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 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’s proprietary SUPERB TM technology is also cleared by the U.S. FDA for a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles.
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 the United States. Overall, 467 facial areas were treated during the study course.
Louis Scafuri, Sofwave's Chief Executive Officer“This major clearance complements our earlier received approval to market SUPERB™ for reduction of facial lines and wrinkle. Further, this study demonstrates the breadth of our proprietary Synchronous Ultrasound Parallel Beam Technology SUPERB TM to address additional high-volume indications”, said Sofwave’s Chief Executive Officer Louis Scafuri.
Dr. Shimon Eckhouse, Chairman of the Board of Directors and Co-founder of Sofwave Medical“The FDA clearance represents another major achievement for the SofwaveTM platform and showcases Sofwave Medical’s ongoing focus on innovation and clinical advancements in energy-based technology,” said Dr. Shimon Eckhouse, Chairman of the Board of Directors and Co-founder of Sofwave Medical. “The SUPERBTM (Synchronous Ultrasound Parallel Beam) 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.”
Sofwave Medical Ltd. has 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.