Sofwave Medical Receives 510(k) Marketing Clearance for Pure Impact Strength and Muscle Toning Body Module Utilizing PlyoPulse EMS Technology

• Pure Impact with PlyoPulse technology is a direct add-on Body module to the existing FDA cleared Sofwave medical aesthetic device platform
• The PlyoPulse technology is an EMS (Electrical Muscle Stimulation) technology to deliver toning and strengthening simultaneously across diverse muscle groups in one treatment session
• Adding Pure Impact to Sofwave’s medical aesthetic device capabilities allows practitioners to expand revenue opportunities beyond existing in-clinic suite of client services utilizing modular add-on technology to the SUPERB ultrasound platform
• U.S. commercial launch expected in the near term

SAN CLEMENTE, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Sofwave Medical Ltd (“the Company”) (TASE: SOFW), an emerging leader in energy-based non-invasive, aesthetic medical devices for practitioners worldwide, announced clearance by the U.S. Food and Drug Administration (FDA) for the Company’s 510(k) premarket notification submission to market Pure Impact utilizing PlyoPulse EMS (“electromagnetic stimulation”) technology in the United States. The approval clears a pathway for Sofwave to expand medical aesthetic treatment beyond the Company’s existing SUPERB platform for eyebrow and submental neck lifting, treatment of fine lines and wrinkles, treatment of cellulite, and treatment of skin laxity to now allow practitioners to include body toning and strength conditioning across diverse muscle groups in one treatment session.

“We continue to deliver on our promise of innovation within the medical aesthetic device space. The 510(k) clearance of Pure Impact allows Sofwave to bring to market a unique EMS device that can deliver muscle toning and strength conditioning simultaneously across diverse muscle groups in one treatment session,” noted, Louis Scafuri, CEO of Sofwave Medical. “Pure Impact with PlyoPulse technology is a modular add-on to Sofwave’s existing industry-leading medical device platform, allowing practitioners to immediately expand their spa or clinics’ suite of services. Moreover, this is a timely addition to our product line as the success and popularity of a new class of GLP-1 drugs in the marketplace intended for weight-loss continues to shape the needs and demands of the aesthetics industry. We are delighted to begin the initial commercial launch of Pure Impact in the United States in the near term, while working to bring this product to other geographies as expeditiously as possible.”