WESTFORD, Mass., July 7, 2015 /PRNewswire/ -- Cynosure, Inc. (NASDAQ: CYNO), a leader in laser- and light-based aesthetic treatments, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market SculpSure™ for non-invasive lipolysis of the abdomen. In May, the FDA cleared SculpSure for non-invasive lipolysis of the flanks.
SculpSure is a safe, clinically proven treatment designed to reduce fat non-invasively by disrupting subcutaneous fat cells. The versatile, hands-free device features a flexible applicator system to treat multiple anatomical areas of the body. SculpSure, which uses a 1060 nm laser, can treat an anatomical area in approximately 25 minutes. Patients are able to achieve desired results without downtime or surgery. The technology is expected to be launched in the U.S. in the second half of 2015.
"SculpSure is the world's first hyperthermic laser treatment for the non-invasive reduction of fat from the abdomen," said plastic surgeon Dr. Lawrence S. Bass, M.D., of Bass Plastic Surgery PLLC, who participated in the clinical evaluation of SculpSure. "Subjects in our study saw a statistically significant reduction in adipose layer thickness, with more than 90% reporting they were satisfied with the treatment."
Cynosure CEO Michael Davin said, "The abdomen and flanks are two areas of the body that are often difficult to target with diet and exercise alone, so the fact that SculpSure can now effectively treat both of these regions is great news for consumers. It's also a significant achievement for our Company, demonstrating the initial breadth of our non-invasive fat reduction platform. We believe that SculpSure's versatility and fast treatment time are key competitive advantages that will drive demand for the technology among aesthetic practitioners and their patients."
About Cynosure, Inc.
Cynosure designs, manufactures and markets medical devices for aesthetic procedures and precision surgical applications worldwide. The Company's products enable plastic surgeons, dermatologists and other medical practitioners to perform non-invasive and minimally invasive procedures to remove hair, treat vascular and benign pigmented lesions, remove multi-colored tattoos, revitalize the skin, liquefy and remove unwanted fat through laser lipolysis, reduce cellulite, clear nails infected by toe fungus, ablate sweat glands and improve vaginal health. Cynosure also markets radiofrequency energy sourced medical devices for precision surgical applications such as facial plastic and general surgery, gynecology, ear, nose, and throat procedures, ophthalmology, oral and maxillofacial surgery, podiatry and proctology. Cynosure's product portfolio is composed of a broad range of energy sources including Alexandrite, diode, Nd: YAG, picosecond, pulse dye, Q-switched lasers, intense pulsed light and radiofrequency technology. Cynosure sells its products globally under the Cynosure, Palomar, ConBio and Ellman brand names through a direct sales force in the United States, Canada, Mexico, France, Germany, Spain, the United Kingdom, Australia, China, Japan and Korea, and through international distributors in approximately 120 other countries. For corporate or product information, visit Cynosure's website at www.cynosure.com.
Any statements in this press release about Cynosure's receipt of FDA 510(k) clearance for SculpSure, as well as other statements containing the words "believes," "anticipates," "plans," "expects," "will" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the market acceptance of SculpSure, levels of demand for procedures performed with Cynosure products and for Cynosure products themselves, competition in the aesthetic laser industry, general business and economic conditions, effects of acquisitions that Cynosure has made or may make, Cynosure's ability to develop and commercialize new products, Cynosure's reliance on sole source suppliers, the inability to accurately predict the timing or outcome of regulatory decisions, and economic, market, technological and other factors discussed in Cynosure's most recent Annual Report on Form 10-K and subsequently filed Quarterly Report on Form 10-Q for the first quarter of 2015, which are filed with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Cynosure's views as of the date of this press release. Cynosure anticipates that subsequent events and developments will cause its views to change. However, although Cynosure may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Cynosure's views as of any date subsequent to the date of this press release.
Sharon Merrill Associates
SOURCE Cynosure, Inc.