ReNerve receives approval in Malaysia

Open PDF
Stock RNV.ASX (RNV.ASX)
Release Time 15 Jan 2026, 9:17 a.m.
Price Sensitive Yes
 ReNerve receives approval in Malaysia
Key Points
  • Provides ReNerve access to Malaysian market, an important part of its Asia-Pacific strategy
  • Result of positive assessment of clinical evaluation report validates ReNerve pursuing approvals in more countries
  • Malaysia has a population of 35 million people and the nerve repair market across Asia-Pacific is estimated to be worth around USD$100 million in 2026
Full Summary

ReNerve Limited (ASX:RNV), a leading Australian medical device innovator focused on solutions for peripheral nerve injury (PNI), is pleased to announce that its NervAlign® Nerve Cuff has received market registration (approval) in Malaysia. The milestone marks another country approval for ReNerve in the Asia-Pacific region, to go with those received for Hong Kong and Thailand. Malaysia has a population of 35 million people and forms an important part of the broader Asia-Pacific strategy for the Company, with many hospitals operating in Malaysia having a presence in multiple other countries. The nerve repair market across Asia-Pacific is estimated to be worth around USD$100 million in 2026. Dr Julian Chick, CEO of ReNerve, stated that the approval in Malaysia is part of the company's regional strategy and is another major piece of validation, showing the strong clinical data package and clear benefit patients receive when the ReNerve Nerve Cuff is used in peripheral nerve repairs. ReNerve looks forward to growing its presence in Malaysia and beyond that within the Asia-Pacific region.

Guidance

ReNerve achieved 53% revenue growth in FY25, reaching $271k in sales. The company's high-margin, scalable products are positioning it as the go-to solution for surgeons seeking superior patient outcomes in the rapidly expanding global nerve repair market, valued at US$1.6 billion in 2024 and projected to reach $6.2 billion by 2031.

Outlook

ReNerve is advancing a complete suite of nerve repair solutions, including the NervAlign® Nerve Cuff, Deep Dermal tissue product, Amniotic tissue product ranges, NervAlign® Nerve Conduit Range, NervAlign® Nerve Guide Matrix, and NervAlign® Bionic Nerve. The company's products are designed to create the ideal healing environment for nerve repair and regeneration, representing the future of peripheral nerve surgery.