Syneron Candela Achieves Approval to Market Its ALEX II System in Japan For Treatment of Benign Dermal Lesions
TOKYO, April 28, 2014 /PRNewswire/ -- Syneron Medical Ltd. (NASDAQ: ELOS), a leading global aesthetic device company, announced today that that its subsidiary in Japan, Candela KK, received registration approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its ALEX II™ system in Japan for the treatment of benign dermal lesions.
A special configuration of Candela's successful Alex TriVantage® platform that has been customized for the Japanese market, the ALEX II is a single wavelength Q-switched alexandrite laser designed to treat congenital pigmented lesions and tattoos. It is the second generation of the 755nm Q-switched laser system popular in Japan for the treatment of pigmented lesions common to Japanese skin types. It features 2mm, 3mm and 4mm treatment spot sizes and is capable of delivering up to 18 J/cm2 fluence.
"In comparison to Q-switched ruby lasers and Q-switched Nd:YAG lasers which are also commonly used in Japan, I believe that Candela's Q-switched alexandrite laser is well-balanced in clinical use. It has an optimal wavelength and pulse duration to obtain high efficacy while reducing the risk of complications, especially hypopigmentation, during the course of treatment," said Dr. Taro Kono, Associate professor, Department of Plastic and Reconstructive Surgery, Tokai University. "I've been using ALEXLAZR for more than 10 years, and have found many advantages to using Candela's Q-switched alexandrite laser."
There are approximately 500 ALEXLAZR systems in Japan at the current time. Candela's ALEX II is now poised to replace these with state-of-the-art technology that offers superior results.
Known to be an exacting process, approval from the MHLW will also facilitate health insurance payments to physicians and patients allowing for certain medical conditions to be reimbursed. Patients with congenital pigmented lesions, such as Nevus of Ota, ectopic Mongolian spots and traumatic tattoos, will now be covered under Japan's National Health Insurance (NHI). Physicians will receive reimbursement for every treatment that is spaced three months apart.
"We are honored that the ALEX II 755 nm Q-switched laser system has been approved for use in Japan," said Toshio Mori, President of Candela K.K. "This marks a significant milestone in our global distribution, as physicians and patients in Japan will now have greater access to the gold standard treatment that Candela's ALEX II offers."
About Syneron Medical Ltd.
Syneron Medical Ltd. (NASDAQ: ELOS) 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, rejuvenation of 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 two distinct brands, Syneron and Candela. 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 US. The Company markets, services and supports its products in 90 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, anticipated regulatory approvals and future product launches, 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 market conditions, market acceptance of new products, and other factors beyond the Company's control and 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 the other factors described in the filings that Syneron Medical makes with the SEC. 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 any future results, performance or achievements 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.
SOURCE Syneron Medical Ltd.