Sofwave receives CE Medical Mark and additional key Regulatory Clearances for its Revolutionary Skin Tightening and Wrinkle Reduction Device
YOQNEAM, Israel, Nov. 16, 2020 /PRNewswire/ -- Sofwave Medical, the emerging leader of energy-based non-invasive aesthetic medical devices, announced today that it has secured CE Mark (Conformité Européenne) for its next-generation Sofwave system which was approved for use for the treatment of fine lines and wrinkles in the EU.
Sofwave's state-of-the-art Synchronous Ultrasound Parallel Beam technology SUPERBTM addresses the growing demand for non-invasive treatments that deliver improvement in skin laxity which results noticeable wrinkle reduction. The device's 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. A single Sofwave treatment improves skin laxity by reducing facial and neck wrinkles in a fast 30 to 45minute non-invasive treatment without any downtime or post-treatment discomfort.
In addition to the CE Mark, the Company also received regulatory approval from the Medical Device Division of the Israeli Ministry of Health (AMAR). This clearance will allow the Company to launch its commercialization efforts in Israel and has placed its first unit with Professor Eyal Gur, M.D., Director of the Department of Reconstructive and Aesthetic Surgery at the Tel Aviv Sourasky Medical Center.
According to Dr. Gur, the device meets an unmet need among patients looking for a non-invasive, fast procedure that addresses the face and neck aging. "The Sofwave treatment has shorter treatment sessions and the results I've observed are pretty impressive. I truly believe that we are introducing something that is effective for people that want to rejuvenate the skin," he said.
Dr. Gur further observes, "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. 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 Louis Scafuri Chief Executive Officer. 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. Our strategy is to expand our commercial footprint outside the U.S. by securing the requisite product registrations for our Sofwave system and identifying strong distribution partners in each respective market. We recently shipped an initial commercial order to several distributors are anticipating additional orders Q4 2020."
ABOUT PROF. EYAL GUR AND THE CLINIC FOR ESTHETIC PLASTIC SURGERY
Prof. Gur is the Director of the Department of Reconstructive and Aesthetic Surgery at the Tel Aviv Sourasky Medical Center, the largest and most advanced plastic surgery department in Israel. In conjunction and parallel to that role, Prof. Gur runs a private aesthetic plastic surgery practice in Ramat Hachayal, Tel Aviv. This boutique clinic provides both surgical and non-surgical solutions, including injectables and facial and body rejuvenation via a variety of energy-based technologies and cosmetics. Prof. Gur was educated at Tel-Aviv University, Sackler Medical School in Israel, specializing in plastic surgery in the Tel Aviv Medical Center and microsurgery and pediatric plastic surgery.
ABOUT SOFWAVE MEDICAL LTD.
Sofwave Medical Ltd. has implemented an innovative approach to wrinkle reduction using proprietary breakthrough technology. Synchronous Ultrasound Parallel Beam technology is FDA-cleared to improve facial lines and wrinkles, providing physicians with smart yet simple, effective and safe aesthetic solutions for their patients. In addition, the device has been approved by the Medical Device Division of the Israeli Ministry of Health (AMAR).
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