Globe Newswire09.02.20
Venus Concept Inc., a global medical aesthetic technology leader, has received U.S. Food and Drug Administration (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, CEO 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.”
Reference
1 Source: Form 10-k for the 12 months ended Dec. 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% for “Energy-Based Feminine Rejuvenation," 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, CEO 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.”
Reference
1 Source: Form 10-k for the 12 months ended Dec. 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% for “Energy-Based Feminine Rejuvenation," respectively.”