Cynosure Receives CE Mark Approval For SculpSure

WESTFORD, Mass., Sept. 10, 2015 /PRNewswire/ -- Cynosure, Inc. (NASDAQ: CYNO), a leader in laser- and light-based aesthetic treatments, today announced that it has received European Medical Device Directive (MDD) certification from its European Notified Body for SculpSure, the world’s first hyperthermic aesthetic laser for non-invasive fat reduction. The certification, from Intertek Semko AB, allows Cynosure to place the “CE” Mark on SculpSure for distribution in the European Union (EU) and its member states.

“The receipt of CE Mark approval is an important step in the commercialization of SculpSure in key European markets, and an integral element in our international growth strategy for this game-changing new device,” said Cynosure Chairman and CEO Michael Davin. “The CE Mark validates product adherence to the European Commission’s quality assurance and safety requirements. With the percentage of overweight adults in the European Region continuing to climb, we believe that millions of men and women in the region have the potential to benefit from this safe and effective treatment option.”

SculpSure is FDA cleared in the United States for non-invasive lipolysis of the flanks and abdomen. Cynosure expects to begin initial product sales in the fourth quarter of 2015 both through its U.S. direct sales force and through its direct subsidiaries in France, Germany, Spain and the United Kingdom. In the EU, SculpSure will be debuted at the 24th European Academy of Dermatology and Venereology Congress, which takes place October 7-11 in Copenhagen, Denmark.

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.

Forward-Looking Statements
Any statements in this press release about Cynosure’s receipt of the CE Mark for SculpSure and the planned European launch of the product, 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 SculpSure, 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.

Contact
Scott Solomon
Sharon Merrill Associates
617-542-5300
cyno@investorrelations.com

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SOURCE Cynosure, Inc.