Newrotex has announced the successful first-in-human implantation of its SilkAxons™ nerve repair technology. The procedure, performed at The Panama Clinic by Dr. Ricardo Bermudez and his surgical team, is the first use of a silk-based bioengineered nerve guide designed to bridge large peripheral nerve gaps beyond the reach of currently available solutions.
Peripheral nerve injuries impact approximately 1.5 million people globally each year, commonly resulting from trauma or cancer surgery and often leading to chronic pain, loss of function, or permanent disability. Existing standard treatments, such as autografting (transplanting a healthy nerve from elsewhere in the patient’s body), can be painful and may not always result in full functional recovery.
SilkAxons™ is an off-the-shelf, patented nerve guide that uses silk-based biomaterials to create a scaffold for nerve regeneration. According to Newrotex, the device is engineered to bridge nerve gaps up to 10 centimeters—over three times longer than current FDA-approved nerve conduits—without the need for donor nerve tissue.
This initial implantation took place as part of a clinical trial managed by bioaccess®, a US-based contract research organization (CRO) specializing in clinical studies in Latin America. Newrotex reports that Panama’s streamlined regulatory process enabled trial approval within two weeks of submission, helping generate early safety and feasibility data for future global regulatory submissions. The company credits support from Innovate UK, its board, and its network of investors and collaborators for reaching this milestone.
Want to keep up on regenerative medicine? Get the weekly newsletter here.
