WESTFORD, Mass., July 29, 2013 /PRNewswire/ -- Cynosure, Inc. (Nasdaq: CYNO), a leader in laser- and light-based treatments for minimally invasive and non-invasive aesthetic applications, today announced that it has received a medical device license issued by Health Canada for the Company's PicoSure™ Picosecond Laser Workstation. Cynosure plans to begin selling PicoSure through its North American direct sales force immediately.
PicoSure is the world's first picosecond laser indicated for the removal of tattoos and benign pigmented lesions. The device received 510(k) clearance from the U.S. Food and Drug Administration at the end of 2012 and was launched in the first quarter of 2013. PicoSure received CE Mark certification in Q1 2013, and is currently being marketed in the European Union.
"Health Canada's authorization of PicoSure supports our long-term growth strategy and broadens our presence internationally," said Michael Davin, Cynosure's Chairman and Chief Executive Officer. "Following a successful launch in both the U.S. and Europe, demand for PicoSure continues to achieve our expectations. This additional clearance generates a first-mover advantage for Cynosure in another key market."
About Cynosure, Inc.
Cynosure develops and markets aesthetic treatment systems that enable plastic surgeons, dermatologists and other medical professionals 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, treat toe fungus and ablate sweat glands. Cynosure's product portfolio is composed of a broad range of energy sources including Alexandrite, diode, Nd: YAG, picosecond, pulse dye, Q-switched lasers and intense pulsed light. Cynosure sells its products globally under the Cynosure, Palomar and ConBio 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 100 other countries. For corporate or product information, visit Cynosure's website at www.cynosure.com.
Any 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 market acceptance of PicoSure in Canada, 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 and other factors discussed in Cynosure's most recent Annual Report on Form 10-K and subsequently filed quarterly report on Form 10-Q, 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.
Sharon Merrill Associates, Inc.
SOURCE Cynosure, Inc.