Syneron Candela Snags New FDA Approval for the CO2RE System

November 5, 2015 |

4 min read

Syneron Candela Announces New FDA Clearance for the CO2RE System

Expanded FDA Clearance Includes: Gynecology Applications, Wrinkles, Scars, and Numerous Dermatology and Plastic Surgery indications

IRVINE, Calif., Nov. 5, 2015 /PRNewswire/ -- Syneron Medical Ltd. (NASDAQ: ELOS), a global market leader in the aesthetic medical device marketplace, announced today that the US Food and Drug Administration (FDA) has granted numerous additional indications for use of the CO₂RE CO₂ device. This clearance, including more than 90 specific indications in total, significantly expands the business opportunity for CO₂RE users for high patient demand treatments. The new indications for use include gynecology applications (including vaginal treatments), wrinkles, scars, and a wide range of dermatology and plastic surgery indications.

CO2RE Wrinkle and Pigmentation Treatment

CO₂RE incorporates proprietary advanced scanner technology, high peak power and a high brightness CO₂ laser. A previously FDA cleared version of the device was initially launched in 2010. The CO₂RE is currently sold in more than 50 countries. CO₂RE is a CO₂ laser offering multi-depth pulse technology, delivering precisely fractionated beam patterns to treat two layers of the epidermis and dermis simultaneously. This precision technology creates areas of superficial and deep ablation and coagulation to activate remodeling at several tissue depths. This same technology presents advantages in treatment of several body areas in addition to the demonstrated performance of the aesthetic treatments.

“This broad range of newly FDA cleared clinical indications of the CO₂RE will enable Syneron Candela to address new physician markets with very high patient demand and creates a significant business opportunity for the Company, including new modalities and applications for dermatology, plastic surgery and gynecology treatments that will be introduced to the market soon,” said Amit Meridor, Chief Executive Officer of Syneron Candela.

Hayes Gladstone, M.D., a dermatologic surgeon said, “For my practice, we selected the CO₂RE CO₂ device because it is so versatile with traditional and fractional resurfacing which means we can treat a wide range of conditions. Adding it to our practice has been easy - it has an excellent graphic interface, as well as a small footprint - and has expanded our patient offerings.”

About Syneron Candela
Syneron Candela is a leading global aesthetic device company with a comprehensive product portfolio and a global distribution footprint. The Company’s technology enables physicians to provide advanced solutions for a broad range of medical-aesthetic applications including body contouring, hair removal, wrinkle reduction, tattoo removal, improving the skin’s appearance through the treatment of superficial benign vascular and pigmented lesions, and the treatment of acne, leg veins and cellulite. The Company sells its products under three distinct brands, Syneron, Candela and CoolTouch, and has a wide portfolio of trusted, leading products including UltraShape, VelaShape, GentleLase, VBeam Perfecta, PicoWay, Profound and elos Plus.

Founded in 2000, the corporate, R&D, and manufacturing headquarters for Syneron Candela are located in Israel. Syneron Candela also has R&D and manufacturing operations in the U.S. The company markets, services and supports its products in 86 countries. It has offices in North America, France, Germany, Italy, Portugal, Spain, UK, Australia, China, Japan, and Hong Kong and distributors worldwide.

For additional information, please visit http://www.syneron-candela.com.

SAFE HARBOR FOR FORWARD-LOOKING STATEMENTS
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including product efficacy, market acceptance of new products, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Company’s most recent Annual Report on Form 20-F, and in the filings that Syneron Medical makes with the SEC, and other factors beyond the Company’s control. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, Syneron Medical Ltd.'s actual results, performance or achievements may vary materially from those expressed or implied by these forward-looking statements. These forward-looking statements should not be relied upon as representing Syneron Medical Ltd.'s views as of any date after the date of this document. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Contacts:
Syneron Medical Public Relations
pr@syneron.com

Hugo Goldman, Chief Financial Officer
+ 972 73 244 2283
Email: hugo.goldman@syneron.com

Zack Kubow, The Ruth Group
646-536-7020
Email: zkubow@theruthgroup.com