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

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Paragraph-level year-over-year comparison of Sensus Healthcare, 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.

+140 added−124 removedSource: 10-K (2026-03-04) vs 10-K (2025-03-05)

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

140 paragraphs added · 124 removed · 105 edited across 5 sections

Item 1. Business

Business — how the company describes what it does

39 edited+14 added−2 removed72 unchanged
Biggest changeSales and Marketing Commercial Compliance Federal anti-kickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering, or paying remuneration, directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order, or recommendation of, any good or service paid for under federal healthcare programs such as the Medicare and Medicaid programs.
Biggest changeThe Company has also received its Medical Device Single Audit Program (MDSAP) certification which allows medical device manufactures to satisfy certain regulatory requirements in USA, Canada, Japan, Australia, and Brazil through a single audit, reducing costs, minimizing operational disruptions, expediting market access, and providing more consistent and transparent regulatory oversight. 8 Sales and Marketing Commercial Compliance Federal anti-kickback laws and regulations prohibit, among other things, persons from knowingly and willfully soliciting, receiving, offering, or paying remuneration, directly or indirectly, in exchange for, or to induce either the referral of an individual, or the purchase, order, or recommendation of, any good or service paid for under federal healthcare programs such as the Medicare and Medicaid programs.
The SRT-100 provides the following clinical and functional advantages: ● Easy touch automatic set-up procedure, including automatic x-ray tube warm-up procedures; ● Specially designed control console for medical physicists and service technicians, providing integrated safety and back-up timer controls, automatic system conditioning procedures, calibration, x-ray output verification and system parameters, including last treatment status information; ● Advanced patient record management with integrated enterprise workflow management; ● Compact mobile design with a small 30” x 30” footprint and unique scissor x-ray tube arm movements, providing a large range of motion for patient access and treatment; and 1 ● High reliability and MTBF (“mean time between failures”) performance that provides availability for patients and practitioners and lowers the total cost of ownership.
The SRT-100 provides the following clinical and functional advantages: ● Easy touch automatic set-up procedure, including automatic x-ray tube warm-up procedures; ● Specially designed control console for medical physicists and service technicians, providing integrated safety and back-up timer controls, automatic system conditioning procedures, calibration, x-ray output verification and system parameters, including last treatment status information; ● Advanced patient record management with integrated enterprise workflow management; 1 ● Compact mobile design with a small 30” x 30” footprint and unique scissor x-ray tube arm movements, providing a large range of motion for patient access and treatment; and ● High reliability and MTBF (“mean time between failures”) performance that provides availability for patients and practitioners and lowers the total cost of ownership.
To date, other available US regulatory pathways (i.e., Self-certification (Class I), Pre-market Authorization Class III, or de novo ) have not been appropriate for our developed products and may involve extended review periods. Ongoing FDA regulation After a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.
To date, other available US regulatory pathways (i.e., Self-certification (Class I), Pre-market Authorization Class III, or de novo ) have not been appropriate for our developed products and may involve extended review periods. 6 Ongoing FDA regulation After a device is entered into commerce in the U.S., regardless of its classification or premarket pathway, numerous additional FDA requirements generally apply.
Patent No. 11,894,123: Radiotherapy Mobile and Wireless Device Workflow Management System (expires June 20, 2039) The Company also owns eight U.S. trademark registrations (expiring from 2025 through 2031). The Company also relies on trade secrets and other unpatented proprietary rights to develop and maintain a competitive position.
Patent No. 11,894,123: Radiotherapy Mobile and Wireless Device Workflow Management System (expires June 20, 2039) The Company also owns eight U.S. trademark registrations (expiring from 2025 through 2031). 5 The Company also relies on trade secrets and other unpatented proprietary rights to develop and maintain a competitive position.
Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assembly (expires September 30, 2025) The following patents were issued to us in 2017: ● Russia Patent No. 2633322: Hybrid Ultrasound-Guided Superficial Radiotherapy System and Method (expires January 12, 2033) ● China Patent No.
Patent No. 7,263,170: Radiation therapy system featuring rotatable filter assembly (expired September 30, 2025) The following patents were issued to us in 2017: ● Russia Patent No. 2633322: Hybrid Ultrasound-Guided Superficial Radiotherapy System and Method (expires January 12, 2033) ● China Patent No.
The Company has implemented policies and procedures related to commercial compliance including with respect to compliance in connection with sales and marketing. 8 Healthcare Fraud and Abuse Healthcare fraud and abuse laws apply to Sensus’s business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid, or most other federally funded healthcare programs.
The Company has implemented policies and procedures related to commercial compliance including with respect to compliance in connection with sales and marketing. 9 Healthcare Fraud and Abuse Healthcare fraud and abuse laws apply to Sensus’s business when a customer submits a claim for an item or service that is reimbursed under Medicare, Medicaid, or most other federally funded healthcare programs.
These include: ● Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807; ● Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820; ● Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products for uncleared or unapproved (i.e., “off-label”) uses; ● Medical Device Reporting regulation, which requires that manufacturers and importers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21 CFR, Part 803; and ● Reports of Corrections and Removals regulation, which requires that manufacturers and importers (a) report to the FDA recalls (i.e., corrections or removals) if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health, and (b) keep records of recalls that they determine to be not reportable, all in accordance with 21 CFR, Part 806. 6 The FDA enforces these requirements by inspection and market surveillance.
These include: ● Establishment registration and device listing requirements, in accordance with 21 CFR, Part 807; ● Quality System Regulation requirements, which govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of finished devices, in accordance with 21 CFR, Part 820; ● Labeling requirements, which mandate the inclusion of certain content in device labels and labeling, and which also prohibit the promotion of products for uncleared or unapproved (i.e., “off-label”) uses; ● Medical Device Reporting regulation, which requires that manufacturers and importers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur, in accordance with 21 CFR, Part 803; and ● Reports of Corrections and Removals regulation, which requires that manufacturers and importers (a) report to the FDA recalls (i.e., corrections or removals) if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health, and (b) keep records of recalls that they determine to be not reportable, all in accordance with 21 CFR, Part 806.
The Company uses a proprietary low-energy X-ray technology known as superficial radiation therapy (“SRT”), which is based on over a decade of dedicated research and development, and has successfully incorporated SRT into a portfolio of treatment devices: the SRT-100 TM , SRT-100+ TM and SRT-100 Vision TM .
The Company uses a proprietary low-energy X-ray technology known as superficial radiation therapy (“SRT”), which is based on decades of dedicated research and development, and has successfully incorporated SRT into a portfolio of treatment devices: the SRT-100 TM , SRT-100+ TM and SRT-100 Vision TM .
To date, SRT technology has been used to effectively and safely treat oncological and non-oncological skin conditions in hundreds of thousands of patients around the world. Our business was organized in 2010 and the Company, incorporated in Delaware, completed its initial public offering in 2016. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida.
To date, SRT technology has been used to effectively and safely treat oncological and non-oncological skin conditions of close to one-million patients around the world. Our business was organized in 2010 and the Company, incorporated in Delaware, completed its initial public offering in 2016. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida.
The patents relate to technology that is pertinent to the Company. The following patents were issued between August 2007 and September 2008: ● U.S. Patent No. 7,372,940: Radiation therapy system featuring rotatable filter assembly (expires September 30, 2025) 4 ● U.S.
The patents relate to technology that is pertinent to the Company. The following patents were issued between August 2007 and September 2008: ● U.S. Patent No. 7,372,940: Radiation therapy system featuring rotatable filter assembly (expired September 30, 2025) ● U.S.
For the year ended December 31, 2024, we incurred $0.9 million in expenses related to regulatory compliance and quality standards. 5 FDA Regulation of Medical Devices The Federal Food, Drug and Cosmetic Act (“FDCA”) and FDA regulations establish a comprehensive system for the regulation of medical devices intended for human use.
For the year ended December 31, 2025, we incurred $3.4 million in expenses related to regulatory compliance and quality standards. FDA Regulation of Medical Devices The Federal Food, Drug and Cosmetic Act (“FDCA”) and FDA regulations establish a comprehensive system for the regulation of medical devices intended for human use.
Finally, the Company may be required to incur additional costs related to ongoing HIPAA compliance as may be necessary to address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations, emerging cybersecurity threats, and other factors.
Finally, the Company may be required to incur additional costs related to ongoing HIPAA compliance as may be necessary to address evolving interpretations and enforcement of HIPAA and other health information privacy and security laws, the enactment of new laws or regulations, emerging cybersecurity threats, and other factors. 10 Research and Development Research and development costs related to development and quality and regulatory costs are expensed as incurred.
Item 1. BUSINESS Overview Sensus Healthcare, Inc. (together, with its subsidiaries, Sensus Medical Devices Ltd. and Sensus Healthcare Services, LLC, unless the context otherwise indicates, “Sensus,” “we,” “us,” “our,” or the “Company”) is a medical device company committed to providing highly effective, non-invasive, and cost-effective treatments for both oncological and non-oncological skin conditions.
Item 1. BUSINESS Overview Sensus Healthcare, Inc. (together, with its subsidiaries, Sensus Medical Devices Ltd. and Sensus Healthcare Services, LLC, unless the context otherwise indicates, “Sensus,” “we,” “us,” “our,” or the “Company”) is a medical device company committed to providing highly effective, non-invasive treatments for non-melanoma skin cancer (NMSC) and post-surgical keloid scar prevention.
The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards with respect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect the confidentiality, integrity, and security of protected health information. 9 The Company has implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law.
The HIPAA privacy and security regulations, including the expanded requirements under HITECH, establish comprehensive federal standards with respect to the use and disclosure of protected health information by covered entities and their business associates, in addition to setting standards to protect the confidentiality, integrity, and security of protected health information.
The Company or manufacturer may terminate the agreement upon 90 days’ prior written notice. The Company maintains internal policies, procedures, and supplier management processes designed to ensure that RbM meets applicable quality standards, including FDA and International Organization for Standardization, or ISO, requirements.
The Company maintains internal policies, procedures, and supplier management processes designed to ensure that RbM meets applicable quality standards, including FDA and International Organization for Standardization, or ISO, requirements.
The privacy and security regulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and security regulations and varying state privacy and security laws.
The Company has implemented policies and procedures related to compliance with the HIPAA privacy and security regulations, as required by law. The privacy and security regulations establish a “floor” and do not supersede state laws that are more stringent. Therefore, we are required to comply with both federal privacy and security regulations and varying state privacy and security laws.
SRT-100 The SRT-100 is a photon x-ray low energy SRT system that provides patients an alternative to surgery for treating non-melanoma skin cancers, including basal cell and squamous cell skin cancers and other skin conditions such as keloids.
As of December 31, 2025, the Company had installed 955 units in 21 countries, primarily in the United States. SRT-100 The SRT-100 is a photon x-ray low energy SRT system that provides patients an alternative to surgery for treating non-melanoma skin cancers, including basal cell and squamous cell skin cancers and other skin conditions such as keloids.
The information on Sensus’s website is not incorporated by reference in this Annual Report on Form 10-K. Reports, proxy statements, and other information regarding issuers that file electronically with the SEC, including Sensus’s filings, are also available to the public from the SEC’s website at http://www.sec.gov. 10
Reports, proxy statements, and other information regarding issuers that file electronically with the SEC, including Sensus’s filings, are also available to the public from the SEC’s website at http://www.sec.gov.
Key competitive factors include improved outcomes for medical conditions, acceptance by doctors treating non-melanoma skin cancer and keloids, acceptance by the patient community, ease of use and reliability, product price and qualification for reimbursement, technical leadership and superiority, effective marketing and distribution, speed to market, and quality of client service.
Key competitive factors include improved outcomes for medical conditions, acceptance by doctors treating non-melanoma skin cancer and keloids, acceptance by the patient community, ease of use and reliability, product price and qualification for reimbursement, technical leadership and superiority, effective marketing and distribution, speed to market, and quality of client service. 3 Sales and Marketing The Company’s focus is mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings.
Based on this certification, we can draw up an EU Declaration of Conformity which allows us to affix the CE mark to our products. 7 Further, the advertising and promotion of Sensus’s products in the EU/EEA is subject to the laws of individual EEA Member States implementing the EU Medical Devices Directive, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EU/EEA Member State laws governing the advertising and promotion of medical devices.
Further, the advertising and promotion of Sensus’s products in the EU/EEA is subject to the laws of individual EEA Member States implementing the EU Medical Devices Directive, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EU/EEA Member State laws governing the advertising and promotion of medical devices.
Employees and Human Capital At December 31, 2024, the Company had 54 employees. None of the Company’s employees are represented by a labor union or covered by a collective bargaining agreement. The Company believes that its success depends on the ability to attract, develop, and retain key personnel.
None of the Company’s employees are represented by a labor union or covered by a collective bargaining agreement. The Company believes that its success depends on the ability to attract, develop, and retain key personnel. It also believes that the skills, experience, and industry knowledge of its key employees significantly benefits its operations and performance.
The Company’s SRT has been used by over 100 U.S. dermatology practices in the treatment of keloids. It has also been used to treat keloids in China since 2017. 3 Radiation Oncology Market For licensed radiation oncologists in the U.S., the Company believes its SRT products offer a simpler, faster method of treatment with a better overall patient experience.
Radiation Oncology Market For licensed radiation oncologists in the U.S., the Company believes its SRT products offer a simpler, faster method of treatment with a better overall patient experience.
The Company believes its SRT products offer dermatologists a competitive advantage by allowing them to retain patients for the treatment of non-melanoma skin cancer, rather than having to refer them to other professionals. In addition to non-melanoma skin cancers, the Company has had an FDA clearance to treat keloid scars since 2014.
Dermatology Market Private dermatology practices in the U.S. represent the point of entry for most non-melanoma skin cancer patients. The Company believes its SRT products offer dermatologists a competitive advantage by allowing them to retain patients for the treatment of non-melanoma skin cancer, rather than having to refer them to other professionals.
The European Union/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. The UK, due to Brexit, also requires a separate clearance.
The time required to obtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ. The European Union/European Economic Area, or EU/EEA, requires a CE conformity mark in order to market medical devices. The UK, due to Brexit, also requires a separate clearance.
This multi-tier sales model uses a direct sales force in the U.S., as well as international dealers and distributors. Sensus plans to continue selling and marketing the Company’s products to both the dermatology and radiation oncology markets concurrently. Dermatology Market Private dermatology practices in the U.S. represent the point of entry for most non-melanoma skin cancer patients.
The Company currently employs a multi-tier sales strategy to optimize geographic coverage and focus on its key markets. This multi-tier sales model uses a direct sales force in the U.S., as well as international dealers and distributors. Sensus plans to continue selling and marketing the Company’s products to both the dermatology and radiation oncology markets concurrently.
Sensus also provides, through the program, turnkey pre-and post-sale services that include the following: ● Providing a pre-install kit for the contractors to prepare the treatment room; ● Room retrofit and shielding; ● System shipping coordination and installation; ● System commissioning by a medical physicist (through a national physics network); ● System registration with the state and daily workflow documentation preparation; ● Clinical applications training with the customer’s SRT staff; and ● Treating the first scheduled patients with our customers (onsite applications training). 2 Other products Transdermal Infusion (TDI) TransDermal Infusion is a biophysical alternative to infuse high weight molecule modalities into the dermis for medical and aesthetic purposes without the use of needles.
Sensus also provides, through the program, turnkey pre-and post-sale services that include the following: ● Providing a pre-install kit for the contractors to prepare the treatment room; ● Room retrofit and shielding; ● System shipping coordination and installation; ● System commissioning by a medical physicist (through a national physics network); ● System registration with the state and daily workflow documentation preparation; ● Clinical applications training with the customer’s SRT staff; and ● Treating the first scheduled patients with our customers (onsite applications training). 2 Fair Deal Agreement The Company offers the Fair Deal Agreement, a recurring revenue program that provides customers with a revenue-share turn-key solution to gain access to the Company’s image-guided superficial radiotherapy technology to treat non-melanoma skin cancer and keloids.
Lasers Sensus also distributes laser devices, for the aesthetic dermatology market, which includes applications for hair removal, vascular lesions, acne treatment, epidermal pigment removal (including removal of spots, freckles, and tattoos), skin toning, and skin rejuvenation. Other services Sensus provides Operational Healthcare Services in the form of Radiation Oncology and Physics oversight in addition Radiotherapy Technologist for dermatology clinics.
Lasers Sensus, from time to time, also distributes laser devices, for the aesthetic dermatology market, which includes applications for hair removal, vascular lesions, acne treatment, epidermal pigment removal (including removal of spots, freckles, and tattoos), skin toning, and skin rejuvenation. The Company did not sell any lasers in 2024 or 2025.
Under this agreement, the Company pays a fixed price per unit, subject to annual adjustments due to changes in the cost of materials. The agreement renews for successive one-year periods unless either party notifies the other party in writing, at least 60 days prior to the anniversary date of the agreement, that it will not renew the agreement.
The agreement renews for successive one-year periods unless either party notifies the other party in writing, at least 60 days prior to the anniversary date of the agreement, that it will not renew the agreement. The Company or manufacturer may terminate the agreement upon 90 days’ prior written notice.
The Notified Body typically audits and examines the quality system for the manufacture, design, and final inspection of devices before issuing a certification demonstrating compliance with the essential requirements.
The Notified Body typically audits and examines the quality system for the manufacture, design, and final inspection of devices before issuing a certification demonstrating compliance with the essential requirements. Based on this certification, we can draw up an EU Declaration of Conformity which allows us to affix the CE mark to our products.
Sensus also works with other third parties that it believes could be relied upon if we needed to change suppliers. The Company has a single preferred supplier for the x-ray tubes and other major components used in its products.
Sensus also works with other third parties that it believes could be relied upon if we needed to change suppliers. The Company also began contracting with another third-party supplier, Koplak, LLC, in 2025 for special projects and assistance with regard to SRT products.
The Company is subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance with applicable state public health regulations. These inspections may include our suppliers’ facilities. International Regulations International sales of medical devices are subject to foreign government regulations, which vary substantially from country to country.
The Company is subject to unannounced establishment inspections by the FDA, as well as other regulatory agencies overseeing the implementation of and compliance with applicable state public health regulations. These inspections may include our suppliers’ facilities. 7 Centers for Medicare and Medicaid Services (CMS) CPT Codes and Local Coverage Determinations (LCDs) CMS is the federal agency within the U.S.
Employee levels are managed to align with the pace of business and management believes it has sufficient human capital to operate its business successfully. Available Information Sensus files annual, quarterly, and current reports, proxy statements, and all amendments to these reports and other information with the SEC.
Available Information Sensus files annual, quarterly, and current reports, proxy statements, and all amendments to these reports and other information with the SEC.
Research and Development Research and development costs related to development and quality and regulatory costs are expensed as incurred. For the years ended December 31, 2024 and 2023, the Company incurred research and development expenses of $4.2 million and $3.7 million, respectively. The Company expects research and development expenses in 2025 to be generally consistent with 2024.
For the years ended December 31, 2025 and 2024, the Company incurred research and development expenses of $7.8 million and $4.2 million, respectively. The Company expects research and development expenses incurred in 2026 to be substantially lower than those incurred in 2025. Employees and Human Capital At December 31, 2025, the Company had 60 employees.
Manufacturing and Supply The Company currently uses third parties located in the U.S. to manufacture products. In 2010, the Company entered into a manufacturing agreement with RbM Services, LLC (“RbM”) pursuant to which RbM agreed to manufacture SRT-100 products.
In 2010, the Company entered into a manufacturing agreement with RbM Services, LLC (“RbM”) pursuant to which RbM agreed to manufacture SRT-100 products. Under this agreement, the Company pays a fixed price per unit, subject to annual adjustments due to changes in the cost of materials.
In February 2024, the Company formed Sensus Healthcare Services, LLC, a wholly-owned subsidiary that provides operational healthcare services to dermatology clinics. For further information see Note 1, Organization and Summary of Significant Accounting Policies - Description of the Business , in the notes to the consolidated financial statements in Part II, Item 8.
The term the Company uses for this service model is the “Fair Deal Agreement.” For further information see Note 1, Organization and Summary of Significant Accounting Policies - Description of the Business , in the notes to the consolidated financial statements in Part II, Item 8. Our Products and Services SRT is the Company’s core technology.
With FDA clearance to treat keloids through SRT, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor. Additionally, the Company believes that plastic surgeons view the non-melanoma skin cancer market as a growth opportunity that can supplement their existing services.
With FDA clearance to treat keloids through SRT, plastic surgeons are recognizing the opportunity to be able to provide an effective treatment solution for this benign tumor. Manufacturing and Supply The Company currently uses third parties located in the U.S. to manufacture products.
In 2022, the Company sourced the product from a manufacturer in Italy. The Company started developing its own TDI system in 2023, which is pending approval from the FDA. The Company is not currently offering TDI.
Other products TransDermal Infusion (TDI) TransDermal Infusion is a biophysical alternative to infuse high weight molecule modalities into the dermis for medical and aesthetic purposes without the use of needles. In 2022, the Company sourced the product from a manufacturer in Italy. The Company started developing its own TDI system in 2023. The Company is not currently offering TDI.
In order to market our products in other countries, the Company must obtain regulatory approvals and comply with safety and quality regulations. The time required to obtain approval by a foreign country may be longer or shorter than that required for FDA clearance or approval, and the requirements may differ.
International Regulations International sales of medical devices are subject to foreign government regulations, which vary substantially from country to country. In order to market our products in other countries, the Company must obtain regulatory approvals and comply with safety and quality regulations.
It also believes that the skills, experience, and industry knowledge of its key employees significantly benefits its operations and performance. The Company believes that it offers competitive compensation and other means of attracting and retaining key personnel.
The Company believes that it offers competitive compensation and other means of attracting and retaining key personnel. Employee levels are managed to align with the pace of business and management believes it has sufficient human capital to operate its business successfully.
Removed
Our Products and Services SRT is the Company’s core technology. As of December 31, 2024, the Company had installed 867 units in 21 countries, primarily in the United States.
Added
In February 2024, the Company formed Sensus Healthcare Services, LLC, a wholly owned subsidiary that provides operational healthcare offerings to dermatology clinics in the form of equipment, radiation oncology and physicist oversight, and on-site device operation by radiotherapy technologists.
Removed
Sales and Marketing The Company’s focus is mainly on two primary markets, private dermatology practices and radiation oncologists in both private and hospital settings. The Company currently employs a multi-tier sales strategy to optimize geographic coverage and focus on its key markets.
Added
Under this service model, the Company provides the customer with a SRT system, a radiotherapy technologist, radiation oncology and physicist oversight. The Company receives in exchange a contractual percentage of all SRT related reimbursement collected from all payors; an economic value proposition as an alternative to a direct purchase.
Added
Sensus Healthcare Financial Services In February 2026, the Company launched Sensus Healthcare Financial Services, a financing program through third party banks, to support the acquisition of the Company’s full line of systems through a streamlined process and flexible financing structures, including outright purchase or several leasing alternatives.
Added
The Company believes this program will improve conversion of purchase-oriented prospects by reducing administrative and financing barriers. The Company also believes that the program will complement the Company’s broader commercial strategy across independent medical practices and corporate accounts, as well as support a scalable go-to-market strategy as customer demand accelerates under the new reimbursement environment.
Added
Sensus Link In February 2026, the Company launched Sensus Link, a cloud-based software and connectivity solution intended to expand advanced operating capabilities across the Company’s SRT-100 system installed base. Through the combination of a new point-of-care software solution with cloud-based connectivity features, Sensus Link enables users of SRT-100 systems to access enhanced workflow, treatment documentation and operating intelligence.
Added
These capabilities historically were associated solely with more advanced image-guided and workstation platforms. The Company expect this solution to strengthen the commercial offering across both direct purchase and Fair Deal Agreement customers.
Added
Other services Sensus provides operational healthcare services for dermatology clinics in the form of radiation oncology and physicist oversight and on-site device operation by radiotherapy technologists.
Added
In addition to non-melanoma skin cancers, the Company has had a Food and Drug Administration (“FDA”) clearance to treat keloid scars since 2014. The Company’s SRT has been used by over 100 U.S. dermatology practices in the treatment of keloids. It has also been used to treat keloids in China since 2017.
Added
Having multiple supplier relationships is intended to assist the Company in ramping up inventory more quickly in the event of significantly increased demand. 4 The Company has a single preferred supplier for the x-ray tubes and other major components used in its products.
Added
The FDA enforces these requirements by inspection and market surveillance.
Added
Department of Health and Human Services responsible for administering the Medicare program, Medicaid, the Children’s Health Insurance Program, and the Health Insurance Marketplace. CMS sets health and safety standards for facilities, manages beneficiary enrollment, and pays claims. Sensus relies on its SRT technology and SRT is reimbursed through CPT codes that CMS establishes and sets the value for.
Added
CMS released brand new CPT codes for SRT beginning on January 1, 2026, however, the announcement of the new CPT codes, which were proposed in July, significantly impacted 2025 sales numbers for the Company, as customers anticipated use of the new codes in 2026.
Added
In addition, an LCD is a regional policy created by Medicare Administrative Contractors that determines whether a specific medical item or service is considered reasonable, necessary, and covered under Medicare Part A or Part B within a particular geographic area. LCD’s define covered diagnosis codes, service frequency, and documentation requirements, and are stored in the Medicare Coverage Database.
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Our corporate governance guidelines, code of business conduct and ethics, board committee charters, and certain other corporate governance policies are also posted on the Investor Relations section of our website. The information on Sensus’s website is not incorporated by reference in this Annual Report on Form 10-K.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIf new products, treatments, and/or technologies are developed by our competitors or other third parties more quickly or more successfully than us that gain wide acceptance among doctors and patients, including products or treatments developed by our significant customers, it could take market share away from the Company, which could adversely affect the Company’s render the Company’s products obsolete, which could impair our ability to compete effectively and adversely affect our results of operations.
Biggest changeIf new products, treatments, and/or technologies are developed by our competitors or other third parties more quickly or more successfully than us that gain wide acceptance among doctors and patients, including products or treatments developed by our significant customers, it could take market share away from the Company, which could adversely affect the Company’s render the Company’s products obsolete, which could impair our ability to compete effectively and adversely affect our results of operations. 12 The Company’s customers, including one U.S. customer accounting for a significant portion of our sales, are concentrated in the U.S., and economic difficulties or changes in the purchasing policies or patterns of the Company’s customers in the U.S. has had and could have in the future a significant impact on our business and operating results.
These provisions include: ● authorizing the issuance of “blank check” preferred stock without any need for action by stockholders; ● requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of the Company’s stock and assets; ● eliminating the ability of stockholders to call and bring business before special meetings of stockholders; 19 ● prohibiting stockholder action by written consent; ● establishing advance notice requirements for nominations for election to the Board of Directors or for proposing matters that can be acted on by stockholders at stockholder meetings; ● dividing the Board of Directors into three classes so that only one third of the directors will be up for election in any given year; and ● providing that the Company’s directors may be removed only by the affirmative vote of at least 75% of the Company’s then-outstanding common stock and only for cause.
These provisions include: ● authorizing the issuance of “blank check” preferred stock without any need for action by stockholders; 19 ● requiring supermajority stockholder voting to effect any merger or sale of all or substantially all of the Company’s stock and assets; ● eliminating the ability of stockholders to call and bring business before special meetings of stockholders; ● prohibiting stockholder action by written consent; ● establishing advance notice requirements for nominations for election to the Board of Directors or for proposing matters that can be acted on by stockholders at stockholder meetings; ● dividing the Board of Directors into three classes so that only one third of the directors will be up for election in any given year; and ● providing that the Company’s directors may be removed only by the affirmative vote of at least 75% of the Company’s then-outstanding common stock and only for cause.
Any of these events could adversely affect Sensus’s ability to declare dividends on its common stock and to achieve future product development and commercialization goals and could have a material adverse effect on our business, financial condition, and results of operations. Consolidation in the healthcare industry could adversely affect the Company’s future revenues and operating income.
Any of these events could adversely affect Sensus’s ability to declare dividends on its common stock and to achieve future product development and commercialization goals and could have a material adverse effect on our business, financial condition, and results of operations. 14 Consolidation in the healthcare industry could adversely affect the Company’s future revenues and operating income.
Furthermore, the laws of some foreign countries may not protect intellectual property rights to the same extent as the laws of the U.S., if at all. 16 In the event a competitor infringes upon one of Sensus’s patents or other intellectual property rights, enforcing those patents and rights may be difficult and time consuming.
Furthermore, the laws of some foreign countries may not protect intellectual property rights to the same extent as the laws of the U.S., if at all. In the event a competitor infringes upon one of Sensus’s patents or other intellectual property rights, enforcing those patents and rights may be difficult and time consuming.
As a result, investors must rely on price appreciation of the Company’s common stock for a return on its investment in the foreseeable future. The Company expects to retain any funds and future earnings to support the operation, growth, and development of its business and does not anticipate paying any cash dividends on its common stock in the foreseeable future.
As a result, investors must rely on price appreciation of the Company’s common stock for a return on its investment in the foreseeable future. 18 The Company expects to retain any funds and future earnings to support the operation, growth, and development of its business and does not anticipate paying any cash dividends on its common stock in the foreseeable future.
Furthermore, any corrective action, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from business operations. Any of the foregoing would negatively impact Sensus’s reputation, business, and financial results. 15 Healthcare policy changes may have a material adverse effect on Sensus’s business.
Furthermore, any corrective action, whether voluntary or involuntary, will require the dedication of time and capital and will distract management from business operations. Any of the foregoing would negatively impact Sensus’s reputation, business, and financial results. Healthcare policy changes may have a material adverse effect on Sensus’s business.
Any of the foregoing would negatively impact Sensus’s business, operations, and financial results. If Sensus’s trademarks or trade names are not adequately protected, then Sensus may be unable to build name recognition in markets of interest and its business may be adversely affected.
Any of the foregoing would negatively impact Sensus’s business, operations, and financial results. 17 If Sensus’s trademarks or trade names are not adequately protected, then Sensus may be unable to build name recognition in markets of interest and its business may be adversely affected.
As a result, we may be subject to the False Claims Act if we knowingly cause the filing of false claims. 14 ● HIPAA, which, among other things, created federal criminal laws that prohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with the delivery of or payment for healthcare benefits, items or services.
As a result, we may be subject to the False Claims Act if we knowingly cause the filing of false claims. 15 ● HIPAA, which, among other things, created federal criminal laws that prohibit knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements in connection with the delivery of or payment for healthcare benefits, items or services.
The Company is focused heavily on the development and commercialization of a limited number of products for the treatment of non-melanoma skin cancer and other skin conditions with SRT. From the Company’s inception in 2010 through December 31, 2024, revenue has primarily been derived from sales of the SRT-100 product line and related services and ancillary products.
The Company is focused heavily on the development and commercialization of a limited number of products for the treatment of non-melanoma skin cancer and other skin conditions with SRT. From the Company’s inception in 2010 through December 31, 2025, revenue has primarily been derived from sales of the SRT-100 product line and related services and ancillary products.
However, these legal means afford only limited protection and may not adequately protect its rights or permit Sensus to gain or keep any competitive advantage. For example, some or all of the pending patent applications or any future pending applications may be unsuccessful. The U.S.
Sensus also has patent applications currently pending and in the process of being submitted. However, these legal means afford only limited protection and may not adequately protect its rights or permit Sensus to gain or keep any competitive advantage. For example, some or all of the pending patent applications or any future pending applications may be unsuccessful. The U.S.
Most of the Company’s sales have been made to customers located in the U.S. (96% and 91% in the years ended December 31, 2024 and 2023, respectively). Additionally, a single customer in the U.S. accounted for 73% and 61% of revenues for the years ended December 31, 2024, and December 31, 2023, respectively.
Most of the Company’s sales have been made to customers located in the U.S. (92% and 96% in the years ended December 31, 2025 and 2024, respectively). Additionally, a single customer in the U.S. accounted for 52% and 73% of revenues for the years ended December 31, 2025, and December 31, 2024, respectively.
Although there have been no serious consequences to date, cyber security incidents or other significant disruption of our information systems or those of our customers or third-party vendors could occur, and, if they do, they could (i) disrupt the proper functioning of our networks and systems and therefore our operations; (ii) result in the unauthorized access to, and destruction, loss, theft, misappropriation, or release of confidential, sensitive, or otherwise valuable information of ours; (iii) result in a violation of applicable privacy, data protection, and other laws, subjecting us to additional regulatory scrutiny and exposing us to civil litigation, enforcement actions, governmental fines, and possible financial liability; (iv) require significant management attention and resources to remedy the damages that result; or (v) harm our reputation.
The development and maintenance of measures to mitigate against cyber security risks is costly and time-consuming, requiring continuous monitoring as technologies change and efforts to overcome security measures evolve. 13 Although there have been no serious consequences to date, cyber security incidents or other significant disruption of our information systems or those of our customers or third-party vendors could occur, and, if they do, they could (i) disrupt the proper functioning of our networks and systems and therefore our operations; (ii) result in the unauthorized access to, and destruction, loss, theft, misappropriation, or release of confidential, sensitive, or otherwise valuable information of ours; (iii) result in a violation of applicable privacy, data protection, and other laws, subjecting us to additional regulatory scrutiny and exposing us to civil litigation, enforcement actions, governmental fines, and possible financial liability; (iv) require significant management attention and resources to remedy the damages that result; or (v) harm our reputation.
The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, comparative effectiveness research, an independent payment advisory board, payment system reforms (including shared savings pilots), and other provisions, one or more of which may significantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs, any of which may materially affect numerous aspects of our business.
The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, included, among other things, comparative effectiveness research, an independent payment advisory board, payment system reforms (including shared savings pilots), and other provisions, one or more of which may significantly affect the payment for, and the availability of, healthcare services and may result in fundamental changes to federal healthcare reimbursement programs, any of which may materially affect numerous aspects of our business. 16 Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for procedures utilizing our products.
The Company’s cash requirements in the future may be significantly different from current estimates and depend on many factors, including: ● the results of commercialization efforts for products; ● the need for additional capital to fund development programs; ● the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property; ● the establishment of high-volume manufacturing and increased sales, marketing, and distribution capabilities; and ● success in entering into collaborative relationships with other parties. 13 To the extent that Sensus raises additional capital through the sale of equity or convertible debt securities, the ownership interests of the existing stockholders will be diluted.
The Company’s cash requirements in the future may be significantly different from current estimates and depend on many factors, including: ● the results of commercialization efforts for products; ● the need for additional capital to fund development programs; ● the costs involved in obtaining and enforcing patents or any litigation by third parties regarding intellectual property; ● the establishment of high-volume manufacturing and increased sales, marketing, and distribution capabilities; and ● success in entering into collaborative relationships with other parties.
If an unfavorable final outcome in any such matter becomes probable and reasonably estimable, the Company’s financial condition could be materially and adversely affected. Risks Related to the Ownership of Sensus’s Securities We have a history of net losses prior to 2021. If we do not maintain profitability, our financial condition and the value of our common stock could suffer.
If an unfavorable final outcome in any such matter becomes probable and reasonably estimable, the Company’s financial condition could be materially and adversely affected. Risks Related to the Ownership of Sensus’s Securities We have a history of net losses prior to 2021 and we reported a net loss in 2025.
Because of these concentrations, revenue could fluctuate significantly due to changes in economic conditions, competitive products (including any developed by our significant customers), or the loss of, reduction of business with, or less favorable terms with, our significant customer or other U.S. customers.
Because of these concentrations, changes in economic conditions, competitive products (including any developed by our significant customers), or the loss of, reduction of business with, or less favorable terms with, our significant customer or other U.S. customers, has caused, and may cause in the future, significant fluctuations in our revenue.
A reduction or delay in orders for the Company’s products for these or other reasons could materially harm business and results of operations. The Company has a single preferred supplier for the x-ray tubes and other major components used in the Company’s products and the loss of this preferred supplier could adversely affect the Company.
The Company has a single preferred supplier for the x-ray tubes and other major components used in the Company’s products and the loss of this preferred supplier could adversely affect the Company. The Company has a single preferred supplier for the x-ray tubes and other major components used in the Company’s products.
Sensus may not pay dividends as a result of any of the foregoing, and in these cases, an investor would need to rely on price appreciation of the Company’s common stock for a return on investment.
Sensus may not pay dividends as a result of any of the foregoing, and in these cases, an investor would need to rely on price appreciation of the Company’s common stock for a return on investment. Sensus’s executive officers and directors may exert control over the Company and may exercise influence over matters subject to stockholder approval.
While Sensus’s common stock is listed and traded on the Nasdaq Capital Market, there has been limited trading activity in the Company’s shares. Due to the limited trading activity of Sensus’s common stock, relativity small trades may have a significant impact on the price of our common stock. The Company does not anticipate paying dividends for the foreseeable future.
Due to the limited trading activity of Sensus’s common stock, relativity small trades may have a significant impact on the price of our common stock. The Company does not anticipate paying dividends for the foreseeable future.
The failure of these information technology systems to perform as the Company anticipates could disrupt business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing business and results of operations to suffer. 12 The Company has experienced, and expects to continue to experience, cyber security threats and incidents, none of which have been material to the Company to date.
The failure of these information technology systems to perform as the Company anticipates could disrupt business and could result in transaction errors, processing inefficiencies, and the loss of sales and customers, causing business and results of operations to suffer.
Sensus relies on three U.S. patents and two foreign patents, as well as a combination of copyright, trade secret, and trademark laws, and nondisclosure, confidentiality, and other contractual restrictions, to protect its proprietary technology. Sensus also has patent applications currently pending and in the process of being submitted.
Sensus’s success significantly depends on its ability to protect proprietary rights to the technologies used in its products. Sensus relies on three U.S. patents and two foreign patents, as well as a combination of copyright, trade secret, and trademark laws, and nondisclosure, confidentiality, and other contractual restrictions, to protect its proprietary technology.
Although the Company has introduced new products, the Company expects most of revenue in the near to medium term to be derived from or related to sales of the SRT-100 product line.
Although the Company has introduced new products, the Company expects most of revenue in the near to medium term to be derived from or related to sales of the SRT-100 product line. Because of this, any decline in the sales of these products will negatively impact the Company’s business, financial condition, and results of operations.
The Company has a single preferred supplier for the x-ray tubes and other major components used in the Company’s products. Although other suppliers exist in the market, the Company believes that our preferred supplier’s products are of a superior quality.
Although other suppliers exist in the market, the Company believes that our preferred supplier’s products are of a superior quality.
Moreover, the terms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights. Debt financing, if available, may involve covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures, or declaring distributions or dividends.
Debt financing, if available, may involve covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures, or declaring distributions or dividends.
Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election of directors and approval of corporate transactions, such as a merger.
Sensus’s executive officers and directors, together with their respective affiliates, beneficially owned approximately 9.0% of our outstanding common stock as of February 12, 2026. Accordingly, these stockholders, if they act together, may exercise substantial influence over matters requiring stockholder approval, including the election of directors and approval of corporate transactions, such as a merger.
The Company’s common stock price may not appreciate in value or maintain the price at which an investor purchased these securities, and in either case, may not realize a return on investment or could lose all or part of an investment in the Company’s securities. 17 Any future determination to declare cash dividends will be made at the discretion of the Company’s Board of Directors (the “Board of Directors”) and will be subject to compliance with applicable laws and covenants under any credit facilities, which may restrict or limit the Company’s ability to pay dividends.
Any future determination to declare cash dividends will be made at the discretion of the Company’s Board of Directors (the “Board of Directors”) and will be subject to compliance with applicable laws and covenants under any credit facilities, which may restrict or limit the Company’s ability to pay dividends.
Neither hospitals nor physicians are likely to use Sensus’s products if they do not receive adequate reimbursement payments for the procedures using these products.
Neither hospitals nor physicians are likely to use Sensus’s products if they do not receive adequate reimbursement payments for the procedures using these products. Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by CMS.
If one or more of these analysts cease coverage of Sensus, or fail to publish reports on Sensus regularly, demand for the Sensus’s securities could decrease, which might cause the price of its securities and trading volume to decline. 18 The Company’s certificate of incorporation and bylaws, and Delaware law contain provisions that could discourage another company from acquiring the Company and may prevent attempts by the Company’s stockholders to replace or remove the current directors and management.
If one or more of these analysts cease coverage of Sensus, or fail to publish reports on Sensus regularly, demand for the Sensus’s securities could decrease, which might cause the price of its securities and trading volume to decline.
For example, the Company’s current revolving line of credit restricts the ability to pay dividends or make any distributions or payments or redeem, retire, or purchase any capital stock without the prior written consent of the lender, provided that the Company may pay dividends solely in common stock and, so long as no default has occurred under the line of credit, the Company may make certain redemptions of its common stock and pay certain tax distributions to its shareholders.
For example, the Company’s current revolving line of credit restricts the ability to pay dividends or make any distributions or payments or redeem, retire, or purchase any capital stock without the prior written consent of the lender (with limited exceptions).
Risks Related to our Intellectual Property If Sensus’s patents and other intellectual property rights do not adequately protect its products, it may lose market share to competitors and be unable to operate business profitably. Sensus’s success significantly depends on its ability to protect proprietary rights to the technologies used in its products.
In addition, other legislative changes may be enacted or existing regulations, guidance, or interpretations may be changed, each of which may adversely affect our operations. Risks Related to our Intellectual Property If Sensus’s patents and other intellectual property rights do not adequately protect its products, it may lose market share to competitors and be unable to operate business profitably.
Risks Related to our Business If third-party payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used, and our revenue will be negatively impacted.
References to past events are provided by way of example only and are not intended to be a complete listing or a representation as to whether or not such factors have occurred in the past or their likelihood of occurring in the future. 11 Risks Related to our Business If third-party payors do not provide coverage and adequate reimbursement for the use of our products, it is unlikely that our products will be widely used, and our revenue will be negatively impacted.
The medical device industry is highly competitive and subject to rapid technological change, and is significantly affected by the introduction of new products and treatment options.
The Company’s technology could be superseded by new products, treatments, or technologies that gain wider acceptance among doctors and patients, which could adversely affect the Company. The medical device industry is highly competitive and subject to rapid technological change, and is significantly affected by the introduction of new products and treatment options.
Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on Sensus’s business and financial operations. Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments from private payors.
In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affect Sensus’s revenues. Changes to existing laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on Sensus’s business and financial operations.
The implementation of cost containment measures or other healthcare reforms may prevent Sensus from being able to increase revenue, attain profitability, or commercialize its devices. In addition, other legislative changes may be enacted or existing regulations, guidance, or interpretations may be changed, each of which may adversely affect our operations.
Any reduction in reimbursement from Medicare or other government programs may result in a reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent Sensus from being able to increase revenue, attain profitability, or commercialize its devices.
The Company has a history of net losses. The historical losses from inception through December 31, 2021 totaled $17.8 million. The Company reported net income of $6.6 million and $0.5 million, respectively, during the years ended December 31, 2024 and 2023.
If we do not return to and maintain profitability, our financial condition and the value of our common stock could suffer. The Company has a history of net losses. The historical losses from inception through December 31, 2021 totaled $17.8 million.
The accumulated net loss was mainly related to the research and development expenses in the early stage of the Company. The Company is continuously managing expenses. However, there can be no assurances that this and other actions will result in the Company’s continued profitability. Limited trading activity for shares of Sensus’s common stock may contribute to price volatility.
Limited trading activity for shares of Sensus’s common stock may contribute to price volatility. While Sensus’s common stock is listed and traded on the Nasdaq Capital Market, there has been limited trading activity in the Company’s shares.
Removed
Some private payors in the U.S. may base their reimbursement policies on the coverage decisions determined by the Center for Medicare & Medical Services, or CMS, which administers the Medicare program and works in partnership with state governments to administer the Medicaid program.
Added
These disclosures reflect the Company’s beliefs and opinions as to factors that could materially and adversely affect the Company and its securities in the future.
Removed
Because of this, any decline in the sales of these products will negatively impact the Company’s business, financial condition, and results of operations. 11 The Company’s technology could be superseded by new products, treatments, or technologies that gain wider acceptance among doctors and patients, which could adversely affect the Company.
Added
A reduction or delay in orders for the Company’s products for these or other reasons has in the past, and could in the future, materially harm our business and results of operations.
Removed
The Company’s customers, including one U.S. customer accounting for a significant portion of our sales, are concentrated in the U.S., and economic difficulties or changes in the purchasing policies or patterns of the Company’s customers in the U.S. could have a significant impact on our business and operating results.
Added
The Company has experienced, and expects to continue to experience, cyber security threats and incidents, none of which have been material to the Company to date.
Removed
The development and maintenance of measures to mitigate against cyber security risks is costly and time-consuming, requiring continuous monitoring as technologies change and efforts to overcome security measures evolve.
Added
To the extent that Sensus raises additional capital through the sale of equity or convertible debt securities, the ownership interests of the existing stockholders will be diluted. Moreover, the terms of newly issued securities may include liquidation or other preferences that adversely affect common stockholders’ rights.
Removed
Other healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the reimbursement received for procedures utilizing our products. In addition, other legislative changes have been proposed and adopted since the law discussed above was enacted that may adversely affect Sensus’s revenues.
Added
While the Company achieved profitability in 2021 and maintained profitability on an annual basis through 2024, the Company reported a net loss of $7.7 million during the year ended December 31, 2025. The accumulated net loss prior to 2021 was mainly related to the research and development expenses in the early stage of the Company.
Removed
Sensus is a “smaller reporting company,” and the reduced reporting requirements applicable to smaller reporting companies may make Sensus’s common stock less attractive to investors.
Added
The Company expects to continue to incur significant expenses as it seeks to grow its business, including costs related to research and development, sales and marketing, and general and administrative functions. The Company is continuously managing expenses and pursuing strategies to improve operational efficiency and increase revenues.
Removed
As a smaller reporting company, Sensus can take advantage of certain reduced governance and disclosure requirements, including not being required to comply with the auditor attestation requirements in the assessment of internal control over financial reporting.
Added
However, there can be no assurances that these and other actions will result in the Company returning to profitability or, if profitability is achieved, that the Company will be able to sustain profitability. The Company’s failure to achieve and maintain profitability could negatively impact our financial condition and the value of our common stock.
Removed
As a result, investors and others may be less comfortable with the effectiveness of Sensus’s internal controls and the risk that material weaknesses or other deficiencies in internal controls go undetected may increase.
Added
The Company’s common stock price may not appreciate in value or maintain the price at which an investor purchased these securities, and in either case, may not realize a return on investment or could lose all or part of an investment in the Company’s securities.
Removed
In addition, as a smaller reporting company, Sensus takes advantage of the ability to provide certain other less comprehensive disclosures in our SEC filings, including, among other things, providing only two years of audited financial statements in annual reports and simplified executive compensation disclosures.
Added
The Company’s certificate of incorporation and bylaws, and Delaware law contain provisions that could discourage another company from acquiring the Company and may prevent attempts by the Company’s stockholders to replace or remove the current directors and management.
Removed
Consequently, it may be more challenging for investors to analyze Sensus’s results of operations and financial prospects, as the information provided to stockholders may be different from what one might receive from other public companies in which one holds shares.
Removed
Sensus’s executive officers and directors may exert control over the Company and may exercise influence over matters subject to stockholder approval. Sensus’s executive officers and directors, together with their respective affiliates, beneficially owned approximately 8.5% of our outstanding common stock as of February 12, 2025.

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeThe CTO maintains regular communication with the Board on matters related to cybersecurity and provides updates to management on a quarterly basis. In the event of a cybersecurity incident, the Board is to be promptly notified. Management considers cybersecurity risk as part of its risk oversight function and is in the process of establishing a cybersecurity governance committee.
Biggest changeThe CTO works with internal personnel and third-party consultants to design and implement controls for the prevention, detection, mitigation, and remediation of cybersecurity risks. The CTO maintains regular communication with the Board on matters related to cybersecurity and provides updates to management on a quarterly basis. In the event of a cybersecurity incident, the Board is to be promptly notified.
In addition, the Company has a strategic plan, which encompasses the following key elements: ● Establishment of a dedicated cybersecurity governance committee; ● Standardization of cybersecurity incident response procedures and formats; ● Conducting penetration tests on a quarterly basis; ● Enhancement of segregation of duties to mitigate the risk of self-review of transactions within the system; The Company has not identified any risks from known cybersecurity threats and did not have any cybersecurity incidents that have materially affected or are reasonably likely to materially affect the Company.
In addition, the Company has a strategic plan, which encompasses the following key elements: ● Establishment of a dedicated cybersecurity governance committee; ● Standardization of cybersecurity incident response procedures and formats; ● Conducting penetration tests on a quarterly basis; ● Enhancement of segregation of duties to mitigate the risk of self-review of transactions within the system; 21 The Company has not identified any risks from known cybersecurity threats and did not have any cybersecurity incidents that have materially affected or are reasonably likely to materially affect the Company.
Risk Factors – “The Company’s operations may be impaired if our information technology systems fail to perform adequately or are the subject of a data breach or cyberattack,” which is incorporated by reference into this Item 1C. 21 Cybersecurity Governance The Board of Directors actively collaborates with management to supervise cybersecurity risks.
For a discussion of whether and how any risks from cybersecurity threats are reasonably likely to materially affect us, refer to Item 1A. Risk Factors – “The Company’s operations may be impaired if our information technology systems fail to perform adequately or are the subject of a data breach or cyberattack,” which is incorporated by reference into this Item 1C.
The cybersecurity governance committee will oversee the management’s implementation of the cybersecurity risk management program.
Management considers cybersecurity risk as part of its risk oversight function and is in the process of establishing a cybersecurity governance committee. The cybersecurity governance committee will oversee the management’s implementation of the cybersecurity risk management program.
Removed
For a discussion of whether and how any risks from cybersecurity threats are reasonably likely to materially affect us, refer to Item 1A.
Added
Cybersecurity Governance The Board of Directors actively collaborates with management to supervise cybersecurity risks. The Chief Technology Officer (“CTO”), with over ten years of experience in technology and engineering within the medical device industry, leads the Company’s overall cybersecurity function and is responsible for monitoring cybersecurity risks.
Removed
The Chief Technology Officer (“CTO”), with over 10 years’ experience in cybersecurity, leads the Company’s overall cybersecurity function and monitors cybersecurity risks. The CTO works with internal personnel and third-party consultants to design and implement the controls on the prevention, detection, mitigation, and remediation of cybersecurity risks.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

4 edited+0 added−0 removed5 unchanged
Biggest changeFor example, the Company’s current revolving line of credit restricts the ability to pay dividends or make any distributions or payments or redeem, retire, or purchase any capital stock without the prior written consent of the lender, provided that the Company may pay dividends solely in common stock without prior consent.
Biggest changeFor example, the Company’s current revolving line of credit restricts the ability to pay dividends or make any distributions or payments or redeem, retire, or purchase any capital stock without the prior written consent of the lender (with limited exceptions).
Unregistered Sales of Securities There were no unregistered sales of securities during the year ended December 31, 2024. Purchases of Equity Securities by the Registrant and Affiliated Purchasers In August 2023, the Company announced that its Board of Directors had authorized a program to purchase up to $3,000,000 of shares of its common stock.
Unregistered Sales of Securities There were no unregistered sales of securities during the year ended December 31, 2025. Purchases of Equity Securities by the Registrant and Affiliated Purchasers In August 2023, the Company announced that its Board of Directors had authorized a program to purchase up to $3,000,000 of shares of its common stock.
No purchases were made during the fourth quarter of 2024 by or on behalf of the Company. Item 6. RESERVED 23
No purchases were made during the fourth quarter of 2025 by or on behalf of the Company. Item 6. RESERVED 23
Item 5. MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information The Company’s Class A common stock is publicly traded on the NASDAQ Capital Market under the symbol “SRTS.” Holders At the close of business on February 13, 2025, there were 17 common stockholders of record.
Item 5. MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information The Company’s Class A common stock is publicly traded on the NASDAQ Capital Market under the symbol “SRTS.” Holders At the close of business on February 26, 2026, there were 16 common stockholders of record.

Item 7. Management's Discussion & Analysis

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

22 edited+11 added−4 removed4 unchanged
Biggest changeResults of Operations For the Years Ended December 31, (in thousands, except shares and per share data) 2024 2023 Revenues $ 41,807 $ 24,405 Cost of sales 17,376 10,345 Gross profit 24,431 14,060 Operating expenses General and administrative 7,147 5,156 Selling and marketing 4,978 5,608 Research and development 4,216 3,678 Total operating expenses 16,341 14,442 Income (loss) from operations 8,090 (382 ) Other income: Gain on sale of assets — 42 Interest income 932 992 Other income, net 932 1,034 Income before income tax 9,022 652 Provision for income taxes 2,375 167 Net income $ 6,647 $ 485 Net income per share – basic $ 0.41 $ 0.03 diluted $ 0.41 $ 0.03 Weighted average number of shares used in computing net income per share – basic 16,312,351 16,259,254 diluted 16,359,616 16,266,139 24 2024 Compared with 2023 Revenues of $41.8 million in 2024 increased by $17.4 million, or 71%, from $24.4 million in 2023.
Biggest changeResults of Operation 24 For the Years Ended December 31, (in thousands, except shares and per share data) 2025 2024 Revenues $ 27,482 $ 41,807 Cost of sales 15,615 17,376 Gross profit 11,867 24,431 Operating expenses General and administrative 7,873 7,147 Selling and marketing 6,523 4,978 Research and development 7,778 4,216 Total operating expenses 22,174 16,341 (Loss) income from operations (10,307 ) 8,090 Other income: Interest income, net 683 932 Other income, net 683 932 (Loss) income before income tax (9,624 ) 9,022 (Benefit from) provision for income taxes (1,905 ) 2,375 Net (loss) income $ (7,719 ) $ 6,647 Net income per share – basic $ (0.47 ) $ 0.41 diluted $ (0.47 ) $ 0.41 Weighted average number of shares used in computing net income per share – basic 16,326,937 16,312,351 diluted 16,326,937 16,359,616 2025 Compared with 2024 Revenues of $27.5 million in 2025 decreased by $14.3 million, or 34%, from $41.8 million in 2024.
Cash flows provided by operating activities primarily include the receipt of revenues offset by the payment of operating expenses incurred in the normal course of business. Non-cash items consisted of credit loss expense, deferred income taxes, stock-based compensation expense, provision for product warranties, amortization of right-of-use asset and depreciation and amortization of property and equipment.
Cash flows provided by operating activities primarily include the receipt of revenues offset by the payment of operating expenses incurred in the normal course of business. Non-cash items consisted of credit loss expense, deferred income taxes, stock-based compensation expense, provision for product warranties, amortization of right-of-use asset and depreciation of property and equipment.
Management has not applied any critical accounting estimates but has identified certain accounting policies as critical to understanding the financial condition and results of operations. For a detailed discussion on the application of these and other accounting policies, see the notes to the consolidated financial statements included in this Annual Report on Form 10-K.
Management has not applied any critical accounting estimates but has identified certain accounting policies as critical to understanding the financial condition and results of operations. For a detailed discussion on the application of these and other accounting policies, see the notes to the consolidated financial statements included in this Annual Report on Form 10-K. Item 7A.
The Company believes that proceeds from maturing cash equivalents, as well as the Company’s borrowing capacity under its existing line of credit and access to capital resources are sufficient to meet operating capital and funding requirements for the next 12 months from the date of this annual report.
The Company believes that proceeds from maturing cash equivalents, as well as the Company’s borrowing capacity under its existing line of credit provide the Company with access to capital resources sufficient to meet operating capital and funding requirements for the next 12 months from the date of this annual report.
For the year ended December 31, 2024, funding was derived primarily from cash generated by the sale of equipment to our customers in the ordinary course of business.
For the year ended December 31, 2025, funding was derived primarily from cash generated by the sale of equipment to our customers in the ordinary course of business.
Inflation During 2024, increased commodity and shipping prices and energy and labor costs resulted in inflationary pressures across various parts of our business and operations, including on our customers, partners, and suppliers.
Inflation During 2025, increased commodity and shipping prices and energy and labor costs resulted in minor inflationary pressures across various parts of our business and operations, including on our customers, partners, and suppliers.
Non-cash charges consisted of credit loss expense, deferred income taxes, stock-based compensation expense, provision for product warranties, amortization of right-of-use asset, depreciation and amortization of property and equipment and gain on sale of assets. 26 Cash flows from investing activities Net cash used in investing activities during the year ended December 31, 2024 reflected $0.3 million of purchases of property and equipment.
Non-cash items consisted of credit loss expense, deferred income taxes, stock-based compensation expense, provision for product warranties, amortization of right-of-use asset and depreciation and amortization of property and equipment. 27 Cash flows from investing activities Net cash used in investing activities during the year ended December 31, 2025 reflected $0.2 million of purchases of property and equipment.
Cash flows The following table provides a summary of the Company’s cash flows for the periods indicated: For the Years Ended December 31 (in thousands) 2024 2023 Net cash provided by (used in): Operating activities $ (831 ) $ (2,145 ) Investing activities (276 ) (187 ) Financing activities 15 (40 ) Total $ (1,092 ) $ (2,372 ) Cash flows from operating activities Net cash used in operating activities was $0.8 million for the year ended December 31, 2024, consisting of net income of $6.6 million and non-cash charges of $1.1 million, offset by an increase in net operating assets of $8.5 million.
Cash flows The following table provides a summary of the Company’s cash flows for the periods indicated: For the Years Ended December 31, (in thousands) 2025 2024 Net cash provided by (used in): Operating activities $ 528 $ (831 ) Investing activities (196 ) (276 ) Financing activities (305 ) 15 Total $ 27 $ (1,092 ) Cash flows from operating activities Net cash provided by operating activities was $0.5 million for the year ended December 31, 2025, consisting of net loss of $7.7 million and non-cash activities of $0.4 million, offset by an increase in net operating assets of $8.6 million.
Net cash used in investing activities during the year ended December 31, 2023 mainly reflected $0.2 million of purchases of property and equipment. Cash flows from financing activities Net cash provided by financing activities during the year ended December 31, 2024 reflected $67 thousand of exercised stock options, offset by $52 thousand of withholding taxes on stock-based compensation.
Net cash used in investing activities during the year ended December 31, 2024 mainly reflected $0.3 million of purchases of property and equipment. Cash flows from financing activities Net cash used in financing activities during the year ended December 31, 2025 reflected $0.3 million of stock repurchase and $5 thousand of withholding taxes on stock-based compensation.
Net cash used in operating activities was $2.1 million for the year ended December 31, 2023, consisting of net income of $0.5 million and non-cash charges of $1.0 million, offset by a decrease in net operating liabilities of $3.6 million.
Net cash used in operating activities was $0.8 million for the year ended December 31, 2024, consisting of net income of $6.6 million and non-cash charges of $1.1 million, offset by an increase in net operating assets of $8.5 million.
Cash and cash equivalents of $22.1 million at December 31, 2024 decreased by $1.0 million, or 4%, from $23.1 million at December 31, 2023. See Cash flows for details on the change in cash and cash equivalents during the year ended December 31, 2024.
See Cash flows for details on the change in cash and cash equivalents during the year ended December 31, 2025. Accounts receivable , net of $6.0 million at December 31, 2025 decreased by $13.7 million, or 70%, from $19.7 million at December 31, 2024.
Net cash used in financing activities during the year ended December 31, 2023 reflected $27 thousand of repurchases of common stock and $59 thousand of withholding taxes on stock-based compensation, offset by $46 thousand of exercised stock options.
Net cash provided by financing activities during the year ended December 31, 2024 reflected $67 thousand of exercised stock options, offset by $52 thousand of withholding taxes on stock-based compensation.
See Note 3, Debt , to the consolidated financial statements for further discussion. 25 Liquidity and Capital Resources Overview In general terms, liquidity is a measurement of the Company’s ability to meet its cash needs.
Liabilities There were no borrowings under our revolving lines of credit at December 31, 2025 or December 31, 2024. See Note 3, Debt , to the consolidated financial statements for further discussion. 26 Liquidity and Capital Resources In general terms, liquidity is a measurement of the Company’s ability to meet its cash needs.
The decrease was primarily attributable to the decrease in marketing agency expense, travel expense, and payroll cost due to lower headcount. Research and development expenses of $4.2 million in 2024 increased by $0.5 million, or 14%, from $3.7 million in 2023.
Selling and marketing expenses of $6.5 million in 2025 increased by $1.5 million, or 30%, from $5.0 million in 2024. The increase was primarily driven by increases in tradeshow costs and payroll cost due to increase in headcount. 25 Research and development expenses of $7.8 million in 2025 increased by $3.6 million, or 86%, from $4.2 million in 2024.
The net increase in general and administrative expense was primarily due to higher compensation, professional fees and bad debt expense, which were offset by a reduction in bank fees and insurance expense. Selling and marketing expenses of $5.0 million in 2024 decreased by $0.6 million, or 11%, from $5.6 million in 2023.
General and administrative expenses of $7.9 million in 2025 increased by $0.8 million, or 11%, from $7.1 million in 2024. The net increase in general and administrative expense was primarily due to higher professional fees and insurance costs and compensation costs.
However, there can be no assurance that it will be able to raise such funds or the terms on which such funds may be raised, if at all.
Sensus’s management regularly evaluates cash requirements for current operations, commitments, capital requirements and business development transactions, and may seek to raise additional funds for these purposes in the future. However, there can be no assurance that it will be able to raise such funds or the terms on which such funds may be raised, if at all.
Accounts receivable , net of $19.7 million at December 31, 2024 increased by $9.1 million, or 86%, from $10.6 million at December 31, 2023, primarily due to the increase in sales to the Company’s primary customer that is subject to extended payment terms.
The decrease was primarily due to the decrease in sales and concentration of sales to the Company’s largest customer that are subject to extended payment terms. Inventories of $14.6 million at December 31, 2025 increased by $4.5 million, or 44%, from $10.1 million at December 31, 2024. The increase was primarily due to the anticipation of increasing future sales.
Please see Note 3, Debt , to the consolidated financial statements for a discussion regarding the Company’s revolving credit facility with Comerica Bank. The Company’s liquidity position and capital requirements may be impacted by a number of factors, including the following: ● ability to generate and increase revenue; and ● fluctuations in gross margins, operating expenses, and net results.
Please see Note 3, Debt , to the consolidated financial statements for a discussion regarding the Company’s revolving credit facility with Comerica Bank.
Overview As discussed elsewhere in this Report, Sensus achieved profitability for the first time in 2021, maintained profitability in 2023 and 2024, and seeks to maintain and increase profitability in 2025 by, among other things, increasing sales and managing operational expenses where necessary in order to continue to invest in research and development of new products and marketing initiatives to promote the Company’s products.
Sensus continues to seek to return to profitability in 2026 by, among other things, increasing sales and managing operational expenses where necessary in order to continue to invest in marketing initiatives to promote the Company’s products. SRT reimbursement was just revalued and increased by CMS, effective as of January 1, 2026.
The increase was primarily due to higher compensation expenses and existing product development cost offset by a decrease in expenses related to a project to develop a drug delivery system for aesthetic use during 2024. Other income, net of $0.9 million and $1.0 million in the years ended December 31, 2024 and 2023, respectively, relate primarily to interest income.
Other income, net of $0.7 million and $0.9 million in the years ended December 31, 2025 and 2024, respectively, relates primarily to interest income. Cash and cash equivalents of $22.1 million at December 31, 2025 was unchanged as compared to December 31, 2024.
The increase was primarily driven by a higher number of units sold, with 115 units sold in the year ended December 31, 2024 compared to 67 units sold in the year ended December 31, 2023. Cost of sales of $17.4 million in 2024 increased by $7.1 million, or 69%, from $10.3 million in 2023.
The decrease in revenue was primarily driven by a lower number of units sold (70 in the year ended December 31, 2025, compared to 115 in the year ended December 31, 2024), reflecting reduced sales to our largest customer, slightly offset by revenue recognized from new placements under the Fair Deal Agreement (the “Program”).
However, Sensus faces a number of uncertainties in 2025 that could impact our ability to achieve this goal. These include inflation and international trade issues. Either of these matters could adversely affect the Company’s ability to do business in a number of countries and geographic regions, including China.
Management expects that the new reimbursement codes will increase the demand for the SRT product. However, Sensus faces a number of uncertainties in 2026 that could impact our ability to achieve this goal.
Removed
The increase in cost of sales was primarily related to a higher number of units sold in the year ended December 31, 2024 compared to the year ended December 31, 2023. Gross profit of $24.4 million, or 58.4% of revenue, in 2024 increased by $10.3 million, or 73%, from $14.1 million, or 57.8% of revenue, in 2023.
Added
Overview As discussed elsewhere in this Report, Sensus achieved profitability for the first time in 2021, and maintained profitability through 2024. The Company incurred a net loss in 2025, mostly related to lobbying costs to secure reimbursement codes and lower demand particularly from our historically largest customer.
Removed
The increase in gross profit was primarily driven by a higher number of units sold in the year ended December 31, 2024 compared to the year ended December 31, 2023. General and administrative expenses of $7.1 million in 2024 increased by $1.9 million, or 37%, from $5.2 million in 2023.
Added
These include further decreased demand from its historically largest customer, increased cost due to hiring more sales representatives, continued inflation, and decreased demand for its higher priced SRT device.
Removed
Inventories of $10.1 million at December 31, 2024 decreased by $1.8 million, or 15%, from $11.9 million at December 31, 2023, primarily due to a shipments of units sold during the year ended December 31, 2024. Liabilities There were no borrowings under our revolving lines of credit at December 31, 2024 or December 31, 2023.
Added
Cost of sales of $15.6 million in 2025 decreased by $1.8 million, or 10%, from $17.4 million in 2024.
Removed
The Company’s primary short-term capital needs, which are subject to change, include expenditures related to: ● expansion of sales and marketing activities; and ● continuation of research and development activities. Sensus’s management regularly evaluates cash requirements for current operations, commitments, capital requirements, and business development transactions, and may seek to raise additional funds for these purposes in the future.
Added
The decrease in cost of sales was primarily related to a lower number of units sold offset by significantly higher costs of servicing systems and the cost associated with new placements under the Program, which generates costs related to installation and training in advance of related revenues.
Added
Gross profit of $11.9 million, or 43.3% of revenue, in 2025 decreased by $12.5 million, or 51%, from $24.4 million, or 58.4% of revenue, in 2024. The decrease in gross profit was primarily driven by lower sales, higher cost of servicing systems and the costs associated with new placements under the Program.
Added
The increase was primarily due to significant lobbying costs related to billing code reimbursement, increased headcount, and an increase in product development costs related to next generation systems. The Company expects research and development expenses incurred in 2026 to be substantially lower than those incurred in 2025.
Added
The Company’s liquidity position and capital requirements may be impacted by a number of factors, including the following: ● ability to generate and increase revenue; ● fluctuations in gross margins, operating expenses and net results; and ● financial market instability or disruptions to the banking system due to bank failures The Company’s primary short-term capital needs, which are subject to change, include expenditures related to: ● expansion of sales and marketing activities; and ● continued research and development activities.
Added
The Company claimed Employee Retention Credits (“ERC”) as provided in the Coronavirus Aid, Relief, and Economic Security Act of 2020 and subsequent amendments. The ERC is a fully refundable payroll tax credit to provide financial incentives to eligible businesses to retain their workforce through the period of financial hardship resulting from the COVID-19 pandemic.
Added
The Company received $0.3 million in the second quarter of 2025 and $0.2 million in the fourth quarter of 2024. These amounts were recorded against the payroll expenses in the consolidated statements of (loss) income. Further claims outstanding will be recorded in the period in which payment is received.
Added
Cash flows provided by operating activities primarily include the receipt of revenues offset by the payment of operating expenses incurred in the normal course of business.
Added
QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK Not applicable.

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