Cynosure Wins FDA Nod to Market New PicoSure Energy Delivery System for Tattoos and Pigmented Lesions
Shipments of New 1064 nm Wavelength to Begin in the Second Half of 2016
WESTFORD, Mass., May 24, 2016 /PRNewswire/ -- Broadening its product platform for tattoo removal and skin revitalization, Cynosure, Inc. (NASDAQ: CYNO) today announced that it has received U.S. Food and Drug Administration 510(k) clearance to market a new Laser Delivery System for PicoSure®, the world's first aesthetic picosecond laser. Together with the FDA cleared 532 nm and 755 nm wavelengths, Cynosure's new 1064 nm Laser Delivery System improves the multi-wavelength laser technology for removing the full color spectrum of tattoo inks in fewer treatments.
The new 1064 nm wavelength is designed for removal of black and other dark tattoo inks. Engineered to complement the highly versatile 755 nm wavelength and the Company's proprietary FOCUS Lens Array, the 1064 nm and 532 nm Laser Delivery Systems enhance PicoSure's ability to remove tattoos and treat a range of dermatologic conditions including wrinkles, acne scars and pigmented lesions.
"PicoSure is widely recognized by aesthetic practitioners for its unsurpassed clinical efficacy and proven performance," said Cynosure Chief Executive Officer Michael Davin. "Consumers simply know it works. With the FDA clearance of the 1064 nm Laser Delivery System we believe our picosecond technology has the broadest range of clearances on the market. The new 1064 nm wavelength builds on our aesthetic industry leadership and expands PicoSure's versatility for tattoos, pigmentation and skin revitalization."
The 1064 nm wavelength will be offered as an upgrade to existing PicoSure customers. Initial shipments of the new Laser Delivery System are expected to begin in the second half of 2016.
The clinical experience with PicoSure was the subject of 11 oral abstracts and three ePosters during the recent American Society for Laser Medicine & Surgery Annual Conference in Boston. In addition to tattoo removal and skin revitalization, researchers reported on studies evaluating PicoSure as a treatment for melasma, a hyperpigmentation of the skin more common in women.
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 non-invasive and minimally invasive laser lipolysis, reduce cellulite, clear nails infected by toe fungus, ablate sweat glands and improve gynecological 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, 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 receipt of FDA clearance for the 1064 nm Laser Delivery System for PicoSure, expectations with respect to timing and success of product launches, 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 discussed in Cynosure's Annual Report on Form 10-K for the 12 months ended December 31, 2015, Quarterly Report on Form 10-Q for the three months ended March 31, 2016 and other periodic reports the Company files 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
Senior Vice President
Sharon Merrill Associates, Inc.
617.542.5300
cyno@investorrelations.com
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SOURCE Cynosure, Inc.
