WESTFORD, Mass., Sept. 17, 2015 /PRNewswire/ -- Cynosure, Inc. (NASDAQ: CYNO), a leader in laser- and light-based aesthetic treatments for non-invasive and minimally invasive applications, today announced that it has received clearance from the China Food and Drug Administration (CFDA) to market the PicoSure 755 nm wavelength for tattoo removal. The product will be marketed through the Company's direct sales force in China.
"This CFDA clearance further advances our strategy to establish PicoSure as a truly global brand for cosmetic medicine of the face and body," said Cynosure CEO Michael Davin. "While our initial focus in China will be tattoo removal, we also are pursuing additional PicoSure clearances for skin rejuvenation and the removal of benign pigmented lesions, indications which we believe will generate significant interest among the country's aesthetic physicians and patients."
"We expect strong demand for PicoSure to continue as we secure new international regulatory registrations and gain clearances in additional indications," Davin said.
PicoSure's ultra-short pulse duration goes beyond photothermal action to create an intense photomechanical impact that results in greater disruption of the target for better clearance with fewer treatments, less fluence and without injury to the surrounding skin. The product effectively treats tattoos as well as previously treated, recalcitrant tattoos.
The 755 nm PicoSure wavelength received U.S. FDA clearance in the fourth quarter of 2012 for the removal of tattoos and benign pigmented lesions, and was subsequently cleared for marketing in Canada, Australia, Korea and Taiwan.
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 CFDA clearance for the 755 nm PicoSure wavelength for tattoo removal, 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 PicoSure in China, 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 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 quarter ended June 30, 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.
Senior Vice President
Sharon Merrill Associates, Inc.
SOURCE Cynosure, Inc.