Cynosure Receives FDA Clearance for PicoSure™, the First Picosecond Device to Remove Tattoos and Benign Pigmented Lesions
WESTFORD, Mass., Dec. 4, 2012 /PRNewswire/ -- Cynosure, Inc. a leader in laser- and light-based treatments for minimally invasive and non-invasive aesthetic applications, today announced that it has received FDA 510(k) clearance to market the PicoSure™ laser workstation for the removal of tattoos and benign pigmented lesions. The Company expects to sell PicoSure initially through its U.S. direct sales force to aesthetic dermatologists and plastic surgeons beginning in early 2013.
"FDA clearance of PicoSure is a major milestone that caps nearly a decade of research and development at Cynosure to commercialize the world's first safe and effective picosecond aesthetic laser specifically designed for the removal of tattoos and benign pigmented lesions," said President and CEO Michael Davin. "PicoSure accomplishes this by delivering short-pulse bursts of energy to the skin in trillionths of a second. With data indicating that an estimated 20 percent of the 45 million Americans with at least one tattoo want to have it removed, the FDA clearance of PicoSure creates a first-mover advantage for Cynosure to treat a large and vastly underserved market."
Roy Geronemus, M.D., Director of the Laser & Skin Surgery Center of New York, performed a study in which 22 subjects with multicolored and recalcitrant tattoos were treated with PicoSure over a two-week period. The results demonstrated greater than 80% overall tattoo clearance. On average, 94% clearance was achieved for blue and green ink.
"The picosecond laser's shorter pulse duration erases tattoo pigment more efficiently, leading to a higher level of patient satisfaction and improved results compared with current nanosecond technology," Dr. Geronemus said. "Our study shows that picosecond technology more effectively targets blue and green pigment, which is typically difficult to remove. In addition, PicoSure more rapidly lightens other colors, with improved recovery time due to less collateral injury to the surrounding tissue."
Boston dermatologists Kenneth A. Arndt, M.D. and Jeffrey Dover, M.D., Directors of SkinCare Physicians in Chestnut Hill, Massachusetts, called PicoSure "the most dramatic improvement in the treatment of tattoos and pigmented lesions in more than two decades" and said they expected the product to rapidly become the "first-in-class treatment" for these indications.
A study led by Drs. Arndt and Dover focused on demonstrating that treatment with a picosecond laser improved clearance of benign pigmented lesions and tattoos with reduced side effects and fewer treatments than other lasers. A total of 15 subjects with tattoos and five subjects with benign pigmented lesions were enrolled in the study. Follow-up was conducted at one month and three months after the last treatment. The study found that 100% of the pigmented lesions were cleared by two treatments, and that tattoo clearance of greater than 75% was achieved in 75% of patients within three to four treatments.
"PicoSure delivers photothermal and significant photomechanical effects to the tattoo or pigmented lesion while leaving the surrounding tissue unheated," Dr. Arndt said. "The speed of the picosecond laser makes this technology ideal for aesthetic applications in which large photomechanical stresses are applied to a particular target."
Davin concluded, "Our multi-year investment in PicoSure reflects our commitment to innovate and develop industry-leading technology. We continue to build a broad intellectual property portfolio targeting a range of high-volume aesthetic applications."
About Cynosure, Inc.
Cynosure, Inc. develops and markets aesthetic treatment systems that are used by physicians and other practitioners to perform non-invasive and minimally invasive procedures to remove hair, treat vascular and pigmented lesions, remove multi-colored tattoos, rejuvenate the skin, liquefy and remove unwanted fat through laser lipolysis, reduce cellulite and treat onychomycosis. Cynosure's products include a broad range of laser and other light-based energy sources, including Alexandrite, pulse dye, Q-switched, Nd:YAG and diode lasers, as well as intense pulsed light. Cynosure was founded in 1991. For corporate or product information, contact Cynosure at 800-886-2966, or visit www.cynosure.com.
Any statements in this press release about future expectations, plans and prospects for Cynosure, Inc., including statements about commercialization or potential market acceptance of PicoSure, 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 levels of demand for procedures performed with Cynosure products and for Cynosure products themselves, Cynosure's ability to maintain its profitability, 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 Quarterly Report on Form 10-Q, 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.
SOURCE Cynosure, Inc.