The surgical sealant developer Tissium obtained a groundbreaking FDA clearance for its method of reconnecting severed nerves, without the use of sutures or permanent materials.
The Paris-based company’s atraumatic method for repairing nerves in the arms, hands and legs employs a light-activated biopolymer platform, first invented by researchers at MIT and Brigham & Women’s Hospital.
The Coaptium Connect system includes a 3D-printed implant that wraps around the two nerve ends, which are held in place by the biopolymer—delivered as a liquid and then cured inside the body using light. The nerve ends reconnect over time as the implant dissolves away.
The agency’s de novo clearance for sutureless peripheral nerve repair marks Tissium’s first greenlight in the U.S.; the company—and former Fierce Medtech Fierce 15 winner—previously obtained a CE Mark in Europe for its surgical sealant, Setalum, in 2017 when it went by the name Gecko Biomedical.
“This FDA marketing authorization validates over a decade of scientific and clinical commitment to developing next-generation solutions in tissue reconstruction,” Tissium’s co-founder and CEO, Christophe Bancel, said in a statement. “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.”
According to the company, hundreds of thousands of patients suffer peripheral nerve injuries annually, which are typically repaired with microsurgical sutures—a complex procedure with less-than-perfect outcomes that carries risks of introducing additional trauma.
A clinical study of 12 patients with injuries to nerves in their fingers saw all procedures successfully completed, Tissium said, with all participants demonstrating full flexion and extension of the injured finger and no pain reported at one year after the operation.
“This first product illustrates the technical versatility and the potential of the Tissium polymer platform, not only in peripheral nerve repair where other solutions are currently under development, but also in other surgical applications, such as atraumatic hernia repair and cardiovascular sealing,” said Maria Pereira, co-founder, co-inventor and chief innovation officer.