Tissium Secures FDA De Novo Clearance for Revolutionary Sutureless Nerve Repair System

Paris-based surgical sealant developer Tissium has achieved a significant milestone with the FDA de novo clearance of its innovative Coaptium Connect system for sutureless peripheral nerve repair. This groundbreaking technology marks Tissium's entry into the U.S. market and represents a major advancement in the field of nerve reconstruction.

A Novel Approach to Nerve Repair

The Coaptium Connect system utilizes a light-activated biopolymer platform, originally developed by researchers at MIT and Brigham & Women's Hospital. This atraumatic method for repairing nerves in the arms, hands, and legs eliminates the need for sutures or permanent materials, potentially revolutionizing the treatment of peripheral nerve injuries.

The system's core components include:

1. A 3D-printed implant that wraps around the severed nerve ends
2. A proprietary biopolymer delivered as a liquid
3. A light-curing mechanism to solidify the biopolymer in situ

As the implant dissolves over time, it allows the nerve ends to reconnect naturally, offering a less traumatic alternative to traditional microsurgical sutures.

Clinical Validation and Patient Outcomes

Tissium's clinical study, involving 12 patients with finger nerve injuries, demonstrated promising results:

• All procedures were successfully completed
• Patients exhibited full flexion and extension of the injured finger
• No pain was reported one year post-operation

These outcomes highlight the potential of the Coaptium Connect system to address the limitations of current nerve repair techniques, which often involve complex procedures and suboptimal results.

Strategic Implications and Future Directions

Christophe Bancel, Tissium's co-founder and CEO, emphasized the significance of this FDA clearance, stating, "This FDA marketing authorization validates over a decade of scientific and clinical commitment to developing next-generation solutions in tissue reconstruction."

The company views this achievement as a stepping stone for broader applications of its polymer platform. Maria Pereira, co-founder and chief innovation officer, noted, "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."

With hundreds of thousands of patients suffering from peripheral nerve injuries annually, Tissium's Coaptium Connect system represents a significant advancement in addressing this widespread medical challenge. As the company continues to expand its portfolio and explore new applications, it is poised to make substantial contributions to the field of tissue reconstruction and regenerative medicine.