Sofwave Receives FDA Clearance for Pure Impact™ in Strengthening and Firming of Arms in the U.S.

• Latest Pure Impact™ indication expansion includes strengthening and improvement in muscle tone and firmness of the arms
• Represents next major step toward Pure Impact™ covering multiple body areas and muscles
• Complements Sofwave’s SUPERB’s current claim to improve the appearance of skin laxity on the upper arm and provides a complete approach to arm treatments
• Launch of Pure Impact™ Arms will be supported by the “Sofwave 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, announced today 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 and improvement in muscle tone and firmness sculpting of the arms.

“Pure Impact™ remains the world’s first plyometric muscle activation device, emulating a variety of complex and compound full-body muscle movements,” noted Louis Scafuri, CEO of Sofwave Medical. “The inclusion of Pure Impact™ plyometrics for the arms enables the emulation of complex upper body cardio-muscular high-intensity interval training workouts, such as burpees and star jumps. Importantly, we believe that Sofwave plus Pure Impact provides an enhancement of physical appearance in conjunction with diet and exercise regimens. As patients age or lose weight, Pure Impact™ Arms contributes to increased tone, and decreased overall arm laxity. Pure Impact’s most recent FDA clearance for strength toning and firmness of the arms is the next major step toward the achievement of total body muscle activation harnessing the power of our PlyoPulse™ electric muscle stimulation technology.”

“It is readily evident that Pure Impact™ was developed by expert physiologists,” said board-certified dermatologist Dr. Jessica Weiser, whose practice resides in New York City. “My patients love the emulation of whole-body plyometric exercises as it not only emphasizes functional core strength and improved posture, but also yields a more sculpted physical appearance in patients through plyometric muscle activation. Pure Impact™ is unlike any previous muscle activation device; we proactively and preventatively integrate treatment into my patients’ wellness journeys. Sofwave plus Pure impact is the ideal treatment for GLP-1 patients to directly counter the risk of muscle loss from inactivity or aging (sarcopenia).“

Pure Impact™ Arms will be supported by the launch of the “Sofwave Endless Summer marketing campaign. Not only can the Sofwave system be used to improve dermal laxity of the arms, but the increased muscle tone achieved with Pure Impact™ module significantly enhances both aesthetic and functional results, making Sofwave plus Pure Impact™ Arms, the ultimate treatment package for anyone looking to improve their look and feel stronger.

About Sofwave Medical

 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), lifting lax skin in the arms, as well as the short-term improvement in the appearance of cellulite and treatment of acne scars. The company’s Pure Impact™ module uses EMS technology and is cleared for muscle toning. Sofwave’s products provide physicians with smart yet simple, effective, and safe aesthetic solutions for their patients. Contact: 

Investor Contact:

Brian Ritchie

LifeSci Advisors LLC

(212) 915-2578