Sofwave Medical Receives 510(k) Marketing Clearance For Pure Impact™

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
S. commercial launch expected in the near term

San Clemente, california, january 3, 2023/ globenewswire/ – 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.

Louis Scafuri, Sofwave’s Chief Executive Officer

“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. 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.”

About Pure Impact™ utilizing PlyoPulse™ EMS Technology:

Clinicians

Pure Impact™ is a unique muscle toning and firming system designed to stimulate multiple muscle groups and body areas simultaneously.
Our PlyoPulse™ technology encapsulates the efficacy of controlled muscle stimulation, all within a concise 30-minute treatment. No electrode rearrangement is required, no delays in treatment time – for greater patient turnover and expedited ROI.
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 treatment protocols to engage diverse muscle groups without the need to manually rearrange electrodes, thus avoiding treatment interruption.
The modular add-on redefines toning with up to 16 synchronized electrodes is designed to achieve effective stimulation of large muscle groups. The device achieves unparalleled muscle strengthening and toning for patients quickly.

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 conjunction with the SUPERB™ system or as a stand-alone treatment that provides the same standard of precise energy delivery and degree of efficacy, safety, treatment comfort and results that the entire Sofwave product portfolio provides.

This new FDA clearance for the Pure Impact module is added to the recently received clearance for using the Company’s SUPERB™ technology for the improvement of skin laxity on upper arms, and its clearance for the improvement in the appearance of cellulite, creating a wide range of off-face applications serving the growing patient demand for non-invasive body treatments and provides additional business opportunities for the Company’s existing and future customers.

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, the short-term improvement in the appearance of cellulite, improvement of skin laxity on upper arms and treatment of acne scars, providing physicians with smart yet simple, effective, and safe aesthetic solutions for their patients. Contact: [email protected]

Investor Contact:

Brian Ritchie

LifeSci Advisors LLC

(212) 915-2578

[email protected]