The US Food and Drug Administration (FDA) has granted de novo marketing authorisation to TISSIUM’s COAPTIUM CONNECT, representing the first atraumatic option for repairing peripheral nerve damage.
Tissium’s Coaptium Connect comprises a 3D-printed chamber and a liquid polymer which affixes to the nerve. After activation with light and removal of silicon accessories, the nerve grows and attaches inside the chamber. The chamber itself is bioresorbable, meaning no implant is left permanently.
Current approaches to treat nerve damage use sutures, which can damage tissue and impair long-term nerve repair. Additionally, sutures may not be suitable for all types of nerve injury, and operations are complex and subsequently require significant training.
Tissium’s CEO Christophe Bancel told Medical Device Network: “Nerve repair options are pretty broad and with limited innovations in the last few years, and we believe that with our technology, we will be able to bring this area to a new age.”
Tissium, which is headquartered in France, plans to initiate commercial rollout of Coaptium Connect in the coming months.
Tissium’s platform, which does not use sutures at any stage of the procedure, gives it an edge over currently marketed products. BioCircuit’s Nerve Tape, which received FDA clearance in 2022, signalled a shift away from sutures, using a tape lined with miniature hooks. Although this removed much of the trauma seen with traditional approaches, it is still not completely atraumatic. Orthocell won FDA clearance for a collagen-based wrap, branded as Remplir, though this is designed to help reduce suture requirements during surgery.
Tissium highlighted results from a clinical study reported in April in which Coaptium Connect was used on 12 patients with digital nerve injuries. Participants achieved 100% procedural success, defined as successful atraumatic sutureless coaptation, with all patients regaining full flexion and extension of the injured digit and reporting no pain a year after the procedure.
According to Orthocell, the global nerve repair market is estimated to be worth more than $3.5bn.
Bancel told Medical Device Network that the simplicity of the company’s technology means it can have wide-ranging applications beyond peripheral nerve repair. Tissium, which has raised over €170m ($197m) since its founding in 2013, is targeting broadening horizons into hernia repair and cardiovascular sealing.
“We believe that our technology has the potential to transform how surgeries are performed. We are going where we can have an impact. Today, we have seven products in development, and those seven products in three domains represent a total addressable market of $4.5bn,” Bancel said.
Editor’s note: This article was updated shortly after publication to correct the location of the company’s headquarters.
“TISSIUM wins FDA approval for sutureless nerve repair platform” was originally created and published by Medical Device Network, a GlobalData owned brand.
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