Quarterly Investor Presentation
Released
Released
Announcement PDF
1
Sales &
Marketing Update
ReNerve Board meeting | July 2025
ReNerve Quarterly Webinar presentation | November 2025
ASX:RNV
Transforming Nerve
Repair Through Science
Important Notice & Disclaimer
Nature of Document: This presentation has been prepared and issued by ReNerve Ltd
(Company) to provide general information about the Company. The information in this
document is in summary form and should not be relied upon as a complete and accurate
representation of any matters that a reader should consider in evaluating the Company.
While management has taken every effort to ensure the accuracy of the material in this
presentation, the Company have not verified the accuracy or completeness of the
material contained in this presentation.
Not an offer: this presentation should not be distributed, transmitted, or viewed by any
person in any jurisdiction where the distribution, transmission or viewing of this document
would be unlawful under the securities or other laws of that or any other jurisdiction.
Not financial product advice: You should not act and should refrain from acting in reliance
on this presentation. Nothing contained in this presentation constitutes investment, legal,
tax or other advice. This presentation does not take into account the individual investment
objectives, financial situation and particular needs of potential investors. Before making a
decision to invest in the Company at any time, you should conduct, with the assistance of
your broker or other financial or professional adviser, your own investigation in light of your
particular investment needs, objectives and financial circumstances and perform your
own analysis of the Company before making any investment decision.
Forward looking statements: This presentation contains forward-looking information about
the Company and its operations. In certain cases, forward-looking information may be
identified by such terms as "anticipates", "believes", “should”, "could", "estimates", “target”,
“likely”, “plan”, "expects", "may", “intend”, "shall", "will", or "would". These statements are based
on information currently available to the Company and the Company provides no
assurance that actual results will meet management's expectations. Forward-looking
statements are subject to risk factors associated with the Company’s business, many of
which are beyond the control of the Company. It is believed that the expectations reflected
in these statements are reasonable but they may be affected by a variety of variables and
changes in underlying assumptions which could cause actual results or trends to differ
materially from those expressed or implied in such statements. There can be no assurance
that actual outcomes will not differ materially from these statements.
2
Disclaimer: No representation or warranty, express or implied, is made by the Company
that the material contained in this presentation will be achieved or proved correct. Except
for statutory liability which cannot be excluded, the Company, its directors, officers, and
employees expressly disclaim any responsibility for the accuracy, fairness, sufficiency or
completeness of the material contained in this presentation and excludes all liability
whatsoever (including in negligence) for any loss or damage which may be suffered by
any person as a consequence of any information in this presentation or any effort or
omission therefrom. The Company will not update or keep current the information
contained in this presentation or to correct any inaccuracy or omission which may
become apparent, or to furnish any person with any further information. Any opinions
expressed in the presentation are subject to change without notice. An offer of Shares in
ReNerve Ltd (ABN 23 614 848 216) is being made in or accompanied by a prospectus dated
at a date to be confirmed. Anyone who wants to acquire Shares pursuant to the offer will
need to complete the application form that accompanies the prospectus. A person should
consider and rely only on the prospectus in deciding whether to invest. A copy of the
prospectus is available by contacting the Company or by downloading from the
Company’s website (www.renerve.com.au).
Speculative nature of investment: Any potential investor should be aware that subscribing
for Shares involves various risks. The Shares to be issued pursuant to the Prospectus
lodged with ASIC by ReNerve Ltd carry no guarantee with respect to the payment of
dividends, returns of capital or the market value of those Shares. An investment in Shares
of the Company should therefore be considered very speculative.
ReNerve Ltd ABN 23 614 848 216
Executive Summary
Development of Novel Nerve Repair & Regeneration Products
ReNerve is developing a comprehensive portfolio of products for the nerve
repair and regeneration markets and related surgical procedures, with clearly
defined commercial demand.
Expanding Product Portfolio
4 product ranges expected on or near market with a developing portfolio
of research and development products.
Strong Sales & Distribution Presence
ReNerve has established logistics, warehouse and invoicing infrastructure
with a strong focus on building a sales distribution network for all products
in the US.
Global Expansion & Commercialisation
Successful ongoing expansion within the first year of ASX listing into
Ex-US markets in Asia, India, The Middle East, and The Americas.
Clinical & Professional Validation
Improved patient outcomes for post-surgical measures of pain and
surgery satisfaction, as well as proven ease of use for surgeons.
3
Quarter Highlights
Launched Dermal and 3 Amniotic Tissue
Product Ranges
Achieved first dermal sale
Achieved first sale of the amniotic tissue
Targeting same surgeons and procedures
as the nerve product range
There to accelerate sales growth
Launch of Empliq
Product Range
Revenue up 38%
qtr on qtr
Sales up 38% to corresponding qtr
- Growing year on year
Launch of two new product ranges
Closing cash of $3.27M
21 US distributors
in place
Small team in the US as we build our US presence
now with multiple product lines in market
Supporting the 21 distributors
ReNerve team to ‘hold the hands’ of distributors
for new products and initial sales
4
Company Portfolio
Nerve Cuff
Nerve Tube
Nerve Protector
Nerve Guide Matrix
Nerve Cap
Dermal Tissue
AmnioLite
AmnioDuo
Placental
R&D
Product
Development
Commercial
Development
On Market
Product
5
Target
Market
USD$2.0Bn
USD$6.0Bn
Global Nerve Repair
Biomaterial Market
USD$1.0Bn
2025
USD$6.19Bn
USD$1.90Bn
USD$1.10Bn
The Global Nerve Repair Biomaterials Market
is projected to grow at a compound annual
growth rate (CAGR) of 17.8% from 2024 to
2031 to USD$6.19Bn.
2031
Our Target Markets
Dermal and Amniotic Tissue
Surgical Applications (Trauma,
plastic surgery)
Dermal and Amniotic Tissue
Orthopedics (Tendon and
Ligament
MarketWide Research – Dermal and Amniotic tissue market report 2025-
2032, Published 2025.
6
ReNerve’s Nerve Opportunity
Product
• Used on damaged or transected
nerves with no gaps or gap closure
• Improved Nerve Cuff developed from
scCO2 tissue, offering better product
profile
• An ‘off-the-shelf’, ready to use nerve
graft replacement with internal
guidance infrastructure
• An ‘off-the-shelf’, continuous nerve
replacement, in a ready to use
nerve structure
Procedure Use
• End to end suturing covered with a
wrap/cuff
• Protective cuff for grafts
• Protecting injured nerve repairs • Replaces damaged nerve section
instead of using donor or harvested
tissue
• The Bionic Nerve is a nerve guide
matrix with ionic polymers
designed to replace injured and
damaged nerves for lengths from
1cm to 20cm
Application
• Trauma
• Breast reconstruction
• Orthopaedics
• Oral & maxillofacial surgery
• Trauma
• Breast reconstruction
• Orthopaedics
• Foot and ankle
• Trauma
• Breast reconstruction
• Orthopaedics
• Hand & wrist
• Trauma
• Craniotomy
• Spinal cord injury
• Spinal cord surgery
Benefit
• Bio-absorbed removing need for
additional surgery
• Pliable and conforms
• Improved product profile to Nerve
Cuff
• Stronger patient reimbursement
• Can be cut to ideal length
• Off-the-shelf, reducing logistics
issues
• Simple to use and cost effective
• Enable production of nerves of
bespoke dimension
FDA Status Approved Targeting market release end ’25/H1 ‘26 Targeting H2 CY27 filing Targeting Q4 CY28 filing
TAM (USD) $314m
$975m
2024 2030
$635m
$1991m
2024 2030
$1015m
$3219m
2024 2030
>$400m
2023
Nerve Cuff Bionic Nerve
Nerve Conduit Nerve Guide Matrix
7
8
01
Product Range
Empliq Product Portfolio
Empliq AmnioLite Empliq AmnioDuo Empliq Placental Empliq Dermal
Description Single-layer amniotic membrane
allograft
Double-layer amniotic
membrane allograft
Placental allograft including
amniotic membrane and chorion
Deep-layer dermal matrix
Clinical Value Natural barrier to protect wounds
from external environment
Thicker barrier for complex
wounds
Improved handling
characteristics
Natural barrier to protect wounds
from external environment
Additional structural support
Natural scaffold for protection,
reinforcement and capillary
formation
No basement membrane -
rapid tissue ingrowth and
healing
Applications DFUs, VLUs, surgical wounds,
vulnerable tissue
DFUs, VLUs, pressure injury, surgical wounds Breast reconstruction, Tendon
augmentation, abdominal wall
repair, hernia repair
DFU = Diabetic foot ulcer; VLU = Venous leg ulcer
9
Robust Portfolio
• Expanded to 21 distributors
across the US
• Full logistics, warehousing
and invoicing in place
• Distributors will sell the
ReNerve product ranges
• Will add additional products
as they come to market
Focus surgical areas
Subspecialties
• Hand (upper extremity)
• Breast
• Lower Extremity (M.D. & DPM)
• Plastics Reconstruction
• Head & Neck
• Spine
Sales and Marketing Update US Market Expanded
Distribution Channels
10
11
ReNerve Distribution
Strategy
Ex-US Sales & Marketing
MIDDLE EAST
Targeting meaningful markets such as India and Asia
Leveraging off FDA approval and US patient data
Will use the US data from the “Align” study for European submission
Sales Highlights
Indian submission completed and in
final Government review. Market valued
at USD$115M and growth at 18+%*
Working with the local Indian partner
to engage with hospitals and
surgeons with extensive leads
identified
Aiming to expand regional approvals
and sales and marketing across Asia
Potential to drive revenue to
complement the US business
11
Leveraging US approval and patient data for entry into global markets
Asia
India
Progressed to final stage of approval
with local pre-approval market
engagement underway
Expanding regional approvals
and local distributor
appointments
Approval in Bahrain as the first
step in the region.
* Global Nerve Repair Biomaterials Market Research Report (2020 –
2031)
12
02
Nerve Cuff
Key Features
ReNerve’s “Align”
Clinical Study
Definitive clinical study on using NervAlign Nerve
Cuff for nerve repair
120 patients per cohort
Comparing standard of care vs treatment with
NervAlign Nerve Cuff
Clinical Use
• Hundreds of patients implanted to date
• Received positive feedback from surgeons stating it handles well,
is pliable and conforms and has resulted in strong patient
outcomes.
• Has been used with attachment methods including sutures, glue,
micro clips and ‘nothing’.
Product
• Bio-absorbed within 6-months.
• Produced using a non-toxic method.
• Terminally sterilised with no residual chemicals.
• Covered under procedural reimbursement rather than individual
product reimbursement.
• Promotes vascular
• Semi-translucent
Patient Benefit
● Requires no change to surgical technique or procedures.
● Available in various sizes and thickness with ability to be trimmed
to required shape.
● Is pliable and conforms, semi-translucent and easy to use
Surgeon Benefit
3
2
1
Patient Results
• Protects nerves during recovery post peripheral nerve
repair
• Great handling characteristics and absorbed within 6
months
13
The “Align” Study
14
Clinical Study on the NervAlign® Nerve Cuff
Undertaking a definitive study in nerve repair and surgical
neurolysis to show the benefit of protecting the nerve post nerve
repair surgery.
Study Design: Two patient cohorts
• Control Group: Standard neurectomy repair
• Test Group: Neurectomy repair with NervAlign Nerve Cuff
• Based on the study which showed clear benefit for using the NervAlign Nerve Cuff
Key Outcomes:
• Looking for significance in Pain Reduction:
‒ Secondary outcomes in patient recovery
‒ Product performance in surgery
• Patient follow up around 6 to 9 months
Data presentation
• Aiming to complete recruitment by mid 2026
• Data accumulated along the way
• First 50 patients recruited to date
• Data likely to be published and presented in late 2026/early 2027
Comparison of Patient Pre & Post
Surgery Pain Score
Standard of Care NervAlign Nerve Cuff
Protected
Figure 1. The comparison of pain scores
between the two cohorts of patients
54%
Improvement
96%
Improvement
7.1 7.1
3.3
0.4
15
03
Conduit Update
Conduit
Update
Able to make it
commercially –
moving to commercial
material production
2
Currently doing scale
up manufacturing and
validation runs
1
17
04
Nerve Guide
Matrix (Graft)
Key Features & Guide Matrix
Product
• The NervAlign® Neve Guide Matrix is an ‘off-
the-shelf’, ready to use nerve graft
replacement with internal infrastructure.
• ReNerve is developing multiple product
options:
- Initial ‘wet’ prep nerve graft;
- Longer lengths out to 7cms+ and various
diameters
• Entering 3rd of 4 stages of commercial
development by late ’25/ early CY’26
Current Options
• Harvesting patients own
nerves.
• Donor tissue graft.
• Conduits (for smaller
repairs).
• High demand need for an
alternative
Benefits
- Doesn’t create secondary surgical site;
- Stored at room temperature, removing
storing issues;
- Doesn’t go through Wallerian degeneration;
- Ease of use allows for immediate repairs;
- Longer lengths enables surgical revisions;
- More cost effective to existing options; and
- Positive outcomes post-surgery
ReNerve Nerve Guide Matrix offers
many benefits, including:
18
Near Term Milestones – 2025/2026
1H 2025 Q4 2025/Q1 2026 Near Term
27 February 2025
Partnership Signed for Mexico Market
7 March 2025
R&D Tax Incentive Refund Received
11 March 2025
Thailand Approval & First Hong Kong Sale
28 March 2025
Clinical Study Results Presented
29 April 2025
Q3 FY25 Results: Revenue Growth & Clinical Validation
10 April 2025
Partnership for Indian Market Announced
NervAlign® Nerve Cuff Approvals in
New Countries & Territories
NervAlign® Nerve Conduit into Market
(Q4 2025/Q1 2026)
Growing the EmpliQ brand
Initial Clinical Cases for the
Nerve Conduit
Nerve Guide Matrix GMP
production
ReNerve ‘Align’ Study
data
NervAlign® Nerve Cuff
filing for European
approval
Starting GMP manufacturing
(Stage 3) runs of the Nerve Guide
Matrix
NervAlign® Nerve Cuff approval in
India
Expansion of the Nerve
Repair product portfolio
Continued sales growth
First clinical cases using
the nerve guide matrix
NervAlign® Nerve Cuff approval in
Taiwan
19
Investment Highlights
In Market Product Immediate Market Need Growing Market
Diverse Product Portfolio Growing Distribution Board & Management
Nerve Cuff transitioned from R&D to
commercial sales post FDA market clearance,
achieving strong initial product margins.
Product offering promotes nerve injury
recovery and regrowth leading to faster
patient recovery and better outcomes.
Nerve repair biomaterials and related
markets are forecasted to grow by >17%
pa, estimated to be worth >US$6.19Bn by
2031.
Four product ranges in market by year
end, all of which are already
developed. Additional products
currently under development.
Continuing to build sales
representation with a targeted-direct
sales approach.
Highly accomplished executive team
with a proven track record in the
development & commercialisation of
medical opportunities.
20
ASX:RNV
Contact
ReNerve Limited
info@renerve.com.au
Level 10/99 Queen St, Melbourne, Victoria 3000 Australia
+61 (03) 9482 3940
21
Share your feedback
Discover