Orthocell Ltd · ASX:OCC
Orthocell — Investor Presentation (April 2025)
21 slides from Orthocell's investor presentation, Apr 4, 2025
Slide 1: US FDA 510(k) Clearance for Orthocell's Flagship Product
US FDA 510(k) Clearance for Orthocell’s Flagship Product April 2025
Slide 2: Disclaimer
Disclaimer This presentation prepared by Orthocell Ltd (“Company”) does not constitute, representations contained in this presentation, and they do not accept any or form part of, an offer to sell or the solicitation of an offer to subscribe for or buy liability whatsoever (including in negligence)
Slide 3: US FDA 510(k) Clearance
US FDA 510(k) clearance Received for its flagship Remplir nerve repair product. Clears the way to commercial distribution into the US which represents a US$1.6 billion total addressable market1 Major Revenue Inflection Provides the catalyst to drive the Company towards breakeven and profitability wi
Slide 4: Redefining Nerve Repair
Redefining Nerve Repair
Slide 5: Redefining Nerve Repair
Redefining Nerve Repair Collagen nerve wrap used in the repair of peripheral nerve injuries. It provides compression-free protection to the nerve, generating an ideal microenvironment to aid nerve healing. Guiding predictable outcomes in peripheral nerve repair ✓ Exceptional ✓ Mimics ✓ Reduces need
Slide 6: Compelling Clinical Results
Compelling Clinical Results Patients regained voluntary muscle movement within 12 months, with increased muscle strength and range of motion at 24 months 100% 80% Useful Function Final results 60% 76% 85% Voluntary movement with improved strength and range of motion 85% (23 of 27) 40% of nerve repai
Slide 7: Indications
Indications Remplir is a highly versatile product that delivers a single solution for either connecting severed CONNECT nerves, protecting damaged nerves Trauma: motor vehicle, power tool, surgical or capping amputated nerves injuries, sports and military related accidents > 180 surgeons now using t
Slide 8: US Peripheral Nerve Repair Trends
US Peripheral Nerve Repair Trends Suturing is still the most commonly performed procedure and considered to be the “gold standard” technique for peripheral nerve repair Over 700,0001 peripheral nerve repair procedures in the US per year, 90% undertaken using suture only method. Suturing • Technicall
Slide 9: Significant US Market Opportunity
Significant US Market Opportunity Clearance paves the way for Orthocell to commence commercial distribution into an estimated US$1.6 billion total addressable nerve repair market1 in the US alone Remplir is not seeking to replace a current dominant market incumbent. Devices are only used in ~10% of
Slide 10: US Commercialisation Platform
US Commercialisation Platform Ready to fill sales orders from day 1 Manufacturing Logistics / Shipping US Market Roll Out Existing GMP facility in place US based central Internal Sales and Med in Western Australia warehousing, order Ed team combined with fulfillment, customer service Distributor Net
Slide 11: Manufacturing / Product Supply
Manufacturing Manufacturing / Product Supply Capacity in place to deliver the volumes through to company profitability • Annual medical device production capacity of 100,000 units in place at certified GMP facility in Western Australia • No near-term requirement for increased production capacity • A
Slide 12: Logistics / Shipping
Logistics / Shipping Logistics / Shipping On the ground logistics in the US to deliver into early sales orders • Stable product for shipping, no temperature control required • Stock to be warehoused at Uniphar’s GMP certified 65,000 square feet facility in the US with central coordination of warehou
Slide 13: US Sales, Marketing and Medical Affairs Executives
US Sales, Marketing and Medical Affairs US Market Roll Out Executives Orthocell has appointed experienced US-based executives to drive the market launch and sales of Remplir John Walker Phillip Edmondson Kevin Leach Vice President – Sales Vice President – Medical Affairs Head of Marketing Mr Walker
Slide 14: US Market Roll Out
US Market Roll Out US Market Roll Out 6 months preparation activities already undertaken. Pre-launch completed in advance of FDA approval Planned Structure • Hybrid sales approach of in-house sales and medical education team combined with engagement of external distributors East Coast Sales West Coa
Slide 15: Pre-launch Completed
Pre-launch Completed Orthocell successfully completed a pre-launch program at the 2025 IFSSH and IFSHT Triennial Congress in the US in advance of FDA approval. Attended by leading peripheral nerve surgeons from the US and other countries. 2025 IFSSH and IFSHT Triennial Congress International Federat
Slide 16: Investment Highlights
Investment Highlights Commercial-stage Best in class products Strengthened board ~$32M cash at bank, Product margins medical device for Bone, Nerve and with the appointments strengthened share retained in-house company at revenue Tendon repair approved of highly experienced register, share market Ma
Slide 17: Upcoming Catalysts
Upcoming Redefining nerve repair Catalysts1 US FDA market clearance and Pre-Launch Achieved Appoint US sales team 2Q CY25 Appoint US distributors 2Q CY25 US first sales 2Q CY25 EU+UK & Brazil submissions lodged 3Q / 4Q CY25 Growing better bone Germany, Austria, Switzerland market launch Achieved Sin
Slide 18: Appendices
Appendices Corporate Snapshot Highly Credentialed Board
Slide 19: Corporate Snapshot
Corporate Snapshot Well funded beyond US market clearance of Remplir, supported by leading life science institutional investors ASX: OCC Trading Information 12 Month Share Price And Volume Share Price (as @ 03rd March 2025) $1.44 Volume (m) 8.0 Price ($) $2.00 $1.80 12 month low/high $0.35/$0.1.79 7
Slide 20: Highly Credentialled Board
Highly Credentialled Board Recent appointments of John Van Der Wielen and Professor Fiona Wood AM places Orthocell in a strong position to drive its products into global markets and accelerate revenue growth Mr John Van der Wielen Mr Paul Anderson Dr Rravi I. Thadhani Professor Fiona Wood AM Hon Kim
Slide 21: Co-Founder and Managing Director, Paul Anderson
Authorised for release by Co-Founder and Managing Director, Paul Anderson Orthocell Limited P: +61 8 9360 2888 E: paul.anderson@orthocell.com.au orthocell.com