Dallas, TX (PRWEB) June 06, 2012
Primcogent Solutions, the exclusive provider in North America and Western Europe for the ZERONA body sculpting and LLLT systems by Erchonia, announced today that it obtained exclusive marketing, sales and distribution rights in those same markets for the recently FDA cleared ZERONA AD system. The Zerona AD has received market clearance (May 2012) by the U.S. Food and Drug Administration to safely and effectively reduce upper arm circumference. The ZERONA AD is the first non-invasive aesthetic device to receive this 510k market clearance in the U.S., and the only device on the market to specifically target and sculpt upper arms.
The ZERONA AD received market clearance following Erchonia’s completion of a placebo‐controlled, randomized, double‐blind multi-center clinical investigation of 62 participants. The results obtained from the study showed a combined reduction in arm circumference of 3.7cm (1.50 inches) in the treatment group versus 0.31cm (0.10 inches) in the placebo-controlled group after six treatments over two weeks. Long-term follow-up at an average of 7.6 months showed results persisted with essentially no change from the two week measurement.
“After seeing firsthand the impressive results of the ZERONA non-invasive body sculpting device on patients’ waist, hips and thighs, we thought it was important to assess the efficacy of the low-level laser on the upper arms,” said Mark S. Nestor, MD, PhD, Director of the Center for Clinical and Cosmetic Research and Center for Cosmetic Enhancement. “The upper arms are unique in that no other confounding factors, such as diet and exercise, can affect the circumference over a relatively short period of time. The results of the study indicate that low-level laser therapy (ZERONA) is effective in reducing upper arm circumference and providing long-lasting results with high patient satisfaction without any pain or side effects.”
ZERONA AD uses the same proven non-invasive body sculpting laser technology as ZERONA, which was FDA-cleared in 2010 to effectively and safely remove fat from multiple areas of the body. They are the only devices cleared for non-temporary, circumferential reduction of fat from the waist, hips, thighs, and now, the upper arms. ZERONA AD can be used in conjunction with the ZERONA body treatment for a targeted sculpting effect.
ZERONA uses a patented LLLT (635nm) and rotating line-generating coherent beam that has been scientifically and clinically proven to target fat cells, causing their immediate collapse and liberating the lipid material (i.e., the fat) from the cell, thereby significantly reducing body volume. Unlike other technologies, ZERONA returns the body’s fat cells to a smaller size, but does not kill or remove fat cells. Through a natural process, the laser‐released fat is safely removed and broken down by the lymphatic system, providing patients with a truly non-invasive procedure with no pain, side effects or recovery time.
ZERONA AD is manufactured by Erchonia Corporation, the world’s leading manufacturer of low-level laser therapy (LLLT) devices. It is expected to be widely available by late summer. For more information, visit http://www.primcogent.com.
ZERONA is a registered trademark of Erchonia Corporation.
About Primcogent Solutions
Primcogent Solutions is dedicated to offering healthcare products to the medical community backed by a clear, logical, and convincing scientific and clinical foundation. Primcogent Solutions’ signature product, ZERONA, manufactured by Erchonia Medical is the only non-invasive platform that is FDA cleared for the safe and effective simultaneous reduction of fat from the hips, waist, thighs and upper arms. Primcogent Solutions’ revolutionary non-invasive body contouring technology, along with its unique physician business model, enhances practice profitability and eliminates the risks associated with purchasing capital equipment. For more information, visit http://www.primcogent.com.
About Erchonia Corporation
Erchonia is the global leader in low-level laser healthcare applications. Over the last 15 years Erchonia has been conducting research and development with the world’s leading physicians to advance the science of low-level lasers. Prior to market introduction, all Erchonia lasers are proven to be safe and effective through independent clinical trials. Currently thousands of Erchonia lasers are used daily for body contouring, treatment of neck and shoulder pain, acne, and post-operative pain in breast augmentation. For additional information, visit http://www.erchonia.com.