Miami, FL – July 7, 2025 – Newrotex Limited, a UK-based biotech company pioneering silk-based medical solutions, has received regulatory approval for its first-in-human clinical trial of SilkAxons™, an advanced bioengineered nerve guide designed 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 organization (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
SilkAxons™ represents a paradigm shift in treating peripheral nerve damage. Unlike traditional solutions such as autografting, which involves harvesting healthy nerve tissue and often yields ≤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.
“This regulatory approval validates our technology and fast-tracks our mission to transform peripheral nerve repair,” said Dr. Alex Woods, Founder and CEO of Newrotex. “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
Newrotex selected Panama for its streamlined regulatory processes and clinical excellence. The trial was approved in just 14 days—significantly faster than traditional pathways in the U.S. or EU, which can take up to 12 months.
bioaccess®, known for its 40% faster approval timelines and deep expertise in early-stage Medtech trials, will oversee regulatory compliance, site activation, and data management.
“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.”
"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," said Julio G. Martinez-Clark, CEO and co-founder of bioaccess®. "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."
Panama: A Rising Medtech Hub
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.
“Our facilities at The Panama Clinic and our collaboration with world-class partners like Newrotex and bioaccess® make Panama a catalyst for global Medtech advancement,” said Dr. Ricardo Bermudez, Principal Investigator for the study. “This approval validates Panama's position as a strategic gateway for Medtech innovation entering global markets," said Dr. Pedro Martinez-Clark, Co-Founder and Medical Advisor to bioaccess®. "We continue demonstrating that Latin America offers world-class research capabilities, accelerated timelines, and cost-effective pathways for bringing revolutionary medical technologies to patients worldwide."
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 U.S., Europe, and beyond. The results are expected to support regulatory filings and ultimately accelerate the pathway to commercial availability of SilkAxons™.
“We’re proud to lead the charge in nerve regeneration science,” concluded Dr. Woods. “Our mission is to restore lives—and this trial is just the beginning.”
About Newrotex Limited
Newrotex is a biotechnology company based in Oxford, UK, focused on developing silk-based medical technologies for the nervous system. Its flagship product, SilkAxons™, is designed to enable long-gap nerve regeneration without the need for autografts. Founded by leading researchers from the University of Oxford, Newrotex aims to revolutionize nerve repair and improve outcomes for patients worldwide.
Acerca de bioaccess
bioaccess® is Latin America's premier first-in-human contract research organization, specializing in accelerated clinical trial pathways for early-stage medical device companies. Founded in 2010 and headquartered in Miami with operations across Latin America, Eastern Europe, and Australia, bioaccess® has supported over 100 startups in achieving successful market entry through its comprehensive clinical trial management services. The company's expertise spans regulatory approval, site activation, patient recruitment, and trial data management, consistently delivering 40% faster approvals and 30% cost reductions compared to traditional markets.