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 (TASE: SOFW), 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.