Syneron Candela Announces CE Mark for CO2RE® Intima
CO2RE Intima Now First In-Office Laser Procedure CE Marked for the Treatment of Vaginal Atrophy and Rejuvenation
IRVINE, California, March 27, 2017 /PRNewswire/ -- Syneron Medical Ltd. (NASDAQ: ELOS), a leading global aesthetic device company, today announced that the company secured the CE Mark for CO2RE Intima, making it the first in-office laser procedure now CE marked for the treatment of vaginal atrophy and rejuvenation. CO2RE Intima is a simple non-surgical treatment that promotes vaginal wellness amongst a broad array of women, while delivering a renewed sense of confidence, comfort, quality of life and enhanced sexual functioning. CO2RE Intima relieves the effects of childbirth and aging by stimulating healing responses in the vaginal canal to enhance moisture levels, while also remodeling the tissue fibers in the vaginal and vulvar areas to restore their flexibility and shape. It is also used to address changes and symptoms associated with painful intercourse.
A survey of menopausal women showed that 75% suffered from vaginal dryness, and 90% said it negatively affects their lives. In the same survey, 63% of post childbirth women felt their vagina was looser since giving birth and would consider a non-surgical procedure to tighten their vaginal canal.1
"I have previously used other technologies for this type of vaginal treatment, but the CO2 technology of CO2RE Intima is more effective because it provides the type of fractional impact that is most effective on mucosal tissue," says César Arroyo, MD, head of the Medical Laser Unit in HM Monteprincipe Hospital, Madrid, Spain. "Additionally, it can be used to treat multiple areas including the vaginal canal, introitus and vulva."
CO2RE Intima delivers favorable results, with mild to no discomfort and little downtime. In a clinical study, conducted by Dr. Arroyo, at the three-month follow-up after the third treatment, 100% of women reported satisfaction with the treatment and 94% would recommend it to others.2 Additionally, 82% of the women showed a statistically significant improvement in the vaginal health index (p<0.05).2 The treatment requires no anesthesia and typically takes around 15 minutes to treat. Most patients feel and see improvement after the very first treatment; however, a series of three treatments, about four weeks apart, is recommended for optimal results.
"We are proud to be the first company to secure the CE Mark for the treatment of vaginal atrophy and rejuvenation," says Amit Meridor, CEO of Syneron Candela. "CO2RE Intima's recent CE Mark demonstrates Syneron Candela's continuing commitment to innovation and leadership in aesthetic medicine, and now in the women's intimate health category."
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, women's intimate health, 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 has a wide portfolio of trusted, leading products including UltraShape Power, VelaShape, CO2RE, CO2RE Intima, GentleLase, VBeam Perfecta, PicoWay, Profound and elōs 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.
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.
For additional information, please visit http://www.syneron-candela.com.
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1 Toluna Quick Study Survey, 2015.
2 3-month results from Clinical Study HM Monteprincipe Hospital, Madrid, Spain, 2016 as presented at the American Society for Laser Medicine & Surgery (ASLMS) 2016 annual meeting.
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