Yoqneam, Israel - Sofwave Medical Ltd., an emerging aesthetic device company, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Sofwave system. The Sofwave device is indicated for use as a non-invasive aesthetic treatment to improve facial lines and wrinkles.
The 510(k) clearance was supported by a blinded study of 59 subjects, demonstrating the safety and performance of the Sofwave System for non-invasive treatment to improve facial lines and wrinkles. The trial was led by Principal Investigators Dr. Roy Geronemus, New York and Dr. Arielle Kauvar, New York.
According to investigators' evaluation, 86% of the subjects demonstrated improvement in wrinkle appearance of at least one Elastosis Score (-1ES), while the blinded reviewers identified correctly the pre- and post-treatment photographs for 78% of the treated subjects.
Dr. Roy Geronemus stated, "The Sofwave technology represents the next-generation in aesthetic devices and is exactly what my patients are looking for - non-invasive, minimal downtime, and with favorable results. The Sofwave device has great potential to fill this void".
Dr. Kauvar added, "Our patients were surprised they could achieve such obvious results after only one treatment. The Sofwave procedure is tolerated very well and it appears that the treatment depth is ideal for improving aging skin".
Dr. Shimon Eckhouse, Sofwave Medical's Chairman of the Board, stated, "Our patented, low-divergence fractional ultrasound technology is a simple solution based on sophisticated science with proven efficacy to treat facial lines and wrinkles. He added, "I am excited to once again bring innovative aesthetic devices to the market."
Louis Scafuri, Sofwave Medical's CEO said, "Receiving FDA clearance for the Sofwave technology is an important milestone for the company as it opens our product to the large market in the United States. Our breakthrough non-invasive ultrasound technology targets a growing customer base of patients who are looking to reduce their wrinkles and facial lines, but did not wish to consider surgery. We believe that our device addresses this demand across broad demographics"
Following FDA clearance, the company will launch marketing and sales activities in the United States. For this purpose, the company has already established an office in the US, which will be the base for all sales, marketing, clinical and customer support activities for the US market.