ReNerve opens Hong Kong and Malaysia markets with first NervAlign surgeries

First Commercial Cases Mark Asia-Pacific Transition

ReNerve Limited (ASX:RNV) has moved its NervAlign Nerve Cuff from regulatory approval into commercial use in Hong Kong and Malaysia, completing the first surgical cases in both markets. The company now has commercial activity across seven jurisdictions: the United States, New Zealand, Hong Kong, Thailand, Malaysia, Indonesia and the Philippines.

The Hong Kong cases followed expanded approval across Hong Kong, Macau and the Greater Bay Area, alongside the appointment of STC as exclusive distributor under a three-year agreement. The territory is tied to an addressable population of approximately 88 million people, while STC has already shipped initial stocking orders and begun surgeon education and product in-servicing at major hospitals.

Malaysia Converts January Approval Into Use

In Malaysia, the first procedure was performed at Thomson Hospital in Kuala Lumpur. ReNerve received market registration for the NervAlign Nerve Cuff in January, and describes the country as an important regional market because hospital groups there operate across several South-East Asian countries and treat patients from the wider region.

No sales or unit volumes were disclosed for either market, making the cases an early commercialisation marker rather than evidence of material revenue contribution. ReNerve said further Hong Kong cases are scheduled for the rest of the year, while its chief executive, Dr Julian Chick, said the Malaysian pipeline gave the company confidence about the coming quarters.

US Revenue Base Continues To Expand

The Asian rollout is being layered onto a growing US operation. ReNerve finished FY26 with sales of $510,357, up from $272,000 in FY25, while the June 2026 quarter produced a record $211,000, 50% above the March quarter. The company said sales have continued at an even stronger level in the current quarter, with more detail due in its next Appendix 4C report.

During FY26, the US distribution network reached 25 partners, purchasing approvals were secured across the US Department of Defense and Veterans Affairs healthcare systems, and the Empliq human tissue range began contributing to revenue through existing NervAlign distribution relationships. A second manufacturing partner, J4 Biologics, was also appointed for Empliq, supporting additional production capacity and supply-chain resilience.

Next Markets And Product Milestones

ReNerve intends to provide further updates as case numbers and sales volumes become material, with commercial entry into Indonesia, the Philippines and India still to come. The company says NervAlign has marketing approval in each of those markets, but has not provided a timetable or sales guidance for their rollout.

Alongside the commercial push, the NervAlign Nerve Guide Matrix is progressing through Stage 3 of a four-stage development program, targeted for completion by the end of calendar 2026. The company also expects to release 12-month preclinical study data in the coming weeks, while its NervAlign Nerve Conduit moves through commercial scale-up ahead of launch. Those milestones will test whether the expanding product and geographic footprint can translate into repeatable sales rather than isolated first cases.