Announcement PDF 1 Sales & Marketing Update ReNerve Board meeting | July 2025 ReNerve Annual General Meeting 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. 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 position and demand. Expanding Product Portfolio 3 product ranges in the US market with more coming 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. Activities for the past 12 months Expanding our commercialisation presence Completed an ASX IPO Multiple regional partners ● Middle East, Mexico, India, Hong Kong Partnership with Berkeley Biologics ● Brings Empliq brand of products ● Adds 4 product lines to the ReNerve sales portfolio ● Helps accelerate company sales ● Complementary to existing product portfolio Added direct salespeople in the US ● 21 US distribution partners ● Ongoing hospital approvals and surgeon engagement Positive NervAlign Nerve Cuff clinical study ● Expanded into a more comprehensive study Company revenue rose 53% year on year 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 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 Orthopaedics MarketWide Research – Dermal and Amniotic tissue market report 2025- 2032, Published 2025. 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 1H ‘26 Targeting CY27 filing Targeting 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 Global Nerve Repair Biomaterial Market - $2.0Bn $4.0Bn $6.0Bn $8.0Bn 2024 2025 2026 2027 2028 2029 2030 2031 USD $Bn Global Nerve Repair Biomaterial Market North America Europe 16% 52% 32% Global Market by Segment Nerve Wrap Nerve Conduit Nerve Grafts USD$1.69Bn The Global Nerve Repair Biomaterials Market was valued at USD$1.69Bn in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 17.8% from 2024 to 2031 to USD$6.19Bn.* ~900k Nerve surgeries occur in the United States (US) per annum, with no more than 24% of nerve surgeries restoring to ‘as good as it was’. Nerve Compression Approximately 1-in-4 nerve repair cases receive surgery repair, with 30% failure/revision rates. * Global Nerve Repair Biomaterials Market Research Report (2020 – 2031) Robust portfolio • Expanded to 21 distributors across the US • Full logistics, warehousing and invoicing in place • Distributors can sell the entire ReNerve product range • Will add additional to the network as products come to market Focus surgical areas Subspecialties • Hand (upper extremity) • Breast • Lower Extremity (M.D. & DPM) • Plastics Reconstruction • Head & Neck • Spine Distribution Network US Market Expanded Distribution Channels ReNerve Distribution Strategy MIDDLE EAST ➢ Targeting meaningful markets such as India and Asia ➢ Leveraging off FDA clearance and US patient data for Europe ➢ More approvals due in the next 12 months Sales Highlights Final stages of approval process in India Seeking multiple approval applications across Asia Will use the US data and “Align” study for European approval submission Looking to support the US sales growth 10 Leveraging US approval and patient data for entry into global markets Asia India Significant potential due to population and open market. Have partnered with NetCentrix for approval and sales and marketing On market 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. * Global Nerve Repair Biomaterials Market Research Report (2020 – 2031) Ex-US Sales & Marketing 11 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. • Positive surgeon feedback when 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 revascularisation and remodelling • Semi-translucent Patient Benefit ● Requires no change to surgical technique or procedures. ● Available in various sizes 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 12 The “Align” Study 13 Clinical Study on the NervAlign® Nerve Cuff Undertaking a definitive study in nerve repair following 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: • Testing 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 The comparison of pain scores between the two cohorts of patients 54% Improvement 96% Improvement 7.1 7.1 3.3 0.4 14 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 Potential 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 16 Product Development Pipeline Product Development Pipeline Nerve conduit range Nerve Conduit and protector ranges ● Includes the Nerve cap ● Entering commercial validation batches ● 3 types of conduits to come to market Nerve guide matrix In the commercial development phase FDA approval pathway confirmed Next step GMP, commercial Value drivers for the next 12 months Driving sales and new products into market ● 4th product coming to market ● Complements the nerve cuff ● Faster sales growth through multiple products ● Ongoing hospital approvals and surgeon engagement Empliq products ranges now in the US market ● Building our network of US distributors ● 2026 is about gaining more customer approvals Working with distributors for additional approvals ● Strong, positive data in 2025 ● Ability to definitive clinical study ● The “Align” study underway and actively recruiting ● Initial data due in 2026 Ongoing Clinical Study ● Establishing partners Ex-USA ● Pending approval in several countries in 2026 ● Will leverage all clinical data and cases to expand globally ● Follow the same path for new products Continue to expand into Ex-US markets 2026 about major commercial progress Company Milestones 2025 Next 6 months Near Term Partnership Signed for Mexico Market R&D Tax Incentive Refund Received Thailand Approval & First Hong Kong Sale Positive Nerve Cuff Clinical Study Results Presented Empliq launched in the US Partnership for Indian Market Announced NervAlign® Nerve Cuff Approvals in New Countries & Territories NervAlign® Nerve Conduit into Market 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 Empliq initial sales Investment Highlights In Market Products Immediate Market Need Growing Market Diverse Product Portfolio Growing Distribution Board & Management Nerve Cuff transitioned from R&D to commercial sales with 3 product lines in market and nerve coduits coming. 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 Building a complete product range in market with 3 in market and more coming in 2026. 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. ASX:RNV Contact ReNerve Limited info@renerve.com.au Level 10/99 Queen St, Melbourne, Victoria 3000 Australia +61 (03) 9482 3940