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Subject: TRI

Sensus Healthcare Announces Low 3% Keloid Recurrence in Multicenter Case Series of 297 Patients Treated with Superficial Radiation Therapy


BOCA RATON, Fla., Dec. 6, 2018 /PRNewswire/ -- Sensus Healthcare, Inc. (NASDAQ: SRTS), a medical device company specializing in the non-invasive treatment of non-melanoma skin cancers (NMSC) and keloids with Image-Guided Superficial Radiation Therapy (IGSRT), announced today positive results of a multicenter case series of patients treated with the SRT-100tm following complete surgical keloidectomy. Of the 297 keloidectomy patients treated post-operatively with superficial radiation, there were only nine cases of observed clinical keloid recurrences, or a recurrence rate of 3%. The results of the study were published in the November issue of SKIN, The Journal of Cutaneous Medicine.

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

"Post-surgery recurrence of keloids has been reported to occur in approximately 71% of cases, therefore the observed recurrence rate being only 3% utilizing superficial radiation post-operatively is significant," explained  Brian Berman, M.D., Ph.D., Professor Emeritus, Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine and Co-Director Center for Clinical and Cosmetic Research and corresponding author of the study.  "Presently the low 3% rate of keloid recurrence was observed in a follow-up period ranging from 1 month to 3 years, or an average of one year, and the long-term prospects for superficial radiation therapy post-surgical keloidectomy is very promising."

Isabelle Raymond, Ph.D., Vice President, Clinical Development at Sensus Healthcare commented, "Keloids not only have a high recurrence rate, but they can be painful and significantly impact a person's quality of life. The power of this technology lies in our ability to deliver a precise, calibrated dose of superficial radiation therapy that penetrates only five millimeters below the skin's surface. This study affirms Sensus' commitment to further develop ways to treat patients who are afflicted with keloids in the most effective way possible."

The following is a link to the study: Low Rate of Keloid Recurrences Following Treatment of Keloidectomy Sites with a Biologically Effective Dose 30 of Superficial Radiation.  SKIN 2: 402-403, 2018

Brian Berman MD, PhD1, Mark S. Nestor MD1, PhD, Michael H. Gold MD2, David J. Goldberg MD, JD3, Joshua Fox MD4, George Schmieder DO5

About Sensus Healthcare
Sensus Healthcare, Inc. is a medical device company that is committed to providing non-invasive and cost-effective treatment for non-melanoma skin cancers and keloids. Sensus uses a proprietary low-energy X-ray technology known as superficial radiation therapy (SRT), which is a result of over a decade of dedicated research and development. Sensus has successfully incorporated SRT into its portfolio of treatment devices, the SRT-100tm, SRT-100+ and SRT-100 Visiontm. To date, SRT technology has been used to effectively and safely treat oncological and non-oncological skin conditions in thousands of patients. Sensus also offers Sensus Laser Systems, three next-generation devices that showcase the latest in technology and function for the aesthetic dermatology market.

For more information, visit https://www.sensushealthcare.com.

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.

Media Contacts:
Caitlin Kasunich / McKenna Miller
KCSA Strategic Communications
212-896-1241 / 347-487-6197
[email protected] / [email protected] 

Investor Contact:
Kim Sutton Golodetz
LHA Investor Relations
(212) 838-3777
[email protected]

1 Center for Clinical & Cosmetic Research, Aventura, FL
2 Gold Skin Care Center, Nashville, TN
3 Skin Laser & Surgery Specialists of NY/NJ
4 Advanced Dermatology, NY, NY
5 Park Avenue Dermatology, Orange Park, FL

SOURCE Sensus Healthcare, Inc.


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