Venus Concept Inc. Announces FDA 510(k) Clearance for Venus Viva MD

Venus Viva MD is a new skin rejuvenation solution with differentiated features that allow clinicians in the traditional medical aesthetics community to treat a wider range of skin conditions

TORONTO, July 01, 2020 (GLOBE NEWSWIRE) -- Venus Concept Inc. (“Venus Concept” or the “Company”) (NASDAQ: VERO), a global medical aesthetic technology leader, today announced that it has received FDA 510(k) clearance to market and sell Venus Viva MD. Venus Viva MD is a non-invasive device intended to be used by aesthetic-related physicians or dermatologists. It expands the Company’s skin rejuvenation offerings beyond the Venus Viva™ and Venus Versa™ which were introduced to the medical aesthetics market in 2015 and 2016, respectively. 

The Venus Viva MD is a portable and versatile tabletop device that enables a wide range of treatments with two applicators. When used with the new Viva MD applicator, the Venus Viva MD device is intended for use in dermatological procedures requiring ablation and resurfacing of the skin including conditions such as acne scars, dyschromia, striae and enlarged pores. The Viva MD applicator is a fractional handpiece that offers a new 80 pin tip design which doubles the output energy up to 124mJ per pin electrode as compared to the 160 pin tip option used with the existing Venus Versa and Viva devices. The new 80 pin tip output results in increased depth of ablation which enhances treatment outcomes while maintaining the safety profile. When used with the Diamondpolar™ applicator, the Venus Viva MD device is intended for the non-invasive treatment of moderate to severe facial wrinkles and rhytides for patients with Fitzpatrick skin type I-IV. The Venus Viva MD is also integrated with the Company’s Internet of Things (IoT) technology that collects technical information to help providers enhance business operations and improve treatment efficiency.

“We are pleased to announce FDA 510(k) clearance for our Venus Viva MD device and are preparing to begin a limited launch by the end of the third quarter,” said Domenic Serafino, Chief Executive Officer and Director of Venus Concept. “The Venus Viva MD is a product we designed specifically for dermatologists and plastic surgeons in the U.S. which leverages our strong skin rejuvenation offerings in Venus Viva and Venus Versa, but offers differentiated features that allow clinicians in the traditional medical aesthetics community to treat a wider range of skin conditions. Importantly, this new product introduction is another example of our continued focus on introducing new and innovative technology solutions each year, while also identifying ways to enhance the contributions to our overall growth from the sale of utilization-based handpieces over time. We expect the U.S. commercialization of the Venus Viva MD to contribute to the Company’s long-term growth profile and believe our expanded portfolio of skin rejuvenation solutions will help us further penetrate the $3.4 billion global energy-based aesthetic device market1 in the years to come.”

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 26 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 Freeze Plus, Venus Heal, Venus Glow, Venus Bliss, Venus Epileve and Venus Viva MD. Venus Concept’s hair restoration systems includes 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, and Aperture Venture Partners.

Cautionary Statement Regarding Forward-Looking Statements

This communication contains “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “1933 Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “1934 Act”). Any statements contained herein that are not of historical facts may be deemed to be forward-looking statements. In some cases, you can identify these statements by words such as such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and other similar expressions that are predictions of or indicate future events and future trends. These forward-looking statements include, but are not limited to, statements about the expected synergies and cost savings from our merger with Venus Concept Ltd. and restructuring program; our financial performance; the growth in demand for our systems and other products; and general economic conditions, including the global economic impact of COVID-19, involve risks and uncertainties that may cause results to differ materially from those set forth in the statements. These forward-looking statements are based on current expectations, estimates, forecasts, and projections about our business and the industry in which we operate and management's beliefs and assumptions and are not guarantees of future performance or developments and involve known and unknown risks, uncertainties, and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this communication may turn out to be inaccurate. Factors that could materially affect our business operations and financial performance and condition include, but are not limited to, those risks and uncertainties described under Part I Item 1A—“Risk Factors” in our most recent Annual Report on Form 10-K, Part II Item 1A—“Risk Factors” in our Form 10-Q for the quarter ended March 31, 2020, and in other documents we may file with the SEC. You are urged to consider these factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are based on information available to us as of the date of this communication. Unless required by law, we do not intend to publicly update or revise any forward-looking statements to reflect new information or future events or otherwise. 

1 Source: Form 10-k for the twelve months ended December 31, 2019: “Based on data from Medical Insights reports published in 2019, we estimate the global energy-based aesthetic device market totaled approximately $3.4 billion in 2018. We also estimate this market will increase at a 9.7% CAGR to more than $5.3 billion by the end of 2023. This projected growth CAGR is based on a weighted-average of expected growth CAGRs per Medical Insights of 6.1% for “Energy-Based Aesthetic Devices”, 12.7% for “Energy-Based Body Shaping & Skin Tightening” and 15.0% for “Energy-Based Feminine Rejuvenation”, respectively.”


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