Evolus Announces Commercial Launch of Estyme® Injectable Hyaluronic Acid Gels in Europe
The Estyme® collection includes four injectable HA gels that will cover a wide range of applications. The collection includes Estyme® Smooth and Estyme® Form, which are currently marketed in
The commercial launch follows the successful CE Mark certification under the European Medical Device Regulation (MDR), one of the most stringent regulatory frameworks globally, validating the safety, efficacy, and quality of the Estyme® collection.
“With the commercial launch of Estyme®, we are entering a new phase of growth as a multi-product aesthetics company in Europe,” said
Dr.
Estyme® marks the company’s second commercial aesthetics product internationally, following the successful launch of Nuceiva® starting in 2022. The European launch of Estyme® Sculpt is particularly significant, as it represents the first commercial availability of this mid-face volumizing product globally, ahead of the anticipated
In addition to Estyme® Sculpt, the Estyme® collection includes three complementary injectable HA gels: Estyme® Form, Estyme® Smooth, and Estyme® Lips. Together, the portfolio provides practitioners with a comprehensive set of products to deliver tailored, natural-looking aesthetic outcomes across multiple indications.
The Estyme® collection, branded as Evolysse® in the
The dermal filler category represents a significant opportunity for
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Forward-Looking Statements
This press release contains forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, including statements about future or anticipated events, our business, financial condition, results of operations and prospects, our industry and the regulatory environment in which we operate. Any statements contained herein that are not statements of historical or current facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, or other comparable terms intended to identify statements about the future. The company’s forward-looking statements include, but are not limited to, statements related to anticipated product launches; market and revenue growth; the expected benefits of anticipated product launches, regulatory approvals and the company's injectable HA gel portfolio; the company's competitive positioning and market leadership expectations; the company's global commercial expansion strategy; and the anticipated clinical performance and market reception of its products.
The forward-looking statements included herein are based on our current expectations, assumptions, estimates and projections, which we believe to be reasonable, and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. These risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond our control, include, but are not limited to uncertainties associated with our ability to comply with the terms and conditions in the Medytox Settlement Agreements, our ability to fund our future operations or obtain financing to fund our operations, our reliance on consumer discretionary spending, unfavorable global economic conditions including trade disputes, tariffs and regulatory actions on imports, uncertainties related to customer and consumer adoption of Jeuveau® and Estyme ®/Evolysse®, the efficiency and operability of our digital platform, competition and market dynamics, our ability to successfully launch and commercialize our products in new markets, including the Evolysse® Hyaluronic Acid (HA) gels in the
Jeuveau®, Nuceiva®, and Evolysse® are registered trademarks of
Estyme® and Cold-X ® are registered trademarks of Symatese Aesthetics S.A.S.
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