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Date Announced: 05 Oct 2011
First Light-based Device Approved by FDA Specifically for Treatment of Toenail Fungus.
WESTFORD, Mass., Oct. 5, 2011 /PRNewswire/ -- Cynosure, Inc. (NASDAQ:CYNO - News), 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.
Source: Cynosure
E-mail: CYNO@InvestorRelations.com
Web Site: www.cynosure.com/
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