{"id":5205,"date":"2022-01-23T23:16:55","date_gmt":"2022-01-23T23:16:55","guid":{"rendered":"https:\/\/www.beamed.co.th\/?p=5205"},"modified":"2025-01-20T04:25:52","modified_gmt":"2025-01-19T21:25:52","slug":"sofwave-announces-fda-clearance-of-new-lifting-indications-for-eyebrow-sub-mental-beneath-the-chin-and-neck-facial-areas","status":"publish","type":"post","link":"https:\/\/www.beamed.co.th\/en\/sofwave-announces-fda-clearance-of-new-lifting-indications-for-eyebrow-sub-mental-beneath-the-chin-and-neck-facial-areas\/","title":{"rendered":"Sofwave\u2122 Announces FDA"},"content":{"rendered":"\r\n<h2>Sofwave\u2122 Announces FDA clearance of New Lifting Indications for Eyebrow, Sub-Mental (beneath the chin) and Neck Facial Areas<\/h2>\r\n<h2><span style=\"font-family: Helvetica;\"><strong>The new indications include Eyebrow lifts and lifting of Lax tissue of the Submental and Neck Areas<\/strong><\/span><\/h2>\r\n<h3><span style=\"font-family: Helvetica;\"><strong>80% of patients participating in a multi-site clinical trial saw improvement in just 12 weeks<\/strong><\/span><\/h3>\r\n<p><span style=\"font-family: Helvetica;\">Sofwave Medical Ltd, an emerging leader in energy-based non-invasive, aesthetic medical devices for practitioners worldwide, today announces that the U.S. Food and Drug Administration (FDA) approves clearance of additional indications, for lifting the eyebrow and lifting lax submental tissue (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental neck regions, for subjects aged 22 or older. In addition, the Sofwave system featuring the Company\u2019s proprietary SUPERB\u00a0<sup>TM\u00a0<\/sup>technology is also cleared by the U.S. FDA for a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles.<\/span> <span style=\"font-family: Helvetica;\">To support the expansion of indications, Sofwave Medical conducted a multi-site, clinical study that evaluated the safety and effectiveness of the device for the non-invasive dermatological aesthetic treatment to lift the eyebrow and lift lax submental and neck tissue. A total of 80 subjects received treatments at five investigational sites in\u00a0<span class=\"xn-location\">the United States<\/span>. Overall, 467 facial areas were treated during the study course.<\/span> <span style=\"font-family: Helvetica;\">\u201cThis major clearance complements our earlier received approval to market SUPERB\u2122 for reduction of facial lines and wrinkle. Further, this study demonstrates the breadth of our proprietary Synchronous Ultrasound Parallel Beam Technology SUPERB\u00a0<sup>TM<\/sup>\u00a0to address additional high-volume indications\u201d, said Sofwave\u2019s Chief Executive Officer\u00a0<span class=\"xn-person\">Louis Scafuri<\/span>.<\/span> <span style=\"font-family: Helvetica;\">\u201cThe FDA clearance represents another major achievement for the Sofwave<sup>TM<\/sup>\u00a0platform and showcases Sofwave Medical\u2019s ongoing focus on innovation and clinical advancements in energy-based technology,\u201d said Dr.\u00a0<span class=\"xn-person\">Shimon Eckhouse<\/span>, Chairman of the Board of Directors and Co-founder of Sofwave Medical. \u201cThe SUPERB<sup>TM \u00a0<\/sup>(Synchronous Ultrasound Parallel Beam)\u00a0 is a unique, industry-leading technology offering practitioners a non-invasive treatment for high demand lifting treatments of face and neck. We will continue to develop innovative products that advance the medical aesthetics industry and meet the needs of our customers and the needs of their patients.\u201d<\/span> <span style=\"font-family: Helvetica;\"><b><\/b>Sofwave Medical Ltd.\u00a0has implemented an innovative approach to wrinkle reduction and lifting using proprietary breakthrough technology. 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 providing physicians with smart yet simple, effective, and safe aesthetic solutions for their patients.<\/span> \u00a0 <span style=\"font-family: Helvetica;\">(https:\/\/sofwave.com\/news\/press-release\/eyebrow-sub-mental-neck-lifting-fda-clearance)<\/span><\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>Sofwave\u2122 Announces FDA clearance of New Lifting Indications for Eyebrow, Sub-Mental (beneath the chin) and Neck Facial Areas The new indications include Eyebrow lifts and lifting of Lax tissue of the Submental and Neck Areas 80% of patients participating in a multi-site clinical trial saw improvement in just 12 weeks Sofwave Medical Ltd, an emerging<\/p>\n","protected":false},"author":1,"featured_media":10403,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-5205","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/www.beamed.co.th\/en\/wp-json\/wp\/v2\/posts\/5205","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.beamed.co.th\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.beamed.co.th\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.beamed.co.th\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.beamed.co.th\/en\/wp-json\/wp\/v2\/comments?post=5205"}],"version-history":[{"count":0,"href":"https:\/\/www.beamed.co.th\/en\/wp-json\/wp\/v2\/posts\/5205\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.beamed.co.th\/en\/wp-json\/wp\/v2\/media\/10403"}],"wp:attachment":[{"href":"https:\/\/www.beamed.co.th\/en\/wp-json\/wp\/v2\/media?parent=5205"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.beamed.co.th\/en\/wp-json\/wp\/v2\/categories?post=5205"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.beamed.co.th\/en\/wp-json\/wp\/v2\/tags?post=5205"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}