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

Rhea-AI Summary

Venus Concept (NASDAQ: VERO) has received FDA 510(k) clearance for its Venus BlissMAX device, expanding its use to include non-invasive lipolysis for the back and thighs, along with a 50% increase in RF energy output to 150 watts. This advancement enhances treatment efficiency and versatility, offering laser fat reduction, cellulite reduction, and muscle conditioning in one platform. The commercial launch of BlissMAX aims to provide physicians with a cost-effective solution that requires little downtime, potentially increasing revenue for customers.

Positive

• FDA clearance boosts the market potential for BlissMAX.
• Expanded treatment areas may attract a broader customer base.
• Increases in RF output enhance treatment efficiency.

Negative

• None.

Clearance Expands Indications for Use to Include Non-Invasive Lipolysis of the Back and Thighs and Increases Maximum Energy Output to 150 Watts

TORONTO, April 28, 2022 (GLOBE NEWSWIRE) -- 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 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.

Cautionary Statement Regarding Forward-Looking Statements

This communication contains contains “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. 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 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, and 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 the Company operates 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 II Item 1A—“Risk Factors” in our Quarterly Reports on Form 10-Q and Part I Item 1A—“Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021. 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, the Company does not intend to publicly update or revise any forward-looking statements to reflect new information or future events or otherwise.

FAQ

What recent FDA clearance did Venus Concept receive for the VERO stock?

Venus Concept received FDA 510(k) clearance for the Venus BlissMAX device, expanding its use for non-invasive lipolysis of the back and thighs.

When was the FDA clearance for Venus BlissMAX announced?

The FDA clearance for Venus BlissMAX was announced on April 28, 2022.

What does the BlissMAX device offer after the FDA clearance?

After the FDA clearance, the BlissMAX device offers non-invasive treatments for fat reduction, cellulite reduction, and muscle conditioning.

What is the new maximum RF energy output level for BlissMAX?

The new maximum RF energy output for BlissMAX is 150 watts, an increase of 50%.

How does the clearance impact Venus Concept's business model?

The clearance enhances Venus Concept's product offerings, increasing potential revenue for physician customers through more versatile treatment options.