Venus Concept Announces First Patient Treatment in Study Evaluating the Safety and Efficacy of Aime™ Next Generation Robotic Technology for the Treatment of Moderate to Severe Facial Wrinkles
Venus Concept (NASDAQ: VERO) has initiated a U.S. Investigational Device Exemption (IDE) clinical study for its Aime™ robotic platform, aimed at treating moderate to severe facial wrinkles. The study, involving up to 70 participants aged 22 to 75, will assess the safety and efficacy of Aime in a multicenter trial across four centers. Initial patient treatment has been successfully completed. The Aime technology may enhance treatment delivery and visualization, potentially positioning Venus Concept as a leader in robotic aesthetic procedures.
- Successful initiation of a clinical study for the Aime robotic platform.
- First patient treated, indicating progress in development.
- Potential for Aime to innovate and differentiate Venus Concept in the aesthetic market.
- None.
TORONTO, April 25, 2022 (GLOBE NEWSWIRE) -- Venus Concept Inc. (“Venus Concept” or the “Company”) (NASDAQ: VERO), a global medical aesthetic technology leader, today announced that the first patient has been treated in a U.S. Investigational Device Exemption (IDE) clinical study evaluating the safety and efficacy of the Company’s Aime™ next generation robotic technology for the treatment of moderate to severe facial wrinkles. Aime is a robotic platform designed to provide micro-coring for medical aesthetic applications.
“The introduction of robotics is one of the most exciting breakthroughs in aesthetic medicine,” said principal investigator Steven Dayan, M.D. “While robotic technologies have impacted nearly all fields of medicine and industry, they have been slow to take a hold in aesthetics given the need to be precise, patient and provider friendly, and affordable, while also delivering a reliable aesthetic improvement. However, recent advancements in technology and thinking are leading to newer designs and treatments.”
Dr. Dayan continued: “We are pleased to have successfully completed the initial patient treatment with the Aime robotic platform for this important clinical study. Aime represents an innovative approach to aesthetic procedures, with the potential to provide clinicians with consistent, predictable treatment delivery and enhanced visualization. Aime could very well differentiate adopting clinicians as the use of robotic technology emerges in aesthetic procedures.”
The study is a prospective, multicenter clinical study evaluating the safety and efficacy of mechanical coring to improve the appearance of wrinkles of the face. It will be conducted at four investigational centers in the U.S. and consist of up to 70 subjects between 22 and 75 years of age. The study will evaluate the progress of subjects after two treatments on the cheeks, delivered 30 days apart. The primary endpoint will be the proportion of correctly identified photograph sets from baseline and Day 120 as assessed by at least 3 independent blinded evaluators.
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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