Renerve Limited · ASX:RNV
Renerve — Investor Presentation (November 2024)
33 slides from Renerve's investor presentation, Dec 2, 2024
Slide 1: Transforming Nerve Repair Through Science
TRANSFORMING NERVE REPAIR THROUGH SCIENCE For personal use only Investor Presentation | November 2024 1
Slide 2: Important Notice & Disclaimer
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 a
Slide 3: Executive Summary
Executive Summary Development of Novel Nerve Repair & Regeneration Products ReNerve is focused on developing a portfolio of products for the nerve repair and regeneration markets, with clearly defined commercial demand. For personal use only Significant Product Portfolio ReNerve currently has one pr
Slide 4: Investment Highlights
Investment Highlights IN MARKET PRODUCT IMMEDIATE MARKET NEED GROWING MARKET For personal use only Nerve Cuff transitioned from R&D to Product offering promotes nerve injury Nerve repair biomaterials market is commercial sales post FDA market recovery and regrowth leading to better forecasted to gro
Slide 5: Company History
Company History 2017 2018 2019 2020 2021 2022 2023 2024 For personal use only ReNerve Ltd Positive animal studies Received marketing Entered into a established with the for the Nerve Cuff and approval for NervAlign® commercial aim to improve short Nerve Guide Matrix. Nerve Cuff in New Zealand. partn
Slide 6: Global Nerve Repair Biomaterial Market
Global Nerve Global Nerve Repair Biomaterial Market* Global Market by Segment* Repair $8.0Bn Biomaterial $6.0Bn 32% 16% Market* USD $Bn $4.0Bn For personal use only 52% $2.0Bn Nerve Wrap Nerve Conduit - Nerve Grafts 2024 2025 2026 2027 2028 2029 2030 2031 North America Europe Asia Pacific Latin Amer
Slide 7: ReNerve's Opportunity
ReNerve’s Opportunity Nerve Cuff Nerve Conduit Nerve Guide Matrix Bionic Nerve For personal use only • Used on damaged or transected • Improved Nerve Cuff developed from • An ‘off-the-shelf’, ready to use nerve • An ‘off-the-shelf’, continuous nerve Product nerves with no gaps or gap closure scCO2 t
Slide 8: PNI Classification, Traditional Treatment Methods and ReNerve Solution
PNI Classification Traditional Treatment Methods ReNerve Solution Suture Autograft Synthetic Conduits • Can result in tension at repair site • Loss of function at harvest site • Limited direction for regrowth leading to ischemia • Complication risk including • Increased failure rate >5mm gaps Transe
Slide 9: Issues with Existing Nerve Repair Methods
Issues with Existing Nerve US Nerve Procedural Breakdown Repair Methods 2% ReNerve’s Opportunity 6% 14% Method Limitations ReNerve Solution • Can result in tension to the repair leading to ischemia. 78% For personal use only Suture • Concentrates sutures at the coaptation site. Trauma Carpal & Cubit
Slide 10: Distribution Network
Distribution Network Defined sales strategy targeting the US as five regions, with aggressive focus to continue building regional sales representation. For personal use only Using third party distribution partnerships and 1099s. Established sales presence in target states with a focus on key hospita
Slide 11: Anticipated Company Milestones
Anticipated Company Milestones (Next 12 – 24 Months) 2026 Ongoing Q1 2025 Q4 2024 – Q4 2025 Mid-2025 2H 2025 Q1 2026 Onwards For personal use only • Partnerships and Approvals for • Complete Development for • First Clinical Graft Cases • Continue to Build Sales & the NervAlign® Nerve Cuff in New Ner
Slide 12: NervAlign Nerve Cuff
NervAlign® Nerve For personal use only Cuff 12
Slide 13: Key Features Clinical Use
Key Features Clinical Use Product Patient Results • The NervAlign® Nerve Cuff is an FDA cleared product used on • 80% of cases to date have been focused on hand and wrist. damaged or transected nerves with no gaps or gap closure • Clinical cases have: achieved by flexion. ✓ All reported positive out
Slide 14: Incorporating eCOO Technology
Incorporating eCOO®Technology eCOO® Technology eCOO® Clean Benefits Over Conventional Tissue Treatments For personal use only Uses carbon dioxide under pressure to create a gas and liquid state. eCOO® Technology is ideal for cleaning • Retains structural & mechanical • Maintains natural crosslinking
Slide 15: Clinical Use
Clinical Use For personal use only Damaged nerve removed from the Removed gap filled with a conduit NervAlign® Nerve Cuff used to Completed repair held in place with right thumb protect the cuff conduit implant micro clips 15
Slide 16: Clinical Use - Carpal Tunnel
Clinical Use - Carpal Tunnel For personal use only Carpal tunnel revision – exposed nerve Implanted NervAlign® Nerve Cuff used as a protective layer between the nerve and surrounding fascia tissue. The cuff sutured in place using the ‘taco’ method. 16
Slide 17: NervAlign Conduit
For personal use only Conduit NervAlign® 17
Slide 18: Key Features
Key Features • ReNerve is focused on developing a conduit from scCO2 tissue from the Nerve Cuff. • ReNerve will be able to leverage existing data from the Nerve Cuff FDA application to accelerate FDA clearance. For personal use only • Offers the followings benefits: — Expands the ReNerve product ran
Slide 19: NervAlign Nerve Guide Matrix (Graft)
NervAlign® Nerve For personal use only Guide Matrix (Graft) 19
Slide 20: Key Features & Guide Matrix
Key Features & Guide Matrix Product • The NervAlign® Neve Guide Matrix is an ‘off-the-shelf’, ready to use nerve graft replacement with internal guidance infrastructure. • ReNerve is developing three product options: — Initial ‘wet’ prep nerve graft; — Dry version that's hydrated within 10 minutes;
Slide 21: Autologous Implantation Study NervAlign Nerve Guide Matrix
Autologous Implantation Study NervAlign® Nerve Guide Matrix (Graft) Nerve graft models have shown: Animal study results showed: • Restored ‘native’ state of nerves and function. ✓ Ready to implant and no special training required. • Formation of functioning axons through full length of the nerve. ✓
Slide 22: Regulatory Framework
Regulatory Framework Ethics Approval FDA Meeting Commercial FDA Clearance Partnership For personal use only ✓ ✓ ✓ Received ethics approval for the Outlined positive path forward for Executed partnership with Collagen ReNerve have established a clear animal model study including ReNerve, requiring no
Slide 23: NervAlign Bionic Nerve
NervAlign® Bionic For personal use only Nerve 23
Slide 24: NervAlign Bionic Nerve
NervAlign® Bionic Nerve • ReNerve are developing the Bionic Nerve to be in lengths from 1cm to 20cm+ long, in a ready to ReNerve's NervAlign® Bionic use nerve structure, to replace damaged nerves. Nerve is intended to be an off- • ReNerve are seeking to develop an effective solution for the most cha
Slide 25: Dura Mater Replacement
Dura Mater Replacement ReNerve are currently developing two products for the replacement of Dura Mater. For personal use only 1 Product One – Short term, remodeling dura replacement • For small craniotomies and back/spinal surgery. • Dura tissue-based on the nerve cuff eCOO® Technology. • Designed t
Slide 26: Board & Management
For personal use only Board & Management 26
Slide 27: Board & Management
Board & Management STEPHEN COOPER DR JULIAN CHICK DR MICHAEL PANACCIO DR DAVID RHODES DR ALEX ADAMIDES CHAIRMAN CEO & MANAGING DIRECTOR NON-EXECUTIVE DIRECTOR EXECUTIVE DIRECTOR & CSO CHIEF MEDICAL OFFICER For personal use only Stephen was previously a Dr Julian Chick is an experienced Dr Michael Pa
Slide 28: Contact
Contact For personal use only E: info@ReNerve.com.au 157 Heidelberg Rd, +61 (03) 9482 3940 www.renerve.com.au Northcote VIC 3070 Investor Presentation | November 2024 28
Slide 29: Appendix
For personal use only Appendix 29
Slide 30: Key Risks
Key Risks ReNerve is in the medical devices business and such businesses require additional capital from time to time in order to progress development programs. There is no Insufficient funding guarantee that ReNerve will be able to raise the funds required in a timely manner or at a reasonable cost
Slide 31: Key Risks
Key Risks EMCM has the technical experience and processes to manufacture the NervAlign® Nerve Cuff. If EMCM were unable to continue operations for example due to loss of Manufacturing and accreditation or insolvency, or alternatively the agreement with EMCM was breached and terminated, ReNerve would
Slide 32: Key Risks
Key Risks There can be no assurance that ReNerve will be able to retain key personnel. The departure of key personnel may adversely affect ReNerve until suitable replacements Reliance on key personnel are recruited. ReNerve may be required to undertake further testing or clinical trials of its produ
Slide 33: Significant Contracts
Significant Contracts On 4 May 2018 ReNerve entered into a Product Development and Supply Agreement (Leader Development Agreement) with Leader Biomedical Europe Holding B.V (Leader) under which ReNerve and Leader agreed to work on developing a collagen patch derived from porcine pericardium for use