In order to support the request submitted to the FDA for approval to improve the appearance of cellulite, the company conducted a multi-center clinical trial, at 4 research sites in the USA on 68 female patients, which evaluated the safety and effectiveness of the Sofwave TM device for aesthetic, dermatological and non-invasive improvement in the appearance of cellulite The approval the company has now received for improving the appearance of cellulite is added to the FDA approval given to the company for non-invasive treatment to improve face and neck wrinkles, as well as the FDA approval for non-invasive treatment to lift the eyebrows and lift loose tissues under the chin. All this, using the unique SUPERB technology of the company.
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Sofwave believes that receiving the approval to improve the appearance of cellulite, as well as the findings of the clinical trial, are disciplinary for the company and significantly expand the company’s business potential. Last month, Sofwave updated that it received marketing approval for the SUPERB device in Brazil, which is the second largest market in the world, after the US, for non-invasive aesthetic procedures. In August, Sofwave updated that it signed a strategic cooperation agreement with the HTDK Group, a large Chinese company in the field The medical solutions, in which HTDK and Sofwave will work to obtain NMPA approval (the Chinese equivalent of FDA approval) for the sale and distribution of Sofwave products in the Chinese market, which is considered one of the medical aesthetics markets, enjoying one of the highest growth rates in the world, and is estimated at approximately 29 billion dollars per year.