Brazil’s Health Regulatory Agency, “Agência Nacional de Vigilância Sanitária” (ANVISA) Grants Sofwave™ Regulatory Approval to Market SUPERB™

San Clemente, California, November 1, 2022/ globenewswire/ – Sofwave Medical Ltd (“the Company”) (TASE: SOFW), an emerging leader in energy-based non-invasive, aesthetic medical devices for practitioners worldwide, today announced that Brazil’s health regulatory agency, ANVISA, the equivalent of the US Food and Drug Administration, has given pre-market approval to market Sofwave’s SUPERB™ Technology in Brazil. Pre-market approval is required prior to the commercialization and marketing of medical devices in Brazil. Permission to distribute Sofwave’s aesthetic devices is immediate, following public notice of the pre-market approval via Brazil’s government newspaper.

Brazil Possesses Favorable Demographics Ahead of SUPERB’s Marketing Launch

  • According to a global survey by the International Society of Plastic Surgery1: Brazil is second only to the US in non-invasive aesthetic procedures worldwide (in 2020, nearly 2 million procedures were performed in Brazil).
  • Roughly 60% of all cosmetic procedures are performed in clinics outside of hospitals1
  • Participants from Brazil are the largest congregation of international registrants attending the American Academy of Dermatology Annual meetings2.

“We are delighted to receive pre-market regulatory approval for SUPERB™. Brazil is strategically important to Sofwave™ and an integral addition to the Company’s global expansion plans,” said Sofwave’s Chief Executive Officer Louis Scafuri. “In light of Brazil’s favorable demographics and positive sentiment towards aesthetic medicine, we anticipate an exciting brand launch as Sofwave™ continues to demonstrate treatment superiority over conventional minimally invasive and non-invasive solutions. We will be able to ramp up plans to distribute our devices in only a short period of time since regulatory approval goes into effect immediately following public notification of SUPERB’s pre-market approval. We expect orders from Brazil to provide a meaningful sales contribution to our growth in the medium to long term.”

The Company continues to have regulatory submissions pending in other countries, including the People’s Republic of China, Japan, Taiwan, and Mexico.

About SUPERB™

Sofwave’s state-of-the-art SUPERB™ (Synchronous Ultrasound Parallel Beam) Technology 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 45-minute non-invasive treatment with no interruption to a patient’s daily routine or post-treatment discomfort.

About Sofwave Medical

Sofwave Medical Ltd. has implemented an innovative wrinkle reduction and lifting approach using proprietary breakthrough technology. 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 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]

Sources:

  • A global survey from the International Society of Aesthetic Plastic Surgery, December 28, 2021, Link.
  • American Academy of Dermatology: Annual Meeting Geographical Report 2014-2019, Link.

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