EndyMed Medical Receives FDA Clearance For Painless, Non-invasive Anti-Wrinkle Treatment System

Main Category: Dermatology
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 18 Aug 2009 - 1:00 PDT

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EndyMed Medical Ltd, an innovative developer of noninvasive, energy-based aesthetic treatment systems for the professional market, announced today the FDA clearance of the EndyMed PRO(TM) (previously Imagine), for the non-invasive treatment of facial wrinkles and rhytides.

The EndyMed PRO implements the third generation 3DEEP(TM) radio frequency (RF) technology which uses multiple, phase controlled sources, and is the first product of this type to receive clearance to be marketed in the USA.

3DEEP(TM) uniquely controls the power, depth and 3-dimensional pattern of RF energy delivered to the skin. The 3DEEP technology results in minimal surface energy flow, thus eliminating the need for cooling, and providing an effective contouring treatment that is personalized, safe & totally painless.

"FDA clearance establishes our company as a significant player in the worldwide aesthetics market," said Uzi Blumensohn, EndyMed CEO. "Our 3DEEP Technology platform is proven to be highly effective in the treatment of facial wrinkles and importantly, has long-lasting effects, an important benefit for both physicians and their patients."

In a multicenter clinical study examining the safety and efficacy of the EndyMed PRO(TM) wrinkle reduction system, dermatological evaluation concluded that a significant reduction of wrinkle grading was evidenced in more than 80 percent of the treated patients, three months after the end of the treatment.

The advanced EndyMed PRO is equipped with a range of features to assure effective and safe treatment:

-- Non-invasive, yet highly effective therapy for the reduction of wrinkles and rhytides.

-- Customized treatment parameters

-- Optimal safety, with no pain and no side effects

-- Short treatment with no downtime

-- Noticeable immediate improvement

-- Long term results

About EndyMed Medical

EndyMed Medical Ltd., established in 2007, is a medical technology company that designs, develops, and commercializes noninvasive, RF-energy based aesthetic treatment systems for the professional market. EndyMed was established and continues to be guided by an experienced management, clinical and development team. The company is characterized by its fast, innovative, market-oriented R&D, targeting the fastest growing segments of the medical aesthetic market. The EndyMed PRO will be marketed exclusively in the United States by Eclipsemed Ltd, a leading distributor of aesthetic high-tech medical devices and supplies.

Source: EndyMed Medical Ltd

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