Evolus Inc. (NASDAQ: EOLS) announced the commercial launch of its Estyme injectable hyaluronic acid gel collection in Europe on May 16, marking the company's entry into the international dermal filler market.

The Estyme collection includes four injectable hyaluronic acid gels: Estyme Smooth and Estyme Form, currently marketed in the United States under the Evolysse brand, along with two new products, Estyme Lips and Estyme Sculpt. Estyme Sculpt is designed for restoring mid-face volume and is expecting U.S. FDA approval later this year.

The products are developed using Symatese's Cold-X technology, which the company states helps preserve the natural structure of the hyaluronic acid molecule. The commercial launch follows CE Mark certification under the European Medical Device Regulation.

"With the commercial launch of Estyme, we are entering a new phase of growth as a multi-product aesthetics company in Europe," said David Moatazedi, President and Chief Executive Officer of Evolus.

The European launch of Estyme Sculpt represents the first commercial availability of this mid-face volumizing product globally, ahead of the anticipated U.S. approval of Evolysse Sculpt later this year. The Estyme collection marks Evolus's second commercial aesthetics product internationally, following the launch of Nuceiva starting in 2022.

According to the company's press release, the Estyme collection has demonstrated clinical performance in U.S. pivotal studies, including non-inferiority and statistical superiority versus a comparator in head-to-head studies. The dermal filler category represents what the company describes as a significant opportunity, effectively doubling its addressable market outside the United States.