ReNerve Targets US Market with Two Tissue-Based Product Launches in Q3 and Q4 2025

Strategic Expansion into Tissue-Based Surgical Solutions

ReNerve Limited (ASX – RNV), a medical device company known for its innovative peripheral nerve repair technologies, has announced a significant strategic partnership with Berkeley Biologics LLC. This collaboration aims to develop and commercialise two new tissue-based product ranges that will broaden ReNerve’s surgical offerings and accelerate growth in 2025.

The partnership leverages Berkeley Biologics’ expertise in biologics and wound care products, with manufacturing based in California. Both product ranges have already received US approval, positioning ReNerve to enter the market swiftly with launches targeted for the third and fourth quarters of this year.

Complementary Products to Enhance Surgical Outcomes

The new product lines focus on human dermal tissue and amniotic tissue products. Dermal tissue, sourced from donor skin’s deeper layers, and amniotic tissue, known for its regenerative properties, are widely used in various surgical applications. These include trauma and wound care, breast reconstruction, extremity repairs, and orthopaedic and plastic surgeries.

Importantly, these products complement ReNerve’s existing NervAlign® range, which is designed for peripheral nerve repair and replacement. By integrating these tissue-based products, ReNerve can offer surgeons a more comprehensive suite of solutions addressing both nerve injuries and the surrounding tissue trauma, all through its established distribution network.

Market Potential and Growth Outlook

The global market for dermal and amniotic tissue products is estimated at approximately USD 2.7 billion in 2024, growing at an annual rate of around 12%. This growth trajectory aligns well with ReNerve’s ambitions to expand its footprint in the broader surgical tissue market beyond nerve repair alone.

ReNerve’s Director, Dr Julian Chick, highlighted the strategic rationale – "Surgeons who perform nerve repairs often require additional tissue grafts for comprehensive treatment. Our partnership enables us to provide a more complete product range, enhancing outcomes for surgeons, hospitals, and patients alike." The five-year supply agreement with Berkeley Biologics includes options for extension, underscoring confidence in the partnership’s long-term potential.

Investor Engagement and Next Steps

To provide further insights, ReNerve will host a live webinar on June 3, 2025, featuring Dr Chick, who will discuss the partnership and answer questions. This event offers investors and analysts a timely opportunity to understand the strategic implications and operational plans behind this expansion.

While the announcement does not disclose financial terms or detailed sales forecasts, the move signals ReNerve’s intent to capitalize on synergies within its existing sales channels and customer base. The success of these launches will be a key indicator of ReNerve’s ability to scale and diversify its product portfolio in a competitive medical device landscape.