Sofwave Receives FDA Clearance for Pure Impact in US Gun Strengthening and Reinforcement

• The latest Pure Impact indication extension includes strengthening and improving muscle tone and firmness of the arms
• Represents the next major step towards Pure Impact, treating multiple body parts and muscles
• Complements Sofwave’s current SUPERB claim to improve the appearance of sagging upper arm skin and provides a complete approach to arm treatments
• The launch of Pure Impact Arms is supported by the “Softwave Endless Summer” marketing campaign

SAN CLEMENTE, Calif., Aug. 12, 2024 (GLOBE NEWSWIRE) — Sofwave Medical Ltd. (“the Company”) (TASE: SOFW), an emerging leader in energy-based non-invasive aesthetic medical devices, today announced that the Company has received 510(k) premarket notification clearance from the U.S. Food and Drug Administration (FDA) to expand the use of Pure Impact in strengthening, improving muscle tone and sculpting arm firmness.

“Pure Impact remains the world’s first plyometric muscle activation device that mimics a variety of complex and compound full-body muscle movements,” said Louis Scafuri, CEO of Sofwave Medical. “The addition of Pure Impact plyometrics for the arms allows for the simulation of complex cardio-muscular high-intensity interval training exercises for the upper body, such as burpees and star jumps. Importantly, we believe that Sofwave plus Pure Impact provides an improvement in physical appearance when combined with diet and exercise regimens. As patients age or lose weight, Pure Impact Arms contributes to increased muscle tone and reduced overall laxity in the arms. The most recent FDA clearance of Pure Impact for strength and toning of the arms is the next major step in achieving total muscle activation by harnessing the power of our PlyoPulse electrical muscle stimulation technology.”