Following the agreements established with EVOLUS in 2023, we are pleased to announce the submission of the final module of the Premarket Approval Application (PMA, to the U.S. FDA for the wrinkle fillers EVOLYSSE™ LIFT and EVOLYSSE™ SMOOTH for the nasolabial fold (NLF), with approval expected in the second half of 2025.
This submission is based on the results of the U.S. pivotal study, which evaluated the safety and efficacy of the products in a multicenter, blinded, split face, controlled trial designed to demonstrate non-inferiority to a control treatment. Patients were followed for 12 months from initial treatment. A total of 140 patients were recruited and divided equally between two experimental groups. Patients were randomized to receive EVOLYSSE™ LIFT or EVOLYSSE™ SMOOTH in one NLF and Restylane-L in the contralateral NLF.
To access the EVOLUS press release, click here
About SYMATESE www.symatese.com
SYMATESE is a private held French company that designs, engineers and manufactures regenerative medical solutions based on its innovative technology platforms. SYMATESE has a unique and combined expertise in the field of hyaluronic acid and injection systems and is well known for the development of the latest generation of Restylane® products in the United States based on XpresHAn / OBT Technology™. During the last 25 years, SYMATESE had a rich history in developing numerous products for aesthetic and therapeutic purposes; SYMATESE has developed its next-generation HA filler product, based on a pioneering crosslinking technology named COLD-X TECHNOLOGY by SYMATESE™ that better preserves hyaluronic acid chains and aims to improve product performance and safety for the benefit of practitioners and their patients, supported by robust clinical data. SYMATESE entered into exclusive Licensing Agreement with EVOLUS for the marketing of its Next-Generation Dermal Fillers respectively in May and December 2023 for the US market and Europe while EVOLUS neurotoxin, NUCEIVA® will be marketed in France by SYMATESE subsidiary
