• Expansion of cohort for a definitive clinical trial to assess the efficacy of the NervAlign® Nerve Cuff
• Study to compare standard of care with and without the NervAlign® Nerve Cuff across multiple US centres
• Preliminary data showed significant improvements in post-operative pain scores and functional recovery

ReNerve Limited, a leading Australian medical device innovator focused on solutions for peripheral nerve injury (PNI), is pleased to announce the expansion of the ongoing clinical study evaluating the NervAlign® Nerve Cuff. The study, which will investigate the Nerve Cuff's role in protecting nerves following neurolysis (nerve repair), will now expand the cohort into a definitive trial phase. The preliminary data presented at the American College of Foot and Ankle Surgeons Annual Conference in March 2025 showed a significant improvement in post-operative pain scores for patients using the NervAlign® Nerve Cuff, with a Visual Analogue Score (VAS) of 0.4 compared to 3.3 for patients not treated with the device. The expanded study will enrol approximately 120 patients in each of the control and intervention groups, with the primary endpoints focused on changes in pre and post-operative pain scores and functional recovery metrics. The study is currently being conducted across three centres in the United States, with ReNerve actively exploring the inclusion of additional sites to accelerate patient recruitment and broaden the geographic diversity of the study population. The results of this study will inform future regulatory and commercial strategies for the NervAlign Nerve Cuff in key global markets.

ReNerve is committed to delivering transformative technologies that address unmet needs in nerve repair and regeneration. The company continues to progress its nerve conduit remains and nerve guide matrix to commercial validation manufacturing ahead of market entry.