Venus Concept Announces CE Mark for Venus Versa Pro in Europe
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Insights
The granting of the CE Mark to Venus Concept's Venus Versa Pro system represents a strategic milestone for the company, as it allows them to expand their market reach within the European Union. This is particularly significant given the EU's stringent regulatory environment for medical devices. The Venus Versa Pro's multi-modal capabilities and its ability to address a variety of skin conditions could cater to the growing demand for advanced aesthetic treatments in Europe.
The aesthetic technology market is competitive, with constant innovation being a key driver. The ability to offer a complete skin rejuvenation solution like 'Tribella' could give Venus Concept a competitive edge. It's worth noting that the aesthetic device market is expected to grow and Venus Concept's expansion into the EU could capitalize on this trend, potentially impacting their market share and revenue positively.
Receiving the CE Mark is likely to have a positive effect on Venus Concept's financial performance, particularly in the context of the company's restructuring efforts mentioned by Dr. Hemanth Varghese. Investors should note that with over 2,200 Venus Versa systems installed globally, the introduction of the Venus Versa Pro could lead to an uptick in sales and strengthen the company's financial position. Moreover, the expansion into the EU market might reflect in the company's future earnings reports.
However, investors should also consider the costs associated with marketing and supporting a new product launch in a diverse market like the EU, as well as the time it typically takes for such investments to translate into significant revenue. It is also important to monitor how the Venus Versa Pro is received in the market and how quickly it gains traction compared to existing solutions.
The CE Mark is a regulatory requirement for medical devices to be sold in the European Economic Area and indicates compliance with EU safety, health and environmental protection standards. For Venus Concept, this certification is crucial for the Venus Versa Pro system as it not only opens the door to the EU market but also serves as a mark of quality that can enhance customer trust. This certification process involves rigorous testing and assessment of the product's safety and performance.
From a regulatory perspective, Venus Concept's ability to secure the CE Mark in a timely manner following the US launch suggests an effective regulatory strategy and could be indicative of their commitment to global compliance and standards. This can be an important factor for investors as it reduces the regulatory risk associated with the company's international expansion plans.
TORONTO, Feb. 22, 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 the CE Mark from DEKRA Certification B.V. to market the Venus Versa Pro system in the European Union. This follows the Company’s announcement on November 1, 2023 regarding the commercial launch of the device in the United States.
The Venus Versa Pro incorporates Venus Concept’s latest advancements in fractional skin resurfacing, enabling enhanced ablation and coagulation to achieve optimal results when treating a wide range of skin conditions including acne scars, skin texture, and stretch marks. It also provides customers in the European Union the ability to incorporate these advancements into unique protocols like “Tribella”, offering a complete skin rejuvenation solution.
“Receiving the CE Mark for Venus Versa Pro reflects our continued commitment to bringing our latest and most innovative products to the international aesthetic markets in parallel with our restructuring efforts,” said Dr. Hemanth Varghese, President and Chief Operating Officer of Venus Concept. “Venus Versa Pro builds on the successful Venus Versa system, with over 2,200 systems installed globally. It is a multi-modal system that incorporates the breadth of Venus Concept’s technologies for clinicians to address the growing needs of the European customer.”
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, 2022. 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 Legacy, Venus Velocity, Venus Fiore, Venus Viva, Venus Glow, Venus Bliss, Venus BlissMAX, 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
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