TISSIUM has received De Novo authorization from the US Food and Drug Administration (FDA) for its COAPTIUM Connect system – the first and only FDA-cleared solution designed for atraumatic, sutureless peripheral nerve repair.

The decision marks the French MedTech company’s commercial entry into the US market and further validates the clinical potential of its programmable polymer platform, originally developed at the Massachusetts Institute of Technology (MIT) and Brigham and Women’s Hospital.

Peripheral nerve injuries affect hundreds of thousands of patients each year and are typically treated using microsurgical sutures – a method that can be technically demanding and carry risks such as additional trauma and inconsistent outcomes. COAPTIUM Connect is designed to overcome these limitations by providing a reproducible, sutureless alternative that supports nerve coaptation without puncturing or compressing the tissue.

In a recent study involving 12 patients with digital nerve injuries, the procedure achieved 100% technical success, with all patients regaining full flexion and extension in the affected digit and reporting no pain 12 months after surgery.

“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.”

The device integrates a bioresorbable, light-activated surgical polymer and a 3D-printed chamber to secure the ends of a severed nerve, promoting healing while reducing procedural complexity. It is used in conjunction with the company’s proprietary TISSIUM Light device to activate the bonding process.

Maria Pereira, co-founder and chief innovation officer at TISSIUM, said: “This first product illustrates the technical versatility and potential of the TISSIUM polymer platform—not only in nerve repair but also in broader applications like hernia and cardiovascular procedures.”

TISSIUM plans to launch the COAPTIUM Connect system in the US in the coming months.