WESTFORD, Mass., July 26, 2016 /PRNewswire/ -- Cynosure, Inc. (NASDAQ: CYNO) today announced that it has received approval from the Korean Ministry of Food and Drug Safety (MFDS) to market SculpSure® for non-invasive lipolysis of the abdomen and flanks. The product will be marketed through the Company's direct sales force in Korea beginning in the third quarter of 2016.
"MFDS approval of SculpSure is another major step in our international growth strategy for this breakthrough non-invasive fat-reduction treatment," said Cynosure President and Chief Executive Officer Michael Davin. "As one of the world's fastest-growing medical aesthetic regions, the Asia Pacific market is an important one for SculpSure and our entire product portfolio. Our Asia-Pac subsidiaries made up 43 percent of our international product revenue in the first half of this year, compared with 33 percent in the same period of 2015. We look forward to showcasing SculpSure at the IMCAS Asia 2016 meeting later this week in Taipei."
SculpSure is a safe and an effective non-invasive treatment that eliminates up to 24 percent of treated fat1 in a 25-minute procedure with no downtime, enabling patients to immediately return to their normal activities. SculpSure is intended for individuals with a body mass index (BMI) of 30 or less.
SculpSure's patented technology utilizes a selective wavelength laser that precisely targets fat cells under the skin. The laser raises the temperature of body fat to disrupt and destroy those subcutaneous fat cells, which are then naturally eliminated over time and do not return. SculpSure is also designed for maximum versatility, offering physicians the ability to customize the treatment to each patient's desired results.
SculpSure works on all skin types and is intended for patients who are struggling with stubborn fat in common trouble spots. Multi-site testing yielded over 90 percent patient satisfaction, with results seen as quickly as 6 weeks and optimal results usually seen in 12 weeks.
About Cynosure, Inc. Cynosure develops, manufactures, and markets aesthetic treatment systems that 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, reduce fat through non-invasive and minimally invasive laser lipolysis, reduce cellulite, clear nails infected by toe fungus, ablate sweat glands and improve gynecological 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, France, Morocco, 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.
Forward-Looking Statements This press release contains forward-looking statements, within the meaning of the federal securities laws, about our business prospects and management transition. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words "believes," "plans," "intends," "expects," "goals" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Our future results may differ materially from our past results and from those projected in the forward-looking statements due to various uncertainties and risks, including, but not limited to, those described in Item 1A of Part II (Risk Factors) of our Quarterly Report on Form 10-Q for the three months ended March 31, 2016. The forward-looking statements speak only as of the date of this press release and undue reliance should not be placed on these statements. We disclaim any obligation to update any forward-looking statements contained herein after the date of this press release.
1 Single treatment of average reduction in fat volume as measured by MRI; Clinical and Histological Evaluations of a 1060nm Laser Device for Non-Invasive Fat Reduction – John W. Decorato, MD., F A C S. Rafael Sierra, Ph.D., Bo Chen, Ph.D., Westford, MA, 2014.
Scott Solomon Senior Vice President Sharon Merrill Associates, Inc. 617.542.5300 [email protected]