Evolus Secures EU Certification to Launch Estyme® Injectable Hyaluronic Acid Gels in Europe

Evolus Expands Market Reach with New Injectable Hyaluronic Acid Gels

Evolus, Inc., a performance beauty company renowned for its focus on aesthetic consumer brands, marks a significant milestone in its growth strategy by securing EU Medical Device Regulation (MDR) certification for its injectable hyaluronic acid (HA) gels, branded as Estyme®. This certification opens the door for Evolus to commercially enter the dermal filler segment, expanding its addressable market outside the U.S. to an estimated $1.8 billion. The CE Mark certification, which Evolus has achieved through a rigorous MDR process, ensures that the company's medical devices meet stringent safety, efficacy, and quality standards required for sale in Europe.

The introduction of Estyme® will initially take place through a limited experience program in collaboration with select physician partners. This strategic move allows Evolus to gather valuable insights and feedback before a wider market launch, which is anticipated in the latter half of 2025. David Moatazedi, the President and CEO of Evolus, underscores this achievement as a testament to the company's unwavering commitment to delivering high-quality products that adhere to rigorous regulatory requirements. The certification not only reinforces Evolus's brand credibility but also positions it competitively in the European aesthetic market.

Moreover, the innovation behind Estyme® is noteworthy. Dr. Rui Avelar, Chief Medical Officer and Head of R&D at Evolus, emphasizes that the product leverages proprietary cold technology and advanced cross-linking techniques to enhance the natural HA chain. This unique formulation sets Estyme® apart from existing competitors in the dermal filler market. With plans for U.S. approval and launch of Evolysse™, the injectable HA gels are set to debut in 2025, further solidifying Evolus's ambition to transform the aesthetic neurotoxin market for a new generation of beauty consumers.

In addition to its product development, Evolus continues to focus on a customer-centric approach, integrating innovative digital platforms that cater to the evolving needs of beauty consumers. This strategic direction not only enhances consumer engagement but also positions Evolus as a leading global multi-product aesthetic company.

Evolus is on a promising path, with both European and U.S. market entries for its innovative HA gels on the horizon. As the company gears up for these launches, it aims to redefine the standards in aesthetic beauty, ultimately enhancing the consumer experience in the rapidly growing dermal filler market.