issuances of preferred stock, which could rank senior to our common stock for the purposes of dividends and liquidating distributions, may adversely affect our common stock price.
Future issuances of debt securities, which would rank senior to our common stock upon our bankruptcy or liquidation, and future issuances of preferred stock, which could rank senior to our common stock for the purposes of dividends and liquidating distributions, may adversely affect our common stock price. 39 Table of Contents In the future, we may attempt to increase our capital resources by offering debt securities.
For example, from December 31, 2023 to December 31, 2024, the high and low sales price of our common stock on the NYSE American has fluctuated from a low of $2.51 to a high of $6.74 per share.
For example, from December 31, 2024 to December 31, 2025, the high and low sales price of our common stock on the NYSE American has fluctuated from a low of $0.71 to a high of $7.17 per share.
Even if we prevail, litigation may be time consuming and force us to incur significant costs, and any damages or other remedies awarded to us may not be valuable and management’s attention could be diverted from managing our business.
For example, the validity of one of our patents in Europe is currently being challenged. Even if we prevail, litigation may be time-consuming and force us to incur significant costs, and any damages or other remedies awarded to us may not be valuable and management’s attention could be diverted from managing our business.
Defects in our products or the software that drives them could adversely affect the results of our operations. The design, manufacture and marketing of the MyoPro products involve certain inherent risks. Manufacturing or design defects, unanticipated use of the MyoPro, or inadequate disclosure of risks relating to the use of MyoPro products can lead to injury or other adverse events.
The design, manufacture and marketing of the MyoPro products involve certain inherent risks. Manufacturing or design defects, unanticipated use of the MyoPro, or inadequate disclosure of risks relating to the use of MyoPro products can lead to injury or other adverse events.
Suppliers may encounter problems that limit their ability to manufacture components for our products, including financial difficulties or damage to their manufacturing equipment or facilities.
Our ability and Cogmedix’s ability to secure adequate quantities of such products may be limited. Suppliers may encounter problems that limit their ability to manufacture components for our products, including financial difficulties or damage to their manufacturing equipment or facilities.
Usage of our line of credit requires us to meet financial and operating covenants, which could place limits on our operations, decrease our liquidity and increase the amount of cash flow required to service our debt.
Our term loan facility with Avenue requires us to meet financial and operating covenants, which could place limits on our operations, decrease our 22 Table of Contents liquidity and increase the amount of cash flow required to service our debt.
Accordingly, if we are unable to expand O&P channel revenues in the United States., expand internationally or manage our international operations successfully, we may not achieve the expected benefits of this expansion and our financial condition and results of operations could be harmed. We depend on the knowledge and skills of our senior management.
These factors may lead to delayed or limited acceptance of our products by patients in these markets. Accordingly, if we are unable to expand O&P channel revenues in the United States, expand internationally or manage our international operations successfully, we may not achieve the expected benefits of this expansion and our financial condition and results of operations could be harmed.
Significant political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial condition or results of operations. We sell our products in countries throughout the world.
Significant political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial condition or results of operations. While it has not had a material impact on our business to date, we sell our products in countries throughout the world and import materials into the United States.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeItem 1C. Cybersecurity Cyber Risk Management and Strategy Our manager of information technology works in conjunction with our third-party managed security service provider to establish and maintain our cybersecurity risk management processes, which are informed by and incorporate elements of recognized industry standards, such as the National Institute of Standards and Technology Cybersecurity Framework.
Biggest changeItem 1C. Cybersecurity Cyber Risk Management and Strategy Our manager of information technology is responsible for establishing and maintaining our cybersecurity risk management processes, which are informed by and incorporate elements of recognized industry standards, such as the National Institute of Standards and Technology Cybersecurity Framework.
We also leverage our managed security services provider and other third-party consultants , providers, and technologies to support our internal information technology resources to monitor, identify, and address cybersecurity risks, including managing our monitoring and alerting tools and conducting periodic assessments of certain system applications.
We also leverage our managed security services providers and other third-party consultants , providers, and technologies to support our internal information technology resources to monitor, identify, and address cybersecurity risks, including managing our monitoring and alerting tools and conducting periodic assessments of certain system applications.
Our efforts to address cybersecurity risks also include training employees, both from programs provided by our third-party managed security service provider and internal policies and training, which are designed to increase awareness of cybersecurity threats.
Our efforts to address cybersecurity risks also include training employees, both from programs provided by third-party managed security service providers and internal policies and training, which are designed to increase awareness of cybersecurity threats.
The technology, quality and regulatory committee periodically reports on cybersecurity risk management to the full board of directors. 42 Table of Contents
The technology, quality and regulatory committee periodically reports on cybersecurity risk management to the full board of directors. 45 Table of Contents
Governance Related to Cybersecurity Risks Our cyber risk management program and related operations and processes are directed by our Chief Financial Officer, in consultation with internal information technology resources, other members of senior management and our third-party security managed service provider.
Governance Related to Cybersecurity Risks Our cyber risk management program and related operations and processes are directed by our Chief Financial Officer, in consultation with our internal information technology resources, other members of senior management and third-party security managed service providers, as appropriate.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeItem 2. Properties Our primary offices are located at 45 Blue Sky Drive in Burlington, Massachusetts, where we have a lease expiring in October 2032 consisting of approximately 28,700 square feet of office, manufacturing and laboratory space, with an additional 7,500 square feet of manufacturing space committed to be leased in June 2025.
Biggest changeItem 2. Properties Our primary offices are located at 45 Blue Sky Drive in Burlington, Massachusetts, where we have a lease expiring in October 2032 consisting of approximately 36,200 square feet of office, manufacturing and laboratory space. We believe our facilities are currently adequate for us to conduct our business.
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Additionally, we have offices at 5601 Bridge St. in, Fort Worth, TX, where we have a lease expiring in December 2025 to operate a customer service call center consisting of approximately 2,800 square feet of office space. We believe our facilities are currently adequate for us to conduct our business.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeItem 4. Mine Safety Disclosures Not applicable. 43 Table of Contents PART II
Biggest changeItem 4. Mine Safety Disclosures Not applicable. 46 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 43 PART II 42 Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 44 Item 6. Reserved 44 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 45
Biggest changeItem 4. Mine Safety Disclosures 46 PART II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 47 Item 6. Reserved 47 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 48

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeHolders of Record On March 1, 2025, the closing price per share of our common stock was $5.07 as reported on The NYSE American, and we had approximately 121 stockholders of record (not including beneficial owners whose shares are held in street name).
Biggest changeHolders of Record On March 2, 2026, the closing price per share of our common stock was $0.75 as reported on The NYSE American, and we had approximately 119 stockholders of record (not including beneficial owners whose shares are held in street name).
Dividend Policy We have never paid or declared any cash dividends on our common stock, and we do not anticipate paying any cash dividends on our common stock in the foreseeable future. In addition, the terms of our existing debt agreement precludes us from paying dividends.
Dividend Policy We have never paid or declared any cash dividends on our common stock, and we do not anticipate paying any cash dividends on our common stock in the foreseeable future. In addition, the terms of our existing debt agreement preclude us from paying dividends.

Item 7. Management's Discussion & Analysis

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

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Biggest changeQuantitative and Qualitative Disclosure about Market Risk Our unrestricted cash, restricted cash, and cash equivalents, totaling approximately $24.7 million as of December 31, 2024, was deposited in bank accounts. The cash in these accounts is held for working capital purposes and invested by the bank in overnight money market funds that invest in short-term government or government backed securities.
Biggest changeThe cash in these accounts is held for working capital purposes and invested by our banks in overnight money market funds that invest in short-term government or government backed securities. Our short-term investments totaling approximately $4.2 million as of December 31, 2025, are only invested in high-quality instruments with maturities of nine months or less.
The net cash used in operating activities for the year ended December 31, 2024 was primarily used to fund a net loss net approximately $6.2 million, adjusted for non-cash expenses in the aggregate amount of approximately $1.6 million of which approximately $0.9 million is related to non-cash adjustments related to stock-based compensation, and approximately $1.3 million of cash generated from changes in operating assets and liabilities, primarily related to an increase in accounts payable and accrued expenses and receipt of a tenant improvement allowance for our new headquarters facility in Burlington, MA., partially offset by increases in inventory and accounts receivable.
The net cash used in operating activities for the year ended December 31, 2024 was primarily used to fund a net loss net approximately $6.2 million, adjusted for non-cash expenses in the aggregate amount of approximately $1.6 million of which approximately $0.9 million is related to stock-based compensation, and approximately $1.3 million of cash generated from changes in operating assets and liabilities, primarily related to an increase in accounts payable and accrued expenses and receipt of a tenant improvement allowance for our new headquarters facility in Burlington, MA., partially offset by increases in inventory and accounts receivable.
The MyoPro Motion G model allows users with severely weakened or clenched hands, such as seen in certain stroke survivors, to open and close their hands and perform a large number of ADLs. 45 Table of Contents • On June 9, 2017, we completed our initial public offering, or IPO, and a private offering concurrent with the IPO, generating net proceeds of $6.9 million in the aggregate. • On July 31, 2017, we met the criteria to apply the CE mark for the MyoPro under the EU MDD.
The MyoPro Motion G model allows users with severely weakened or clenched hands, such as seen in certain stroke survivors, to open and close their hands and perform a large number of ADLs. 48 Table of Contents • On June 9, 2017, we completed our initial public offering, or IPO, and a private offering concurrent with the IPO, generating net proceeds of $6.9 million in the aggregate. • On July 31, 2017, we met the criteria to apply the CE mark for the MyoPro under the EU MDD.
Because of these limitations, you should consider Adjusted EBITDA alongside other financial performance measures including net income (loss) and our financial results presented in accordance with U.S.
Because of these limitations, you should consider Adjusted EBITDA alongside other financial performance measures including net income (loss) and our financial results presented in accordance with U.S. GAAP.
The EU MDR repealed and replaced the EU MDD on May 26, 2021, and we therefore worked with our EU-Authorized Representative to ensure all EU MDR requirements were met, which enabled us to establish a new declaration of conformity under the EU MDR to allow continued to CE mark application.
The EU MDR repealed and replaced the EU MDD and became applicable on May 26, 2021, and we therefore worked with our EU-Authorized Representative to ensure all EU MDR requirements were met, which enabled us to establish a new declaration of conformity under the EU MDR to allow continued to CE mark application.
We also sell our products to O&P providers in the United States. Europe and Australia, to the VA and to rehabilitation hospitals. Though we increasingly provide devices directly to patients, we sometimes utilize the clinical services of O&P providers for which they are paid a fee.
We also sell our products to O&P providers in the United States. Europe and Australia, to the VA and evaluation units to rehabilitation hospitals. Though we increasingly provide devices directly to patients, we sometimes utilize the clinical services of O&P providers for which they are paid a fee.
Recent Accounting Standards In October 2023, the FASB issued ASU 2023-06, “Disclosure Improvements, Codification Amendments in Response to the SECs Disclosure Update and Simplification Initiative”, that adds 14 of the 27 identified disclosure or presentation requirements to the Codification, each amendment in the ASU will only become effective if the SEC removes the related disclosure or presentatioTn from its existing regulations by June 30, 2027.
Recent Accounting Standards In October 2023, the FASB issued ASU 2023-06, “Disclosure Improvements, Codification Amendments in Response to the SEC's Disclosure Update and Simplification Initiative”, that adds 14 of the 27 identified disclosure or presentation requirements to the Codification, each amendment in the ASU will only become effective if the SEC removes the related disclosure or presentation from its existing regulations by June 30, 2027.
Income tax expense Income tax expense recorded during the years ended December 31, 2024 and 2023 represents the provision for income taxes for our wholly-owned subsidiary, Myomo Europe GmbH. The increase in income tax expense relates to increased income from Myomo Europe GmbH in 2024 compared to 2023.
Income tax expense Income tax expense recorded during the years ended December 31, 2025 and 2024 represents the provision for income taxes for our wholly-owned subsidiary, Myomo Europe GmbH. The increase in income tax expense relates to increased income from Myomo Europe GmbH in 2025 compared to 2024.
Once the prospective patient contacts us or is referred to us, either our trained clinical staff or a trained O&P provider will evaluate the patient for their suitability as a candidate. Initial evaluations by our trained clinical staff are conducted using telehealth techniques, followed by an in-person clinical evaluation of the candidate.
Once the prospective patient contacts us or is referred to us through our MyoConnect program, either our trained clinical staff or a trained O&P provider will evaluate the patient for their suitability as a candidate. Initial evaluations by our trained clinical staff are conducted using telehealth techniques, followed by an in-person clinical evaluation of the candidate.
Adjusted EBITDA is an important supplemental measure used by our board of directors and management to evaluate our operating performance from period-to-period on a consistent basis and as a measure for planning and forecasting overall expectations and for evaluating actual results against such expectations.
Adjusted EBITDA is an important supplemental measure used by our board of directors and management to evaluate our operating performance from period-to-period on a consistent 52 Table of Contents basis and as a measure for planning and forecasting overall expectations and for evaluating actual results against such expectations.
Comparison of the year ended December 31, 2024 to the year ended December 31, 2023 The following table sets forth our revenue, gross profit and gross margin for each of the years presented.
Comparison of the year ended December 31, 2025 to the year ended December 31, 2024 The following table sets forth our revenue, gross profit and gross margin for each of the years presented.
We base our estimates on historical experience and on various other assumptions that we believe are reasonable under the circumstances. These estimates and assumptions are reviewed on an on-going basis and updated as appropriate. Materially different results can occur if circumstances change and 51 Table of Contents additional information becomes known. Actual results may differ from these estimates.
We base our estimates on historical experience and on various other assumptions that we believe are reasonable under the circumstances. These estimates and assumptions are reviewed on an on-going basis and updated as appropriate. Materially different results can occur if circumstances change and additional information becomes known. Actual results may differ from these estimates.
Our business is dependent upon reimbursement of our products by insurance companies and government-controlled health care plans such as Medicare and Medicaid in the United States and by statutory health insurance plans in Germany, which could prevent our revenues from growing to the level necessary to return to ash flow breakeven on a 50 Table of Contents sustaining basis.
Our business is dependent upon reimbursement of our products by insurance companies and government-controlled health care plans such as Medicare and Medicaid in the United States and by statutory health insurance plans in Germany, which could prevent our revenues from growing to the level necessary to return to cash flow breakeven on a sustaining basis.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations The following discussion should be read in conjunction with our financial statements and the related notes contained elsewhere in this Annual Report on Form 10-K and in our other Securities and Exchange Commission filings.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations The following discussion should be read in conjunction with our financial statements and the related notes contained elsewhere in this Annual Report on Form 10-K and in our other SEC filings.
For other Medicare Advantage and other commercial insurance payers, we have determined that we do not have sufficient collection history with the payer to assert evidence of an arrangement and collectibility. For these payers, revenue is recognized at payment, which is when we can determine how much we will be paid for the device.
For the majority of Medicare 55 Table of Contents Advantage and other commercial insurance payers, we have determined that we do not have sufficient collection history with the payer to assert evidence of an arrangement and collectability. For these payers, revenue is recognized at payment, which is when we can determine how much we will be paid for the device.
Considering our cash balance and availability under our debt arrangements as of December 31, 2024 and our operating plans discussed below, we believe there will be sufficient cash to fund our operations and capital expenditures for the next 12 months from the date of this report.
Considering our cash balance, our debt service and our operating plans discussed below, we believe there will be sufficient cash to fund our operations and capital expenditures for the next 12 months from the date of this report.
In particular: • Adjusted EBITDA does not include interest income, net; • Adjusted EBITDA does not reflect the amounts we paid in taxes or other components of our tax provision; • Adjusted EBITDA does not include depreciation expense from fixed assets, or amortization of leasehold improvements; • Adjusted EBITDA does not include the impact of stock-based compensation; and • Adjusted EBITDA does not include the loss on equity investment in the JV Company.
In particular: • Adjusted EBITDA does not include interest expense (income), net; • Adjusted EBITDA does not include the change in fair value of derivative liabilities; • Adjusted EBITDA does not reflect the amounts we paid in taxes or other components of our tax provision; • Adjusted EBITDA does not include depreciation expense from fixed assets, or amortization of leasehold improvements; and • Adjusted EBITDA does not include the impact of stock-based compensation.
Selling, clinical and marketing Selling expenses consist of costs for our field clinical staff, clinical training organization, and marketing personnel, including salaries, benefits, stock-based compensation and sales commissions, costs of digital advertising, marketing and promotional events, corporate communications, product marketing and travel expenses.
Selling, clinical and marketing Selling, clinical and marketing expenses consist of costs for our business development, customer experience, field clinical, clinical training and marketing personnel, including salaries, benefits, stock-based compensation and sales commissions, costs of digital advertising, marketing and promotional events, corporate communications, product 51 Table of Contents marketing and travel expenses.
Cost of Revenue and Gross margin Cost of revenue consists of direct costs for the manufacturing, casting/printing of orthotic parts, fabrication and fitting of our products, inventory reserves, warranty costs and overhead costs allocated to cost to revenue. Gross margin increased to 71.2% in 2024 compared to 68.5% in 2023.
Cost of Revenue and Gross margin Cost of revenue consists of direct costs for the manufacturing, casting/printing of orthotic parts, fabrication and fitting of our products, inventory reserves, warranty costs and overhead costs allocated to cost to revenue. Gross margin decreased to 65.7% in 2025compared with 71.2% in 2024.
Cash used in investing activities in 2023 was primarily for our purchases of short-term investments and purchases of equipment. Financing Activities . During the year ended December 31, 2024 cash provided by financing activities of approximately $20.9 million was due to net proceeds received from our equity offerings in January and December 2024.
During the year ended December 31, 2024 cash provided by financing activities of approximately $20.9 million was due to net proceeds received from our equity offerings in January and December 2024.
The net cash used in operating activities for the year ended December 31, 2023 was primarily used to fund a net loss net approximately $8.1 million, adjusted for non-cash expenses in the aggregate amount of approximately $1.7 million of which approximately $1.1 million is related to non-cash adjustments related to stock-based compensation, and approximately $0.3 million of cash generated from changes in operating assets and liabilities, primarily related to an increase in accounts payable and accrued expenses, offset by increases in inventory and accounts receivable.
The net cash used in operating activities for the year ended December 31, 2025 was primarily used to fund a net loss net approximately $15.6 million, adjusted for non-cash expenses in the aggregate amount of approximately $4.9 million of which approximately $2.1 million is related to non-cash adjustments related to stock-based compensation, and approximately $3.0 million of cash generated from changes in operating assets and liabilities, primarily related to an increase in accounts payable and accrued expenses and receipt of a tenant improvement allowance for our new headquarters facility in Burlington, MA., partially offset by increases in inventory and accounts receivable.
Selling, clinical, and marketing expenses increased by approximately $3.2 million or 35% in 2024 compared to 2023. The increase during 2024 was driven primarily by higher advertising spending as well as an increases in clinical and customer service headcount in support of our direct billing channel.
Selling, clinical, and marketing expenses increased by approximately $8.1 million or 67% in 2025 compared to 2024. The increase during 2025 was driven primarily by higher advertising spending as well as increases in clinical and field operations headcount in support of our direct billing channel.
In addition, this non-GAAP measure is not based on any comprehensive set of accounting rules or principles. As a non-GAAP measure, Adjusted EBITDA has limitations in that it does not reflect all of the amounts associated with our results of operations as determined in accordance with U.S. GAAP.
As a non-GAAP measure, Adjusted EBITDA has limitations in that it does not reflect all of the amounts associated with our results of operations as determined in accordance with U.S. GAAP.
Financial Statemen ts and Supplementary Data See the financial statements filed as part of this Annual Report on Form 10-K as listed under Item 15 below. Item 9. Changes in and Disagreements with Accou ntants on Accounting and Financial Disclosure Not Applicable.
Financial Statemen ts and Supplementary Data See the financial statements filed as part of this Annual Report on Form 10-K as listed under Item 15 below.
We define Adjusted EBITDA as earnings before interest and other income (expense), taxes, depreciation and amortization, adjusted for stock-based compensation and the loss on equity investment in the JV Company. Adjusted EBITDA is not in accordance with, or an alternative to, measures prepared in accordance with U.S. GAAP.
We define Adjusted EBITDA as earnings before interest and other expense (income), taxes, depreciation and amortization, adjusted for stock-based compensation. Adjusted EBITDA is not in accordance with, or an alternative to, measures prepared in accordance with U.S. GAAP. In addition, this non-GAAP measure is not based on any comprehensive set of accounting rules or principles.
Payment history is also used to estimate how much we expect to be paid upon delivery of our device and submission of an insurance claim, which determines how much revenue we recognize.
For these payers, payment history is also used to estimate how much we expect to be paid upon delivery of our device and submission of an insurance claim, which determines how much revenue we recognize. The transaction pricing for these providers are based on the expected value method, based on previous history.
Any short-term investments are only in high-quality instruments with maturities of nine months or less. Our primary objective is to preserve our capital for purposes of funding our operations. 52 Table of Contents Item 7A. Quantitative and Qualitat ive Disclosures about Market Risk This item is not applicable to us as a smaller reporting company. Item 8.
Our primary objective is to preserve our capital for purposes of funding our operations. Item 7A. Quantitative and Qualitat ive Disclosures about Market Risk This item is not applicable to us as a smaller reporting company. Item 8.
We used $3.3 million in cash for operating activities during the year ended December 31, 2024. In the fourth quarter of 2024, the Company generated positive cash flow from operations of $3.4 million, as well as positive free cash flow of $2.5 million. We have historically funded our operations through financing activities, including raising equity and debt capital.
We used $14.5 million in cash for operating activities during the year ended December 31, 2025. We have historically funded our operations through financing activities, including raising equity and debt capital.
With respect to patients with Medicare Advantage or other commercial insurance, except for a small number of payers, we do not have contracts to establish pricing or provide evidence of an arrangement.
With respect to patients with Medicare Advantage or other commercial insurance, except for a small number of payers, we do not have contracts to establish pricing or provide evidence of an arrangement, however we are able to rely on a history of payments after receiving an insurance authorization, delivery of the device and submission of a claim as evidence of an arrangement.
The increase during 2024 was driven primarily by higher payroll costs due to higher engineering headcount in 2024 as a result of a larger number of new product development and sustaining engineering projects.
The increase during 2025 was driven primarily by higher payroll costs due to higher engineering headcount in 2025 as a result of investing in order to accelerate our sustaining engineering and product development efforts for our MyoPro 3.
(the "JV Company"), which is obligated to purchase $10.75 million of MyoPro control system units over the next 10 years, subject to receipt of regulatory approvals necessary to permit sales of the product in the greater China territory. • In July 2021, we announced that we became accredited as a Medicare provider. • In January 2022, we introduced the MyoPro 2+ and began in-house fabrication of the device. • On November 1, 2023, CMS issued a final rule that resulted in a change in the benefit category associated with products billed under the HCPCS codes for our products from durable medical equipment rental to a brace, which would permit reimbursement of MyoPro sales on a lump sum basis.
At that time, our products were classified as durable medical equipment rental at that time. • In 2019 we transitioned our business to become a direct provider of the MyoPro to patients and bill insurance companies directly. • In July 2021, we announced that we became accredited as a Medicare provider. • In January 2022, we introduced the MyoPro 2+ and began in-house fabrication of the device. • On November 1, 2023, CMS issued a final rule that resulted in a change in the benefit category associated with products billed under the HCPCS codes for our products from durable medical equipment rental to a brace, which would permit reimbursement of MyoPro sales on a lump sum basis.
During the year ended December 31, 2024 our cash provided by investing activities of $0.3 million was primarily due to a greater amount of maturities compared to purchases of short-term investments, offset by purchases of furniture and fixtures related to the move to our new headquarters facility in December 2024 and demo units for O&P practices as we look to increase revenue from this channel in 2025.
During the year ended December 31, 2025 our cash used by investing activities of $7.1 million was primarily due to a greater amount of purchases compared to maturities of short-term investments of approximately $3.7 million, capital expenditures of approximately $1.7 million for purchases of furniture and fixtures related to the move to our new headquarters facility expansion within the facility and demo units for O&P practices and approximately $1.6 million used for capitalized software development costs.
Refer to Note 2 - Summary of Significant Accounting Policies. Our most critical accounting estimates include • The timing and amount of revenue recognition based on assertions and estimates of payments from certain insurance payers • The discount rate on leases Timing and Amount of Revenue Recognition The timing and amount of revenue recognized is determined based on certain estimates.
Our most critical accounting estimates include • The timing and amount of revenue recognition based on assertions • Revenue recognition based on transaction pricing estimated from payments from certain insurance payers • Valuation of derivative liabilities Timing and Amount of Revenue Recognition The timing and amount of revenue recognized is determined based on certain estimates.
Our products are designed to help regain function in individuals with neuromuscular conditions due to brachial plexus injury, stroke, traumatic brain injury, spinal cord injury and other neurological disorders. We utilize digital ads on various platforms as well as television ads to reach patients who are potential candidates for our product.
Our products are designed to help regain movement in individuals with neuromuscular conditions due to brachial plexus injury, stroke, traumatic brain injury, spinal cord injury and other neurological disorders. We advertise on television and through social media.
Variable compensation for personnel engaged in sales and marketing activities is generally earned and recorded as expense when the product is delivered. We expect sales and marketing expenses to increase in 2025 as we increase our advertising spending and clinical capacity to grow revenues in our direct billing channel.
Variable compensation for personnel engaged in sales and marketing activities is generally earned and recorded as expense when the product is delivered. We expect the growth rate in selling, clinical and marketing expenses to be significantly lower in 2026.
Cash Flows Year Ended December 31, 2024 2023 Net cash used in operating activities $ (3,289,904 ) $ (6,172,764 ) Net cash provided by (used in) investing activities 259,981 (2,029,565 ) Net cash provided by financing activities 20,932,429 9,713,457 Effect of foreign exchange rate changes on cash (26,439 ) 14,211 Net increase in cash and cash equivalents $ 17,876,067 $ 1,525,339 Operating Activities .
Cash Flows Year Ended December 31, 2025 2024 Net cash used in operating activities $ (14,511,454 ) $ (3,289,904 ) Net cash provided by (used in) investing activities (7,057,968 ) 259,981 Net cash provided by financing activities 11,427,379 20,932,429 Effect of foreign exchange rate changes on cash 101,697 (26,439 ) Net increase in cash and cash equivalents $ (10,040,346 ) $ 17,876,067 54 Table of Contents Operating Activities .
GAAP. 49 Table of Contents The following table provides a reconciliation of net loss to Adjusted EBITDA for each of the years indicated: 2024 2023 GAAP net loss $ (6,183,729 ) $ (8,147,565 ) Adjustments to reconcile to Adjusted EBITDA: Interest income, net (388,586 ) (410,274 ) Loss on equity investment — 169,503 Income taxes 365,617 156,002 Depreciation and amortization expense 205,910 164,306 Stock-based compensation 874,438 1,115,602 Adjusted EBITDA $ (5,126,350 ) $ (6,952,426 ) Liquidity and Capital Resources Liquidity We measure our liquidity in a number of ways, including the following: December 31, 2024 2023 Cash and cash equivalents $ 24,372,373 $ 6,871,306 Short-term investments $ 492,990 $ 1,994,662 Working capital 22,618,158 8,173,925 We had working capital and stockholders’ equity of approximately $22.6 million and $24.7 million respectively, as of December 31, 2024.
The following table provides a reconciliation of net loss to Adjusted EBITDA for each of the years indicated: 2025 2024 GAAP net loss $ (15,573,884 ) $ (6,183,729 ) Adjustments to reconcile to Adjusted EBITDA: Interest expense (income), net 450,832 (388,586 ) Income taxes 504,532 365,617 Depreciation and amortization expense 859,354 205,910 Stock-based compensation 2,084,042 874,438 Change in fair value of derivatives liabilities 216,673 — Adjusted EBITDA $ (11,458,451 ) $ (5,126,350 ) Liquidity and Capital Resources Liquidity We measure our liquidity in a number of ways, including the following: December 31, 2025 2024 Cash and cash equivalents $ 14,132,027 $ 24,372,373 Short-term investments $ 4,261,782 $ 492,990 Working capital 19,211,756 22,618,158 We had working capital and stockholders’ equity of approximately $17.6 million and $11.4 million respectively, as of December 31, 2025.
Years Ended December 31, Year-to-year change 2024 2023 $ % Research and development $ 4,772,013 $ 2,636,487 $ 2,135,526 81 % Selling, clinical, and marketing 12,236,910 9,042,698 3,194,212 35 % General and administrative 12,383,118 9,734,747 2,648,371 27 % Total operating expenses $ 29,392,041 $ 21,413,932 $ 7,978,109 37 % Research and development R&D expenses consist of costs for our engineering and research personnel, including salaries, benefits, incentive and stock-based compensation, product development costs, clinical studies and the cost of certain third-party contractors and travel expense.
Years Ended December 31, Year-to-year change 2025 2024 $ % Research and development $ 6,943,838 $ 4,772,013 $ 2,171,825 46 % Selling, clinical, and marketing 20,385,098 12,236,910 8,148,188 67 % General and administrative 13,961,235 12,383,118 1,578,117 13 % Total operating expenses $ 41,290,171 $ 29,392,041 $ 11,898,130 40 % Research and development R&D expenses consist of costs for our engineering and research personnel, including salaries, benefits, incentive and stock-based compensation, product development costs, clinical studies and the cost of certain third-party contractors and travel expense.
We expect our gross margin to vary depending on the mix of channel revenues and timing of reimbursements from certain third-party payers, which impacts revenue recognition. 47 Table of Contents Operating expenses The following table sets forth our operating expenses for each of the years presented.
We expect our gross margin to improve in 2026 due to higher volume and cost reduction actions, however gross margin may vary depending on the mix of channel revenues, which impacts our average selling price. Operating expenses The following table sets forth our operating expenses for each of the years presented.
The increase was primarily due to an increase in headcount in the human resource and reimbursement functions, as well as a higher bonus. 48 Table of Contents Other expense (income) The following table sets forth our interest and other expense (income) for each of the years presented.
The increase was primarily due to increases in payroll and benefits, consulting and insurance costs, as well as lease costs and depreciation associated with the move to our new facility in Burlington, MA. Other expense (income) The following table sets forth our interest and other expense (income) for each of the years presented.
In January 2023, we completed a public equity offering, whereby we sold 13,169,074 shares of common stock and 6,830,926 pre-funded warrants at $0.325 per share, or $0.3249 per pre-funded warrant. Each pre-funded warrant in the above offerings entitles the holder to one share of common stock upon exercise at a nominal exercise price of $0.0001 per share.
Each pre-funded warrant in the above offerings entitles the holder to one share of common stock upon exercise at a nominal exercise price of $0.0001 per share. See section titled “Liquidity” for further discussion.
These fees were subsequently updated to approximately $34,300 for the Motion W and approximately $67,500 for the Motion G, effective January 1, 2025. These fees are subject to annual inflationary adjustments.
These fees were subsequently updated to approximately $34,970 for the Motion W and approximately $68,800 for the Motion G, effective January 1, 2025. These fees are subject to annual inflationary adjustments. • On April 30, 2025, we introduced an enhanced version of our flagship product, now known as the MyoPro 2x in the United States.
See section titled “Liquidity” for further discussion. 46 Table of Contents Results of Operations We have been growing revenues while incurring net losses and negative cash flows from operations since inception and anticipate this to continue for most of 2025. Our financial performance in 2024 reflected our ability to be reimbursed by Medicare for providing the MyoPro to their beneficiaries.
Results of Operations We have been growing revenues while incurring net losses and negative cash flows from operations since inception and anticipate this to continue in 2026.
Years Ended December 31, Year-to-year change 2024 2023 $ % Product revenue $ 32,551,199 $ 17,476,238 $ 15,074,961 86 % License revenue - 1,764,920 (1,764,920 ) NM Total revenue 32,551,199 19,241,158 13,310,041 69 Cost of revenue 9,365,856 6,058,775 3,307,081 55 Gross profit $ 23,185,343 $ 13,182,383 $ 10,002,960 76 Gross margin 71.2 % 68.5 % 2.7 % Revenues We derive revenue primarily from providing devices directly to patients and billing insurance companies directly.
Years Ended December 31, Year-to-year change 2025 2024 $ % Total revenue $ 40,928,042 $ 32,551,199 $ 8,376,843 26 % Cost of revenue 14,039,718 9,365,856 4,673,862 50 % Gross profit $ 26,888,324 $ 23,185,343 $ 3,702,981 16 % Gross margin 65.7 % 71.2 % (5.5 %) Revenues We derive revenue primarily from providing devices directly to patients and billing insurance companies directly.
R&D costs are expensed as they are incurred. We intend to accelerate our R&D efforts in 2025 and expect R&D costs to increase on an annual basis. R&D expenses increased by approximately $2.1 million or 81% in 2024 compared to 2023.
R&D costs are expensed as they are incurred. We intend to manage R&D expenses in 2026, while maintaining the pace of our R&D efforts as cash flows allow, as well as to fund a randomized control trial being conducted by the University of Utah. R&D expenses increased by approximately $2.2 million or 46% in 2025 compared to 2024.
During the year ended December 31, 2023 cash provided by financing activities of approximately $9.7 million was due to net proceeds received from the sale of common stock and pre-funded warrants, net of offering costs.
During the year ended December 31, 2025 cash provided by financing activities of approximately $11.5 million was due to net proceeds of our term loan with Avenue, net of debt issuance costs and refinancing fees paid to the lender of our previous credit facility.
The product revenue increase was driven primarily by higher direct billing revenues due to a higher average selling price, or ASP, as well as a higher number of revenue units as we were able to serve Medicare Part B beneficiaries in volume in 2024.
Total revenue in 2025 increased by approximately $8.4 million, or 26%, compared with 2024. The total revenue increase was driven by a higher number of revenue units and a higher average selling price, or ASP.
We expect that general and administrative expenses will increase in 2025 as a result of increasing our reimbursement capacity in order to grow revenue in the direct billing channel. General and administrative expenses increased by approximately $2.6 million or 27% in 2024 compared to 2023.
We intend to reduce the growth rate in general and administrative expenses in 2026. General and administrative expenses increased by approximately $1.6 million or 13% in 2025 compared to 2024.
Removed
At that time, our products were classified as durable medical equipment rental at that time. • In 2019 we transitioned our business to become a direct provider of the MyoPro to patients and bill insurance companies directly. • In January 2021, we entered into a joint venture with Beijing Ryzur Medical Investment Co., Ltd.
Added
In addition, we perform in-services for therapists and physicians to generate referrals under a new program we refer to as MyoConnect, and we directly educate and inform those individuals who are potential candidates for our products.
Removed
(“Ryzur Medical”), a medical device manufacturer based in Beijing, China to manufacture and sell our current and future products in greater China, including Hong Kong, Macau and Taiwan. Under the agreement with Ryzur Medical, we own 19.9% of the joint venture company, Jiangxi Myomo Medical Assistive Appliance Co. Ltd.
Added
Term Loan Facility On November 4, 2025 (“the Closing Date”), we entered into a Loan and Security Agreement with Avenue which provides us $17.5 million in committed funding under two tranches. The first tranche of $12.5 million was funded on the Closing Date.
Removed
Net proceeds from the offering are expected to be used to grow revenues in our direct billing channel through additional advertising spending and the addition of clinical, reimbursement and manufacturing headcount to support expected increasing demand, to increase R&D spending in order to accelerate the completion of sustaining and new product development activities, to fund systems and headcount to support growth in the O&P channel, to fund associated working capital requirements and general corporate purposes.
Added
The remaining $5.0 million becomes available at our discretion between 12 and 18 months from the Closing Date, subject to maintaining compliance with covenants. We are paying interest only on the term loan for a period of 18 months from the Closing Date, which could be extended to 24 months if we borrowed under the second tranche.
Removed
On August 29, 2023, we completed a public equity offering, selling 5,413,334 shares of common stock and 1,920,000 pre-funded warrants at $0.60 per share, or at $0.5999 per pre-funded warrant, generating net proceeds after fees and expenses of approximately $3.9 million.
Added
After the expiration of the interest-only period, we will re-pay the principal balance in 24 equal monthly installments. The term loan matures on June 1, 2029.
Removed
Our plan for 2025 is to invest in increasing demand and adding capacity to support our direct billing channel, while making investments to increase revenues in the U.S. O&P channel.
Added
Proceeds from this loan were used to repay the outstanding borrowings under the credit facility with Silicon Valley Bank and to pay fees and expenses, with the remainder being used for general corporate purposes China Joint Venture 49 Table of Contents In November 2025, we were notified that Ryzur Medical filed for bankruptcy in China and is in the process of being liquidated.
Removed
We expect that our revenues will continue to grow, primarily as a result of investments to grow our direct billing channel and through expected higher revenue from O&P practices both inside and outside of the United States. Product revenue in 2024 increased by approximately $15.1 million, or 86%, compared to 2023.
Added
As a result, the operations of the JV Company are now severely limited. Chinaleaf Capital, a minority investor in the JV Company, is currently leading the process of restructuring the JV Company and raising additional capital in order to re-start normal operations.
Removed
Including the license revenue received from our joint venture partner in China in 2023, total revenue increased 69%. Revenues generated through the direct billing channel were approximately $25.3 million, or 78% of product revenue in 2024, compared to approximately $12.3 million, or 71%, of product revenue in 2023.
Added
According to the terms of the JV Contract, the sale of shares in the JV Company will not dilute our ownership. We cannot provide any assurance that we will accept any terms and conditions that new investors, if any, will require and we may exercise our right to terminate the joint venture in the future.
Removed
The increase in gross margin was driven primarily by the increase in ASP discussed above and greater absorption of fixed costs into inventory. Excluding the license fees in 2023, gross margin on product sales was 65.3% for the year ended December 31, 2023. The increase in gross margin on product sales, was driven by the aforementioned factors.
Added
All assets associated with our investment in the JV Company were either reserved or written off in prior periods. As a result, these events had no impact on our financial statements for the year ended December 31, 2025.
Removed
Years Ended December 31, Year-to-year change 2024 2023 $ % Interest income, net $ (388,586 ) $ (410,274 ) $ 21,688 (5 )% Other expense, net - 785 (785 ) (100 ) Loss on equity investment - 169,503 (169,503 ) (100 ) Total other income $ (388,586 ) $ (239,986 ) $ (148,600 ) 62 % Interest income decreased primarily due to lower average investment balances in 2024.
Added
Our financial performance in 2025 reflected our ability to be reimbursed by Medicare for providing the MyoPro to their beneficiaries, as well as challenges around marketing efficiency and patient acquisition which increased Cost Per Pipeline Add.
Removed
Loss on equity investment represents our share of the losses incurred by the JV Company, which began limited operations in 2023. Our investment in the JV Company was written off during the year ended December 31, 2023.
Added
Our plan for 2026 is to begin to pivot away from relying on direct to patient advertising to generate revenues and invest in generating revenues from recurring sources, including the MyoConnect referral program and from O&P providers in the U.S. and Germany, while implementing marketing initiatives to reduce Cost Per Pipeline Add in the direct billing channel and minimizing the growth of fixed expenses.
Removed
In August 2023, we completed a public equity offering pursuant to which we sold 5,413,334 shares of common stock and 1,920,000 pre-funded warrants at $0.60 per share or at $0.5999 per warrant, generating proceeds after fees and expenses of approximately $3.9 million.
Added
We expect that our revenues will continue to grow in 2026, primarily as a result of investments to grow revenues from recurring sources, including generating patient referrals under our MyoConnect program, as well as from O&P practices in the U.S. and Germany, which we expect to increase operating leverage and reduce our dependence on advertising-driven direct-to-patient revenues.
Removed
In January 2023, we completed an equity offering under which we sold 13,169,074 shares of common stock and 6,830,926 pre-funded warrants at $0.325 per share, generating proceeds after fees and expenses of approximately $5.7 million.
Added
Revenues by sales channel were as follows for the years ended December 31, 2025 and 2024: 50 Table of Contents 2025 2024 Direct billing $ 30,420,785 $ 25,334,313 International 6,758,096 4,553,475 U.S.
Removed
In July 2024, we entered into a Loan and Security Agreement with Silicon Valley Bank, a division of First-Citizens Bank & Trust Company, which provides us the ability to borrow up to $4.0 million against eligible accounts receivable. The line of credit remains undrawn as of the issuance date of these financial statements.
Added
O&P 2,923,130 1,464,828 VA 826,031 1,198,583 Total revenue $ 40,928,042 $ 32,551,199 Revenues generated through the direct billing channel represented 74% of revenue, increasing by 20% to $30.4 million in 2025 compared with $25.3 million in 2024. Revenue growth in the direct billing channel was negatively impacted by lead generation and patient acquisition issues during 2025.
Removed
Availability under the line of credit is approximately $1.0 million based on eligible accounts receivable as of December 31, 2024. We amended the Loan and Security Agreement in February 2025 to provide for, among other changes, a $3 million term loan facility, which is available to be drawn at any time until February 28, 2026.
Added
Revenues generated through the International channel represented 17% of revenue and increased by 48% to approximately $6.8 million, compared with $4.6 million in 2024. Revenues generated through the U.S. O&P channel represented 7% of revenues and doubled to approximately $2.9, compared with $1.5 million in 2024.
Removed
Our operating plans are primarily focused on growing revenues in our direct billing channel in 2025, while we work concurrently on growing revenues in the O&P channel. This involves increasing our advertising spending and adding headcount to increase our clinical, reimbursement and manufacturing capacity in order to serve a higher volume of patients in 2025.
Added
Revenues generated through the VA channel represented 2% of revenue and decreased 31% to approximately $0.8 million, compared with approximately $1.2 million in 2024.
Removed
These investments are expected to result in negative cash flows for at least the first three quarters of 2025.
Added
The decrease in gross margin was driven primarily by an unfavorable change in the amount of overhead capitalized in inventory compared to the prior year and higher warranty expense.

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Other MYO 10-K year-over-year comparisons