Newrotex Achieves World-First Implantation of SilkAxons™ Nerve Repair Technology, Pioneering a New Frontier for Large-Gap Peripheral Nerve Injuries
Oxford, UK and Panama City, Panama — Newrotex Ltd., an Oxford-based medical technology company, today announced the successful first-in-human implantation of its flagship nerve repair technology, SilkAxons™. The procedure marks a world-first for a technology designed to bridge large peripheral nerve gaps beyond the capabilities of currently available solutions. The procedure was performed by the surgical team led by Dr. Ricardo Bermudez at The Panama Clinic, a leading international hospital, representing a pivotal milestone for patients with complex and debilitating nerve injuries.
Peripheral nerve injuries affect an estimated 1.5 million people worldwide each year, often resulting from trauma or cancer surgery and leading to chronic pain, loss of function, and permanent disability.1 The current gold standard for repairing large nerve gaps is autografting, a painful procedure that involves sacrificing a healthy nerve from another part of the patient’s body and often yields functional recovery rates of SilkAxons™ is a patented, off-the-shelf bioengineered nerve guide that utilizes advanced silk-based biomaterials to create a scaffold for regeneration. It is engineered to bridge nerve gaps of up to 10 centimeters, more than triple the reach of current FDA-approved nerve conduits, thereby eliminating the need for a donor nerve.
This first-in-human implantation was completed as part of a clinical trial strategically managed by bioaccess®, a US-based contract research organization (CRO) specializing in accelerating clinical studies in Latin America. Newrotex selected Panama for its streamlined regulatory pathway, which enabled clinical trial approval just two weeks after submission, demonstrating a capital-efficient approach to generating crucial safety and feasibility data for future global submissions. Newrotex acknowledges the vital support of Innovate UK, the UK’s national innovation agency, its Board of Directors, and a global group of investors and collaborators who have been instrumental in reaching this landmark achievement.
