Press release from PR Newswire
Cynosure Receives FDA Clearance for At-Home Device for the Treatment of Wrinkles
Wednesday, July 18, 2012
Cynosure Receives FDA Clearance for At-Home Device for the Treatment of Wrinkles08:30 EDT Wednesday, July 18, 2012Consumer Aesthetic Device Being Developed with Unilever Targeted for Launch in 2013WESTFORD, Mass., July 18, 2012 /PRNewswire/ -- Cynosure, Inc. (NASDAQ: CYNO) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market a home-use over the counter device for the treatment of facial wrinkles. The device was developed in partnership with Unilever (NYSE: UL), a leading global consumer goods company. The device, which is indicated for the treatment of both periorbital and perioral wrinkles, is expected to be launched commercially by Unilever in 2013. "FDA clearance of this device marks a significant milestone in our alliance with Unilever to develop light-based devices for the consumer market," said Michael Davin, Cynosure's President and Chief Executive Officer. "Our strategic partnership with Unilever blends our expertise in developing market leading light-based technology that emphasizes patient safety and clinical results, with Unilever's unparalleled innovation, branded marketing and distribution." According to the research firm Medical Insight, worldwide sales of home-use aesthetic devices are expected to grow at a compound annual rate of 12.3% from $740.4 million in 2011 to more than $1.3 billion in 2016. In North America, Medical Insight estimates the home-use category is expected to grow by a compound annual rate of 12.1% from $451.6 million in 2011 to approximately $800 million by 2016. Cynosure signed a multi-year funded cooperative development agreement with Unilever in June 2009 to develop and commercialize light-based devices targeting the home use personal care market. About Cynosure, Inc.Cynosure, Inc. develops and markets aesthetic treatment systems that are used by physicians and other practitioners to perform non-invasive and minimally invasive procedures to remove hair, treat vascular and pigmented lesions, rejuvenate the skin, liquefy and remove unwanted fat through laser lipolysis, reduce the appearance of cellulite and treat Onychomycosis. Cynosure's products include a broad range of laser and other light-based energy sources, including Alexandrite, pulse dye, Q-switched, Nd:YAG and diode lasers, as well as intense pulsed light. Cynosure was founded in 1991. For corporate or product information, contact Cynosure at 800-886-2966, or visit www.cynosure.com. Forward-Looking StatementsAny statements in this press release about future expectations, plans and prospects for Cynosure, Inc., 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 global economy and lending environment and their effects on the aesthetic laser industry, Cynosure's history of operating losses, its reliance on sole source suppliers, the inability to accurately predict the timing or outcome of regulatory decisions, changes in consumer preferences, competition in the aesthetic laser industry, 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, while 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.Timothy BakerScott SolomonExecutive VP, Treasurer and CFOVice President Cynosure, Inc. Sharon Merrill 978.256.4200617.542.5300TBaker@cynosure.comCYNO@investorrelations.com SOURCE Cynosure, Inc.