Cynosure Announces FDA Clearance of New 532 nm Laser Delivery System for PicoSure
Wednesday, February 25, 2015
Cynosure, Inc. (NASDAQ: CYNO) recently announced FDA 510(k) clearance of its new 532 nm Laser Delivery System for PicoSure®, creating a powerful, dual-wavelength laser system for removing tattoos of all colors in fewer treatments. PicoSure, the world's first picosecond aesthetic laser, is widely recognized for its technology leadership, unmatched clinical versatility and proven performance.
"The new 532 nm Laser Delivery System further builds on the clinical and commercial success of the 755 nm PicoSure for the removal of tattoos and benign pigmented lesions as well as the treatment of acne scars and wrinkles," said Cynosure Chairman and Chief Executive Officer Michael Davin. "We are pleased to offer this system as an upgrade to our current PicoSure customer base."
"The integration of the 532 nm wavelength into the PicoSure platform allows for more effective removal of red, orange and yellow tattoo ink, which can now be cleared in fewer treatments," said Roy G. Geronemus, M.D., Director of the Laser & Skin Surgery Center of New York. "Based on my picosecond wavelength clinical experience, I believe that the combination of PicoSure's 755 nm and 532 nm wavelengths provides unmatched tattoo clearance across the full color spectrum."
Cynosure expects to introduce the 532 nm Laser Delivery System for PicoSure at the American Academy of Dermatology's 2015 Annual Meeting March 20-24 in San Francisco. Initial shipments are expected to begin by the end of the second quarter of 2015.
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 clearance for the 532 nm Laser Delivery System for PicoSure, 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, 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 which is 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.