Sofwave Medical Ltd announced clearance by the U.S. Food and Drug Administration for the Company’s 510 premarket notification submission for the improvement of the appearance of skin laxity on the upper arms and paves the way for Sofwave™ to further expand into additional treatment indications.
- FDA clearance supported by highly compelling clinical study results demonstrating 93% of subjects treated arms were “improved” or “very much improved” in appearance, following treatment utilizing SUPERB™
- The U.S. brachioplasty (surgical arm lift) market grew 25% from 2019-2022, Sofwave’s SUPERB™ technology introduces a noninvasive alternative to improve the appearance of skin laxity on the upper arms without the associated risks and recovery time of conventional surgery and minimally invasive body contouring procedures
SAN CLEMENTE, Calif., Dec. 26, 2023 (GLOBE NEWSWIRE) -- Sofwave Medical Ltd (TASE: SOFW), an emerging leader in energy-based non-invasive, aesthetic medical devices for practitioners worldwide, today announced 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 and paves the way for Sofwave™ to further expand into additional treatment indications.
Mr. Louis Scafuri, Sofwave CEO, commented: “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%. Sofwave’s 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.
Study results and design leading to FDA clearance of premarket notification submission:
- Study Design and Results
- A total of 46 subjects were enrolled and treated on both upper arms at 4 sites in the United States.
- Subjects attended 2 treatment sessions (1-3 weeks apart) and a follow-up visit 3 months after the final treatment visit.
- 93% of treated arms 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 U.S., 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.
About Sofwave Medical Ltd.
Sofwave Medical Ltd. has implemented an innovative approach to wrinkle reduction lifting and cellulite using its proprietary breakthrough technology. SUPERB™, Synchronous Ultrasound Parallel Beam technology is FDA-cleared to improve facial lines and wrinkles, lifting the eyebrow and lifting lax submental tissue (beneath the chin), neck tissue and arm, as well as the short-term improvement in the appearance of cellulite and treatment of acne scars, providing physicians with smart yet simple, effective, and safe aesthetic solutions for their patients.
Contact: Info@sofwave.com
Investor Contact:
Brian Ritchie
LifeSci Advisors LLC
(212) 915-2578
britchie@lifesciadvisors.com
