ReNerve - 2026 Annual Report
Released
Released
Announcement PDF
ANNUAL
2026
REPORT
ASX : RNV
renerve.com.au
Table of Contents
About ReNerve 3
Chair’s Letter 5
Corporate Directory 9
Directors’ Report 10
Auditors’ Independent Declaration 26
Statement of Profit or Loss and Other Income 28
Statement of Financial Position 29
Statement of Changes in Equity 30
Statement of Cash flows 31
Directors’ Declaration 54
Independent Auditors’ Report 55
Shareholder Information 60
About ReNerve Limited
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
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™ 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 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 2031.1
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)
Chair's Letter
Dear Shareholders,
It is a privilege to write to you as Chair of ReNerve Limited following my appointment to the
Board and subsequently as Non-Executive Chair. I would like to thank shareholders for
their continued support as the Company advances its mission of transforming peripheral
nerve repair through innovative medical technologies. My appointment forms part of the
Board's renewal process and reflects our commitment to strong governance, strategic
discipline and sustainable value creation.
Over the past year, ReNerve has continued to successfully complete major company
milestones over the past 12 months, continuing its strategy of expanding the commercial
footprint of its FDA-cleared NervAlign® Nerve Cuff while progressing the broader product
portfolio and strengthening the foundations required for long-term growth. The Board
believes the Company is increasingly well positioned to participate in the significant
global opportunity within peripheral nerve repair and regeneration.
A major achievement during the period was the continued expansion of ReNerve's
international market access. The Company secured marketing approvals for NervAlign®
Nerve Cuff in Hong Kong, Malaysia, Indonesia, the Philippines and India, significantly
broadening the potential patient population and creating multiple new commercial
pathways across the Asia-Pacific region. These approvals represent important validation
of our technology and provide a platform for future revenue growth through local
distribution partnerships and surgeon adoption.
ReNerve also continued to strengthen its commercial infrastructure. The establishment of
additional distribution arrangements across strategic markets, together with the
appointment of J4 as a second manufacturing partner for the Empliq product range,
enhances the Company's ability to scale efficiently while maintaining supply chain
resilience. These initiatives are important building blocks as we seek to increase market
penetration and support future demand.
From a financial and operational perspective, management delivered encouraging
progress. For the June 2026 quarter, ReNerve reported record sales of approximately
$211,000, and annual sales growth of 88% compared with the prior corresponding period.
This outcome demonstrates growing market acceptance of the Company's products and
provides further evidence that our commercialisation strategy is gaining momentum.
The Company also took important steps to strengthen its balance sheet and funding
flexibility through the execution of a funding facility of up to A$5 million with RiverFort. The
facility provides access to growth capital that can support ongoing commercial
expansion, product development initiatives and entry into new geographic markets. The
Board remains focused on carefully managing capital while ensuring the Company has
the resources required to pursue its strategic objectives.
Alongside commercial progress, ReNerve continued to advance its innovation pipeline.
During the year, the NervAlign® Nerve Guide Matrix program progressed into Stage 3 of
commercial development, representing another important milestone in the Company's
strategy to build a comprehensive portfolio addressing the spectrum of peripheral nerve
injuries. The Board believes continued investment in differentiated products will be critical
to creating long-term shareholder value and improving outcomes for patients globally.
While we are pleased with the progress achieved, we remain focused on the work ahead.
Our priorities include accelerating sales growth in existing markets, converting newly
approved jurisdictions into meaningful revenue opportunities, further developing our
product pipeline and maintaining disciplined capital management. We will also continue
to strengthen governance and operational capabilities as ReNerve evolves from an
emerging medical technology company into a broader commercial organisation.
The need for innovative and effective nerve repair solutions remains substantial. With a
growing international presence, a clinically validated flagship product, an expanding
development pipeline and an experienced management team, ReNerve is well positioned
to pursue this opportunity.
Looking ahead, our focus is firmly on converting the foundations established to date into
sustainable commercial growth and broader market adoption. Over the coming period,
we will prioritise accelerating sales of NervAlign® Nerve Cuff in the United States,
supporting our distribution partners and converting our expanding international
regulatory approvals into new revenue opportunities. At the same time, we will continue to
advance the NervAlign® Nerve Conduit and Nerve Guide Matrix through their respective
development and clinical pathways, while building the evidence and market presence
required to support future adoption. Importantly, we will remain disciplined in how we
deploy capital and allocate resources, balancing investment in growth and innovation
with the need to build a sustainable and increasingly valuable medical technology
company. Our goal is clear: to expand ReNerve’s commercial footprint, broaden our
product offering and strengthen our position as a leader in peripheral nerve repair.
On behalf of the Board, I would like to thank our shareholders, clinicians, distribution
partners, employees and management team for their dedication and support. Their
commitment continues to drive ReNerve's progress and brings us closer to our vision of
improving the lives of patients suffering from peripheral nerve injuries around the world.
I look forward to updating shareholders on our continued progress in the year ahead.
Yours sincerely,
Maja McGuire
Non-Executive Chair
ReNerve Limited
ReNerve Limited
ABN 23 614 848 216
Annual Report - 30 June 2026
ReNerve Limited
Corporate directory
30 June 2026
1
Directors Maja McGuire – Independent Chair & Director
Dr Paul Savage – Independent Non-Executive Director
Dr Julian Chick – Director & Chief Executive Officer
Company secretary Mr David Lilja
Notice of annual general meeting The details of the annual general meeting of ReNerve Limited are:
Date: Monday 6th October 2026
Time: 2:00PM (AEDT)
Location: To be confirmed
Registered office DLK Advisory Pty Ltd, Level 10, 99 Queen Street
Melbourne, 3000, Australia
Principal place of business 157 Heidelberg Road
Northcote VIC 3070, Australia
Auditor William Buck
Level 20, 181 William Street
Melbourne VIC 3000, Australia
Solicitors Cornwalls
Level 4, 380 Collins Street
Melbourne VIC 3000, Australia
Bankers ANZ
Ground Floor, 55 Collins Street
Melbourne VIC 3000, Australia
Bendigo Bank
The Bendigo Centre
Bendigo VIC 3550, Australia
Stock exchange listing ReNerve Limited shares are listed on the Australian Securities Exchange (ASX code:
RNV)
Website https://renerve.com.au
Corporate Governance Statement The directors and management are committed to conducting the business of ReNerve
Limited in an ethical manner and in accordance with the highest standards of
corporate governance. ReNerve Limited has adopted and has substantially complied
with the ASX Corporate Governance Principles and Recommendations (Fourth
Edition) (‘Recommendations’) to the extent appropriate to the size and nature of its
operations.
The company’s 2025 Corporate Governance Statement that sets out the corporate
governance practices that were in operation during the financial year and identifies
and explains any Recommendations that have not been followed, which is approved at
the same time as the Annual Report, can be found at:
https://renerve.com.au/company-policies/
ReNerve Limited
Directors' report
30 June 2026
2
The directors present their report, together with the financial statements, on the consolidated entity (referred to hereafter as
the 'company') consisting of ReNerve Limited (referred to hereafter as the 'company' or 'parent entity') and the entities it
controlled at the end of, or during, the year ended 30 June 2026.
Directors
The following persons were directors of the company during the whole of the financial year and up to the date of this report,
unless otherwise stated:
Ms Maja McGuire - Independent Chair & Non-Executive Director (Appointed 4 December 2025)
Dr Paul Savage – Independent Non-Executive Director (Appointed 4 December 2025)
Mr Reginald Stephen Cooper – Independent Chair & Non-Executive Director (Ceased 4 December 2025)
Dr Michael Panaccio – Independent Non-Executive Director (Ceased 4 December 2025)
Dr Julian Chick – Director & Chief Executive Officer
Dr David Rhodes – Executive Director & Chief Scientific Officer (Ceased as Director 30 April 2026)
Principal activities
ReNerve has FDA market clearance and is selling its NervAlign® Nerve Cuff product in the US market. During FY2026, the
company continued to broaden its commercial activities, with three product lines now being sold in the US and approvals
obtained across several Asian markets. ReNerve remains focused on building a portfolio of regenerative biological based
tissue products for the repair and replacement of injured peripheral nerves and related surgical procedures.
ReNerve continues to develop its portfolio of medical devices used in the repair and/or replacement of damaged peripheral
nerves, with three further product ranges at various stages of development:
a) The NervAlign® Nerve Conduit range
b) The NervAlign® Nerve Guide Matrix
c) The NervAlign® Bionic Replacement Nerve
In addition, ReNerve has expanded its commercial product range through the launch of the Empliq™ human tissue product
range, comprising deep dermal and amniotic tissue products. These products are complementary to ReNerve’s existing nerve
repair products, are sold through the company’s existing distribution channels, and are used in the same or related surgical
procedures.
Dividends
There were no dividends paid, recommended or declared during the current or previous financial year.
Review of operations
The loss for the company after providing for income tax amounted to $5,572,439 (30 June 2025: $3,733,918).
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During FY26, ReNerve progressed from a single-product commercial organisation to a multi-product regenerative medicine
company, supported by expanding distribution networks, increasing hospital adoption, new international regulatory approvals
and ongoing advancement of its development pipeline. The company believes these achievements position it favourably for
continued commercial growth and product portfolio expansion.
The 2026 financial year was a period of significant commercial and operational progress for ReNerve. The company delivered
strong sales growth, expanded its portfolio of on-market products, established new commercial channels across the Asia-
Pacific region and advanced the development of its next-generation peripheral nerve repair technologies.
Full-year sales increased by 88% to approximately $510k, compared with $271k in FY25. Growth accelerated during the
second half, culminating in record quarterly sales of $211,000 in the June quarter, an increase of more than 50% from the
previous quarter and the company’s largest sales quarter to date.
The growth reflected increasing adoption of the NervAlign® Nerve Cuff, the launch and commercial rollout of the Empliq™
human tissue product range and continued progress in securing new hospital approvals and purchasing approvals. ReNerve
also expanded its geographic footprint beyond the United States through regulatory approvals and distribution partnerships in
key Asia-Pacific markets.
Alongside its commercial activities, the company continued to invest in the NervAlign® Nerve Conduit and NervAlign® Nerve
Guide Matrix development programs. The Nerve Guide Matrix entered Stage 3 of ReNerve’s four-stage scaled commercial
production process during the year, marking an important step towards formal preclinical testing and a future FDA marketing
submission. The company has progressed the initial nerve conduit program to commercial product scale up stage ahead of
its launch later in 2026.
ReNerve maintained commercial momentum throughout FY26, with quarterly sales increasing from $66,000 in the September
quarter to $97,000 in the December quarter, $135,000 in the March quarter and $211,000 in the June quarter. March 2026
was the first month in which the company recorded sales of more than $100,000.
The stronger performance was driven primarily by growth in the Empliq range and the increasing contribution of multiple
products to the company’s revenue base. The broader portfolio allows ReNerve to offer hospitals and surgeons a more
comprehensive selection of products through the same sales and distribution channels established for the NervAlign Nerve
Cuff.
During the year, the company continued to progress new hospital approvals. Three new hospital approvals were secured for
the Empliq range during the March quarter, with further applications submitted across six targeted hospital systems. These
approvals support adoption across the broader ReNerve portfolio and provide an established pathway for the introduction of
future products, subject to regulatory clearance.
The United States remained ReNerve’s principal commercial market during FY26. The company continued to build its network
of distribution partners, engage surgeons and pursue approvals within individual hospital systems.
A significant milestone was the approval of the NervAlign Nerve Cuff for purchasing through the United States Department of
Defense and Department of Veterans Affairs healthcare networks. This provides a simplified purchasing pathway across a
network of more than 1,000 military hospitals, clinics, medical centers and outpatient facilities.
ReNerve ended the first half with 21 distribution partners operating across the United States. The combination of distributor
coverage, hospital approvals, surgeon engagement and supporting clinical evidence provides a platform from which the
company can expand sales of both its existing products and future additions to the NervAlign portfolio.
ReNerve launched the Empliq human tissue product range during FY26, achieving its first sale of the Empliq Deep Dermal
product during the September quarter and its first sales of the Empliq amniotic tissue products in October 2025. The range
includes a deep dermal product for reconstructive and cosmetic surgical applications and three amniotic tissue product ranges
used to support wound healing.
The company introduced the products to surgeons at the American Society for Surgery of the Hand conference in October
2025 and subsequently progressed hospital approvals and commercial adoption through its existing sales channels.
In June 2026, ReNerve appointed J4 Biologics as a second approved manufacturing partner for the Empliq range. J4 is a
United States-based human tissue processor specialising in amnion and dermal products. Its appointment followed a
qualification and evaluation process covering ReNerve’s quality, compliance and production requirements.
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The second manufacturing relationship was established in response to growing demand and increasing hospital adoption. It
is intended to expand available manufacturing capacity, improve product availability, shorten lead times and reduce supply
concentration risk. The arrangement also gives the company greater flexibility to scale Empliq inventory production in line with
demand.
ReNerve made significant progress in extending its commercial footprint across the Asia-Pacific region during FY26.
The NervAlign Nerve Cuff received market registration in Malaysia and broader listing approval in Hong Kong, including access
to public and private hospitals and hospitals operating within the Greater Bay Area. These approvals complemented ReNerve’s
existing market access in jurisdictions including the United States, New Zealand and Thailand.
Following the Hong Kong approval, ReNerve entered into an exclusive distribution agreement with Swedish Trading Company
covering Hong Kong, Macau and the Greater Bay Area. Swedish Trading Company has established relationships across
hospitals and surgical networks in the region and is responsible for importation, warehousing, marketing, sales and distribution.
The first stocking orders were shipped into the region during the year.
ReNerve also appointed UG Medical as its commercialisation partner in Malaysia. UG Medical will support importation,
regulatory management, warehousing, marketing and distribution of the NervAlign product range through its established
Malaysian hospital network. ReNerve will provide clinical and technical support, product training and regulatory liaison as
commercial activities progress.
Subsequent to the end of the financial year, the company secured marketing approval for the NervAlign Nerve Cuff in each of
India, Indonesia and the Philippines. These are all very significant markets for the growth prospects of ReNerve, with large
populations, high road trauma burdens and therefore outstanding market opportunities for the company.
The FDA-cleared NervAlign Nerve Cuff is a bioabsorbable protective wrap designed to provide an environment that supports
nerve healing following surgical repair. The product is naturally absorbed within approximately six months of surgery, making
it unique in terms of its handling characteristics, its absorption within an ideal time period relative to nerve repair and clean
manufacturing process resulting in a clean, safe nerve protective nerve cuff.
During FY26, ReNerve continued its post-market clinical evaluation of the Nerve Cuff, building on statistically significant interim
data presented in March 2025. The interim analysis showed that patients treated with the NervAlign Nerve Cuff experienced
a reduction in average pain scores from 7.1 before surgery to 0.4 after surgery, compared with a reduction from 7.1 to 3.3
among patients receiving the standard of care without the device. Based on the successful outcomes from this study, ReNerve
has initiated a more comprehensive study to illustrate the utility and benefits of the NervAlign Nerve Cuff in the repair of injured
nerves.
The clinical evidence continued to support surgeon engagement, hospital purchasing applications and regulatory submissions
in new markets.
ReNerve continued to develop its NervAlign Nerve Conduit range during the year. The conduits use the company’s proprietary
eCOO™ biomaterial technology and are designed to facilitate nerve growth across short gaps between severed nerve ends.
During the early part of FY26, ReNerve finalised the production hardware and manufacturing process for the first products in
the conduit range. Development and regulatory work continued during the remainder of the year, with preparations underway
for the planned introduction of the product in selected markets, including Malaysia.
The Nerve Conduit is expected to broaden the NervAlign portfolio and allow the company to address nerve injuries that require
support across a physical gap, complementing the protective function of the existing Nerve Cuff. The Nerve Conduit has a
broader appeal due to the use of nerve conduits globally being a larger segment of the nerve repair market compared to nerve
cuffs.
The NervAlign Nerve Guide Matrix is being developed as a ready-to-use solution for the repair or replacement of more severely
injured nerves. The product is intended to provide surgeons with an alternative to donor nerve grafts, which can be constrained
by limited availability and require patients to undergo an additional nerve-harvesting procedure.
During FY26, ReNerve and its development partner progressed the volume production of prototype Nerve Guide Matrix
products. The program subsequently entered Stage 3 of the company’s four-stage scaled commercial production process.
Stage 3 represents the manufacturing verification phase and is expected to generate product for formal preclinical testing,
associated packaging development and manufacture of the final product configuration. Completion of Stage 3 is targeted for
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the end of calendar 2026.
Stage 4 will involve the final production and testing of Nerve Guide Matrix batches ahead of a formal marketing submission.
ReNerve continued to engage with the FDA during the development process, with testing activities being designed in
consideration of the feedback received.
The program has previously generated positive preclinical results in a nerve regeneration model, supporting the potential of
the Nerve Guide Matrix as an alternative for the repair and replacement of injured or damaged nerves.
ReNerve completed a significant Board renewal process during FY26 to strengthen governance, commercial oversight and
strategic capability as the company progresses its transition from a development-stage company towards commercialisation.
Ms Maja McGuire was appointed as an Independent Non-Executive Director and Interim Chair on 4 December 2025 and
subsequently appointed Non-Executive Chair on 19 December 2025. Dr Paul Savage was appointed as an Independent Non-
Executive Director on 4 December 2025. Together, the appointments add substantial expertise in governance, medical
technology, manufacturing innovation, commercial strategy and ASX-listed company leadership. The Board renewal process
coincided with the retirement of Mr Stephen Cooper and Dr Michael Panaccio from the Board.
Dr David Rhodes stepped down as a Director effective 30 April 2026 after nine years of service on the Board. Dr Rhodes
remained with ReNerve as Chief Scientific Officer, retaining responsibility for supporting the company’s research and
development activities and the delivery of its next generation of products.
During the year, ReNerve completed a $3.2 million capital raising. Approximately $2.6 million was received during the
December quarter, with the remaining approximately $0.6 million received following shareholder approval and settlement in
January 2026.
In February 2026, the company received a Research and Development Tax Incentive refund of $517,133 relating to eligible
activities undertaken during the 2025 financial year. The refund recognised ReNerve’s continued investment in its proprietary
biomaterial and medical device programs.
ReNerve recorded customer cash receipts of $382,739 during FY26. Net cash used in operating activities was approximately
$5.80 million, reflecting continued investment in product manufacturing, commercial expansion, staffing and corporate
activities.
During the year, the company increased its investment in the Nerve Guide Matrix program, which entered Stage 3 during the
June quarter. The company held cash and cash equivalents of approximately $1.49 million at 30 June 2026.
Key risks and uncertainties
The company is subject to risks specific to its business activities, as well as general risks. The major risks and uncertainties
are summarised below.
Successful Commercialisation of Assets
The nature of medical device research and development is inherently uncertain at times. There are substantial risks including
that clinical studies may fail to achieve acceptable endpoints for efficacy or safety, or the products may not secure acceptance
from surgeons and clinicians. Failure in any of these areas would have a material impact on the company’s prospects. ReNerve
seeks to mitigate risk through a diversified product pipeline, a maturing portfolio of products some of which are on market,
continuous engagement with surgeons, careful design of its clinical studies, and collaboration with reputable and experienced
partners.
Research and Development Risk
ReNerve’s ongoing and future projects require research and development. It is possible that the development of its product
portfolio may be more costly or take more time than expected, or may not achieve the expected clinical endpoints. Delays or
increased costs could materially impact the company’s ability to bring products to market or achieve commercial milestones.
Regulatory and Product Approval Risks
As a medical device company, ReNerve’s products are subject to stringent regulatory approval processes in each jurisdiction.
The loss, delay or failure to secure required approvals (such as FDA clearance or comparable authorities in other markets)
may prevent the commercialisation of its products or expose the company to additional costs and delays. The withdrawal or
suspension of existing approvals could significantly affect operations and financial performance. ReNerve monitors regulatory
developments and maintains relationships with regulatory consultants and agencies to manage this risk.
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Product Acceptance and Commercial Risks
ReNerve relies on acceptance of its products by surgeons. If products are not accepted by surgeons or fail to generate repeat
usage, commercial uptake may be limited. The company mitigates this risk through active engagement with opinion leaders,
development of clinical data, and education initiatives.
Intellectual Property and Competitive Risk
ReNerve’s strategy is to rely on a combination of proprietary know-how, trade secrets, and, to a lesser extent, patents. There
is a material risk that competitors could seek to reverse-engineer or copy the company’s products, or develop superior
alternatives. If ReNerve’s trade secrets are not adequately protected, or if key intellectual property is lost or circumvented, it
could harm the company’s market position. The company proactively manages confidentiality but acknowledges some risks
are outside its control.
Manufacturing, Supply Chain, and Dependency on Key Partners
ReNerve’s lead products are currently manufactured by a single supplier (EMCM) under an exclusivity agreement that
depends on meeting certain obligations. Loss of exclusivity or termination of the supply agreement - whether through default,
insolvency, or operational disruption—would require rapid transition to alternative suppliers, which may not be feasible without
significant disruption and cost, although ReNerve has identified an alternative manufacturer. Key raw materials (porcine tissue)
are sourced from the Netherlands and could be subject to disruption by disease outbreaks or export restrictions although
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