Sensus Healthcare Receives FDA 501(k) Clearance to Market Next-Generation SRT-100+ Superficial Radiation Therapy for Treating Non-Melanoma Skin Cancer and Keloids
BOCA RATON, Fla., Aug. 2, 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), today announced that the Company has received 501(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new SRT-100+, the next-generation Superficial Radiation Therapy solution that adds several innovative features to Sensus’ existing SRT-100 product.
“We have integrated both clinical and patient feedback to bring to life exciting new elements with the SRT-100+—from live lesion and patient cameras for monitoring during treatment to best-in-class system enhancements for better patient setup and comfort,” said Kal Fishman, Chief Technology Officer, Sensus Healthcare. “The sophisticated operation of the SRT-100+ also offers significant benefits to doctors specifically, as it will be integrated with practices’ information technology and management / electronic medical records (EMR), as well as provide vital data backup and logging. This represents the technology of the future when it comes to treating NMSC and keloids safely and effectively.”
The SRT-100+ offers all of the same features of the SRT-100, with:
- An expanded energy range for customized, more precise treatment
- Remote diagnostics, including operation tracking
- New X-ray tube with extended functionality and performance
- Advanced console and enhanced system mobility to optimize clinical practice
“The SRT-100+ is truly the next step forward for Sensus’ transformative products that have treated more than 400,000 skin cancer and keloids patients all around the world,” added Joe Sardano, CEO, Sensus Healthcare. “This new offering is the culmination of all of our clinical experience and best practices that we have learned from our broad global user base of physicians and patients. Most importantly, this 501(k) market clearance uniquely positions Sensus to fuel continued innovation in the clinical dermatology space.”
The SRT-100+ is available for sale immediately.
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-100™, SRT-100+ and SRT-100 Vision™. 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.
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 the SRT-100 product line; our ability to successfully commercialize our products, including the SRT-100; 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, including the SRT-100, 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 significantly 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 cost of the SRT-100; 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; geographic concentration of our customers in the U.S. and China; 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 for the fiscal year ended December 31, 2016.
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.
Kim Sutton Golodetz
LHA Investor Relations
The Benefits of SRT
Along with eliminating the risks for post-surgical infections and complications, the SRT-100™ provides patients and physicians with a safe and effective treatment option that offers many benefits, including:
- 95%+ cure rates that rival surgery
- No anesthesia, cutting, bleeding, stitching or pain
- No downtime or lifestyle restrictions
- Super cosmesis, no unsightly scarring
- No need for post-treatment reconstructive surgeries