The US Food and Drug Administration (FDA) has expanded clearance to Sofwave Medical’s technology to improve the appearance of skin laxity on the upper arm.
The synchronous ultrasound parallel beam (SUPERB) technology delivers pulsed energy to collagen located in the deeper skin layers. The heat energy induces a wound-healing response involving neo-collagenisis and neo-elastogenesis – both of which lead to a reduction in fine lines and wrinkles.
The non-invasive technology, applied via 30–45-minute treatment windows, is already FDA-cleared to improve lines and wrinkles on the face and lifting the eyebrow. It is also cleared to lift the lax tissue beneath the chin and on the neck, as well as short-term improvement in cellulite and acne scars.
In a 26 December press release, Israel-based Sofwave said that the FDA based its decision on results from a study that showed 93% of arms treated with the technology showed improvement in skin laxity measured by the Global Aesthetic Improvement Scale. The study enrolled a total of 46 subjects across four sites in the US, with each participant receiving two treatment sessions 1-3 weeks apart. None to mild levels of pain were reported by most trial participants, with no discomfort post-treatment.
Sagging or loose skin is most often caused by ageing, but it can also be a result of weight loss, genetics, and external factors such as ultraviolet radiation.
Sofwave’s CEO Louis Scafuri said: “Lax skin on the upper arms is a prevalent issue that can impact individuals not only from a physical appearance aspect but also emotionally.
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We look forward to continuing to expand the use of our innovative technology to other aesthetic treatment applications throughout the body.”
According to a 2022 report by the American Society of Plastic Surgeons, surgical arm lift procedures have grown 25% since 2019.
A market model by GlobalData estimates the global aesthetic medical device market will reach $18.8bn by 2030, growing at a CAGR of 5.4%. Body contouring devices are expected to comprise $1bn of the market, growing at a CAGR of 1.8%. The aesthetic injectables segment is growing the fastest, with a CAGR of 7.4% and is forecasted to constitute $13.3bn of the global market by 2030.
In 2021, the US FDA stated it was receiving an increasing number of therapeutic ultrasound device submissions. Applications for the brain, cardiovascular system, pain management, and immunotherapy were highlighted by the agency.
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- Source: https://www.medicaldevice-network.com/news/sofwave-medical-secures-fda-clearance-for-skin-laxity-improvement-device/
