Venus gets 510(k) clearance for Fractional Skin Resurfacing

03 January 2023

Fractional Skin Resurfacing, venus, skin, medical, devices

Venus Concept Inc. (“Venus Concept” or the “Company”) (NASDAQ: VERO), 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 its AI.ME next generation robotic technology for fractional skin resurfacing.

“We are very pleased to receive the first FDA regulatory clearance for our non-surgical robotic technology platform, AI.ME, and believe it showcases Venus Concept’s ongoing investment in technology, innovation, and clinical research towards robotics applications in the field of medical aesthetics,” said Rajiv De Silva, Chief Executive Officer of Venus Concept. “AI.ME is a first-of-its-kind robotic platform offering physicians minimally-invasive treatments for high-demand procedures requiring fractional skin resurfacing. We see AI.ME as a versatile platform and we will continue to develop the platform to provide innovative solutions in various areas of medical aesthetics, starting with fractional skin resurfacing. The AI.ME technology will be critical to maximising the synergy between our well-established medical aesthetic business and our pioneering robotics business driven by a robust R&D pipeline developed by our team in San Jose. This 510(k) clearance brings us one step closer to our goal of commercialising AI.ME in the U.S., and we look forward to introducing our first AI.ME systems with Venus Concept’s leading physician partners in 2023.”

The AI.ME robotic system utilises an advanced visualisation system, machine vision, and Artificial Intelligence algorithms to target the dermis in a pre-planned selective, and predictable manner. It uses a smart array of micro-coring hollow punches to precisely core and excise micro-skin fractions at a precise depth to remove up to 10% of skin in the treatment area, leading to collagen deposition and fractional skin resurfacing of the treated area.

“Integrating the advancements of robotics into the area of minimally-invasive aesthetic procedures is very promising,” said Girish (Gilly) Munavalli, MD, MHS, FACMS board-certified dermatologist and advisor to Venus Concept. “This new technology may become a real game-changer in the area of medical aesthetics, offering a new level of consistency, predictability, and visualisation which will differentiate it from existing energy-based solutions. We had the privilege to participate in the early clinical studies of AI.ME and it is clear that the advancements that its robotic technology presents to our practice can go far beyond fractional skin resurfacing. I’m encouraged to see some true innovation in the area of minimally-invasive aesthetic treatments and I’m looking forward to seeing the technology evolve to produce consistent transformational results.”

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 16 direct 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, Venus Viva MD and AI.ME. Venus Concept’s hair restoration systems include NeoGraft® and the ARTAS iX® Robotic Hair Restoration system. 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.

This new on-surgical robotic technology platform removes the need of heavy surgical treatments on the skin. Are you currently planning to develop a new device but are short on staff? Let our experts help you by finding the right match for your Life Science organisation. Learn more about how we can help you here!

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