Evolus says Estyme receives EU Medical Device Regulation certification

Evolus (EOLS) announced the EU Medical Device Regulation certification was received for four unique injectable hyaluronic acid gels under the brand name Estyme, branded as Evolysse in the U.S. market. This certification marks a key regulatory milestone for Evolus, enabling it to commercially enter the dermal filler segment and doubling its addressable market outside the U.S. to $1.8B. The CE Mark certification, through the new MDR process represents more stringent requirements, designed to ensure the safety, efficacy, and quality of medical devices sold in Europe. Achieving this certification demonstrates that the Estyme injectable HA gels meet the highest standards for product design, production, and performance. Evolus will introduce Estyme through a limited experience program with select physician partners. The limited experience program will allow Evolus to collaborate with leading aesthetic practitioners across Europe, gathering valuable insights to refine its broader launch strategy. A broader European launch is planned for the second half of 2025. “The MDR CE Mark certification for Estyme, is a critical milestone in our strategic path to expand our product portfolio and reflects our commitment to delivering high-quality gels that adhere to the most rigorous regulatory standards,” said David Moatazedi, President and Chief Executive Officer. “With Estyme, we are bringing a new level of excellence to the dermal filler category, as we grow our product portfolio to meet growing consumer demand for premium, cash-pay aesthetic treatments.” The company remains on track for the U.S. approval and launch of the Evolysse injectable HA gels beginning in 2025.