Sofwave Medical Ltd. 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. 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 stringentity 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 review 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 facial, 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.