Nerve Guide Matrix Enters Stage 3 of Commercial Development
Released
Released
Announcement PDF
+61 (03) 9482 3940
157 Heidelberg Rd,
Northcote, VIC 3070
www.renerve.com.au
ASX Announcement
15 April 2026
ReNerve’s Nerve Guide Matrix Enters Stage 3 of Commercial Development
ReNerve Limited (ASX, "ReNerve" or "the Company"), an Australian biotechnology company developing
innovative products for peripheral nerve injury ("PNI") repair, is pleased to announce that its NervAlign Nerve
Guide Matrix has entered stage 3 of the 4-stage scaled commercial production process in preparation for FDA
submission.
Stage 3 is the verification process of development and is anticipated to generate product that will be used in
the commencement of formal preclinical testing, production of the related packaging and manufacturing of
the final product. Stage 3 is expected to be completed by the end of calendar 2026.
"This is a very important stage forward in moving the Nerve Guide Matrix to FDA submission and into the
market. This will be a significant product for ReNerve, with testing in large animal models highlighting its
suitability for the replacement of damaged nerves, and we expect this will provide surgeons with an
alternative to donor nerves, which have limitations.” said Dr Julian Chick, CEO of ReNerve.
The Nerve Guide Matrix is in commercial development with a GMP production facility in preparation for its
formal marketing submission to the FDA.
Stage 4 will be the final production and testing of the Nerve Guide Matrix batches. ReNerve has been holding
ongoing meetings with the FDA throughout the commercial development process, and testing will be
undertaken in consideration of feedback provided by the FDA.
ReNerve is developing the NervAlign Nerve Matrix for the repair and replacement of injured and damaged
nerves. The global market for nerve repair is estimated to be around USD$2Bn. The NervAlign Nerve Guide
Matrix complements the rest of the ReNerve NervAlign product portfolio.
- ENDS -
This announcement has been approved for release by the Company’s Board of Directors.
For further information and enquiries, please contact:
Dr Julian Chick
CEO & Managing Director
ReNerve Ltd
+61 (03) 9482 3940
info@renerve.com.au
Matthew Wright
Investor & Media Relations
NWR Communications
+61 (0) 451 896 420
matt@nwrcommunications.com.au
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Follow ReNerve:
Website: www.renerve.com.au
LinkedIn: https://www.linkedin.com/company/renerve-ltd
InvestorHub: https://investors.renerve.com.au/
About ReNerve Limited (ASX:RNV)
ReNerve Limited (ASX:RNV) is transforming nerve repair and improving lives through breakthrough medical
technology. Founded by a neurosurgeon and medtech researchers, ReNerve is a rapidly growing medical device
company that has revolutionised peripheral nerve surgery with its innovative, ready-to-use solutions for peripheral
nerve injuries (PNI). Our scientifically backed products are delivering measurably better outcomes for patients
worldwide.
Proven Clinical Success
ReNerve’s first flagship product, the FDA-cleared NervAlign® Nerve Cuff, is already making a dramatic difference
in surgical outcomes across the United States. A recently announced clinical study has demonstrated remarkable
results, showing that patients treated with the NervAlign® Nerve Cuff experienced post-surgical pain scores
dropping from 7.1 to just 0.4, compared to from 7.1 to 3.3 without the device being used – a statistically significant
improvement that's changing lives.
Comparison of Patient Pre & Post Surgery Pain Score
Standard of Care vs NervAlign™ Nerve Cuff Protected Nerve Repairs
The comparison of pain scores between the two cohorts of patients
3.3
0.4
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Comprehensive Product Portfolio
ReNerve is advancing a complete suite of nerve repair solutions and related surgical repairs:
On market
• NervAlign® Nerve Cuff – Our bioabsorbable protective wrap, naturally absorbed within six months of
surgery.
• Empliq™ Deep Dermal tissue product -- A unique deep dermal product used in the repair of reconstructive
and cosmetic surgical cases.
• Empliq™ Amniotic tissue product ranges -- Three amniotic tissue product ranges used to aid the healing
of wounds.
In development
• NervAlign® Nerve Conduit Range – Next-generation nerve conduit leveraging advantages of eCOO
technology in a material designed to facilitate nerve growth over short gaps between nerve ends.
• NervAlign® Nerve Guide Matrix – a customised and ready-to-use alternative to existing nerve grafts, for
treatment of longer nerve gaps and more severe nerve injuries. It will eliminate the need for patients to
undergo additional sural nerve harvesting.
• NervAlign® Bionic Nerve – Next-generation combination technology for the most challenging nerve
repairs.
Market Leadership and Growth
With demonstrated market traction since the Company’s 2022 product launch, ReNerve achieved 53% revenue
growth in FY25, reaching $271k in sales and YTD FY2026 sales revenues showing further significant increases across
its porfolio.Our high-margin, scalable products are positioning us 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 is projected to reach $6.2 billion by 2031.1
Vision and Values
We're not just developing medical devices – we're engineering hope. By creating the ideal healing environment for
nerve repair and regeneration, ReNerve bridges critical gaps in healthcare while empowering the human body's
natural healing process. Our cleaner, safer, and more effective solutions represent the future of peripheral nerve
surgery.
1
Global Nerve Repair Biomaterials Market Research Report (2020 – 2031)
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