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Pure Impact™ with PlyoPulse™ Technology is a direct add-on Body module to Sofwave’s existing FDA-cleared medical aesthetic device platform
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PlyoPulse™ technology is an EMS (Electrical Muscle Stimulation) technology to provide stimulation and strengthening simultaneously to various muscle groups in one treatment session
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Add Pure Impact™ at Sofwave’s The medical aesthetic device capabilities allow physicians to expand revenue opportunities beyond their existing in-clinic customer service suite by using modular add-on technology to the SUPERB™ ultrasound platform
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Commercial release in the US is expected in the near future
SAN CLEMENTE, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) — Sofwave Medical Ltd (“the Company”) (TASE: SOFW ), an emerging leader in non-invasive, aesthetic energy-based medical devices for professionals worldwide, announced the approval by the US Food and Drug Administration (FDA) to submit a 510(k) premarket notification to market Pure Impact™ using PlyoPulse™ EMS (“electromagnetic stimulation”) technology in the United States. The approval paves a way for Sofwave to expand medical aesthetic treatment beyond the Company’s existing SUPERB™ platform for brow lift and submental neck lift, fine line and wrinkle treatment, cellulite treatment and skin relaxation treatment, now allowing professionals to include body toning and strength conditioning in various muscle groups in one treatment session.
“We continue to deliver on our promise of innovation in the field of medical aesthetic devices. The 510(k) clearance of Pure Impact™ allows Sofwave to bring to market a unique EMS device that can deliver muscle stimulation and strengthening simultaneously to multiple muscle groups in one treatment session,” noted Louis Scafuri, CEO of Sofwave Medical . “Pure Impact™ with PlyoPulse™ technology is a modular add-on to Sofwave’s existing industry-leading medical device platform, allowing professionals to instantly expand their spa or clinic service line. Additionally, this is a timely addition to our product line as the success and popularity of a new class of GLP-1 drugs on the market intended for weight loss continues to shape the needs and demands of the beauty industry. We are pleased to begin the initial commercial launch of Pure Impact™ in the United States soon, while working to bring this product to other geographies as quickly as possible.”
About Pure Impact™ using PlyoPulse™ EMS technology:
Clinicians
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Pure Impact™ is a unique muscle toning and tightening system designed to stimulate multiple muscle groups and areas of the body simultaneously.
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Our PlyoPulse™ technology incorporates the effectiveness of controlled muscle stimulation, all within a concise 30-minute treatment. No reordering of electrodes required, no delay in treatment time required – for greater patient turnover and rapid ROI.
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Advanced next-generation wireless connectivity demystifies and complicates clinicians’ ability to deliver superior therapy to multiple muscle groups without the need for gels, fluids or belts.
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Easy digital programming allows different treatment protocols to engage different muscle groups without the need to manually rearrange electrodes, thus avoiding treatment interruption.
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The modular plug-in redefines stimulation with up to 16 synchronized electrodes designed to achieve effective stimulation of large muscle groups. The device achieves unparalleled muscle strengthening and toning for patients quickly.
Patients
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Designed to simultaneously stimulate different muscle groups and areas of the body, Pure Impact™ aims to effectively achieve intense muscle strengthening and toning in one session.
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As a modular Sofwave platform product, Pure Impact therapy can be used in conjunction with the SUPERB™ system or as a stand-alone therapy providing the same standard of precise energy delivery and degree of efficacy, safety, treatment comfort and results as the entire product portfolio Softwave.
This new FDA clearance for the Pure Impact unit is in addition to the recently received clearance for the use of the company’s SUPERB™ technology to improve upper arm skin laxity and clearance to improve the appearance of cellulite, creating a broad spectrum off-face applications that serve the growing patient demand for non-invasive body treatments and provide additional business opportunities for the Company’s existing and future clients.
About Sofwave Medical
Sofwave Medical Ltd. has implemented an innovative approach to wrinkle reduction, lifting 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) and neck tissue, short-term improvement in appearance of cellulite, improving skin laxity on the arms and treating 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
