FDA Clears New Lifting Indications for Sofwave
Sofwave is now FDA-cleared for lifting the eyebrow and lifting lax submental tissue and neck tissue in people aged 22 or older.
Sofwave is now U.S. Food and Drug Administration (FDA)-cleared for lifting the eyebrow and lifting lax submental tissue and neck tissue in people aged 22 or older.
In addition, the Sofwave system featuring the Company's proprietary Superb TM (Synchronous Ultrasound Parallel Beam) 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 people received treatments at five investigational sites in the United States. Overall, 467 facial areas were treated during the study course.
"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," says Sofwave's Chief Executive Officer Louis Scafuri, in a news release.
"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," adds Dr. Shimon Eckhouse, Chairman of the Board of Directors and Co-founder of Sofwave Medical. "The Superb TM (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."