Sofwave Medical Receives Marketing Clearance in Canada for Pure Impact™ Strength and Muscle Toning Device

– Approval by Health Canada regulatory authority immediately clears the way for Pure Impact™ with PlyoPulse™ device launch and commercialization in Canada

– Canada Represents Another Substantial Market Opportunity for Sofwave’s Pure Impact™

SAN CLEMENTE, Calif., June 11, 2024 (GLOBE NEWSWIRE) — Sofwave Medical Ltd (“the Company”) (TASE: SOFW), an emerging leader in energy-based non-invasive, aesthetic medical devices for practitioners worldwide, today announced marketing clearance from Health Canada to commercialize Pure Impact™ utilizing PlyoPulse™ EMS (“Electric Muscle Stimulation”) technology in that region. Pure Impact™ with PlyoPulse™ technology, which is currently also approved and marketed in the U.S., was purposefully designed as a modular add-on component to the SUPERB™ system.

“The latest regulatory approval from Health Canada allows the Company to immediately initiate Sofwave’s second Pure Impact™ launch in North America. Pure Impact™ with PlyoPulse™ technology is the result of years of research and development and was developed in response to consumers’ growing demand for a cost-effective, non-invasive muscle toning treatment alternative to conventional plastic surgery,” noted Louis Scafuri, CEO of Sofwave Medical. “The U.S. Pure Impact™ product launch has been a major milestone this year for Sofwave, and we continue to seek additional approvals in other key markets for this highly innovative product. We are delighted to have this opportunity to offer a growing base of enthusiastic Canadian Sofwave practitioners an exciting, full body muscle toning solution and SUPERB™ product line extension, which we expect will further contribute to our growing base of recurring utilization revenues.”

About Pure Impact™ utilizing PlyoPulse™ EMS Technology:
Providers

• Pure Impact™ is a first-of-its-kind plyometric muscle toning and firming system designed to stimulate multiple muscle groups and body areas simultaneously.
• Our PlyoPulse™ technology encapsulates the efficacy of plyometric exercises, all within a concise 30-minute treatment. No electrode rearrangement is required, no delays in treatment time – for greater patient turnover and expedited ROI.
• The modular add-on redefines toning with up to 16 synchronized electrodes designed to emulate plyometric exercises. The device achieves unparalleled muscle strengthening and toning for patients quickly.

Clinicians

• Advanced next generation wireless connectivity untangles and uncomplicates clinicians’ ability to provide a superior treatment across multiple muscle groups without the need for gels, liquids, or belts.
• Easy digital programming allows different exercise protocols to engage diverse muscle groups without the need to manually rearrange electrodes, thus avoiding treatment interruption.

Patients

• Designed to simultaneously stimulate diverse muscle groups and body areas, Pure Impact ™ goal is to efficiently achieve intense muscle strengthening and toning all in one session.
• As a modular Sofwave platform product, the Pure Impact treatment can be used in combination with the SUPERB™ system or as a stand-alone treatment that provides the same standard of precise energy delivery and degree of efficacy, unparalleled safety, treatment comfort and results that the entire Sofwave product portfolio provides.

According to McKinsey & Company’s latest medical aesthetic report the Canadian market in combination with the United States collectively hold an “outsized” share of the medical aesthetics market which rebounded immediately after COVID-19 and remains underpenetrated.

About Sofwave Medical
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) and neck tissue and the short-term improvement in the appearance of cellulite 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