Movmedix Wins FDA Nod for LARS ACJ System

Movmedix, the French company behind the LARS synthetic ligament platform, has obtained U.S. Food and Drug Administration (FDA) clearance for the LARS ACJ (acromioclavicular joint) system.

LARS ACJ is a third-generation synthetic implant made from biocompatible polyethylene terephthalate (PET). The knitted surgical scaffold is meant to provide fixation during the healing process after syndesmostic trauma, like fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

Though the first clearance targets ACJ injuries, Movmedix said it also marks the U.S. arrival of an established ligament technology. The platform has transformed ligament reconstruction and reinforcement for many anatomical indications for over 30 years.

The company said it’s preparing for U.S. market entry though a phased commercial strategy. It will establish local presence and build partnerships to support adoption, while working with leading orthopedic surgeons and sports medicine specialists to progress clinical education and market development.

Movmedix said it plans to begin broader regulatory moves by submitting additional products from the LARS portfolio to the FDA.

“Mobility is one of the greatest determinants of long-term health and quality of life,” said CEO Hervé Legrand. “Receiving our first FDA clearance validates years of investment in clinical science, manufacturing excellence and regulatory expertise. More importantly, it allows us to bring decades of French innovation in ligament reconstruction and reinforcement to American surgeons and their patients.”

“Our ambition is not simply to enter the U.S. market,” Legrand went on. “Our ambition is to contribute to the future of ligament reconstruction by combining French engineering excellence with scientific evidence and close collaboration with surgeons worldwide.”