Approval to Market Sofwave™ in South Korea

Key Regulatory Milestone in Company’s International Growth Strategy for Unrivaled Ultrasound Technology Treating Fine Lines and Wrinkles

YOQNEAM, IsraelAug. 30, 2021 /PRNewswire/ — Sofwave Medical LTD, today announced it has received approval from the Korean Ministry of Foods and Drug Safety (MFDS) to market Sofwave its proprietary next-generation Synchronous Ultrasound Parallel Beam technology SUPERB for reducing the appearance of fine lines and wrinkles while also revitalizing the skin.

“MFDS approval of Sofwave is another major step in our international product growth strategy for this novel non-invasive wrinkle reduction ultrasound treatment,” said Sofwave’s Chief Executive Officer Louis Scafuri.* “As one of the world’s fastest-growing medical aesthetic regions, the Asia Pacific market is an important one for Sofwave. Furthermore, recent industry estimates suggest the Korean medical aesthetics market size was valued at over USD 1.6 billion in 2019 and is anticipated to grow at a compound annual growth rate (CAGR) of 13.3% from 2020 to 2027. The market is majorly driven by the increasing adoption of minimally invasive and non-invasive procedures.”

Chief Medical Officer at Sofwave Dr. Ruthie Amir, stated, “Sofwave has developed a technology that is at the fore-front of some of the latest research and newest energy-based applications brought to market. With our innovative SUPERB technology rapidly gaining in popularity and accessibility around the world, we are confident that Sofwave will be well received in South Korea as it has been elsewhere, where physicians report a very safe and effective treatment for men and women who are looking for an anti-aging treatment that does not require surgery or needles.”

“Our goal is to continue to enhance our presence in high-growth regions by capitalizing on our outstanding brand reputation, broad distribution and strong customer relationships. Sofwave is playing an integral role in driving the growth of the global aesthetic market with novel pioneering solutions,” said Sofwave Chairman Dr. Shimon Eckhouse.

Sofwave’s state-of-the-art Synchronous Ultrasound Parallel Beam technology SUPERB addresses the growing demand for non-invasive treatments that deliver noticeable wrinkle reduction. The device’s seven cooled transducers are directly coupled to the epidermis, creating a unique 3D array of volumetric thermal zones that deliver parallel energy simultaneously, heating precisely at the right depth in the mid-dermis to improve the overall appearance. A single Sofwave treatment reduces facial wrinkles in a fast 30 to 45minute non-invasive treatment with no interruption to a patient’s daily routine or post-treatment discomfort.