WAYLAND, Mass., Nov. 17, 2014 /PRNewswire/ -- Syneron Medical Ltd. (NASDAQ: ELOS), a leading global aesthetic device company, announced today the US Food and Drug Administration (FDA) clearance of the U-Sculpt™ transducer for its UltraShape™ non-invasive fat destruction platform. The FDA also cleared the V3.1 platform for 25% increase in Ultrasound power in the new U-sculpt transducer and the previously cleared larger VDF transducer. This 25% power enhancement is designed to increase the efficacy of treatment and improve both the user experience and patient comfort.
The UltraShape System is a non-invasive body shaping treatment that uses pulsed focused ultrasound energy to precisely target subcutaneous fat, while keeping the surrounding tissue, vasculature, nerves and muscles intact. UltraShape uses a pure mechanical effect to destroy fat cells without inducing thermal damage.
With this new clearance, the UltraShape system is now available with two transducers, the currently cleared VDF transducer as well as the new U-Sculpt transducer. The new U-Sculpt transducer is smaller and 50% lighter than the existing full-size VDF transducer, it is ergonomically designed to treat any shape and size of fat pockets and is easily interchangeable with the full-size VDF transducer during treatment sessions. With the new FDA clearance the VDF transducer can be operated in two energy density levels and utilizes four available treatment modes.
"As a long time and satisfied UltraShape user, I find the new U-Sculpt transducer a great enhancement to our treatments," commented Christopher Inglefield BSc, FRCS, a Plastic Surgeon in London UK. "The U-Sculpt transducer gives me the flexibility to fully customize the treatment of small pockets of fat in any areas. In my practice, 98% of patients reported satisfaction with the UltraShape procedure confirming that it is meeting patient expectations and the high demand for comfortable, safe and effective non-invasive fat reduction treatments."
"UltraShape is already showing remarkable success in the US since we initiated its controlled launch several months ago," stated Amit Meridor, CEO of Syneron Candela, "We are confident that the FDA clearance of U-Sculpt and enhanced power of both transducers provide additional significant features to the UltraShape platform and will further enhance the business opportunity of our UltraShape doctor partners"
Syneron Medical Ltd. 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, 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.
Founded in 2000, the corporate, R&D, and manufacturing headquarters for Syneron Medical Ltd. are located in Israel. Syneron 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.
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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 potential clinical successes, 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.
Additional information can be found at www.syneron-candela.com
SOURCE Syneron Medical Ltd