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Five-Year Retrospective Study Shows 98.9 Percent Cure Rate for Non-Melanoma Skin Cancer Patients Treated with Sensus Healthcare’s Superficial Radio Therapy

April 23, 2019
Sensus’ SRT-100™ Indicates High Cure Rates in Long-Term Retrospective Study

BOCA RATON, Fla., April 23, 2019Sensus Healthcare, Inc. (NASDAQ: SRTS), a medical device company specializing in non-invasive treatments for both oncological and non-oncological conditions, announced today topline results from a five-year retrospective study of non-melanoma skin cancer (NMSC) patients treated with Superficial Radio Therapy (SRT) (ClinicalTrials.gov Identifier: NCT03693937). The study, which was conducted across four U.S. sites, showed a 98.9 percent cure rate among 516 male and female patients. These patients had a collective total of 776 NMSC lesions treated with Sensus’ SRT-100™.

Sensus Healthcare logo. (PRNewsFoto/Sensus Healthcare) (PRNewsfoto/Sensus Healthcare)

Most patients in the study population were elderly with a mean age of 79 years. Kaplan-Meier estimates of cumulative recurrence rates of all tumors at both 2 and 5 years were 1.1 percent; basal cell carcinoma cumulative recurrence rates at five years were 1.2 percent, and squamous cell carcinoma cumulative recurrence rates were 0.9 percent.

“As we approach Skin Cancer Awareness Month in May, the results of this five-year study are not only timely and relevant but also show excellent cure rates,” said Dr. William Roth, lead investigator of the study and Voluntary Clinical Professor at The University of Miami School of Medicine, Department of Dermatology. “As the study confirms that SRT is a highly effective therapy, it’s critical that this modality be available, especially to patients who have comorbidities or advancing age.”

“SRT is a good option to offer patients with NMSC,” added Dr. Thomas Bender, dermatologist at Advanced Dermatology and Skin Care Centre, a Forefront Dermatology practice in Alabama. “We all have patients who aren’t good candidates for surgery, and patients feel empowered when they can choose their own therapy as opposed to only having surgery to treat their skin cancer.”

“These study results confirm what we’ve been hearing from our physicians,” concluded Isabelle Raymond, Ph.D., Vice President, Clinical Development, Sensus Healthcare. “Sensus is committed to advancing research and development for optimal SRT treatment to improve patient outcomes, and we look forward to presenting detailed study results at an upcoming scientific meeting.”

About Sensus Healthcare

Sensus Healthcare, Inc. is a medical device company specializing in highly effective, non-invasive, minimally-invasive, and cost-effective treatments for both oncological and non-oncological conditions. The Sculptura™ robotic radiation oncology system provides targeted intraoperative triple-modulated radiotherapy (IORT) and Brachytherapy utilizing our proprietary, state-of-the-art 3D Beam Sculpting™ to treat patients undergoing cancer treatment during surgery, or at the tumor site, with a single dose. Sensus also offers its proprietary low-energy X-ray technology known as superficial radiation therapy (SRT), which is the culmination of more than a decade of research and development, to treat non-melanoma skin cancers and keloids with its SRT-100™, SRT-100+™ and SRT-100 Vision™ systems. With its portfolio of innovative medical device products, Sensus provides revolutionary treatment options to enhance the quality of life of patients around the world.

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Forward-Looking Statements

This press release includes statements that are, or may be deemed, ‘forward-looking statements.’ In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately,” “potential” or, in each case, their negative or other variations thereon or comparable terminology, although not all forward-looking statements contain these words.

By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, and healthcare, regulatory and scientific developments and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that forward-looking statements are not guarantees of future performance and that 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, among other factors: our ability to achieve and sustain profitability; market acceptance of our product lines; our ability to successfully commercialize our products; our ability to compete effectively in selling our products and services, including responding to technological change and cost containment efforts of our customers; our need and ability to obtain additional financing in the future, as well as complying with the restrictions our existing revolving credit facility imposes; our ability to expand, manage and maintain our direct sales and marketing organizations; our actual financial results may vary significantly from forecasts and from period to period; our ability to successfully develop new products, improve or enhance existing products or acquire complementary products, technologies, services or businesses; our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, and our ability to avoid infringing or otherwise violating the intellectual property rights of third parties; market risks regarding consolidation in the healthcare industry; the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing from third party payors for procedures using our products declines; the level and availability of government and third party payor reimbursement for clinical procedures using our products; our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel; the regulatory requirements applicable to us and our competitors; our ability to manufacture our products to meet demand; our reliance on third party manufacturers and sole- or single-source suppliers; our ability to reduce the per unit manufacturing costs; our ability to efficiently manage our manufacturing processes; the regulatory and legal risks, and certain operating risks, that our international operations subject us to; off label use of our products; the fact that product quality issues or product defects may harm our business; the accuracy of our financial statements and accounting estimates, including allowances for accounts receivable and inventory obsolescence; any product liability claims; limited trading in our shares and the concentration of ownership of our shares; cyberattacks and other data breaches and the adverse effect on our reputation; new legislation, administrative rules, or executive orders, including those that impact taxes and international trade regulation; the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or that limit certain disputes to be brought exclusively in the Delaware Court of Chancery; concentration of our customers in the U.S. and China, including the concentration of sales to one particular customer in the U.S.; and other risks described from time to time in Sensus Healthcare’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K.

In addition, even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent with the forward-looking statements contained in this press release, they may not be predictive of results or developments in future periods. 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. You should read carefully our “Cautionary 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.

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SOURCE Sensus Healthcare