Tissium has received FDA de novo marketing authorization for Coaptium Connect with Tissium Light, a groundbreaking solution for sutureless peripheral nerve repair. This marks the U.S. commercialization debut for the Paris-based company’s bioresorbable polymer platform.
Coaptium Connect is the first FDA-authorized system specifically designed for atraumatic, sutureless nerve coaptation, offering a reproducible and nerve-preserving alternative to traditional repair. Developed by MIT and Brigham & Women’s Hospital researchers, the system uses a light-activated polymer and a 3D-printed applicator.
In a recent clinical study of 12 patients, Coaptium Connect achieved 100% procedural success, with all patients regaining full finger motion and reporting no pain 12 months after surgery.
Tissium plans a commercial launch soon, with additional applications in hernia repair and cardiovascular sealing under development.
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