- Approval granted by Mexico’s Food and Drug Administration, the Federal Commission for the Protection from Sanitary Risks (COFEPRIS), a division of Mexico’s Ministry of Health
San Clemente, California, January 23, 2023/ globenewswire/ – Sofwave Medical Ltd (“the Company”) (TASE: SOFW), an emerging leader in energy-based non-invasive, aesthetic medical devices, today announced market approval for Sofwave’s™ SUPERB Technology in Mexico. Approval was granted by Mexico’s Food and Drug Administration, the Federal Commission for the Protection from Sanitary Risks (COFEPRIS), a division of the Mexico’s Ministry of Health.
Mexico Aesthetic Medical Device Market Drivers1,2,
- The medical aesthetic device market is expected to have a CAGR of over 8% from 2021-2026
- Medical tourism remains popular in Mexico, the second largest aesthetic medical market in Latin America
- Aesthetic medical device procedures broadly available through hospitals, dermatology clinics and other non-hospital settings
- Demand for youthful appearance rises as minimally invasive and non-invasive aesthetic medical treatments rise in popularity driving growth of the market, ranked 6th in total number of non-surgical skin tightening procedures performed across the globe
Louis Scafuri, Sofwave’s Chief Executive Officer“Gaining market approval for Sofwave TM from Mexican regulators is yet another important milestone attributed to Sofwave’s commercial expansion strategy”.
“The tailwinds associated with Mexico’s growing aesthetic medical device market which is growing at more than 8% annually is expected to benefit our anticipated brand launch. Additionally, as we have done in other markets we look forward to replicating our positive results; demonstrating the superior results, safety and return on investment of the Sofwave device platform to both physicians and medi-spa owners alike.”
The Company has regulatory submissions pending in other large markets including the People’s Republic of China and Japan. Additionally, Sofwave has also recently received U.S. Food and Drug Administration clearance to expand SUPERB’s treatment indications to be used for the short-term improvement in the appearance of cellulite.
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 improved 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 approach to wrinkle, lifting and cellulite treatment using 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 and the short term improvement in the appearance of cellulite providing physicians with smart yet simple, effective, and safe aesthetic solutions for their patients Contact: [email protected]
LifeSci Advisors LLC
- Technavio, Aesthetic Devices Market in Mexico by Device and End-user – Forecast and Analysis 2022-2026, Link.
- International Society of Aesthetic Plastic Surgery (ISAPS), ISAPS International Survey on Aesthetic Surgery Procedures (2021 survey), Link.
Sofwave™ destributor in Mexico:
Founded in 1989, its founder formed the company in order to offer its customers the best products and the highest technology, as well as the best service, Arfamex with its 32 years of experience in the Area of Dermatology, Plastic and Aesthetic Surgery As well as in Ophthalmology, it has always sought to represent the leading companies in the market which can offer us products of the highest quality, but at the same time with great profitability that adapt to the Mexican market.
Contact: [email protected]