Approval for first-in-human trial of nerve regeneration technology using spider silk

27 July 2025

Newrotex, based at The Oxford Science Park, has received regulatory approval for its first-in-human clinical trial of SilkAxons™, an advanced bioengineered nerve guide which uses the silk of spiders to repair severe peripheral nerve injuries.

The trial will be conducted at The Panama Clinic in Panama City, with bioaccess®, Latin America’s leading first-in-human contract research organisation (CRO), managing regulatory and clinical operations.

This approval - secured just two weeks after ethics board submission - marks a critical milestone in the global development of SilkAxons™, positioning Newrotex at the forefront of next-generation nerve regeneration therapies.

A breakthrough for patients with severe nerve injuries

Newrotex’s product represents a paradigm shift in treating peripheral nerve damage. Unlike traditional solutions such as autografting, which involves harvesting healthy nerve tissue and often yields less than 50% recovery rates with significant complication risks, SilkAxons™ uses silk from spiders to bridge nerve gaps of up to 10 centimetres -more than triple the reach of current FDA-approved devices.

Preclinical studies have shown that SilkAxons™ supports superior axonal regeneration, offering hope to the estimated 1.5 million patients worldwide who suffer from debilitating nerve injuries each year.

Dr Alex Woods, founder and CEO of Newrotex, said: “This regulatory approval validates our technology and fast-tracks our mission to transform peripheral nerve repair. We're thrilled to partner with bioaccess® and The Panama Clinic to bring this first-in-human study to life and generate critical safety and efficacy data.”

Strategic trial location and expert clinical partnership

With access to diverse patient populations, internationally accredited hospitals, and cost-effective clinical services, Panama is rapidly emerging as a strategic destination for medical innovation.

Newrotex selected Panama for its streamlined regulatory processes and clinical excellence. “Panama’s efficient regulatory system and bioaccess®'s proven expertise create an ideal launchpad for transformative technologies like SilkAxons™,” added Dr Woods. “This collaboration accelerates our global development roadmap, including future submissions to the FDA and EMA.”

Julio G. Martinez-Clark, CEO and co-founder of bioaccess®, said: "Securing this approval in just two weeks after submission is a testament to Panama's world-class research infrastructure and bioaccess®'s unparalleled expertise in accelerating Medtech innovation. We're proud to partner with Newrotex to bring this potentially life-changing therapy to patients while demonstrating how Latin America continues to lead in early-stage clinical development."

Addressing a critical unmet need

Peripheral nerve injuries are among the most challenging conditions in modern medicine, often resulting in permanent disability, chronic pain, and loss of function. SilkAxons™ aims to eliminate the need for donor nerve tissue and enable immediate, off-the-shelf treatment options.

“This trial represents a beacon of hope for patients facing life-altering nerve damage,” concluded Dr Martinez-Clark, “Newrotex’s innovation could redefine standards of care worldwide.”

Looking ahead

This study will generate foundational data for Newrotex’s global clinical strategy and pave the way for pivotal trials in the US, Europe, and beyond. The results are expected to support regulatory filings and ultimately accelerate the pathway to commercial availability of SilkAxons™.

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