WESTFORD, Mass., Oct. 5, 2011 /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 acquired from NuvoLase, Inc. worldwide exclusive rights to distribute the PinPointe FootLaser. The PinPointe FootLaser is the world's first FDA cleared light-based device for the treatment of Onychomycosis (toenail fungus), a condition that affects approximately 36 million people in the United States and an estimated 10 percent of the population worldwide.
The PinPointe FootLaser received U.S. Food and Drug Administration clearance in October 2010 for the treatment of Onychomycosis. The system also is cleared for marketing in Australia, Canada and the European Union.
"The treatment of Onychomycosis represents an emerging opportunity for light-based technology," said Cynosure President and Chief Executive Officer Michael Davin. "We are acquiring the worldwide exclusive rights to a system that we believe is considered the leading solution for treating this indication. With almost 100,000 PinPointe FootLaser treatments performed worldwide to date, our distribution agreement with NuvoLase immediately gives us a leadership position in the market."
The distribution agreement gives Cynosure rights to distribute both current and future NuvoLase products for the treatment of Onychomycosis. In North America, Cynosure plans to sell the PinPointe FootLaser through a new dedicated podiatry direct sales team supported by the Company's existing direct sales force. The American Podiatric Medical Association estimates that there are approximately 15,000 podiatrists currently practicing in the United States. In Europe, the system will initially be marketed through Cynosure's direct subsidiaries. Cynosure expects to launch the product in additional markets in the Asia Pacific region and through select international distributors in the future.
"We believe Cynosure's expansive distribution network will help drive the adoption of the PinPointe FootLaser system on a global basis," said NuvoLase President and Chief Executive Officer Steven P. Duddy. "The expertise Cynosure has demonstrated in developing and marketing laser- and light-based treatments for minimally invasive and non-invasive aesthetic applications will be crucial in gaining market share for this fast-growing indication."
Onychomycosis is a condition marked by the growth of fungus under the nail. Fungi feed on keratin, the protein that makes up the hard surface of the toenails. The infected nail often turns darker in color, and debris may accumulate under the nail. As the infection continues, the nail either may crumble gradually and fall off or thicken.
PinPointe FootLaser uses laser light to kill the fungus that lives in and under the nail without causing damage to the nail or the surrounding skin. The treatment typically takes 20 minutes with no downtime. In a 12-Month Multi-Site Retrospective Study conducted on more than 250 sequential patients, 71.4% of patients experienced continuous improvement in clear nail area after a single treatment. By contrast, the current standard of care for Onychomycosis oral drugs and topical medications are estimated to be only between 30-50% effective in treating the indication and have the potential for significant side effects.
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, rejuvenate the skin, liquefy and remove unwanted fat through laser lipolysis and reduce the appearance of cellulite. Cynosure's products include a broad range of laser and other light-based energy sources, including Alexandrite, pulse dye, 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.
About NuvoLase, Inc.
NuvoLase, Inc. develops innovative devices for healthcare providers worldwide. NuvoLase products provide superior clinical performance the result of solid research, sound science, and extensive clinical experience. The NuvoLase PinPointe FootLaser is available worldwide.
Any statements in this press release about future expectations, plans and prospects for Cynosure, Inc., including those related to the market potential of the PinPointe FootLaser, 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 global economy and lending environment and their effects on the aesthetic laser industry, Cynosure's ability to successfully market and sell the PinPointe FootLaser system in current and future markets, reliance on sole source suppliers, the inability to accurately predict the timing or outcome of regulatory decisions, changes in consumer preferences, competition in the aesthetic laser industry, economic, market, technological and other factors discussed in Cynosure's most recent Annual Report on Form 10-K and 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, while 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.