FDA grants de novo clearance to TISSIUM for their COAPTIUMĀ® CONNECT device in non-traumatic, sutureless peripheral nerve repair.
In a significant milestone for the MedTech industry, TISSIUM, a clinical and commercial stage company specializing in tissue restoration solutions, has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for their COAPTIUMĀ® CONNECT System. This authorization marks TISSIUM's entry into the U.S. market.
Founded in 2013, TISSIUM is built on breakthrough research and intellectual property originating from the laboratories of Professor Robert Langer (MIT) and Professor Jeffrey M. Karp (Brigham and Women's Hospital). The company, headquartered in Paris, France, with additional locations in Cambridge, USA, and a manufacturing site in Roncq, France, is led by Dr. Stephane Bancel as CEO, and Maria Pereira as Co-Founder and Chief Innovation Officer.
The COAPTIUMĀ® CONNECT System is the only FDA-authorized system designed for atraumatic sutureless nerve coaptation. This first-of-its-kind atraumatic sutureless solution for peripheral nerve repair addresses limitations of traditional microsurgical sutures by offering a reproducible, atraumatic sutureless alternative.
In a clinical study on 12 patients with digital nerve injuries, COAPTIUMĀ® CONNECT achieved 100% procedural success. All patients regained full flexion and extension of the injured digit and reported no pain 12 months after the procedure. These promising results are currently submitted for publication in 2025, in a study titled "A Sutureless Approach to Nerve Repair: Results from a Clinical Study in Digital Nerves."
Maria Pereira, Co-Founder and Chief Innovation Officer, believes the TISSIUM polymer platform has potential in other surgical applications beyond peripheral nerve repair. The biopolymer platform includes a bioresorbable light-activated surgical polymer and a 3D-printed polymer chamber, which are key components of the COAPTIUMĀ® CONNECT System.
Christophe Bancel, Co-Founder and CEO of TISSIUM, stated that this authorization validates over a decade of scientific and clinical commitment. TISSIUM's diversified pipeline is designed to optimize tissue repair through controlled and consistent procedures with specialized delivery and activation devices. The pipeline includes seven products across three core verticals: sutureless nerve repair, atraumatic hernia repair, and cardiovascular sealants.
TISSIUM plans to initiate commercial rollout of COAPTIUMĀ® CONNECT in the coming months. This entry into the U.S. market is a significant step forward for TISSIUM, as they continue to revolutionize the field of tissue restoration solutions.
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