BUFFALO GROVE, Ill., April 30 /PRNewswire/ -- 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
"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
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 www.almalasers.com.
SOURCE Alma Lasers