Sofwave™ Granted FDA Clearance For Latest Innovation: The

• “Precise” offers the same SUPERB™ technology in a compact applicator head for more comfortable and precise treatment of small curved areas, e.g. B. around the eyes and mouth
• The modular, smaller applicator head and its benefits are a direct add-on feature that requires no modification to current SUPERB™ console systems

SAN CLEMENTE, Calif., March 15, 2023 (GLOBE NEWSWIRE) — Sofwave Medical Ltd (“the Company”) (TASE: SOFW), an emerging leader in energy-based, non-invasive, aesthetic medical devices for physicians worldwide, announced today Received U.S. Food and Drug Administration (FDA) clearance for the company’s 510(k) filing for its “Precise” compact SUPERB™ applicator for improving facial lines and wrinkles, lifting eyebrows and lifting sagging submental (under the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and cervical regions. The “Precise” applicator is also FDA cleared for short-term improvement in the appearance of cellulite.

“Following the recent FDA approval of Sofwave’s SUPERB™ technology for short-term cellulite improvement last December, we are pleased to introduce existing and potential customers to the new ‘Precise’ applicator,” said Louis Scafuri, CEO of Sofwave Medical. “The applicator’s compact transducer array delivers the same safe and effective synchronous parallel-beam ultrasound technology as existing large applicators, but has been engineered with a fused transducer configuration for more precise and convenient delivery of pulses around small, curved areas, such as the eyes and mouth. We expect these enhanced features and applicator configurations to be well received by Sofwave customers and intend to use the new Precise applicator in additional indications in the future.”

Sofwave’s SUPERB™ system consists of two main functional components: 1) the console and 2) the applicator. The console includes the power sources, cooling unit, electrical components, and user interface. The applicator consists of a series of ultrasonic transducers that emit continuous acoustic waves and an active cooling element that is used to cool the area of ​​skin in contact with the applicator’s transducers.

“We continue to add functional yet transformative feature sets to the design of the original SUPERB™ platform,” said Dr. Shimon Eckhouse, Chairman and Co-Founder. “The Precise SUPERB™ enables treatment of hard-to-reach anatomical sites with the ability to precisely target the treatment area and with a superior ergonomic design, while providing the same safe, comfortable and highly effective treatment.”

About Softave Medical
Softwave Medical Ltd. has implemented an innovative approach to wrinkle reduction, lifting and cellulite with proprietary breakthrough technology. SUPERB™ synchronous parallel beam ultrasound technology is an FDA-cleared head to improve facial lines and wrinkles, lift eyebrows, and lift sagging submental (under the chin) and cervical tissues; which can also affect the appearance of sagging tissues in the submental and cervical regions, and to improve the appearance of cellulite in the short-term, providing physicians with smart, yet simple, effective and safe aesthetic solutions for their patients. Contact: [email protected]

Investor contact:
Brian Richie
LifeSci Advisors LLC
(212) 915-2578
[email protected]