Venus Concept Announces Regulatory Approval for Venus Bliss MAX in Canada

Rhea-AI Summary

Venus Concept Inc. (NASDAQ: VERO) has received regulatory approval from Health Canada to market its Venus Bliss MAX system in Canada. This 3-in-1 body shaping solution, first launched in the U.S. in early 2022, combines three technologies:

• Diode laser for fat reduction
• Proprietary (MP)2 applicator for cellulite reduction and skin treatments
• FlexMax EMS applicators for muscle toning and conditioning

The approval expands Venus Concept's market reach, offering Canadian clinicians and aesthetic practices a comprehensive non-invasive body treatment solution. Dr. Hemanth Varghese, President and COO, emphasized the benefits this unique combination of technologies brings to the evolving aesthetic marketplace.

Positive

• Received regulatory approval for Venus Bliss MAX in Canada
• Expands market reach for flagship body platform
• Offers 3-in-1 body shaping solution combining multiple technologies

Negative

• None.

Insights

Medical Device Regulatory Expert

The approval of Venus Bliss MAX by Health Canada marks a significant milestone for Venus Concept in the Canadian aesthetic market. This regulatory green light opens up new opportunities for the company in a key North American market, potentially boosting its revenue streams and market share.

From a regulatory perspective, Health Canada's approval indicates that the Venus Bliss MAX meets the country's stringent safety and efficacy standards. This validation could pave the way for easier approvals in other markets that recognize Health Canada's rigorous review process.

However, it's important to note that regulatory approval is just the first step. The company now faces the challenge of market penetration and adoption by Canadian clinicians. The success will depend on factors such as:

• Training and support provided to clinicians
• Pricing strategy in the Canadian market
• Competition from existing body contouring devices
• Marketing efforts to build awareness among consumers

While the approval is certainly positive, investors should monitor the company's execution in the Canadian market over the coming quarters to gauge the real impact on Venus Concept's bottom line.

Medical Aesthetics Industry Analyst

The introduction of Venus Bliss MAX to the Canadian market is a strategic move by Venus Concept, potentially strengthening its position in the rapidly growing non-invasive body contouring segment. This 3-in-1 platform addresses multiple consumer demands - fat reduction, cellulite treatment and muscle toning - which could give it a competitive edge in a crowded market.

Key points to consider:

• Market Potential: The global body contouring market is projected to reach $9.1 billion by 2030, growing at a CAGR of 16.1%. Canada, with its aging population and increasing focus on aesthetics, represents a lucrative opportunity.
• Competitive Landscape: Venus Concept will face stiff competition from established players like Allergan (CoolSculpting), Cynosure (SculpSure) and BTL (Emsculpt). The success of Venus Bliss MAX will depend on its ability to differentiate itself in terms of results, treatment comfort and cost-effectiveness.
• Revenue Impact: While specific pricing for the Canadian market isn't disclosed, multi-functional platforms like Venus Bliss MAX typically command premium prices. This could potentially boost Venus Concept's average selling price and gross margins.

Investors should watch for adoption rates among Canadian clinics and any impact on the company's financial performance in upcoming quarterly reports. The true test will be whether this approval translates into meaningful revenue growth in the Canadian market.

TORONTO, July 29, 2024 (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 medical device license issued by Health Canada to market the Venus Bliss MAX system in Canada. The Venus Bliss MAX was first available in the United States in early 2022 and subsequently offered in approved jurisdictions around the world.

The Venus Bliss MAX is a 3-in-1 body shaping solution featuring three of Venus Concept’s market leading technologies in one complete platform, including diode laser for Fat Reduction treatments, our proprietary (MP)² applicator that combines Multi-Polar Radio Frequency with Pulsed Electro Magnetic Fields and advanced VariPulse™ technology for Cellulite Reduction and Skin treatments, and the Company’s FlexMax EMS applicators for Muscle Toning and Conditioning.

“Venus continues to expand the availability of our flagship body platform, the Venus Bliss MAX, with our entry into Canada, providing our customers a comprehensive solution to deliver multiple advanced non-invasive body treatments in one system,” said Dr. Hemanth Varghese, President and Chief Operating Officer of Venus Concept. “Clinicians and aesthetic practices of all experiences and size in the Canadian market will benefit from this unique combination of proprietary technologies, further elevating the results they can deliver to the evolving aesthetic marketplace.”

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 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 “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “should,” “could,” “estimates,” “predicts,” “potential,” and other similar expressions that are predictions of or indicate future events and future trends. These forward-looking statements are based on current expectations, estimates, 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, 2023. 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.

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 12 direct markets. Venus Concept's product portfolio consists of aesthetic device platforms, including Venus Versa, Venus Versa Pro, Venus Legacy, Venus Velocity, Venus Viva, Venus Glow, Venus Bliss, Venus Bliss MAX, 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.

FAQ

What regulatory approval did Venus Concept (VERO) receive for Venus Bliss MAX in Canada?

Venus Concept received a medical device license from Health Canada to market the Venus Bliss MAX system in Canada.

When was Venus Bliss MAX first launched in the United States?

Venus Bliss MAX was first available in the United States in early 2022.

What technologies does the Venus Bliss MAX system include?

Venus Bliss MAX includes diode laser for fat reduction, (MP)2 applicator for cellulite reduction and skin treatments, and FlexMax EMS applicators for muscle toning and conditioning.

How does the Venus Bliss MAX approval benefit Venus Concept (VERO)?

The approval expands Venus Concept's market reach, offering Canadian clinicians and aesthetic practices a comprehensive non-invasive body treatment solution.