Venus Concept Announces Australian Regulatory Approval for Venus Bliss MAX

Rhea-AI Summary

Venus Concept Inc. (NASDAQ: VERO) has received clearance from the Therapeutic Goods Administration (TGA) in Australia to market its Venus Bliss MAX system. This flagship platform offers a comprehensive body treatment solution, combining three of Venus Concept's leading technologies:

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

The Venus Bliss MAX is already available in select markets globally and has received positive feedback from service providers. Dr. Hemanth Varghese, President and COO of Venus Concept, expressed confidence that the system's success will be replicated in Australia.

Positive

• Received regulatory approval for Venus Bliss MAX in Australia
• Expansion into new market with flagship product
• Positive feedback from existing markets

Negative

• None.

Medical Technology Expert

The TGA approval for Venus Bliss MAX in Australia marks a significant milestone for Venus Concept. This multi-functional platform combines three advanced technologies for comprehensive body treatments, potentially positioning the company as a strong competitor in the Australian aesthetic market.

The device's versatility, offering cellulite reduction, skin treatments, muscle conditioning and fat reduction in one system, could be appealing to clinics looking to expand their services without investing in multiple machines. This cost-effective approach might drive adoption among Australian aesthetic providers.

However, success will depend on factors like pricing strategy, training support and marketing efforts. The Australian market's response and the system's performance compared to existing solutions will be important in determining its impact on Venus Concept's market share and revenue growth in the region.

Market Research Analyst

The Australian aesthetic device market presents a significant opportunity for Venus Concept. With a growing demand for non-invasive body contouring treatments, the Venus Bliss MAX's all-in-one approach could resonate well with both clinicians and consumers.

Key factors to watch include:

• Market penetration rate compared to established competitors
• Pricing strategy and its alignment with the Australian market
• Clinical outcomes and customer satisfaction in real-world settings

The success of Venus Bliss MAX in Australia could serve as a springboard for expansion into other Asia-Pacific markets. However, the company must navigate regulatory landscapes and tailor its marketing approach to local preferences to maximize its potential in the region.

Financial Analyst

While the TGA approval is positive news for Venus Concept, investors should temper their expectations. The company's Q2 2023 revenue was $18.9 million, down 19% year-over-year, indicating ongoing challenges. The Australian market alone is unlikely to dramatically alter the company's financial trajectory in the short term.

Key financial considerations include:

• Potential impact on revenue growth in upcoming quarters
• Margins on the Venus Bliss MAX system compared to other products
• Marketing and distribution costs associated with the Australian launch

Investors should monitor the adoption rate and revenue contribution from the Australian market in future earnings reports to gauge the true impact of this regulatory approval on Venus Concept's financial health.

TORONTO, Sept. 18, 2024 (GLOBE NEWSWIRE) -- Venus Concept Inc. (“Venus Concept” or the “Company”) (NASDAQ: VERO), a global medical aesthetic technology leader, today announced that it has clearance from the Therapeutic Goods Administration (TGA) in Australia to market the Venus Bliss MAX system. The Venus Bliss MAX is the Company’s flagship platform that offers a comprehensive, world-class solution for all customers’ body treatment needs and is currently available in select markets globally.

Featuring three of Venus Concept’s market leading technologies in one, the Venus Bliss MAX is a body shaping solution consisting of 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, Venus’ FlexMax EMS applicators for Muscle Conditioning and a diode laser for Fat Reduction treatments.

“We are excited to introduce to the Australian market the Venus Bliss MAX, our device that offers aesthetic clinicians an all-in-one body solution to customers,” said Dr. Hemanth Varghese, President and Chief Operating Officer of Venus Concept. “The Venus Bliss Max continues to receive strong positive feedback globally from service providers of its complete body offering, and we are confident the same success will be replicated in Australia.”

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 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 in Australia?

Venus Concept (VERO) received clearance from the Therapeutic Goods Administration (TGA) in Australia to market its Venus Bliss MAX system.

What technologies does the Venus Bliss MAX system offer?

The Venus Bliss MAX system combines three technologies: (MP)2 applicator for cellulite reduction and skin treatments, FlexMax EMS applicators for muscle conditioning, and a diode laser for fat reduction treatments.

When did Venus Concept (VERO) announce the Australian regulatory approval?

Venus Concept (VERO) announced the Australian regulatory approval for Venus Bliss MAX on September 18, 2024.

Is the Venus Bliss MAX system available in other markets besides Australia?

Yes, the Venus Bliss MAX system is currently available in select markets globally, with Australia being a new addition.