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
$ \leq 50\% $.2 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.1
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.3 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.3 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.
“Today is more than a milestone—it’s proof that persistence, belief, and teamwork can turn a clinical need I’ve seen firsthand as a surgeon into a tangible solution that can change lives,” said Dr. Alex Woods, CEO-Founder of Newrotex and a Consultant Upper Limb Orthopaedic Surgeon.6 “I am deeply grateful to the first patient who placed their trust in us, to Dr. Ricardo Bermudez and the exceptional team at The Panama Clinic for achieving this world-first implantation, and to our partners and investors who share our unwavering commitment to patients.”
“The Panama Clinic is proud to be at the forefront of medical innovation by collaborating with Newrotex on this historic procedure,” said Dr. Ricardo Bermudez, the lead surgeon. “The SilkAxons™ device represents a significant leap forward, offering a new horizon of hope for patients who have historically faced limited and often inadequate treatment options. The procedure was seamless, and we are optimistic about the transformative potential of this technology.”
“We congratulate Newrotex on this landmark achievement, which exemplifies the power of a strategic global approach to clinical development,” said Julio G. Martinez-Clark, CEO of bioaccess. “This first-in-human success demonstrates how rigorous science, strong clinical leadership, and streamlined execution in Latin America can accelerate access to breakthrough technologies for patients worldwide while generating FDA/EMA-ready data.”
SilkAxons™ is a novel nerve repair platform engineered to support and guide regeneration across challenging peripheral nerve defects. Developed through interdisciplinary research spanning biomaterials, surgical practice, and translational science, SilkAxons™ is intended to expand the therapeutic window for patients with complex nerve injuries by providing an off-the-shelf solution that eliminates the need for donor nerve harvesting. The product is currently under clinical investigation; its safety and efficacy have not been established.
Newrotex Ltd. is a UK-based medical technology company headquartered in Oxford, dedicated to transforming outcomes in peripheral nerve repair.8 Founded by surgeon-innovator Dr. Alex Woods, Newrotex integrates surgical insight with advanced silk biomaterials and translational research to deliver next-generation solutions for patients with complex nerve injuries. The company is developing a pipeline of silk-based technologies for nervous system applications.7
The Panama Clinic is a leading, internationally accredited tertiary care hospital in Panama City, Panama, recognized for clinical excellence, patient-centric care, and medical innovation.10 As a premier medical center in Latin America, it offers a comprehensive range of advanced services and is a strategic destination for international clinical trials and medical tourism.12
bioaccess is a US-based contract research organization (CRO) that empowers MedTech, Biopharma, and Radiopharma innovators to accelerate first-in-human and early-phase clinical studies.4 Through its global network of clinical trial sites in Latin America, Eastern Europe, and Australia, bioaccess offers a proven model for achieving faster regulatory approvals, quicker patient enrollment, and significant cost savings, delivering high-quality, FDA/EMA-ready data.13
Innovate UK is the UK’s national innovation agency and part of UK Research and Innovation (UKRI).14 It supports business-led innovation across all sectors, technologies, and UK regions to drive productivity and economic growth by helping companies develop and commercialize new products, processes, and services.14