Sofwave Medical, a medical aesthetic technology provider, has secured CE Mark for its next generation Sofwave system which was permitted for use in the treatment of wrinkles and fine lines in the EU.
Sofwave’s Synchronous Ultrasound Parallel Beam technology SUPERBTM provides non-invasive treatments that enhance in skin laxity, resulting in wrinkle reduction.
The device’s seven cooled transducers are directly attached to the epidermis, creating a 3D array of volumetric thermal zones that offer continuous parallel energy, leading to collagen remodeling in the mid-dermis.
Without any downtime or post-treatment discomfort, a single Sofwave treatment will improve skin laxity in about 30-45 minutes through non-invasive treatment.
Furthermore, the company also received regulatory approval from the Medical Device Division of the Israeli Ministry of Health (AMAR).
This clearance will help the company in its commercialisation efforts in Israel.
Sofwave Medical has placed its first unit with Professor Eyal Gur, director of the Department of Reconstructive and Aesthetic Surgery at the Tel Aviv Sourasky Medical Center.
Gur said: “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.
“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.”
Sofwave Medical CEO Louis Scafuri said: “We are very pleased to obtain regulatory approvals to market and sell our Sofwave products in Europe and Israel. 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.”
