Sensus Healthcare Announces Publication of Study Showing Use of Superficial Radiation Therapy Post-Keloidectomy Prevents Keloid Recurrence
- Keloid recurrence rate of 10.4% at 12 months for patients treated with SRT following keloidectomy compares with more than 80% with surgical excision alone
- Retrospective study published in Journal of Clinical and Aesthetic Dermatology
BOCA RATON, Fla., Oct. 22, 2020 (GLOBE NEWSWIRE) -- 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 conditions, announces the publication of a retrospective study showing keloidectomy followed by superficial radiation therapy (SRT) had an approximate 10% recurrence rate, compared with an expected recurrence rate of more than 80% following surgical excision alone. The study was published in the Journal of Clinical and Aesthetic Dermatology and can be found here. Authors were:
- Brian Berman, M.D., Ph.D. and Mark S. Nestor, M.D., Ph.D., The Center for Clinical and Cosmetic Research in Aventura, Florida;
- Michael H. Gold, M.D., Gold Skin Care Center in Nashville, Tennessee;
- David J. Goldberg, M.D., J.D., Skin Laser & Surgery Specialists of NY/NJ in New York City;
- Eduardo T. Weiss, M.D., Memorial Health System in Hollywood, Florida; and,
- Isabelle Raymond, Ph.D., Memorial Health System in Boca Raton, Florida.
The study reviewed 61 subjects with 96 keloid scars who were treated with SRT following the removal by sutured excision (93%) or tangential excision with secondary intention technique (7%). Almost all subjects (98%) received biological effective dose (BED) 30Gy with irradiation scheme of three 6Gy SRT treatments on Days 1, 2 and 3 following surgery. Ten treated keloidectomy sites (10.4%) had recurrences (i.e., presence of any new tissue growth on the surgical scar) within 12 months, increasing to 11 sites (12.7%) at 18 months. Kaplan-Meier survival probability cure rate was 85.6% from 24 months post-SRT treatment onwards.
“The Sensus SRT has become a game-changer for my keloid patients, who have suffered for many years with these difficult to treat skin lesions,” said Dr. Michael H. Gold of Gold Skin Care Center in Nashville, Tennessee. “The results of this study confirm what we have thought clinically, in that surgery plus post-operative superficial radiation therapy can prevent almost 90% of these lesions from recurring at one year. I am not sure that any other therapy came claim such amazing results.”
“We thank the dedicated physicians and their staffs who rid their patients of keloids, which are unsightly, cause significant pain and swelling, and have a considerable negative impact on quality of life,” said Joe Sardano, chief executive officer of Sensus Healthcare. “We are heartened by this study’s low rate of recurrence, which compares favorably with both surgical excision alone, and with surgery in combination with various other forms of radiation treatments.”
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™ modulated robotic brachytherapy radiation oncology system provides targeted directional anisotropic radiation therapy (ART) 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, fast and efficiently. 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.
For more information, visit www.sensushealthcare.com.
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 "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: the continuation and severity of the COVID-19 pandemic, including its impact on sales and marketing; 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; our ability to expand, manage and maintain our direct sales and marketing organizations; 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; 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 current reliance on third party manufacturers and sole- or single-source suppliers, as well as our ability to successfully transition manufacturing of our products in-house; 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; 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; new legislation, administrative rules, or executive orders, including those that impact taxes and international trade regulation; 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 our 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.
LHA Investor Relations
Kim Sutton Golodetz
# # #
Upcoming Life Sciences Events
- March 2021
- 2nd Annual European HealthTech CEO Forum
- Pharma-Biotech Product & Company Valuation Course
- 14th Annual European Life Sciences CEO Forum