Breakthrough spider silk nerve guide set to transform peripheral nerve repair; clinical trial to launch at The Panama Clinic with bioaccess® as CRO partner Newrotex Limited 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 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.” “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.” 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.”
The article describes some of the incredible uses of silk and the work we’re doing to bring a new standard of treatment for patient’s who have suffered catastrophic nerve injuries. Check out the article on the University of Oxford website here: https://oxford.shorthandstories.com/spiders-surgery-and-sustainable-silk/index.html
The finalists for the “Value Award” are selected by large strategics, entrepreneurs and investors to showcase the companies bringing a great value proposition with their technology. Following the great response from the recent presentation at the American Society of Plastic Surgeons (ASPS) conference, this is further recognition of the value of our silk repair technology and the huge impact it will have on patients lives. Read the full press release here: https://medtechinnovator.org/medtech-innovator-announces-finalists-of-inaugural-2023-mid-stage-competition/. We’re looking forward to the competition at the MedTech Strategist Innovation Summit in San Francisco.
Newrotex wins a prize in Austin, Texas at the American Society of Plastic Surgeons (ASPS) 92nd Annual Plastic Surgery The Meeting! Newrotex was selected by the ASPS Plastic Surgery Accelerator powered by MedTech Innovator, and featured as one of 5 best-in-class startups: Newrotex Ltd, ImmersiveTouch, Fingy3D, 4th Dimension EMR, Inc and Cellulora. The culmination of the program was a live competition at the plastic surgery annual meeting where the audience voted Fingy3D for Best Overall Winner and Newrotex Ltd for Runner-Up. We were delighted with all the positive feedback from plastic surgeons and strategic companies on our technology and the clear need for patients. We’re looking forward to all of the exciting new collaborative opportunities going forwards.
Dr Woods said, “The MedTech Innovator Acceleartor programme has been hugely valuable to Newrotex. Working with so many expert entrepreneurs, clinical experts and large strategics to refine our value proposition, strategy and market value has been invaluable. As well as making friends with so many incredible entrepreneurs! It was a great honour for Newrotex to have been selected as one of the top 5 companies from the MedTech Innovator 2023 cohort – from an initial 1,150 companies across the world who applied this year – it really shows the value of what we’re trying to achieve for patients. Congratulations to winners StrokeDx and to the other incredible companies who were included in the Finals IFPx, Fingy3D, and Neurava Inc.
Take a listen here! https://soundcloud.com/devicetalks/hear-the-last-10-start-ups-standing-in-medtech-innovators-pitch-competitions
Newrotex are delighted to announce that we have been selected to join the prestigious MedTech Innovator programme. 61 companies were selected from over 1,150 applicants worldwide and the team will kick off in San Francisco next week. CEO Alex Woods “We’re incredibly proud to have been selected for the MedTech Innovator Accelerator programme including the American Society of Plastic Surgeons (ASPS) cohort. It recognises how our regenerative silk technology can help to address the large unmet need for patients to have a robust and effective treatment for nerve injuries”. Read more
