Sofwave Medical has received CE Mark (Conformité Européenne) for its Sofwave system, which was approved for use for the treatment of fine lines and wrinkles in the EU.
Sofwave's Synchronous Ultrasound Parallel Beam technology (SUPERB) is designed to improve skin laxity and reduce facial and neck wrinkles. The noninvasive treatments take 30 to 45 minutes with no downtime or post-treatment discomfort.
Sofwave also received regulatory approval from the Medical Device Division of the Israeli Ministry of Health (AMAR). With this approval, Sofwave can launch its commercialization efforts in Israel and has placed its first unit with Professor Eyal Gur, MD, director of the department of reconstructive and aesthetic surgery at the Tel Aviv Sourasky Medical Center.
"While some people need to have a surgical procedure, there is a different patient population that does not require surgery, or they fear surgery or are not fit for surgery," said Dr. Gur. "They look good enough but have lots of wrinkles or some skin laxity. After trying lasers and different energy sources to rejuvenate the skin, Sofwave seems to be the answer."
"We are very pleased to obtain regulatory approvals to market and sell our Sofwave products in Europe and Israel," said Sofwave CEO, Louis Scafuri. "I am particularly pleased that Dr. Gur has chosen to offer Sofwave treatments in his world-class center in Tel Aviv. We are focused on pursuing regulatory clearances in international markets as one of our key strategic priorities to enhance Sofwave's long-term growth profile."