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Evolus Announces Commercial Launch of Estyme® Injectable Hyaluronic Acid Gels in Europe

EOLS
  • Evolus, Inc. announced the commercial launch of its injectable hyaluronic acid (HA) gel collection, Estyme ®, in Europe scheduled for May 16th, marking the company's entry into the international dermal filler market.
  • The Estyme ® collection includes four products: Estyme ® Smooth, Estyme ® Form, Estyme ® Lips, and the flagship Estyme ® Sculpt, with the latter expected to receive U.S. FDA approval later in 2026.
  • Estyme ® Smooth & Estyme ® Form are currently marketed in the United States under the brand name Evolysse ®, while Estyme ® Lips & Estyme ® Sculpt represent new introductions for the European market.
  • Estyme ® Sculpt is designed for mid-face volumizing & utilizes Symatese's Cold-X ® technology to preserve the natural structure of the HA molecule for long-lasting, natural-looking results.
  • The launch follows successful CE Mark certification under the European Medical Device Regulation (MDR), validating the safety, efficacy, & quality of the collection.
  • This launch represents Evolus' second commercial aesthetics product internationally, following the 2022 launch of Nuceiva ®, & expands the company's addressable market outside the United States.
  • Estyme ® Sculpt is the first commercial availability of this specific mid-face volumizing product globally, preceding the anticipated U.S. approval of Evolysse ® Sculpt.
  • Clinical studies in the U.S. demonstrated the collection's performance through non-inferiority & statistical superiority versus leading comparators in head-to-head trials.
  • CEO David Moatazedi stated the launch positions Evolus as a multi-product aesthetics company with a unique neurotoxin & filler portfolio in Europe.
  • Dr. Benji Dhillon highlighted the versatility of the gel range & the integrity-preserving technology as key factors for practitioner flexibility & patient outcomes.
  • The press release includes forward-looking statements regarding future product launches, regulatory approvals, & market growth projections based on management estimates.