{"id":444667,"date":"2024-01-02T19:00:00","date_gmt":"2024-01-03T00:00:00","guid":{"rendered":"https:\/\/platohealth.ai\/sofwave-medical-receives-510k-marketing-clearance-for-pure-impact-strength-and-muscle-toning-body-module-utilizing-plyopulse-ems-technology-biospace\/"},"modified":"2024-01-03T14:40:22","modified_gmt":"2024-01-03T19:40:22","slug":"sofwave-medical-receives-510k-marketing-clearance-for-pure-impact-strength-and-muscle-toning-body-module-utilizing-plyopulse-ems-technology-biospace","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/sofwave-medical-receives-510k-marketing-clearance-for-pure-impact-strength-and-muscle-toning-body-module-utilizing-plyopulse-ems-technology-biospace\/","title":{"rendered":"Sofwave Medical Receives 510(k) Marketing Clearance for Pure Impact\u2122 Strength and Muscle Toning Body Module Utilizing PlyoPulse\u2122 EMS Technology | BioSpace","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"<ul>\n<li><em>Pure Impact\u2122 with PlyoPulse\u2122 technology is a direct add-on Body module to the existing FDA cleared Sofwave medical aesthetic device platform<\/em><\/li>\n<li><em>The PlyoPulse\u2122 technology is an EMS (Electrical Muscle Stimulation) technology to deliver toning and strengthening simultaneously across diverse muscle groups in one treatment session<\/em><\/li>\n<li><em>Adding Pure Impact\u2122 <\/em>to Sofwave\u2019s <em>medical aesthetic device capabilities allows practitioners to expand revenue opportunities beyond existing in-clinic suite of client services utilizing modular add-on technology to the SUPERB\u2122 ultrasound platform <\/em><\/li>\n<li><em>U.S. commercial launch expected in the near term <\/em><\/li>\n<\/ul>\n<p align=\"left\">SAN CLEMENTE, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) &#8212; Sofwave Medical Ltd (\u201cthe Company\u201d) (TASE: SOFW), an emerging leader in energy-based non-invasive, aesthetic medical devices for practitioners worldwide, announced clearance by the U.S. Food and Drug Administration (FDA) for the Company\u2019s 510(k) premarket notification submission to market Pure Impact\u2122 utilizing PlyoPulse\u2122 EMS (\u201celectromagnetic stimulation\u201d) technology in the United States. The approval clears a pathway for Sofwave to expand medical aesthetic treatment beyond the Company\u2019s existing SUPERB\u2122 platform for eyebrow and submental neck lifting, treatment of fine lines and wrinkles, treatment of cellulite, and treatment of skin laxity to now allow practitioners to include body toning and strength conditioning across diverse muscle groups in one treatment session.<\/p>\n<p align=\"left\">\u201cWe continue to deliver on our promise of innovation within the medical aesthetic device space. The 510(k) clearance of Pure Impact\u2122 allows Sofwave to bring to market a unique EMS device that can deliver muscle toning and strength conditioning simultaneously across diverse muscle groups in one treatment session,\u201d noted, Louis Scafuri, CEO of Sofwave Medical. \u201cPure Impact\u2122 with PlyoPulse\u2122 technology is a modular add-on to Sofwave\u2019s existing industry-leading medical device platform, allowing practitioners to immediately expand their spa or clinics\u2019 suite of services. Moreover, this is a timely addition to our product line as the success and popularity of a new class of GLP-1 drugs in the marketplace intended for weight-loss continues to shape the needs and demands of the aesthetics industry. We are delighted to begin the initial commercial launch of Pure Impact\u2122 in the United States in the near term, while working to bring this product to other geographies as expeditiously as possible.\u201d<\/p>\n<p align=\"left\"><strong>About Pure Impact\u2122 utilizing PlyoPulse\u2122 EMS Technology:<\/strong><\/p>\n<p align=\"left\">Clinicians<\/p>\n<ul>\n<li>Pure Impact\u2122 is a unique muscle toning and firming system designed to stimulate multiple muscle groups and body areas simultaneously.<\/li>\n<li>Our PlyoPulse\u2122 technology encapsulates the efficacy of controlled muscle stimulation, all within a concise 30-minute treatment. No electrode rearrangement is required, no delays in treatment time \u2013 for greater patient turnover and expedited ROI.<\/li>\n<li>Advanced next generation wireless connectivity untangles and uncomplicates clinicians\u2019 ability to provide a superior treatment across multiple muscle groups without the need for gels, liquids, or belts.<\/li>\n<li>Easy digital programming allows different treatment protocols to engage diverse muscle groups without the need to manually rearrange electrodes, thus avoiding treatment interruption.<\/li>\n<li>The modular add-on redefines toning with up to 16 synchronized electrodes is designed to achieve effective stimulation of large muscle groups. The device achieves unparalleled muscle strengthening and toning for patients quickly.<\/li>\n<\/ul>\n<p align=\"left\">Patients<\/p>\n<ul>\n<li>Designed to simultaneously stimulate diverse muscle groups and body areas, Pure Impact \u2122 goal is to efficiently achieve intense muscle strengthening and toning all in one session.<\/li>\n<li>As a modular Sofwave platform product, the Pure Impact treatment can be used in conjunction with the SUPERB\u2122 system or as a stand-alone treatment that provides the same standard of precise energy delivery and degree of efficacy, safety, treatment comfort and results that the entire Sofwave product portfolio provides.<\/li>\n<\/ul>\n<p align=\"left\">This new FDA clearance for the Pure Impact module is added to the recently received clearance for using the Company\u2019s SUPERB\u2122 technology for the improvement of skin laxity on upper arms, and its clearance for the improvement in the appearance of cellulite, creating a wide range of off-face applications serving the growing patient demand for non-invasive body treatments and provides additional business opportunities for the Company\u2019s existing and future customers.<\/p>\n<p align=\"left\"><strong><u>About Sofwave Medical<\/u><\/strong><br \/><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.globenewswire.com\/Tracker?data=EsTcuBb4gRtztHeEiWTp1p5UUS6FnGuRHTauAWTFf298PRhf-gEEOG5B2kVksUBztclPONsxvThGfOTobxtvOnfI29sdv0cKRYHKcS8BdwhakxR7ycikugW52ssGDflIIPMEjYE6OdkZJ55Qe9xstqYop9cpaXIScpus6qzzf32XI5L9B5F3-Y63N84hmpFKke_BKTBTI-qwJRYs2JVSa2jlgMSdBjZNtQDi_Ez3SJVHHfAQyNgTczlnxK2vNF_GnD4qtF0mlSUgmvj7z2Xi-DKMV9V0HhMHjlY7kf04GwJWEY02ZXkHwZ9otXEzPmB7lIMbNXH-eMay18qdCjEEEQ==\">Sofwave Medical Ltd.<\/a>&nbsp;has implemented an innovative approach to wrinkle reduction, lifting and cellulite using its proprietary breakthrough technology. SUPERB\u2122, Synchronous Ultrasound Parallel Beam technology is FDA-cleared to improve facial lines and wrinkles, lifting the eyebrow and lifting lax submental tissue (beneath the chin) and neck tissue, the short-term improvement in the appearance of cellulite, improvement of skin laxity on upper arms and treatment of acne scars, providing physicians with smart yet simple, effective, and safe aesthetic solutions for their patients. Contact:&nbsp;<a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.globenewswire.com\/Tracker?data=bGvjsOUX1R2496lJFya_8To7LfOrEOqiDljfhbrrAjiQqfdhXQEd_LuYT39Bi-Jd3xuKWOl2VMqXfMAbsIq_Xg==\">Info@sofwave.com<\/a><\/p>\n<p align=\"left\">Investor Contact:<br \/>Brian Ritchie<br \/>LifeSci Advisors LLC<br \/>(212) 915-2578<br \/><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.globenewswire.com\/Tracker?data=QtUCp8m0zWYOAm6dLf-HgM_LR-JyvpWM0BKYVQwvGdunneBZlNHucn110MUYJw_bzUBwe6pRqs8h_06bJwWj2xdFA6BnXGWmGop37U-FEd0XAQPG-0Y6phsn7ED50rZn\">britchie@lifesciadvisors.com<\/a><\/p>\n<p><img decoding=\"async\" alt class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/01\/sofwave-medical-receives-510k-marketing-clearance-for-pure-impact-strength-and-muscle-toning-body-module-utilizing-plyopulse-ems-technology-biospace.gif\"><br \/><img decoding=\"async\" alt src=\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/01\/sofwave-medical-receives-510k-marketing-clearance-for-pure-impact-strength-and-muscle-toning-body-module-utilizing-plyopulse-ems-technology-biospace-1.gif\"><\/p>\n<p><a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.globenewswire.com\/NewsRoom\/AttachmentNg\/9fbd88c7-2eaf-45c3-b046-2d055fe94a07\"><img decoding=\"async\" alt=\"Primary Logo\" border=\"0\" height=\"49\" src=\"https:\/\/platohealth.ai\/wp-content\/uploads\/2024\/01\/sofwave-medical-receives-510k-marketing-clearance-for-pure-impact-strength-and-muscle-toning-body-module-utilizing-plyopulse-ems-technology-biospace.png\" width=\"150\"><\/a><\/p>\n<ul class=\"plato-post-bottom-links\">\n<li class=\"plato-post-bottom-link-amplifi\">SEO Powered Content &amp; PR Distribution. <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.amplifipr.com\">Get Amplified Today.<\/a><\/li>\n<li class=\"plato-post-bottom-link-platodata-network\">PlatoData.Network Vertical Generative Ai. 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Biotech and Clinical Trials Intelligence. <a href=\"https:\/\/platohealth.ai\" target=\"_blank\" rel=\"noopener\">Access Here.<\/a><\/li>\n<li class=\"plato-post-bottom-link-source\"><span>Source:<\/span> <a rel=\"noopener\" target=\"_blank\" href=\"https:\/\/www.biospace.com\/article\/releases\/sofwave-medical-receives-510-k-marketing-clearance-for-pure-impact-strength-and-muscle-toning-body-module-utilizing-plyopulse-ems-technology\/?s=93\">https:\/\/www.biospace.com\/article\/releases\/sofwave-medical-receives-510-k-marketing-clearance-for-pure-impact-strength-and-muscle-toning-body-module-utilizing-plyopulse-ems-technology\/?s=93<\/a><\/li>\n<\/ul>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"excerpt":{"rendered":"<p>Pure Impact\u2122 with PlyoPulse\u2122 technology is a direct add-on Body module to the existing FDA cleared Sofwave medical aesthetic device platform The PlyoPulse\u2122 technology is an EMS (Electrical Muscle Stimulation) technology to deliver toning and strengthening simultaneously across diverse muscle groups in one treatment session Adding Pure Impact\u2122 to Sofwave\u2019s medical aesthetic device capabilities allows [&hellip;]<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":444677,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[52],"tags":[],"acf":[],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/444667"}],"collection":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/comments?post=444667"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/444667\/revisions"}],"predecessor-version":[{"id":444676,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/444667\/revisions\/444676"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/444677"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=444667"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=444667"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=444667"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}