Tissium announced today that it received FDA de novo marketing authorization for Coaptium Connect with Tissium Light.
The Paris-based company, which has its U.S. headquarters in Cambridge, Massachusetts, designed Coaptium Connect as a first-of-its-kind atraumatic sutureless solution for peripheral nerve repair.
According to Tissium, the authorization further validates its biopolymer platform and enables U.S. commercialization of its first product. The company says the de novo nod makes Coaptium Connect the only FDA-authorized system designed for atraumatic sutureless nerve coaptation.
“This FDA marketing authorization validates over a decade of scientific and clinical commitment to developing next-generation solutions in tissue reconstruction,” said Christophe Bancel, co-founder and CEO of Tissium. “Coaptium Connect is the first demonstration of the transformative potential of our polymer platform and an important step in making atraumatic tissue repair available to patients.”
More about the Tissium Coaptium Connect offering
Coaptium Connect addresses peripheral nerve injury challenges with a reproducible alternative. The system preserves nerve integrity and simplifies the coaptation process. It leverages a unique biopolymer platform invented by Maria Pereira, Jeffrey Karp and Robert Langer. They invented it at the MIT and Brigham & Women’s Hospital. The platform uses a bioresorbable, light-activated polymer and a 3D-printed polymer changer.
A recent study of 12 patients with digital nerve injuries saw 100% procedural success with Coaptium Connect. The study defined procedural success as successful atraumatic sutureless coaptation using the polymer-assisted coaptation device. All patients regained full flexion and extension of the injured digit, reporting no pain 12 months post-procedure.
Tissium plans to begin a launch for the offering in the coming months.
“This first product illustrates the technical versatility and the potential of the Tissium polymer platform, not only in peripheral nerve repair where other solutions are currently under development, but also in other surgical applications, such as atraumatic hernia repair and cardiovascular sealing,” said Pereira, Tissium’s co-founder and chief innovation officer.
