Sensus Healthcare's biggest risks in the FY2024 10-K
- Sensus Healthcare relies heavily on sales of its SRT-100 product line for non-melanoma skin cancer treatments.
- Operations depend on a single preferred supplier for x-ray tubes and third-party reimbursement coverage.
- Regulatory compliance under healthcare laws and FDA reporting is critical to ongoing business success.
The risks most specific to Sensus Healthcare
- 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
Sensus depends on Medicare, Medicaid, and private insurers providing adequate reimbursement for procedures using its products.
- Risks Related to our Business
Substantially all of the Company’s revenue is generated from the sale of the SRT-100 and related products, and any decline in the sales of these products will negatively impact the Company’s business, financial condition, and results of operations
Substantially all revenue depends on the sales and services of the SRT-100 product line and related non-melanoma skin cancer treatments.
- Risks Related to our Business
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 relies on a single preferred supplier for x-ray tubes and other major product components.
- Risks Related to our Business
Sensus may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all
Sensus may need additional capital, and its revolving line of credit restricts incurring certain indebtedness or asset encumbrances.
- Risks Related to our Regulatory Environment
Sensus’s operations are, and will continue to be, directly and indirectly affected by various federal, state, and foreign healthcare laws, including, but not limited to, those described below
Operations are subject to strict federal, state, and foreign healthcare laws, including the Anti-Kickback Statute.
- Risks Related to our Regulatory Environment
Sensus is required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with its products, which can result in voluntary corrective actions or agency enforcement actions
FDA medical device reporting regulations require reporting device malfunctions, deaths, or serious injuries, risking agency enforcement.
- 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
Success depends on protecting proprietary rights using three U.S. patents and two foreign patents.
- 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
Historical net losses totaled $17.8 million through 2021, though the company reported net income of $6.6 million in 2024 and $0.5 million in 2023.
All 21 risk factors
Headings as the filing states them, in filing order.
Risks Related to our Business
- 01If 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
- 02Substantially all of the Company’s revenue is generated from the sale of the SRT-100 and related products, and any decline in the sales of these products will negatively impact the Company’s business, financial condition, and results of operations
- 03The 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
- 04The 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
- 05The 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
- 06Sensus may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all
- 07Consolidation in the healthcare industry could adversely affect the Company’s future revenues and operating income
- 08Pandemics, natural disasters, global climate change, acts of terrorism and global conflicts may have a negative impact on our business and operations
Risks Related to our Regulatory Environment
- 09Sensus’s operations are, and will continue to be, directly and indirectly affected by various federal, state, and foreign healthcare laws, including, but not limited to, those described below
- 10Sensus is required to comply with medical device reporting requirements and must report certain malfunctions, deaths, and serious injuries associated with its products, which can result in voluntary corrective actions or agency enforcement actions
- 11Healthcare policy changes may have a material adverse effect on Sensus’s business
Risks Related to our Intellectual Property
- 12If 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
- 13If 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
- 14Adverse outcomes in litigation or similar proceedings could adversely impact business
Risks Related to the Ownership of Sensus’s Securities
- 15We 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
- 16The Company does not anticipate paying dividends for 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
- 17Sensus 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
- 18Sensus’s executive officers and directors may exert control over the Company and may exercise influence over matters subject to stockholder approval
- 19If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about Sensus, the price of Sensus’s securities and trading volume could decline
- 20The 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
- 21If the Company fails to maintain proper and effective internal controls, the Company’s ability to produce accurate and timely financial statements could be impaired and investors’ views of the Company or its business could be harmed, resulting in a decrease in value of the Company’s common stock
Other Sensus Healthcare 10-Ks
- FY2025 10-K risk factors20 risks1 dropped2 reworded
Sensus reported a net loss of $7.7 million in 2025, breaking prior years of maintained profitability. The company dropped its smaller reporting company risk disclosure.
Filed Mar 04, 2026
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.