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Cynosure (CYNO) Receives CFDA Clearance To Market The Icon Aesthetic System In China



11/29/2016 9:27:18 AM

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WESTFORD, Mass., Nov. 29, 2016 /PRNewswire/ -- Cynosure, Inc. (NASDAQ: CYNO) today announced that it has received clearance from the China Food and Drug Administration (CFDA) to market the Icon Aesthetic System, the Company's next-generation platform technology for multiple aesthetic indications. With Icon, aesthetic practices in China will be able to deliver the industry's most popular energy-based treatments, including facial vessel and pigment clearance, wrinkle reduction, hair removal and scar and stretch mark treatment, in a single system.

"Cynosure was the first U.S. aesthetic laser company to establish a wholly owned subsidiary in China more than 10 years ago, and we continue to expand our competitive position in that country and the entire Asia Pacific (APAC) region as part of our international growth strategy," said Michael Davin, the Company's president and CEO. "Today, China is our largest subsidiary in the world. Gaining CFDA approval to market Icon there is another milestone as we strive to grow our APAC business at a pace ahead of the overall market. With strong customer relationships, an established direct sales force, and the rapid growth of medical aesthetics in China, we believe we are positioned to achieve that objective."  

Cynosure will begin selling Icon late in the fourth quarter of 2016 from its direct sales offices in Beijing and Suzhou.

About Icon

The expandable Icon Aesthetic System offers high peak power, state-of-the-art contact cooling and the proprietary Skintel® Melanin Reader, resulting in fast treatments with excellent results. Treatments include vessel and pigment clearance, surgical and acne scar treatment, stretch mark treatment, wrinkle reduction, leg vein clearance and permanent hair reduction. The addition of Skintel, the industry's only melanin reader, provides additional safety and efficacy by determining the average melanin density of skin prior to treatment for ideal treatment settings.

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 laser lipolysis, reduce cellulite, clear nails infected by toe fungus, ablate sweat glands and improve women's health. The Company also markets radiofrequency (RF) 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 RF 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

Any statements in this press release about future expectations, plans and prospects for Cynosure, Inc., including Cynosure's expectations with respect to timing and success of product launches and expansions, regulatory clearances and international registrations, as well as other statements containing the words, "believes," "looks forward," "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 price of Cynosure's stock prevailing from time to time, the nature of other investment opportunities presented to the Company from time to time, the Company's cash flow from operations, 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 described in Item 1A of Part II (Risk Factors) of our Quarterly Report on Form 10-Q for the three months ended September 30, 2016. 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 after the date of this press release.

Contact:

Scott Solomon
Senior Vice President
Sharon Merrill Associates, Inc.
617.542.5300
cyno@investorrelations.com

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/cynosure-receives-cfda-clearance-to-market-the-icon-aesthetic-system-in-china-300369642.html

SOURCE Cynosure, Inc.


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