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The FDA clearance is supported by extremely compelling clinical study results showing that 93% of treated subjects were “improved” or “much improved” in appearance after treatment using SUPERB™
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US brachioplasty (arm lift surgery) market to grow 25% from 2019-2022, Sofwave’s SUPERB™ technology introduces a non-invasive alternative to improving the appearance of sagging skin on the arms without the associated risks and recovery time of conventional surgery and minimally invasive body contouring procedures
SAN CLEMENTE, Calif., Dec. 26, 2023 (GLOBE NEWSWIRE) — Sofwave Medical Ltd (TASE: SOFW ), an emerging leader in non-invasive, aesthetic energy-based medical devices for professionals worldwide, today announced the approval by the US Agency Food and Drug Administration (FDA) to submit the Company’s 510(k) premarket notification for improving the appearance of skin laxity on the arms and paves the way for Sofwave™ to be further expanded into additional treatment indications.
Mr. Louis Scafuri, CEO of Sofwave, commented: “We are pleased to receive FDA approval to improve the appearance of upper arm skin laxity in the US supported by compelling clinical study results. Loose skin on the arms is a common issue that can affect people not only physically but also emotionally. Whether the presence of sagging or lax skin on their upper arms is the result of aging, weight loss, genetics or a combination of factors, the results of our upper arm laxity study provide a clear, objective set of clinical data and patient outcomes further progress us to become the leading provider of choice in the growing non-invasive medical aesthetics industry. We look forward to continuing to expand the use of our innovative technology to other full-body aesthetic treatment applications.”
According to the American Society of Plastic Surgeons, 2022 Procedural Statistics Release, 2019-2022, brachioplasty (arm lift surgery) procedures increased by 25%. Sofwave’s SUPERB™ platform introduces a viable, non-invasive, FDA-cleared alternative to improving the appearance of sagging upper arm skin without the associated risks and recovery time of conventional surgery, body contouring based on laser and other minimally invasive procedures.
Study results and design leading to FDA clearance to submit premarket notifications:
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Study Design and Results
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A total of 46 subjects were enrolled and treated in both upper arms at 4 sites in the United States.
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Subjects attended 2 treatment sessions (1–3 weeks apart) and a follow-up visit 3 months after the final treatment visit.
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93% of treated arms were “improved” or “much improved” in appearance as assessed by blinded reviewers using the Global Aesthetic Improvement Scale.
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Most subjects reported no to mild pain during treatment and no discomfort afterwards.
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In the US, Sofwave’s technology is currently approved for use as a non-invasive cosmetic treatment to improve facial lines and wrinkles, lift the browbones and lift the sagging submental (under the chin) and neck. which can also affect the appearance of loose tissue in the submental and neck areas for people aged 22 and over. The Sofwave System is also cleared for short-term improvement in the appearance of cellulite and for the treatment of acne scars.
About Sofwave Medical Ltd.
Sofwave Medical Ltd. has implemented an innovative approach to lifting wrinkles and cellulite using its exclusive breakthrough technology. SUPERB™, Synchronous Ultrasound Parallel Beam technology is FDA cleared to improve facial lines and wrinkles by lifting the brow and lifting loose submental tissue (under the chin), neck and arm tissue, as well as the short-term improvement of the appearance of cellulite and the treatment of acne scars, providing doctors with smart yet simple, effective and safe cosmetic solutions for their patients.
Contact: info@sofwave.com
Contact with investors:
Brian Ritchie
LifeSci Advisors LLC
(212) 915-2578
britchie@lifesciadvisors.com
