Venus Concept Receives New FDA 510(k) Clearance for Venus BlissMAX

Thursday, April 28, 2022

Venus Concept Inc., a global medical aesthetic technology leader, today announced that it has received a 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market the Venus BlissMAX device (“BlissMAX”) with an expanded indication for use in new areas of the body and an increase in RF energy output.

“We are excited to receive this new 510(k) clearance for BlissMAX, the next generation of our Venus Bliss system, which expands its indication for use to include non-invasive lipolysis of the back and thighs – in addition to the abdomen and flanks – in individuals with a Body Mass Index of 30 or less,” said Domenic Serafino, Chief Executive Officer of Venus Concept. “We believe BlissMAX is the only technology on the market to offer laser fat reduction, cellulite reduction and muscle conditioning in a single body contouring workstation, and this new 510(k) clearance further expands its versatility. In addition, increasing maximum RF energy output by 50% allows for more efficiency and flexibility in treatments, which ultimately increase revenue for our customers. With the recent commercial launch of BlissMAX during the second quarter of this year, we are pleased to make this compelling addition to our body treatment franchise available to our physician customers, providing them with a cost-effective platform to deliver compelling results with little-to-no downtime.”

BlissMAX is a medical aesthetic platform that offers a comprehensive solution for fat reduction, cellulite reduction and muscle conditioning with three technologies in one platform. Like the Company’s Venus Bliss™ system, BlissMAX employs advanced diode laser applicators for non-invasive lipolysis of the abdomen, flanks, back and thighs in individuals with a Body Mass Index 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 addition to these technologies, BlissMAX also features the Company’s FlexMAX EMS applicators, designed for muscle conditioning to stimulate healthy muscles.

About Venus Concept

Venus Concept is an innovative global medical aesthetic technology leader with a broad product portfolio of minimally invasive and non-invasive medical aesthetic and hair restoration technologies and reach in over 60 countries and 18 direct markets. Venus Concept focuses its product sales strategy on a subscription-based business model in North America and in its well-established direct global markets. Venus Concept’s product portfolio consists of aesthetic device platforms, including Venus Versa, Venus Legacy, Venus Velocity, Venus Fiore, Venus Viva, Venus Glow, Venus Bliss, Venus BlissMAX, Venus Epileve and Venus Viva MD. Venus Concept’s hair restoration systems include NeoGraft®, an automated hair restoration system that facilitates the harvesting of follicles during a FUE process and the ARTAS® and ARTAS iX® Robotic Hair Restoration systems, which harvest follicular units directly from the scalp and create recipient implant sites using proprietary algorithms. Venus Concept has been backed by leading healthcare industry growth equity investors including EW Healthcare Partners (formerly Essex Woodlands), HealthQuest Capital, Longitude Capital Management, Aperture Venture Partners, and Masters Special Situations.

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