Tuesday, December 20, 2022
Sofwave Medical Ltd, an emerging leader in energy-based non-invasive, aesthetic medical devices announced the U.S. Food and Drug Administration’s (FDA) clearance of Sofwave’s SUPERB™ technology to be used for the short-term improvement in the appearance of cellulite.
Dr. Shimon Eckhouse, Chairman & Co-Founder commented on the occasion, “We are pleased to receive FDA clearance to use the Company's proprietary SUPERB™ technology to improve the appearance of cellulite in the short term. Non-invasive treatment of cellulite is one of the most desired body treatments in medical aesthetics because of the high prevalence of cellulite in women of all ages and the lack of effective and safe solutions with no patient down-time. Sofwave has shown once again that its investment in the development of the SUPERB™ technology to treat highly prevalent aesthetic indications bears significant fruit and will support the continued rapid growth of the Company. Our disruptive SUPERB™ technology was designed to be efficient and easy to use, and the Company invests and plans to continue investing in bringing innovative solutions to the growing aesthetic technology market generating great ROI to our physician customers.”
In the clinical trials submitted to the FDA as part of the 510(k) application in support of the cellulite FDA clearance, the Company conducted a multi-site clinical study that evaluated the safety and effectiveness of the device for the non-invasive dermatological aesthetic improvement in cellulite appearance. A total of 68 women were treated at 4 sites in the United States. Eligible patients received 2 treatments (2-4 weeks apart) using SUPERB™ technology on one side (right or left) of the lateral / posterior upper thigh or buttocks. Serial clinical photographs were collected under standardized conditions before treatment (baseline) and at the 3-month follow-up visits. Photographs were assessed by blinded independent reviewers to identify pre-treatment images when compared to post treatment images and to grade the pre-treatment and post-treatment images using the Cellulite Severity Scale (CSS). Improvement was also evaluated using the Global Aesthetic Improvement Scale (GAIS) and Laxity Scale (LS). Safety assessments included evaluation of adverse events via physician examination during and after the treatment.
Post-study, the blinded reviewers correctly identified the post treatment images for 89% of the subjects. No serious or unanticipated adverse event was reported during the study.
“The FDA's clearance of SUPERB™ for use in cellulite could not have come at a timelier moment,” said Lou Scafuri, Sofwave's CEO. “Our dedicated U.S. direct sales force is positioned to expand our growing presence and market share of the aesthetic medical device market in the U.S. In addition, our recent regulatory clearance in Brazil further extends our global footprint, letting us immediately launch sales in this important and sizeable market. Furthermore, our partnership in China with HTDK, one of Asia's strongest healthcare solutions providers, covers our expansion in that territory. Our focused commitment across these major markets, will go a long way towards further accelerating global sales and brand-recognition of our devices in the upcoming new year.”
In 2021, the FDA cleared additional indications for SUPERB™ technology, for lifting the eyebrow and lifting lax submental tissue (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental neck regions. In addition, the Sofwave SUPERB™ technology is also cleared by the U.S. FDA for a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles.
