Orthocell Ltd · ASX:OCC
Orthocell — Canaccord Annual Growth Conference 2025
22 slides from Orthocell's conference presentation, Aug 15, 2025
Slide 1: Canaccord Annual Growth Conference
For personal use only Canaccord Annual Growth Conference Boston, August 2025
Slide 2: Disclaimer
Disclaimer For personal use only 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 (inc
Slide 3: Orthocell at a glance
Orthocell at a glance Australian medical device company with growing international revenue and US market clearance of its flagship nerve repair product, Remplir For personal use only BEST IN CLASS PRODUCTS APPROVED MANUFACTURED IN AUSTRALIA IN NINE JURISDICTIONS Scaled facility certified to manufact
Slide 4: Corporate Snapshot
Corporate Snapshot Well-funded beyond US market clearance of Remplir, supported by leading life science institutional investors For personal use only ASX: OCC Trading Information 12 Month Share Price And Volume Share Price (as @ 05th August 2025) $1.23 Volume (m) Price ($) 8.0 $2.00 12 month low/hig
Slide 5: Highly Credentialed Board
Highly Credentialed 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 For personal use only Mr John Van der Wielen Mr Paul Anderson Dr Ravi I. Thadhani Professor F
Slide 6: Growing Revenue
Growing Revenue Orthocell’s rapid market penetration continues with a record revenue of $9.19m for FY2025 underscoring For personal use only Orthocell’s market penetration and sales growth of its flagship nerve repair product Remplir in Australia Total Revenue Key Highlights $10,000,000 • US Striate
Slide 7: Orthocell's First US Remplir Surgical Use Achieved
Orthocell’s First US Remplir Surgical Use Achieved First use into US$1.6 billion total addressable market1 achieved within 3 months of achieving US FDA 510(k) Flagship clearance. Low volumes initially to build surgical familiarity. For personal use only Product: US Remplir Commercialisation on Targe
Slide 8: US Path to High Volume Sales
US Path to High Volume Sales First surgical use completed, 1H FY26 ramp up expected For personal use only Market Access Product Launch Operations FDA Clearance Customer Segmentation US Team State Licenses Pricing East Coast distributors (14 in pause) Hospital Procurement Approvals Medical Education
Slide 9: Redefining Nerve Repair
For personal use only Redefining Nerve Repair
Slide 10: 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, For personal use only generating an ideal microenvironment to aid nerve healing Guiding predictable outcomes in peripheral nerve repair Exceptional Mimic
Slide 11: 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 For personal use only 100% 80% Useful Function Final results 60% 76% 85% Voluntary movement with improved strength and range of motion 85% (23 of
Slide 12: Superiority over Standard Nerve Repair Technique
Superiority over Standard Nerve Repair Technique Interim results from new study evaluating the impact of sutures on nerve regeneration and functional recovery in surgical repair of severed peripheral nerves For personal use only • Suturing Study commissioned by Orthocell to support US sales roll out
Slide 13: Indications
Indications Remplir is a highly versatile product that delivers a single solution for either CONNECT For personal use only connecting severed nerves, protecting Trauma: motor vehicle, power tool, surgical damaged nerves or capping amputated injuries, sports and military related accidents nerves > 20
Slide 14: 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 For personal use only Over 700,0001 peripheral nerve repair procedures in the US per year, 90% undertaken using suture only method.
Slide 15: Significant US Market Opportunity
Significant US Market Opportunity Orthocell has commenced commercial distribution into an estimated US$1.6 billion total addressable nerve repair market1 in the US alone For personal use only Remplir is not seeking to replace a current dominant market incumbent. Devices are only used in ~10% of proc
Slide 16: US Commercialisation Platform
US Commercialisation Platform First surgical use completed, 1H FY26 ramp up expected For personal use only 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 fulfil
Slide 17: Manufacturing
Manufacturing Manufacturing / Product Supply For personal use only 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 p
Slide 18: Logistics / Shipping
Logistics / Shipping Logistics / Shipping For personal use only On the ground logistics in the US to deliver into early sales orders • Stable product for shipping, no temperature control required • First inventory of 1,000 units in place, additional 1,000 units shipped from Australia • Stock warehou
Slide 19: US Market Roll Out
US Market Roll Out US Market Roll Out First 14 distributors appointed For personal use only • Hybrid sales approach of in-house sales and medical education team combined with engagement of external distributors • Immediate focus post FDA clearance was signing a portfolio of nerve repair specialist d
Slide 20: Upcoming Catalysts
Upcoming Redefining nerve repair Catalysts1 US FDA market clearance and Pre-Launch Achieved For personal use only Appoint initial US distributors Achieved HKG product registration Achieved US first surgical use Achieved US first sales Achieved Appoint further US sales team members 3Q CY25 Appoint fi
Slide 21: Investment Highlights
Investment For personal use only Highlights Commercial-stage Product margins Strengthened board Best in class products ~$28.7M cash at bank, medical device retained in-house with the appointments for Bone, Nerve and strengthened share company at revenue Manufacturing facility of highly experienced T
Slide 22: Authorised for release by Paul Anderson
For personal use only 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