ReNerve builds momentum with expanded NervAlign nerve repair study

• ReNerve expands study evaluating its flagship NervAlign nerve cuff
• Expansion builds on statistically significant interim data presented in March
• The US-based study will compare standard of care with and without NervAlign

Special Report: ReNerve has expanded the ongoing clinical study evaluating its flagship NervAlign nerve cuff, following encouraging interim results.

ReNerve (ASX:RNV) said the study, examining Nerve Cuff’s ability to protect nerves after neurolysis (nerve repair), will expand its cohort as it moves into the definitive trial phase.

NervAlign is designed to provide a protective, biocompatible barrier around repaired nerves, potentially improving surgical outcomes and patient recovery.

The study will serve as a definitive evaluation of the overall benefit of using the nerve cuff to protect nerves and would include two randomised parallel cohorts.

The control group patients will receive the current standard of care for nerve repair.

The intervention group patients will be receiving the standard of care with addition of the NervAlign applied to the repaired nerve.

Each cohort will enrol ~120 patients with primary endpoints focusing 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.

Study to also support European market approval

The study is currently being conducted across three centres in the US. ReNerve is actively exploring potentially adding more sites to accelerate patient recruitment and increase geographic diversity of the study population.

To date, approximately one-third of the total target enrolment has been achieved, and ReNerve anticipates completing recruitment around mid-2026.

The trial results will guide future regulatory and commercial strategies for NervAlign Nerve Cuff in key global markets, including supporting a European market approval filing.

NervAlign is the first product in a portfolio ReNerve is developing for the repair and replacement of injured peripheral nerves.

ReNerve is also advancing its nerve conduit and nerve guide matrix toward commercial validation and manufacturing ahead of market entry.

The global market for peripheral nerve repair is ~US $1.6 billion and growing at more than 17% annually.

In September, ReNerve announced it had also launched its human tissues products Empliq range in the US.

Developed in conjunction with US-based Berkeley Biologics, the Empliq range is complementary to ReNerve’s product portfolio.

The global dermal and amniotic tissue market was valued at ~US$2.7 billion in 2024, growing at a CAGR of 12%, with these products applied across a range of clinical settings.

More from RNV: ReNerve achieves first sales of EmpliQ amniotic tissue range

‘Building on positive study data’

ReNerve CEO Dr Julian Chick said it would be an important trial for ReNerve as it extends the cohort from interim data presented by Dr Adams at the American College of Foot and Ankle Surgeons Annual Conference in March 2025.

“The trial data presented there emphasised the benefit of using the nerve cuff to protect the nerve post-surgery,” Chick said.

“A Visual Analogue Score (VAS) of 7.1 pre-surgery reduced to 0.4 post-surgery for patients using the NervAlign nerve cuff, compared to a 3.3 post-surgery VAS for patients not treated with the NervAlign.”

Chief scientific officer Dr David Rhodes said the company was eager to advance its clinical program and further validate the potential of the NervAlign to improve outcomes for patients undergoing nerve repair procedures.

“The expansion of this study reflects both the strength of our preliminary data and the growing interest from the surgical community in innovative solutions for peripheral nerve protection,” he said.

This article was developed in collaboration with ReNerve, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.