Alma Lasers(TM) Receives FDA Clearance For The Accent(TM) Dual Mode RF System

Main Category: Dermatology
Also Included In: Cosmetic Medicine / Plastic Surgery;  Medical Devices / Diagnostics
Article Date: 01 May 2007 - 0:00 PDT

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Alma Lasers, a global leader in laser, light-based and radio frequency (RF) technologies used in aesthetic medicine, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market the Accent(TM) Dual Mode RF System in the United States.

Receiving its first FDA indication for the treatment of wrinkles and rhytids, the Accent system has been used successfully by medical professionals worldwide to treat a variety of dermatological and aesthetic conditions.

"We're delighted to receive the marketing clearance for the Accent product in the United States," stated Howard Kelly, CEO for Alma Lasers. "The unique dual mode RF modalities of the Accent system will provide physicians with the most advanced technology available in non-invasive aesthetic medicine; creating a higher standard in patient satisfaction. The company is committed to pursuing additional clearances from the FDA, in order to expand the clinical indications for the Accent system in the United States."

Non-invasive, non-ablative and virtually pain free, the Accent system combines two radio frequency modes into one device. Each mode is delivered by a discrete handpiece to enable volumetric RF thermotherapy at different tissue depths within the body.

Ziv Karni, PhD, President and founder of Alma Lasers stated, "The Accent product was engineered for safety and ease of use, while maximizing efficacy. The continuous movement of either handpiece results in a gradual build-up of heat to achieve the optimal therapeutic effect, while providing greater patient comfort. With over one thousand Accent systems installed worldwide, the product has enjoyed an unparalleled safety record."

"Non-invasive treatments are the largest and fastest growing category in aesthetic medicine," said Yariv Matzliach, Executive Vice President of Global Marketing for Alma Lasers. "Now with its first FDA indication, the Accent system is poised to provide medical professionals and their patients in the United States with a new level of safety, efficacy and satisfaction in non-invasive treatments."

"We have found the Accent system to be very safe and relatively comfortable with a high percentage of responders," states David H. McDaniel, MD, Assistant Professor of Clinical Dermatology and Plastic Surgery, Eastern Virginia Medical School, Director of the Institute of Anti-Aging Research Center of Virginia, and a principal investigator in the FDA study. "Compared to other RF devices we have used, treatment with the Accent system is much less painful, faster and easier to perform. It also allows more 'artistic' use on the face. Although responses vary, a high percentage of treated subjects showed a visible response. Some observe an immediate skin tightening of the face."

According to Maurice Sherman, MD, Associate Professor of Clinical Surgery, University of California -- San Diego, and the owner of the Del Mar Cosmetic Medical Center in southern California, "We obtained remarkably good results with the Accent system. It was consistent for all of the patients that followed the protocol. All of them showed an improvement. Some dramatic, some moderate, but every patient expressed satisfaction with the results. Everyone said that their skin felt tighter the day after the first treatment." Added Dr. Sherman, "Of all the RF systems on the market today, I feel the Accent is the most effective technology out there."

About Alma Lasers

Alma Lasers is a global developer, manufacturer and marketer of laser, light-based and radio frequency devices for aesthetic applications.

The Company's mission is to provide modular, cost-effective and high performance systems that enable medical practitioners to confidently offer safe, effective and profitable aesthetic treatments. More information about Alma Lasers can be found at http://www.almalasers.com.

Alma Lasers
http://www.almalasers.com