Sofwave Medical Ltd, an emerging pioneer in energy-based non-invasive, cosmetic medical devices, announced the FDA’s approval of Sofwave’s SUPERBTM technology 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 downtime. 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 for our physician customers.”
The Company conducted a multi-site clinical study that evaluated the device’s safety and effectiveness for non-invasive dermatological aesthetic improvement in cellulite appearance in the clinical trials submitted to the FDA as part of the 510(k) application in support of the cellulite FDA clearance. A total of 68 women were treated at four different locations in the United States. Eligible patients underwent two SUPERBTM treatments (2-4 weeks apart) on one side (right or left) of the lateral/posterior upper thigh or buttocks. Before therapy (baseline) and during the 3-month follow-up visits, serial clinical photos were taken under standardized settings. Blinded independent reviewers evaluated the photographs to identify pre-treatment photos when compared to post-treatment images and to rate the pre-treatment and post-treatment images using the Cellulite Severity Scale (CSS). The Global Aesthetic Improvement Scale (GAIS) and the Laxity Scale were also used to assess improvement (LS). Adverse occurrences were evaluated for safety during and after therapy by physician examination.
Blinded reviewers accurately recognized the post-treatment photos for 89% of the individuals after the research. During the research, no major or unexpected adverse events were recorded.
“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.”
The FDA approved new indications for SUPERBTM technology in 2021, including raising the brow and lifting lax submental tissue (below the chin) and neck tissue, which can also change the look of lax tissue in the submental neck areas. Furthermore, the Sofwave SUPERBTM technology has been certified by the US Food and Drug Administration as a non-invasive dermatological cosmetic therapy to address facial lines and wrinkles.
Source: Sofwave Medical. Ltd.