Sofwave’s SUPERB™ Non-Invasive Skin Treatment Technology Receives Regulatory Clearance in Japan Significantly Expanding its Coverage of the APAC Region

Japan represents third largest non-surgical medical aesthetic market in the world

SAN CLEMENTE, Calif., April 21, 2025 (GLOBE NEWSWIRE) — Sofwave Medical Ltd (“the Company”) (TASE: SOFW), an emerging leader in energy-based non-invasive, aesthetic medical devices, today announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has granted the Company approval to commercially market Sofwave’s SUPERB™ Technology. Market approval in Japan further extends Sofwave’s sales reach in the APAC territories, which now comprises major regional medical aesthetic device markets, including Japan, Australia, Taiwan, and South Korea.

“We are delighted to broaden Sofwave’s commercial reach to Japan in 2025, which now enables us to sell additional devices across major markets in the APAC region,” said Sofwave’s Chief Executive Officer Louis Scafuri. “Receipt of regulatory approval in Japan, one of the world’s largest medical technology markets, represents a significant growth opportunity to expand both device sales and brand awareness, which are both being driven worldwide by the fast adoption of GLP1-inverse agonist weight loss medications, aging populations and the increasing demand for minimally invasive medical aesthetic procedures. With a strong go-to-market strategy, including a growing distribution network, dedicated in-house sales, marketing, and field force teams, as well as increasing consumer awareness supported by traditional, digital, and social media marketing campaigns, we look forward to continuing to expand Sofwave’s commercial footprint.”

According to the International Society of Aesthetic Plastic Surgery’s (ISAPS) most recent global surveys, conducted in 2023 and 2024, Japan represented the third largest non-surgical medical aesthetic procedures market worldwide in 2022 and had the third highest number of plastic surgeons of all ranked countries worldwide in 2023.

About Sofwave Medical Ltd.
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), to improve the appearance of skin laxity on the upper 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 4^th generation 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: Info@sofwave.com

Investor Contact:
Brian Ritchie
LifeSci Advisors LLC
(212) 915-2578
britchie@lifesciadvisors.com

Source:
https://www.isaps.org/media/rxnfqibn/isaps-global-survey_2023.pdf
https://www.isaps.org/media/a0qfm4h3/isaps-global-survey_2022.pdf