Evolus Announces EU Approval of Estyme® Injectable Hyaluronic Acid Gels Under New Medical Device Regulation [Yahoo! Finance]
Evolus, Inc. (EOLS)
Last evolus, inc. earnings: 2/25 07:00 am
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US:NASDAQ Investor Relations:
us.evolis.com/investor-relations
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Source: Yahoo! Finance
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 billion 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 acros
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