Evolus Secures EU Approval for Estyme® Injectable Gels
Evolus Announces Exciting Milestone with Estyme® Gels in Europe
In an exciting development for the beauty industry, Evolus, Inc. (NASDAQ: EOLS) has announced the receipt of EU Medical Device Regulation (MDR) certification for its unique injectable hyaluronic acid gel line, branded as Estyme® (pronounced "esteem"). This groundbreaking achievement empowers Evolus to enter the lucrative dermal filler sector, doubling its market potential to a staggering $1.8 billion.
Significance of CE Mark Certification
The certification process marked by the CE Mark signifies rigorous standards ensuring the safety, quality, and efficacy of medical devices throughout Europe. Evolus's Estyme® gels embody these high standards, establishing the necessary credibility for effective distribution. To strategically introduce Estyme®, Evolus will initiate a limited experience program working closely with selected physician partners.
Collaborative Launch Plan
This limited experience program serves a dual purpose: it allows leading aesthetic practitioners to provide valuable insights while fostering a collaborative environment in Europe. These insights are crucial for refining the broader launch strategy, which is expected to unfold in the latter half of 2025. This approach not only demonstrates Evolus's commitment to quality but also shows its dedication to understanding practitioners’ needs.
Impact on Aesthetic Treatments
David Moatazedi, Evolus's President and CEO, emphasized the importance of this certification, stating, “We are poised to bring a new level of excellence to the dermal filler category, meeting the rising consumer demand for high-quality, cash-pay aesthetic treatments.” This sentiment captures the essence of Evolus's innovative spirit and commitment to enhancing the beauty experience.
Estyme®: A Revolutionary Product
Dr. Rui Avelar, Chief Medical Officer, highlighted that Estyme® stands out due to its advanced technology. The proprietary cold technology utilized in these gels is the first innovation of its kind in a decade, promising to set a new standard in the injectable HA gel market. This cutting-edge cross-linking technology not only preserves the natural hyaluronic acid (HA) chains but also ensures a superior product design made with precision.
Focus on Patient Safety and Efficacy
As the aesthetic market evolves, consumer safety remains paramount. With Estyme®, Evolus is deeply committed to creating a product that prioritizes patient safety and efficacy, providing practitioners and patients with confidence in its use.
Looking Ahead: U.S. Approval on the Horizon
Evolus is also making strides in the U.S. market, aiming to secure approval for the Evolysse™ line of injectable HA gels. The anticipated launch is set to commence in 2025, presenting another significant step in Evolus's growth strategy to expand their aesthetic offerings.
About Evolus, Inc.
Evolus (NASDAQ: EOLS) is dedicated to revolutionizing the performance beauty sector, particularly the aesthetic neurotoxin market. With a focus on merging innovation with customer-centric solutions, Evolus is expanding its product portfolio, including the exclusive U.S. distribution of Evolysse™ and the distinguished Estyme® in Europe. As they progress, Evolus aims to reshape beauty aesthetics, enhancing the experiences of both practitioners and clients.
Jeuveau® (prabotulinumtoxinA-xvfs) remains their flagship product, marking Evolus's commitment to excellence in aesthetic solutions. Follow Evolus's journey as they pave the way for the next generation of beauty consumers, focusing on quality and broadening their reach through exciting partnerships.
Frequently Asked Questions
What is the significance of the Estyme® approval for Evolus?
The EU approval allows Evolus to expand into the dermal filler market, significantly increasing their addressable market potential.
What innovative technology is used in Estyme® gels?
Estyme® utilizes proprietary cold technology and advanced cross-linking technology to enhance product performance and safety.
When can we expect the broader launch of Estyme® in Europe?
A broader launch of Estyme® is planned for the latter half of 2025.
What are Evolus's plans for the U.S. market?
Evolus is on track for the U.S. approval and plans to launch their Evolysse™ injectable gels beginning in 2025.
How does Evolus ensure product safety and efficacy?
Through rigorous certification processes and advanced technology, Evolus prioritizes patient safety and product efficacy in all its offerings.
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