Venus Concept Announces Financial Results for the Second Quarter and First Six Months of 2019 and FDA 510(k) Clearance of Venus Bliss - Seite 2

Venus Concept Receives FDA 510(k) Clearance for Venus Bliss For Non-Invasive Lipolysis of the Abdomen and Flanks, as Well as Cellulite Reduction

On June 25, 2019, Venus Concept received U.S. Food and Drug Administration (FDA) 510(k) clearance to market and sell Venus Bliss, a medical aesthetic platform that offers a comprehensive solution to fat reduction and cellulite reduction, with two technologies in one platform. It employs advanced diode laser applicators for non-invasive lipolysis of the abdomen and flanks in individuals with a BMI of 30 or less, resulting in reduction of  unwanted focal fat,  as well as an (MP)² applicator that combines Multi-Polar Radio Frequency and Pulsed Electro Magnetic Fields with advanced VariPulse technology to reduce the appearance of cellulite.  

In a 60-patient clinical study done with the Venus Bliss device, all participants received a single 1064nm diode laser treatment to either their flanks or abdomen. "Subjects in our clinical study saw a statistically significant reduction in adipose layer thickness as measured by ultrasound, 6- and 12-weeks following treatment," said Dr. Susan L. Kilmer, Principal Investigator, Director at Laser & Skin Surgery Center of Northern California and Clinical Professor at the University of California. "Greater than 90% of the subjects found the treatment to be comfortable and the majority were highly satisfied with the results."

"Fat reduction is one of the fastest growing non-surgical, non-injectable, procedure categories in the medical aesthetics industry today," said Domenic Serafino, Chairman and CEO of Venus Concept. "It is more important than ever that treatment providers be able to offer a comprehensive solution that can effectively address fat. This is why we're excited to announce the clearance of Venus Bliss, our fat reduction solution for the abdomen and flanks. The Venus Bliss is comfortable for patients, provides excellent results, and has little-to-no downtime. The Venus Bliss will be a preferred solution for providers as there is no disposable cost per treatment, which makes the profitability per procedure extremely compelling for physicians. We look forward to a full commercial launch of the Venus Bliss in the fourth quarter of 2019."