ReNerve Limited (ASX: RNV), an Australian medical device innovator focused on solutions for peripheral nerve injury (PNI), announced the expansion of its clinical study evaluating the NervAlign Nerve Cuff. ReNerve’s flagship product, the FDA-cleared NervAlign Nerve Cuff, is designed to provide a protective barrier around repaired nerves, potentially improving surgical outcomes and patient recovery. The expansion builds upon statistically significant interim data presented in March 2025, aiming for a definitive assessment of the Nerve Cuff’s efficacy.
The study will compare the standard of care with and without the NervAlign Nerve Cuff across multiple US centres. It features two randomised parallel cohorts, with approximately 120 patients in each: a control group receiving standard care and an intervention group receiving standard care plus the NervAlign Nerve Cuff. The primary endpoints will focus on changes in pre and post-operative pain scores and functional recovery metrics. Secondary endpoints include assessments of patient quality of life and surgical site outcomes.
According to ReNerve CEO Dr Julian Chick, the expansion extends the study cohort from trial data presented earlier this year, which emphasised the benefit of using the nerve cuff to protect the nerve post-surgery. He highlighted that the previous data showed a significant reduction in pain scores for patients using the NervAlign Nerve Cuff. Dr David Rhodes, Chief Scientific Officer at ReNerve, added that the company is eager to advance this important clinical program and further validate the potential of the NervAlign Nerve Cuff.
The study is currently being conducted across three centres in the United States, with ReNerve exploring the inclusion of additional sites to accelerate patient recruitment. Approximately one-third of the target enrolment has been achieved, and ReNerve anticipates completion of recruitment around midyear 2026. The study will also support a European market approval filing for the NervAlign Nerve Cuff.
