Sensus Healthcare Receives Regulatory Approval to Sell the SRT-100™ in China for the Treatment and Prevention of Keloids
July 26th, 2017 1:28 pm | Press Release
BOCA RATON, Fla. (July 26, 2017) – Sensus Healthcare, Inc. (Nasdaq: SRTS), a medical device company specializing in the non-invasive treatment of non-melanoma skin cancers and keloids with superficial radiation therapy (SRT), announces that the SRT-100™ has been cleared by the China Food and Drug Administration (CFDA) to treat and prevent keloids. China accounts for more than 20% of the world’s patient population.
The Company’s partner in China is Chindex Medical Limited, a wholly owned subsidiary of Fosun Pharma International. Chindex Medical plans to launch the SRT-100 for the treatment of keloids into the market during the fourth quarter of 2017, with a focus on preventing and treating keloids associated with Cesarean sections (C-sections). Chindex Medical has been selling the SRT-100 in China for the treatment of non-melanoma skin cancer since 2014.
“CFDA clearance of the SRT-100 for the treatment and prevention of keloids is an important milestone for Sensus, and a step forward for healthcare in China, especially women’s health,” commented Joe Sardano, chief executive officer of Sensus Healthcare. “According to a study in 2010 by the World Health Organization, 46.2% of Chinese babies were delivered via C-section. Additionally, although the exact numbers are not known, Asians have the highest incidence of post-surgical keloid scar formation. With the relaxing of China’s one-child policy in 2015, the prevention of keloids that form over the surgical scar following a first C-section will lessen complications of a second C-section. We believe the SRT-100 will be a major force in preventing these keloids from forming.”
Chindex Medical will launch the SRT-100 for the treatment and prevention of keloids at the International Congress of the Dermatologic & Aesthetic Surgery International League in Shanghai, taking place October 24-28. Several dermatologists from the U.S. will be in attendance to train and educate Chinese physicians during a very large workshop dedicated to SRT and a session on scar treatments.
William Wang, chief executive officer of Chindex Medical said, “We are very pleased by the CFDA’s decision to grant permission to treat keloids with SRT. This is another example of continued efforts by Chindex Medical Ltd to bring cost effective solutions to our healthcare system. Our doctors now have a very important tool in a proven technology like SRT to remedy the keloids that impact millions of our citizens.”
Keloids are benign fibrous tissue formed at the site of a scar or injury to the skin. Although keloids have been known to form in all races, they are seen most frequently among those of African, Latin and Asian descent. Surgery and other treatment methods may reduce the size of the keloid, but with a reoccurrence rate of 90%, the current treatment methods are not a permanent solution. Sensus Healthcare’s SRT device is a safe alternative in treating existing keloid conditions and is proven to be most effective for reducing the recurrence of keloids when combined with excision surgery.
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.
About Sensus Healthcare
Sensus Healthcare, Inc. is a medical device company that is committed to providing non-invasive and cost-effective treatment options for non-melanoma skin cancers and keloids. Sensus uses a proprietary low energy X-ray technology known as superficial radiation (SRT), which is a result of over a decade of dedicated research and development. Sensus has successfully incorporated SRT therapy into its portfolio of treatment devices, the 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. For more information, visit https://www.sensushealthcare.com.
LHA Investor Relations
Kim Sutton Golodetz
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