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Sensus Healthcare Announces Study Showing Single Low Dose of Superficial Radiation Therapy Prevents Keloid Recurrence Following Surgical Excision

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Sensus Healthcare, Inc. (Nasdaq: SRTS) announced the publication of a prospective study in the Journal of the American Academy of Dermatology, demonstrating a significantly low recurrence rate of keloids after superficial radiation therapy (SRT) post-excision. The study showed a 6.25% recurrence rate at six months, with no recurrences at 24 months for the follow-up group. The study suggests that a single 8 Gy dose of SRT may effectively reduce keloid recurrence, especially in steroid-resistant cases. This research highlights the growing acceptance of SRT in dermatology.

Positive
  • Reported a 6.25% recurrence rate for keloids at six months after SRT treatment.
  • No keloid recurrences were observed at 24 months in selected patients.
  • Study suggests a single 8 Gy dose of SRT may be sufficient, minimizing radiation exposure and costs.
Negative
  • None.

Prospective study published in Journal of the American Academy of Dermatology

BOCA RATON, Dec. 01, 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 prospective clinical study showing that a single low dose of superficial radiation therapy (SRT) following excision of 14 keloids had an approximate 6.25% recurrence rate at six months, and for the 10 patients available for follow-up at 24 months none of the keloids had recurred.

The study was published in the Journal of the American Academy of Dermatology and can be found here. Lead authors were Yuna Son, M.S., Ernest Owen Nicandro Phillips B.S. and Kristin Magrini Price, M.D., all of the Department of Biomedical Sciences and Division of Dermatology, Florida State University College of Medicine.

A total of 15 black patients with 20 untreated keloids in various anatomic locations were recruited for the study to undergo surgical excision followed by a single dose of superficial radiation. The authors concluded that a single 8 Gy dose of superficial 50 kV radiation delivered an average of 34 days after keloid excision may be sufficient to minimize recurrence, including in individuals who are resistant to steroids. The authors noted that higher radiation energies, doses or fractions may be unnecessary for keloid therapy.

“Although this was a small study, the outcome is important,” said Joe Sardano, chief executive officer of Sensus Healthcare. “The investigators noted that there are few prospective studies with SRT following keloidectomy, and that the doses of SRT studied have not been standardized. This study shows that just one low dose of SRT can be impactful.  Not only does this minimize radiation exposure to the patient, but it also is cost effective. 

“We are delighted that the dermatology community is becoming increasingly aware of the role of SRT in treating disfiguring keloids. The publication of this study comes on the heels of a retrospective study published in the Journal of Clinical and Aesthetic Dermatology showing keloidectomy followed by SRT had an approximate 10% recurrence rate, compared with an expected recurrence rate of more than 80% following surgical excision alone,” Mr. Sardano added.

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.

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 "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.

Contact:
LHA Investor Relations
Kim Sutton Golodetz
212-838-3777
kgolodetz@lhai.com


FAQ

What were the findings of the SRTS study published in December 2020?

The study found a 6.25% recurrence rate of keloids at six months after superficial radiation therapy and no recurrences at 24 months.

How does SRT affect keloid recurrence rates according to the study?

The study suggests that a single 8 Gy dose of superficial radiation therapy effectively minimizes keloid recurrence, especially in patients resistant to steroids.

What is the significance of the published study in the Journal of the American Academy of Dermatology?

The study is significant as it demonstrates an effective treatment option for keloids with a low recurrence rate, contributing to the understanding of SRT's role in dermatology.

How many patients were involved in the keloids study by SRTS?

The study involved 15 black patients with a total of 20 untreated keloids.

Sensus Healthcare, Inc

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