Sofwave Medical Ltd, which develops energy-based non-invasive, aesthetic medical devices for practitioners worldwide, recently received clearance by the U.S. Food and Drug Administration (FDA) for the Company’s 510(k) premarket notification submission for the improvement of the appearance of skin laxity on the upper arms, expanding Sofwave use to additional treatment indications.
Louis Scafuri, Sofwave’s CEO, said, “We are pleased to receive FDA clearance for improvement of the appearance of skin laxity on the upper arms in the U.S. supported by compelling clinical study results. Lax skin on the upper arms is a prevalent issue that can impact individuals not only from a physical appearance aspect but also emotionally. Whether the presence of sagging or loose skin on their upper arms is a result of aging, weight loss, genetics, or a combination of factors, the results of our upper arm laxity study provide a clear, objective clinical data set and patient outcomes further advancing our progress to become the leading provider of choice in the growing non-invasive medical aesthetic industry. We look forward to continuing to expand the use of our innovative technology to other aesthetic treatment applications throughout the body.
According to the American Society of Plastic Surgeons, 2022 Procedural Statistics Release, 2019-2022, brachioplasty (surgical arm lift) procedures grew 25%. According to the Sofwave, its SUPERB platform introduces a viable FDA-cleared, non-invasive alternative to improve the appearance of skin laxity on the upper arms without the associated risks and recovery time of conventional surgery, laser-based body contouring, and other minimally invasive procedures.
The study leading to FDA clearance of premarket notification submission included a total of 46 subjects who were enrolled and treated on both upper arms at four sites in the United States. Subjects attended two treatment sessions (1-3 weeks apart) and a follow-up visit 3 months after the final treatment visit. Of the treated arms, 93% were “improved” or “very much improved” in appearance, as rated by the blinded reviewers using the Global Aesthetic Improvement Scale. Most subjects reported none to mild levels of pain during treatment and no discomfort afterward.
In the United States, Sofwave’s technology is currently cleared for use as a non-invasive aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck regions for subjects aged 22 and older. The Sofwave system is also cleared for short-term improvement in the appearance of cellulite and for the treatment of acne scars.
