Sofwave Medical has received approval from the US Food and Drug Administration (FDA) for its synchronous ultrasound parallel beam (SUPERB) technology for the short-term improvement in cellulite appearance.
The technology has been designed to address the increasing demand for non-invasive treatments.
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It comprises cooled transducers which are coupled to the epidermis directly. This creates a 3D array of volumetric thermal zones to provide parallel energy simultaneously.
The company stated that a single treatment with the technology is capable of reducing facial wrinkles in 30 to 45 minutes without interruption to a patient’s daily routine.
As part of the 510(k) application, Sofwave Medical has submitted data from clinical trials to support the FDA clearance in cellulite.
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It has also conducted a multi-site clinical study that assessed the device’s safety and effectiveness for the non-invasive dermatological aesthetic improvement in cellulite appearance.
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By GlobalDataIn the study, 68 women were treated at four sites in the US and the eligible participants received two treatments using SUPERB technology on the right or left of the lateral/posterior upper thigh or buttocks.
To evaluate the subjects, serial clinical photographs were taken under standardised conditions prior to treatment as well as at the three-month follow-up visits.
Blinded independent reviewers assessed the photos to spot the pre-treatment images when compared to post-treatment images.
Using the Cellulite Severity Scale (CSS), the reviewers also graded the pre-treatment and post-treatment images.
They correctly identified the post-treatment images in 89% of the participants in the post-study.
Sofwave Medical CEO Lou Scafuri said: “The FDA’s clearance of SUPERB for use in cellulite could not have come at a timelier moment.
“Our dedicated US direct sales force is positioned to expand our growing presence and market share of the aesthetic medical device market in the US.
“In addition, our recent regulatory clearance in Brazil further extends our global footprint, letting us immediately launch sales in this important and sizeable market.”
