Receipt of MDSAP Certification for Sensus Healthcare’s Full SRT Product Portfolio to Streamline and Accelerate International Sales Efforts

By: Sensus Healthcare, Inc. via Business Wire

July 24, 2025 at 08:00 AM EDT

Sensus Healthcare, Inc. (Nasdaq: SRTS), a medical device company specializing in highly effective, non-invasive, minimally-invasive and cost-effective treatments for oncological and non-oncological skin conditions, announces that its entire portfolio of superficial radiation therapy (SRT) systems – including the SRT-100®, SRT-100+™ and SRT-100 Vision™ – has received certification under the Medical Device Single Audit Program (MDSAP). This certification is expected to streamline the Company’s international regulatory efforts and enable faster commercial expansion into key global markets.

The MDSAP certification allows a single regulatory audit to satisfy the Quality Management System (QMS) requirements of the U.S. Food and Drug Administration (FDA), Health Canada, Brazil’s ANVISA, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and Australia’s Therapeutic Goods Administration (TGA). This certification underscores the Company’s commitment to maintaining robust quality standards and ensuring consistent product performance across global markets. With MDSAP certification, Sensus can more efficiently support its growing base of distribution partners through global regulatory alignment, eliminating duplicative audit requirements and expediting the product registration process in participating countries.

“Receipt of MDSAP certification marks a meaningful milestone as we look to expand our international commercial footprint,” said Michael Sardano, President and General Counsel of Sensus Healthcare. “This certification enables us to satisfy QMS requirements and accelerate commercial deployments in several key geographies with large addressable markets. Additionally, upon receipt of FDA clearance, our TransDermal Infusion (TDI) product is also expected to be granted MDSAP certification, enhancing its commercial prospects outside the U.S.”

MDSAP certification builds on the Company’s global compliance infrastructure and is expected to reduce approval timelines and associated costs in jurisdictions that recognize the program. It further enhances the ability of Sensus’ international sales and distribution teams to engage hospital systems and specialty clinics with confidence in the regulatory standing of Sensus’ SRT (IG-SRT) products. As a result, Sensus can deliver its non-invasive SRT solutions more quickly and reliably to physicians and healthcare institutions outside the U.S.

“This certification provides a compelling advantage in markets where regulatory pathways can be a burdensome barrier to entry,” said Benson Suen, Sensus Healthcare’s Vice President of International Sales. “We believe MDSAP will significantly enhance our efforts to scale SRT system adoption across international markets while deepening our engagement with distributors and prospective customers who prioritize validated manufacturing and quality systems.”

About Sensus Healthcare

Sensus Healthcare, Inc. is a global pioneer in the development and delivery of non-invasive treatments for skin cancer and keloids. Leveraging its cutting-edge superficial radiotherapy (SRT and IG-SRT) technology, the company provides healthcare providers with a highly effective, patient-centric treatment platform. With a dedication to driving innovation in radiation oncology, Sensus Healthcare offers solutions that are safe, precise, and adaptable to a variety of clinical settings. For more information, please visit www.sensushealthcare.com.

Forward-Looking Statements

This press release includes statements that are, or may be deemed, ''forward-looking statements.'' In some cases, these statements can be identified by the use of forward-looking terminology such as "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," “approximately,” "potential" or negative or other variations of those terms or comparable terminology, although not all forward-looking statements contain these words.

Forward-looking statements involve risks and uncertainties because they relate to events, developments, and circumstances relating to Sensus, our industry, and/or general economic or other conditions that may or may not occur in the future or may occur on longer or shorter timelines or to a greater or lesser degree than anticipated. In addition, even if future events, developments, and circumstances are consistent with the forward-looking statements contained in this press release, they may not be predictive of results or developments in future periods. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this press release, as a result of the following factors, among others: the possibility that inflationary pressures continue to impact our sales; the level and availability of government and/or third party payor reimbursement for clinical procedures using our products, and the willingness of healthcare providers to purchase our products if the level of reimbursement declines; concentration of our customers in the U.S. and China, including the concentration of sales to one particular customer in the U.S.; the development by others of new products, treatments, or technologies that render our technology partially or wholly obsolete; the regulatory requirements applicable to us and our competitors; our ability to efficiently manage our manufacturing processes and costs; the risks arising from doing business in China and other foreign countries; legislation, regulation, or other governmental action that affects our products, taxes, international trade regulation, or other aspects of our business; the performance of the Company’s information technology systems and its ability to maintain data security; our ability to obtain and maintain the intellectual property needed to adequately protect our products, and our ability to avoid infringing or otherwise violating the intellectual property rights of third parties; and other risks described from time to time in our filings with the Securities and Exchange Commission, including our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q.

Any forward-looking statements that we make in this press release speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this press release, except as may be required by applicable law. You should read carefully our "Introductory Note Regarding Forward-Looking Information" and the factors described in the "Risk Factors" section of our periodic reports filed with the Securities and Exchange Commission to better understand the risks and uncertainties inherent in our business.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250724911578/en/

Contacts

Alliance Advisors IR

Tirth T. Patel

tpatel@allianceadvisors.com

212-201-6614

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Receipt of MDSAP Certification for Sensus Healthcare’s Full SRT Product Portfolio to Streamline and Accelerate International Sales Efforts

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