Cynosure Receives Expanded FDA Clearance to Market PicoSure™ for Treatment of Acne Scars
Demonstrates Ability of FOCUS Lens Array Technology to Treat Additional High-Volume Indications
WESTFORD, Mass., July 24, 2014 /PRNewswire/ -- Cynosure, Inc. (NASDAQ: CYNO), a leader in laser- and light-based aesthetic treatments for non-invasive and minimally invasive applications, today announced that it has received FDA 510(k) clearance to market its flagship PicoSure™ Picosecond Laser Workstation for the treatment of acne scars with the FOCUS lens array, the Company's new disposable energy delivery system. In the fourth quarter of 2012, PicoSure became the world's first picosecond device to receive FDA clearance for the removal of tattoos and benign pigmented lesions.
"The clearance to treat acne scarring with PicoSure represents a significant milestone in our strategy to pursue expanded indications that demonstrate the breadth of this technology," said Cynosure President and Chief Executive Officer Michael Davin. "PicoSure continues to be well received by physicians and consumers in the U.S. as well as internationally. The treatment of acne scarring represents a large global market, and we believe that approval of PicoSure effectively positions us to capitalize on this opportunity. At the same time, we continue to pursue new FDA marketing clearances for PicoSure in additional indications such as the treatment of wrinkles."
"Our FOCUS lens array microscopically concentrates laser energy on small treatment areas of tissue while stimulating collagen production and remodeling," Davin said. "With its unique pulse format, we believe FOCUS technology presents the opportunity for physicians to offer highly customizable treatments for their patients."
About Cynosure, Inc.
Cynosure develops 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, liquefy and remove unwanted fat through laser lipolysis, reduce cellulite, clear nails infected by 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, and 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 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 FDA clearance to market PicoSure for the treatment of acne scars, 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 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 flows 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 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.
Contact
Scott Solomon
Vice President
Sharon Merrill Associates
617-542-5300
[email protected]
SOURCE Cynosure, Inc.
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