ReNerve Secures Marketing Approval in Indonesia
Released
Released
Announcement PDF
+61 (03) 9482 3940
157 Heidelberg Rd,
Northcote, VIC 3070
www.renerve.com.au
ASX Announcement
7 July 2026
ReNerve Secures Marketing Approval for NervAlign® Nerve Cuff in
Indonesia
Key Highlights
• ReNerve Limited (ASX: RNV) has received marketing approval (registration) for its NervAlign® Nerve
Cuff in Indonesia.
• Indonesia joins ReNerve’s growing Asia-Pacific footprint alongside the United States, New Zealand,
Hong Kong, Thailand and Malaysia.
• As the world’s fourth most populous nation — with over 280 million people — Indonesia represents
one of the largest single-country opportunities in ReNerve’s regional strategy.
• The Asia-Pacific nerve repair market is estimated to be worth around USD $100 million in 20261
, with
Indonesia’s scale and high burden of trauma-related nerve injury making it a strategically significant
market.
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 it has received
marketing approval for its NervAlign® Nerve Cuff in Indonesia.
The approval opens access to Southeast Asia’s largest economy and one of the region’s most significant
addressable markets for nerve repair. Indonesia’s demographic and clinical profile points to substantial and
growing demand for peripheral nerve repair solutions:
Population scale. Indonesia is the world’s fourth most populous country, with a population of over 280
million.
Trauma burden. Road trauma is a leading source of peripheral nerve injury. The World Health Organisation
(WHO) estimated more than 30,000 road-traffic deaths in Indonesia, with far larger numbers of serious
injuries due to reduced road speeds and motorcycles, the dominant mode of transport accounting for the
majority of crashes and severe limb injuries. Road crashes were estimated to cost Indonesia around USD $38
billion in 2021, roughly 3% of GDP.2
“Securing approval in Indonesia is a significant milestone in our Asia-Pacific expansion strategy. Indonesia is
one of the largest and fastest-growing healthcare markets in the region, and the clinical need for effective
peripheral nerve repair — driven by both trauma and diabetes — is substantial,”
1
Global Nerve Repair Biomaterials Market Research Report (2020 – 2031)
2
https://www.worldlifeexpectancy.com/indonesia-road-traffic-accidents
https://asiantransportobservatory.org/analytical-outputs/roadsafetyprofiles/indonesia-road-safety-profile-2025/
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“This approval is further validation of the strength of our clinical data and the clear benefit the NervAlign®
Nerve Cuff delivers to patients and surgeons. We look forward to working with our partners to bring the
product to Indonesian clinicians and patients,” said Dr Julian Chick, CEO of ReNerve.
- 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
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.
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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
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.
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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 portfolio. 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 2031.3
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.
3
Global Nerve Repair Biomaterials Market Research Report (2020 – 2031)
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