Anti-aging skin treatment receives Health Ministry, FDA, CE approval
With the approval by the Medical Equipment Division of the Health Ministry, the technology has received the go ahead from both the CE certification board as well as the US FDA.
By JERUSALEM POST STAFFSofwave SUPERBTM solution(photo credit: SOFWAVE)
Israeli start-up Sofwave has received Health Ministry approval for its Synchronous Ultrasound Parallel Beam technology Super BTM solution.The ultrasound technology is meant to improve on existing non-evasive ultrasound treatments that could be deemed as anti-aging solutions, primarily removing wrinkles and firming up skin on the face and neck - and can garner results within a single treatment."Sofwave seven-cooled transducers are directly coupled to the epidermis, creating a unique 3D array of volumetric thermal zones that deliver continuous parallel energy simultaneously, resulting in significant collagen remodeling in the mid-dermis," Sofwave explained in a statement. "A single Sofwave treatment improves skin laxity by reducing facial and neck wrinkles in a fast 30 to 45 minute non-invasive treatment without any downtime or post-treatment discomfort."This technology effectively treats the dermis without damaging the epidermis by focusing all its energy about 1.5 mm below the surface of the skin (a depth that has been shown in previous studies to be a very effective area for improving skin texture and firming)," the statement said. "Technologies that have been used until now damage the epidermal layer and can create hyper-pigmentation and scars."With the approval by the Medical Equipment Division of the Health Ministry, the technology has received the go ahead from both the CE certification board as well as the US FDA.Prof. Eyal Gur, director of The Division of Reconstructive and Aesthetic Surgery at Ichilov Medical Center, claims that Sofwave's technology is "the cutting edge of treatments for firming and rejuvenating skin on the face and neck," adding that "the results of the treatment are among the most effective, safe and groundbreaking seen to date in a specific area following a fall, or when there are double chin effects or a need for a targeted treatment of the neck and other such conditions."Because of my commitment to excellence, I am a strong believer in advanced technologies – and I am convinced that Super BTM technology is going to lead the market in the years ahead," he added. "It is valuable as a single stand-alone treatment that yields exceptional results, an alternative for those who advocate a pro-aging approach or a supportive addition to the integrated protocol approach used in my clinic."Through clinical trials, research ascertains that 87% of people who underwent the treatment saw "significant improvement" within three months. Even those with dark skin, who have troubles with non-invasive skin surgeries and a tendency to develop hyper-pigmentation, saw success during the trials."We are pleased to play on the home field by adding the Israeli market to the company's prestigious portfolio," said CEO of Sofwave Louis Scafuri. "The field of aesthetics in Israel has grown in recent years and there is a growing awareness and interest in it, along with the availability of a wide variety of proactive aesthetic procedures for men and women alike."Thanks to the simplicity and convenience of the technology, it is easy to incorporate into any clinic, so we anticipate that by the end of 2021, we will significantly increase our domestic market presence and match its popularity in North America, Europe, Asia and Africa," he said.
"We believe that this development, which began in the Alon Medtech Ventures incubator, will be a game changer in the industry, thanks to the innovative and unique results it achieves after just one treatment, whether it be for corrective or preventive reasons," said Sofwave's Clinical Director and Regulator, Dr. Ruthie Amir.“At the same time, we are working hard to expand the technology and adapt it to body treatments designed for the arms, buttocks and knees – so there is no doubt regarding its future growth.”
