FDA clearance to market the UltraShape System

Approval positions Syneron with disruptive product offering in fast growing body contouring and fat treatment market.

April 17, 2014
Manufacturing Group
Contract Manufacturing Design/Engineering Devices/Implants/Equipment Industry/Regulations People/Facilities

Irvine, California – Syneron Medical Ltd., a global market leader in the aesthetic medical device marketplace, has received the United States Food and Drug Administration (FDA) 510(k) clearance to market the UltraShape System for non-invasive reduction of abdominal circumference via fat cell destruction.

The UltraShape System is the first and only non-invasive body shaping treatment that uses pulsed focused ultrasound energy that precisely targets subcutaneous fat, while keeping the surrounding tissue, vasculature, nerves, and muscles intact. Unlike other body shaping technologies, UltraShape uses a pure mechanical effect to destroy fat cells without inducing thermal damage. This unique feature of the UltraShape technology results in a safe and comfortable treatment experience.

"The UltraShape technology is one of the two pillars of our body shaping strategy," stated Shimon Eckhouse, PhD., active chairman of the board of directors of Syneron. "Our significant investment in the development of non-invasive body shaping products puts us in a unique position to lead the market with UltraShape mechanical fat destruction technology, and with our unique VelaShape III el s based thermal technology. With these two FDA cleared technologies we have a wide range of body shaping indications including circumferential reduction in various body areas and reduction in cellulite appearance. These two complementary technologies will be key factors for serving our global customer base in the fast growing body shaping market." Dr. Eckhouse concluded: "Our investment in the UltraShape technology of over two years resulted in a clear demonstration of the unique clinical value of this technology for safe and comfortable non-invasive fat destruction."

"The unique set of features of this technology and the high level of consumer interest in non-invasive body shaping based on direct fat destruction, create a very important opportunity for Syneron to significantly enhance not only its capital equipment sales but also the recurring revenue part of its business," stated Amit Meridor, Syneron's CEO. "We plan to limit the highly anticipated initial launch of UltraShape in the US in 2014 to a select list of key opinion leaders in aesthetic medicine. This initial launch phase will enable us to fully develop our recurring revenue part of the business, which we plan to combine with account managers that will support the business needs of our customers. In parallel to the U.S. effort, we plan to gradually implement similar models in international markets, in which the lack of FDA clearance of the technology was a drawback to its growth. We expect to see the full impact of this effort in 2015," concluded Meridor.

"UltraShape is a nonsurgical device that precisely delivers focused ultrasound energy strong enough to destroy fat cells while leaving neighboring tissue unharmed. The benefit of UltraShape is that each treatment can be customized to the individual patient. UltraShape uses non thermal ultrasound providing efficacy and the non-heat dependent energy is tolerated well by the patients," said Jeffrey M Kenkel, MD, FACS, professor and vice chairman of the Department of Plastic Surgery at the University of Texas Southwestern Medical Center at Dallas, one of the primary investigators in the multi-center IDE study.

In the randomized, controlled clinical study of UltraShape, which was performed at three clinical sites in the U.S. and one site outside of the U.S., a total of 150 subjects were treated and followed for up to four months. In this multi-site study, patients demonstrated an average reduction of 2.5cm in the treatment phase and 0.5cm reduction in the control phase.

"We observed clinically significant circumference reduction of truncal fat. The results demonstrated progressive improvement over time in circumference reduction, beginning after the first treatment session with UltraShape. The treatment was administered without the need for anesthetic and was well tolerated by patients. No serious adverse events were reported," stated William Coleman M.D., clinical professor of dermatology, adjunct professor of surgery (Plastic Surgery), Tulane University Health Sciences Center and a principal investigator in the study. "In our practice, patients were very satisfied with the results of the UltraShape treatment."

The UltraShape System received CE mark in 2005 and is marketed in European countries, Canada, and Asia Pacific countries. The device has been used in over 220,000 procedures worldwide, with a positive safety and effectiveness profile. Syneron acquired UltraShape in March 2012. Since the acquisition, Syneron's main focus has been to gain FDA regulatory clearance for the system in the United States, which opens a significant market opportunity for the product and provides important validation for potential customers around the world.

Source: Syneron Medical Ltd.