Evolus Announces EU Approval of Estyme® Injectable Hyaluronic Acid Gels Under New Medical Device Regulation

Rhea-AI Summary

Evolus (NASDAQ: EOLS) has received EU Medical Device Regulation certification for four Estyme® injectable hyaluronic acid gels, marking its entry into the dermal filler segment. This certification doubles the company's addressable market outside the U.S. to $1.8 billion. The products, branded as Evolysse™ in the U.S., utilize proprietary cold technology and breakthrough cross-linking technology. Evolus plans a experience program with select physicians in Europe, followed by a broader launch in the second half of 2025. U.S. approval and launch of Evolysse™ remains on track for 2025.

Positive

• EU MDR certification received for four injectable HA gels
• Doubles addressable market outside U.S. to $1.8 billion
• First innovation breakthrough in a decade with proprietary cold technology
• On track for U.S. approval and launch in 2025

Negative

• Broader European launch delayed until second half of 2025
• Initial launch to select physician partners

Insights

Medical Device Regulatory Expert

The EU MDR certification for Estyme® injectable HA gels represents a significant regulatory achievement that opens up a $1.8 billion addressable market opportunity outside the U.S. The new MDR process, implemented in 2021, sets substantially higher bars for safety and efficacy compared to the previous CE marking system. The approval of four unique formulations demonstrates robust clinical data and manufacturing standards.

The proprietary cold technology and novel cross-linking approach represents the first major innovation in HA fillers in 10 years. This positions Evolus competitively in the premium segment of the European aesthetics market. The staged launch approach, starting with a experience program, aligns with best practices for medical device commercialization and will help optimize the full commercial rollout planned for H2 2025.

Market Research Analyst

This approval represents a major commercial catalyst for Evolus by doubling their addressable market and diversifying beyond their current neurotoxin focus. The dermal filler market is highly profitable with strong margins and recurring revenue potential. The strategic decision to target the premium segment with innovative technology could drive higher price points and margins compared to existing options.

The phased launch approach through 2025 allows for careful market positioning and relationship building with key opinion leaders. While revenue impact won't be immediate, this expansion significantly strengthens Evolus's long-term growth trajectory and competitive position in the global aesthetics market.

NEWPORT BEACH, Calif.--(BUSINESS WIRE)-- Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today announced the EU Medical Device Regulation (MDR) certification was received for four unique injectable hyaluronic acid (HA) gels under the brand name Estyme^® (pronounced “esteem”), 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 $1.8 billion¹.

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.”

Dr. Rui Avelar, Chief Medical Officer and Head of R&D, added, “We are proud that Estyme^® has achieved CE Mark certification under the MDR’s stringent standards, which reflects a commitment to the highest standards of patient safety and product efficacy. Estyme^® is a differentiated line of injectable HA gels currently being studied globally and the first innovation breakthrough, with proprietary cold technology, in a decade. These gels utilize breakthrough cross-linking technology that better preserves the natural HA chain, which we believe will help distinguish it from other products in this category. Designed with the highest level of precision to meet the needs of both practitioners and patients, we look forward to seeing its positive impact on the European aesthetic market.”

The company remains on track for the U.S. approval and launch of the Evolysse^™ injectable HA gels beginning in 2025.

About Evolus, Inc.

Evolus (NASDAQ: EOLS) is a global performance beauty company evolving the aesthetic neurotoxin market for the next generation of beauty consumers through its unique, customer-centric business model and innovative digital platform. Our mission is to become a global, multi-product aesthetics company based on our flagship product, Jeuveau^® (prabotulinumtoxinA-xvfs), the first and only neurotoxin dedicated exclusively to aesthetics and manufactured in a state-of-the-art facility using Hi-Pure™ technology. Evolus is expanding its product portfolio having entered into a definitive agreement to be the exclusive U.S. distributor of Evolysse^™, and the exclusive distributor in Europe of Estyme^®, a line of unique injectable hyaluronic acid (HA) gels. These injectable HA gels are currently in the late stages of the regulatory approval process, with plans, upon approval, for a launch starting in 2025. Visit us at www.evolus.com, and follow us on LinkedIn, X, Instagram or Facebook.

Jeuveau^® and Nuceiva^®, are registered trademarks and Evolysse^™ is a trademark of Evolus, Inc.
Hi-Pure^™ is a trademark of Daewoong Pharmaceutical Co, Ltd.
Estyme^® is a trademark of Symatese Aesthetics S.A.S.

¹ Source: Medical Insights Dermal Filler Market Study, March 2023 (www.miinews.com) and Aesthetic Injectables | Market Insights | Europe 2024 © 2023 Clarivate

View source version on businesswire.com: https://www.businesswire.com/news/home/20241031746242/en/

Investors:

Nareg Sagherian, Vice President, Head of Global Investor Relations and Corporate Communications

Phone: (248) 202-9267

Email: ir@evolus.com

Media:

Email: media@evolus.com

Source: Evolus

FAQ

When did Evolus (EOLS) receive EU approval for Estyme® injectable gels?

Evolus recently received EU Medical Device Regulation (MDR) certification for Estyme® injectable hyaluronic acid gels, as announced in their latest press release.

What is the market size opportunity for Evolus (EOLS) with Estyme® approval?

The EU approval doubles Evolus's addressable market outside the U.S. to $1.8 billion.

When will Evolus (EOLS) launch Estyme® in Europe?

Evolus plans a experience program initially, followed by a broader European launch in the second half of 2025.

What is the difference between Estyme® and Evolysse™ for Evolus (EOLS)?

Estyme® is the brand name for the European market, while Evolysse™ is the same product branded for the U.S. market.