Announcement PDF ASX:RNV Sales & Transforming Nerve Repair Marketing Through Science Update ReNerve Board meeting | July 2025 ReNerve Company presentation | September 2025 1 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. 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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 2 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 market by year end (CY’25), with more in development and research. 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. Global Market by Segment $8.0Bn 16% 32% $6.0Bn USD $Bn Global Nerve Repair Biomaterial Market Global Nerve Repair Biomaterial Market $4.0Bn 52% $2.0Bn - Nerve Wrap 2024 2025 2026 2027 2028 North America 2029 Europe 2030 2031 Nerve Conduit Nerve Grafts USD$1.69Bn ~900k Nerve Compression The Global Nerve Repair Biomaterials Nerve surgeries occur in the United Approximately 1-in-4 nerve repair Market was valued at USD$1.69Bn in 2023 States (US) per annum, with no more cases receive surgery repair, with 30% and is projected to grow at a compound than 24% of nerve surgeries restoring failure/revision rates. annual growth rate (CAGR) of 17.8% from to ‘as good as it was’. 2024 to 2031 to USD$6.19Bn. ReNerve’s Nerve Opportunity Nerve Conduit Nerve Cuff Product Nerve Guide Matrix Bionic Nerve • 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 • • 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 • • • • Trauma Craniotomy Spinal cord injury Spinal cord surgery • Enable production of nerves of bespoke dimension Procedure Use • End to end suturing covered with a wrap/cuff Protective cuff for grafts Application • • • • Trauma Breast reconstruction Orthopaedics Oral & maxillofacial surgery • • • • Trauma Breast reconstruction Orthopaedics Foot and ankle • • • • Trauma Breast reconstruction Orthopaedics Hand & wrist • 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 Benefit • FDA Status Approved • Targeting market release 4th qtr CY’25 • Targeting Q2 CY27 filing $3219m TAM (USD) $314m 2024 $975m $1015m 2030 2024 $1991m >$400m $635m 2030 Targeting Q3 CY28 filing 2024 2030 2023 Distribution Network US Market Expanded Distribution Channels 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 Ex-US Sales & Marketing Sales Highlights ReNerve Distribution India has significant potential due to the open market and population with the market valued at USD$115M and growth at 18+%* India a training ground for surgeons due to number and diversity of cases so good location to globally brand promote India Asia MIDDLE EAST Significant potential due to population and open market. Have partnered with NetCentrix for approval and sales and marketing Approved in Hong Kong and Thailand, moving to strategic partners across the region Entered into exclusive partnership with Union Mediscience B.S.C in the Middle East. Strategy ReNerve pursuing approvals across the regions with their partners Leveraging US approval and patient data for entry into global markets ➢ Targeting meaningful markets such as India and Asia Potential to drive revenue to ➢ Leveraging off FDA approval and US patient data complement the US business ➢ Approved in Hong Kong, Bahrain and Thailand, with approval in India anticipated by year end * Global Nerve Repair Biomaterials Market Research Report (2020 – 2031) 7 Continued Market Engagement 3 new products ranges into the US market this CY • Company value drivers for H2 CY25 Dermal and amniotic products now in market and launched • Have achieved first dermal sale • First conduit product by year end • Provides sales teams a range of four products by year end, expected to aid sales of NervAlign nerve cuff and grow company revenue Working with distributors for additional approvals • Sales infrastructure suitable for all products • Indian and other Asian countries in process US Direct ReNerve sales • Small team in the US • Supporting the 21 distributors • ReNerve team to ‘hold the hands’ of distributors for new products and initial sales NervAlign® Nerve Cuff 01 Key Features Product • The NervAlign® Nerve Cuff has market clearance in USA, Hong Kong, Thailand and Bahrain • The product is used as a barrier between the repaired nerve and surrounding tissue. Patient Benefit • Bio-absorbed within 6-months. • Produced using a non-toxic method. • Terminally sterilised with no residual chemicals. Clinical Use Patient Results • Majority of cases to date have been focused on hand and wrist. • • • Shown clinical benefit (published) • Promotes vascular tissue formation on surrounding fascia tissue post-implant. Surgeon 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 Shown better than expected outcomes for patients Clinical Use • • Hundreds of patients implanted to date • Has been used with attachment methods including sutures, glue, micro clips and ‘nothing’. • Covered under procedural reimbursement rather than individual product reimbursement. All reported positive outcomes; and Received positive feedback from surgeons stating it handles well, is pliable and conforms and has resulted in strong patient outcomes. Clinical Validation Clinical Study on the NervAlign® Nerve Cuff An independent comparative clinical study was presented at theAmerican College of Foot and Ankle Surgeons Conference (27–30 March 2025), ReNerve presented a comparative clinical study showing statistically significant improvements in patient outcomes using the NervAlign® Nerve Cuff for peripheral nerve repair. Comparison of Patient Pre & Post Surgery Pain Score 7.1 7.1 54% Improvement Study Design: Two patient cohorts • Control Group: Standard neurectomy repair • Test Group: Neurectomy repair with NervAlign® Nerve Cuff 3.3 Key Outcomes: • Pain Reduction: 96% Improvement ‒ Control: 7.1 ➝ 3.3 ‒ NervAlign : 7.1 ➝ 0.4 0.4 • Satisfaction & Recovery: ‒ Higher satisfaction and improved recovery in the NervAlign® group Standard of Care ‒ Pain assessment conducted independently NervAlign® Nerve Cuff significantly reduces post-operative pain and enhances patient satisfaction compared to standard surgical methods. NervAlign® Nerve Cuff Protected Figure 1. The comparison of pain scores between the two cohorts of patients Efficacy of a Porcine Pericardium Nerve Wrap in Peripheral Nerve Surgery” March 2025 Namany et al. ACFAS 2025, (https://imis.acfas.org/ACFAS2025/ACFAS2025/Abstracts.aspx?hkey=5209f2e8-69fc-4935-8823-799c8f5c2922) Abstract Ref ID Sci-743 Clinical Use Damaged nerve removed from the thumb Gap filled with a conduit NervAlign® Nerve Cuff used to protect the cuff conduit implant Completed repair held in place with micro clips NervAlign® Conduit 02 Key Features • ReNerve developing a conduit product range from scCO2 tissue also used in the Nerve Cuff. • ReNerve is leverage existing data from the Nerve Cuff FDA application to accelerate FDA approval. • Offers the followings benefits: • Expands the ReNerve product range and portfolio; • Better reimbursement for the conduits; and • Same outcome and better product profile as the Nerve Cuff. • Expands offerings into hospital systems • ReNerve is targeting the first conduit product on market by end of year 2025 NervAlign® Nerve Guide Matrix (Graft) 03 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 Benefit • ReNerve Nerve Guide Matrix offers many benefits, including: - 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. Human Tissue Products 04 Empliq Product Portfolio Empliq AmnioLite Empliq AmnioDuo Empliq Placental 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 Natural barrier to protect wounds from external environment Natural scaffold for protection, reinforcement and capillary formation Improved handling characteristics Empliq Dermal Additional structural support 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 The Berkeley – ReNerve Product Ranges Expanding the company product range to the same target markets 1| Surgeons using NervAlign 2| They also use dermal and 3| Taking on these products products routinely use dermal amniotic membranes in cases expands ReNerve’s revenue and amniotic membranes in where a nerve repair is not opportunity nerve repair cases required 4| Suitable for the same sales 5| Similar mechanism of action to 6| Market approved, and distribution channel Nerve Repair portfolio – a matrix and first sale achieved already established protects healing tissue, enabling controlled reconstruction while minimising scarring 20 Dermal & Amniotic Tissue Sales for Specific Surgical Applications in USD$Bn $2,500.00 Global Dermal & Amniotic Tissue Repair Markets $2,000.00 $1,500.00 $1,000.00 $500.00 $0.00 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 MarketWide Research – Dermal and Amniotic tissue market report 2025-2032, Published 2025. Orthopedics (Tendon and Ligament Repair) Surgical Applications ( Trauma, Plastic Surgery) Benefits of Amniotic Product Range • Used in orthopaedic, plastic and general surgery – especially for chronic wounds and wound closure • Enables rapid, non-pathologic healing and remodelling of surgical and reconstructive wounds • Acts as a natural barrier to protect from external environment • Provide a reservoir of growth factors and cytokines that can help to kick-start healing • Processed using a proprietary method that improves levels of growth factors, supporting cell attachment and reepithelialization • ‘High sterility’ assurance level (gold standard of 10-6) without compromising natural structure • Room temperature storage Deep-Layer Dermal Product Range • Used in orthopaedic, plastic and general surgery • Provides a scaffold for cell infiltration and organised healing • Scaffold is made from natural bioactive components (collagen, elastin, glycosaminoglycans) • Unlike competitor products, the deep-layer dermal products are produced using a method that removes the basement membrane layer • The basement membrane slows down cell penetration and tissue regeneration • Basement membrane removed to promote a faster healing process • Pre-hydrated, pliable and flexible to support precise placement • High sterility assurance level (gold standard of 10-6) without compromising natural structure • Room temperature storage Key Dermal Product Benefits Unprocessed Dermal Tissue DESIGNED AND PROCESSED TO PRESERVE THE NATURAL MATRIX AS CLOSELY AS POSSIBLE TO UNPROCESSED DERMIS FOR OPTIMAL TISSUE REPAIR AND REGENERATION. CLOSEST TO NATURAL DERMAL TISSUE, COMPARED TO OTHER DERMAL PRODUCTS1. ACHIEVES HIGH STERILITY-ASSURANCE LEVELS, WHILE MAINTAINING A STRUCTURALLY-INTACT MATRIX THAT RETAINS SIMILAR COLLAGEN INTEGRITY, MECHANICAL STRENGTH, AND BIOACTIVE COMPONENTS AS THE NATURAL DERMIS. New ReNerve Dermal Product Natural Dermal Integrity is Preserved 1) Data on file Near Term Milestones – 2025/2026 1H 2025 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 10 April 2025 Partnership for Indian Market Announced 29 April 2025 Q3 FY25 Results: Revenue Growth & Clinical Validation Q4 2025/Q1 2026 NervAlign® Nerve Conduit into Market (Q4 2025/Q1 2026) Initial sales of the dermal and amniotic product ranges Initial Clinical Cases for the Nerve Conduit Starting GMP manufacturing (Stage 3) runs of the Nerve Guide Matrix NervAlign® Nerve Cuff approval in India NervAlign® Nerve Cuff Approvals in New Countries & Territories Near Term Nerve Guide Matrix GMP production First clinical cases using the nerve guide matrix Expansion of the Nerve Repair product portfolio Continued sales growth NervAlign® Nerve Cuff filing for European approval Investment Highlights In Market Products Immediate Market Need Growing Market Nerve Cuff transitioned from R&D to commercial sales with 3 product lines in market and another coming by year end. Products promote nerve injury recovery and wound repair leading to faster patient recovery and better outcomes. Nerve repair biomaterials and related markets are forecast to grow by >17% pa, estimated to be worth >US$6.19Bn by 2031. USD$1Bn+ market for human tissue product ranges Diverse Product Portfolio Growing Distribution Board & Management 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. Expanding globally. Highly accomplished executive team with a proven track record in the development & commercialisation of medical opportunities. Management owns over 30% - Top 20 around 58% ASX:RNV Contact ReNerve Limited +61 (03) 9482 3940 info@renerve.com.au Level 10/99 Queen St, Melbourne, Victoria 3000 Australia Board & Management STEPHEN COOPER CHAIRMAN DR JULIAN CHICK CEO & MANAGING DIRECTOR DR MICHAEL PANACCIO NON-EXECUTIVE DIRECTOR DR DAVID RHODES EXECUTIVE DIRECTOR & CSO DR ALEX ADAMIDES CHIEF MEDICAL OFFICER Stephen was previously Managing Director at Grant Samuel, a leading Australian investment bank. Dr Julian Chick is an experienced healthcare executive with over 20 years’ experience in senior management including in ASX listed companies Avexa and Admedus, and is currently NonExecutive Director at LTR Pharma (ASX:LTP). Dr Michael Panaccio is one of the founders of Starfish Ventures, a venture capital firm that invests in early-stage technology companies and plays an active role in the management of its portfolio. Dr David Rhodes has more than 20 years’ experience in healthcare and biotechnology industries, where he has held numerous senior management roles and developed technologies through to market approval. Dr Alex Adamides studied medicine at the University of Nottingham, UK, and completed his basic surgical training in Edinburgh before undertaking his neurosurgical training in Australia. Michael has been a director of numerous technology businesses in Australia and the USA including SIRTeX Medical Ltd, Engana Pty Ltd (now part of Finisar Corporation), Energy Response (sold to EnerNoc Inc), ImpediMed Ltd, and Protagonist Therapeutics Inc. David has been involved in obtaining several FDA USA and European marketing authorisation approvals for medical devices. Stephen has over twenty-five years of experience in Investment Banking and has been responsible for numerous corporate advisory assignments including public company takeovers, mergers, business sales and acquisitions, schemes of arrangement, capital raisings and business valuations. Stephen has previously served as Chairman of Avexa, an ASX-listed biotechnology company. Julian’s previous roles include Chief Executive Officer, COO and Head of Business Development, as well as running early and latestage R&D projects and launching medical devices into the global markets. Julian has been involved in developing and obtaining FDA USA clearance for four tissue based medical devices. Julian, while COO at Admedus Ltd was involved in the R&D development, regulatory approval and launch of several tissue products in North America, Europe and Asia. Julian has eight years’ investment banker experience focused on healthcare and biotechnology. Julian has a PhD in Muscle Physiology. Previous roles include senior researcher at Amrad, Chief Scientific Officer of the medical devices company Admedus Ltd, COO of AdAlta Ltd and senior executive and Head of Drug Discovery and Senior Vice President Biology at Avexa Ltd. David has successfully led multiple technology development programs attracting significant levels of funding from many State and Federal Government initiatives and research institute programs. Dr Adamides became a fellow of the Royal Australasian College of Surgeons in 2012 and has since been a consultant neurosurgeon at the Royal Melbourne Hospital. Dr Adamides is an honorary clinical senior lecturer at Melbourne University and a reviewer for the Journal of Clinical Neuroscience. Working with ReNerve, Dr Adamides has developed preclinical models testing the safety and efficacy of surgical implants for the repair of peripheral nerves and dura. David has a PhD in Biochemistry. 28