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Syneron Candela gets FDA clearance for Profound SubQ to improve appearance of Cellulite

Syneron Medical, a global aesthetic device company, announced that it has achieved two major milestones to further strengthen Profound's position in the marketplace.

Profound is a minimally invasive, fractional radiofrequency (RF) microneedling device indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Specifically, the 25º Dermal handpiece and cartridge are used for percutaneous treatment of facial wrinkles, and the 75º SubQ handpiece and cartridge are used to improve the appearance of cellulite in patients with Fitzpatrick skin types I-III as supported by long-term clinical data (6 months).

Syneron Candela has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Profound™ when using the SubQ handpiece and cartridge to improve the appearance of cellulite in patients with Fitzpatrick skin types I-III, as supported by long term data (6 months).

A recent multi-center clinical study of Profound showed improvement of cellulite severity (in dimples and/undulation irregularities) in 94% of treated thighs assessed at a three month follow up by blinded review.

Sustained improvement was observed at six month follow up in 93% of the treated thighs. When considering improvement in each cellulite feature separately, 86% of the treated thighs (of the 80 thighs with dimples at baseline) showed improvement in dimples, and 76% of the thighs (all thighs had undulation at baseline) showed improvement in undulation irregularities.

Per subject results were similar, where 88% of the treated subjects showed improvement in the appearance of cellulite in both thighs in dimples and/or undulation at 3 months follow up, and 86% of the treated subjects showed improvement at 6 months follow up. 

"The FDA clearance of Profound for treatment of cellulite is a major addition to the capabilities of this device and to our body shaping offering. Cellulite is one of the most disturbing aesthetic problems bothering women and one of the most difficult to treat,” Philippe A. Schaison, CEO of Syneron Candela North America.

FDA clearance for Profound to improve the appearance of cellulite using the SubQ cartridge and handpiece is based on positive data from utilizing the device in an institutional review board (IRB) reviewed multi-center study.

 The study measured success by analyzing the dimples and/or undulation irregularities in the thighs of 50 women with Fitzpatrick skin types I-III. Syneron Candela plans to release the product in 2017.

The United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance, indicating that yet another patent will issue with claims covering the technology used in the Company's Profound device. The new allowed claims cover any device that uses an array of needles to deliver energy into the dermal layer of skin to induce fractional thermal damage. The allowed claims and eventual patent are owned by Massachusetts General Hospital (MGH) and

Syneron holds an exclusive worldwide license to this intellectual property for use in aesthetic applications. In addition to this intellectual property, Syneron holds several additional U.S. and international patents covering the Profound™ RF micro-needle fractional system.

Dr. Shimon Eckhouse, Chairman of Syneron Medical, commented, "The allowance of these broad new claims protecting our RF micro-needling technology is a significant development that further strengthens our position in this fast growing market and enhances our ability to enforce the Profound intellectual property against current or future violators.

We believe this broad coverage has the potential of positioning Syneron as the only company in the U.S. utilizing a micro-needle array to deliver RF energy into the dermis. This technology has been clinically proven to induce growth of new collagen, elastin and hyaluronic acid significantly improving the appearance of skin.