Syneron Candela Announces FDA Clearance of PicoWay Picosecond Laser for Tattoo Removal

WAYLAND, Mass., Nov. 3, 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 new PicoWay picosecond device. PicoWay is a state-of-the-art dual wavelength device, with 1064nm and 532nm wavelengths, which utilizes the proprietary PicoWay Technology^TM to generate picosecond pulses for the removal of tattoos. The FDA clearance is for all tattoo colors: red, yellow and orange for the 532nm wavelength; black, brown, green, blue and purple for the 1064nm wavelength. The US launch of PicoWay will begin immediately, following the launch of the product in the international market in October.

PicoWay incorporates picosecond (one trillionth of a second) pulse duration to generate an ultra-short pulse and very high peak power of laser energy on the skin. The high energy ultra-short picosecond laser pulse creates a strong photo-mechanical impact that optimizes fracturing of tattoo ink. The innovative PicoWay Technology is integrated into a proven, reliable Syneron Candela platform which offers high reliability, superior performance and low cost of ownership.

In support of the FDA 510(K) clearance, the performance of the PicoWay system was evaluated in a prospective, US multicenter study conducted by Eric Bernstein, MD, Arielle Kauvar, MD, and Tina Alster, MD as the primary investigators.  A large majority of subjects (86%) achieved at least 50% tattoo clearance after only 3 treatments based on blinded, independent review.  Device treatment also presented a favorable safety profile with no device-related serious adverse events, and low levels of pain or discomfort throughout the study. 

Dr. Eric Bernstein, President of Main Line Center for Laser Surgery, said, "PicoWay is an innovative and exciting breakthrough for tattoo removal. As a dual wavelength Nd:YAG laser, it delivers extremely high peak-power, picosecond pulses enabling the treatment of all skin types. What this means is extremely impressive results, which translate into very happy patients. PicoWay is a game-changing laser for tattoo removal, and could not have come at a better time." 

Amit Meridor, Chief Executive Officer of Syneron Candela, said, "We expect a strong interest in PicoWay. Tattoo removal represents a significant market opportunity, with estimates that of the 45 million Americans with at least one tattoo, 20% want to have their tattoo removed. PicoWay provides a powerful new option, which clinical trials have shown to offer high rates of tattoo removal in very few treatments."

Dr. Shimon Eckhouse, Chairman of the Board of Syneron Candela commented, "PicoWay represents a new era in aesthetic and dermatologic laser applications due to its mechanism of action which is mainly based on the photomechanical (photo-acoustic) effect compared to photo-thermal effect which is used in longer pulse duration aesthetic laser and IPL devices. With the shortest picosecond pulse and the highest peak power on the market the PicoWay enables efficient tattoo removal with less treatment sessions, more comfort to patients and new revenue streams for our customers. The different mechanism of action of the PicoWay turns it into a new aesthetic platform with wide range of new aesthetic applications that our scientists and doctors are working on. The highly trusted, reliable Candela platform used on the PicoWay was demonstrated in the multi-site clinical trials performed with the device in the US and internationally on a wide range of indications. This very high reliability and ease of use for the doctor are important advantages of the PicoWay".

Dr. Arielle N.B. Kauvar, Clinical Professor of Dermatology at New York University, said, "The PicoWay laser allows us to treat a broader range of skin types and a wide array of tattoo ink colors. With the ultra-short picosecond pulse duration, there is minimal discomfort during treatment.  Professional and multicolored tattoos are cleared in very few treatment sessions offering greater patient convenience compared to longer treatment regimens."

About Syneron
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.

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 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

Contacts:

Zack Kubow, The Ruth Group [email protected], 646-536-7020
Hugo Goldman, Chief Financial Officer, Syneron [email protected]
Syneron Medical Public Relations
 [email protected]  

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SOURCE Syneron Medical Ltd.

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