TISSIUM Receives FDA Authorisation for De Novo Sutureless Nerve Repair System

TISSIUM, a medical technology company specialising in biomorphic programmable polymers, has received De Novo marketing authorisation from the U.S. Food and Drug Administration (FDA) for its COAPTIUM® CONNECT with TISSIUM Light system. 

This approval allows the company to bring its first product to the United States market.

The COAPTIUM® CONNECT system is the first FDA-approved device specifically designed for atraumatic, sutureless peripheral nerve repair. 

It marks a significant step forward in the treatment of nerve injuries, which typically require complex microsurgical suturing. Traditional techniques often involve risks such as added trauma to the nerve and inconsistent surgical outcomes.

This newly authorised system uses a light-activated, bioresorbable surgical polymer combined with a 3D-printed chamber to enable nerve repair without the use of sutures. 

The approach is intended to maintain nerve integrity, reduce surgical complexity, and improve consistency in outcomes.

Clinical results from a recent study involving 12 patients with digital nerve injuries showed 100% procedural success. 

All participants recovered full movement in their injured fingers and experienced no pain 12 months after the procedure.

Developed using a proprietary biopolymer platform originally created at the Massachusetts Institute of Technology (MIT) and Brigham and Women’s Hospital, the system represents over ten years of scientific and clinical development.

The FDA’s approval of COAPTIUM® CONNECT underscores a key achievement for TISSIUM and highlights the promise of sutureless nerve repair. 

This development could change the standard of care for peripheral nerve injuries, offering a simpler and less invasive alternative for surgeons and improved outcomes for patients.