NervAlign® Nerve Cuff Trial Grows to 240 Patients Following 7.1 to 0.4 Pain Score Drop
ReNerve Limited is scaling up its clinical trial for the NervAlign® Nerve Cuff following promising interim results that show significant pain reduction in nerve repair patients. The expanded study aims to solidify evidence for broader regulatory approval and market adoption.
- Clinical trial cohort expanded to 240 patients across multiple US centers
- Interim data shows post-surgery pain scores drop from 7.1 to 0.4 with NervAlign®
- Study compares standard nerve repair care with and without the NervAlign® Nerve Cuff
- Recruitment expected to complete by mid-2026, supporting European market approval
- ReNerve reports 53% revenue growth in FY25, advancing a broad nerve repair product portfolio
Clinical Trial Expansion Signals Confidence
ReNerve Limited, an Australian medical device innovator, has announced a significant expansion of its clinical study evaluating the NervAlign® Nerve Cuff, a device designed to protect repaired peripheral nerves and improve patient recovery. Building on statistically significant interim results presented earlier this year, the company is now enrolling approximately 240 patients across multiple US centers in a definitive trial phase.
The expanded study pits the current standard of care against the addition of the NervAlign® Nerve Cuff, with patients randomly assigned to either group. Early data revealed a remarkable reduction in post-operative pain scores, from an average of 7.1 before surgery to just 0.4 after surgery for patients treated with the nerve cuff, compared to a post-surgery score of 3.3 for those without the device. This clear patient benefit has propelled the company to broaden the trial to validate efficacy across a wider range of nerve injuries.
Strategic Importance and Market Potential
The NervAlign® Nerve Cuff is a bioabsorbable, biocompatible wrap that provides a protective barrier around repaired nerves, potentially reducing complications and enhancing functional recovery. The trial’s primary endpoints focus on pain reduction and functional outcomes, while secondary measures assess quality of life and surgical site healing.
ReNerve’s CEO, Dr Julian Chick, emphasized the importance of this study not only for clinical validation but also as a foundation for regulatory submissions in Europe and beyond. The global market for peripheral nerve repair is estimated at USD 1.6 billion and growing rapidly, with ReNerve positioning itself as a key player through its innovative product suite.
Broader Product Pipeline and Growth Trajectory
Beyond the nerve cuff, ReNerve is advancing a comprehensive portfolio including nerve conduits, guide matrices, and amniotic tissue products aimed at addressing various nerve injury complexities. The company reported a 53% revenue increase in FY25, reflecting growing market traction since its 2022 product launch.
Chief Scientific Officer Dr David Rhodes highlighted the surgical community’s increasing interest in novel nerve protection solutions, underscoring the potential for NervAlign® to become a standard adjunct in nerve repair surgeries. With recruitment on track to complete by mid-2026, the study’s outcomes will be pivotal in shaping ReNerve’s regulatory and commercial strategies.
Bottom Line?
As ReNerve scales its clinical evidence, the nerve repair market watches closely for a potential new standard in patient recovery.
Questions in the middle?
- Will the expanded trial confirm long-term functional improvements beyond pain reduction?
- How quickly can ReNerve secure European regulatory approval following trial completion?
- What impact will broader geographic recruitment have on study timelines and data diversity?
