Orthocell Ltd · ASX:OCC
Orthocell — Corporate Update (February 2025)
24 slides from Orthocell's corporate update, Feb 26, 2025
Slide 1: Orthocell Webinar Presentation - Accelerating Global Expansion
Orthocell Webinar Presentation -Accelerating Global Expansion- Perth, Australia; 26 February 2025: Regenerative medicine company Orthocell Limited (ASX: OCC, “Orthocell” or the “Company”) is pleased to attach the Webinar Presentation to be delivered by the CEO and MD Paul Anderson at 11am EST today.
Slide 2: Remplir Global expansion update
For personal use only Remplir Global expansion update February 2025
Slide 3: Disclaimer
Disclaimer For personal use only This presentation prepared by Orthocell Ltd (“Company”) does not constitute, or contained in this presentation, and they do not accept any liability whatsoever form part of, an offer to sell or the solicitation of an offer to subscribe for or buy (including in neglig
Slide 4: Orthocell at a glance
Orthocell at a glance Australian medical device company with growing international revenue and US market clearance of For personal use only breakthrough nerve repair device pending BEST IN CLASS PRODUCTS APPROVED MANUFACTURED IN AUSTRALIA IN NINE JURISDICTIONS Scaled facility certified to manufactur
Slide 5: 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 Volume (m) Price ($) Share Price (as @ 25th February) $1.24 8.0 $2.00 7.0 12 month low/hi
Slide 6: Growing Revenue
Growing Revenue Orthocell’s rapid market penetration continues with a third consecutive quarter of record revenue of $2.21 For personal use only million reported in the December 24 Quarter. Total Revenue Key Highlights $8,000,000 CAGR 93% • US Striate+ and AUS Remplir product sales commenced $7,000,
Slide 7: Highly Credentialed Board
Highly Credentialed Board Appointments of John Van Der Wielen and Professor Fiona Wood AM places Orthocell in a strong position to drive For personal use only its products into global markets and accelerate revenue growth 6
Slide 8: SMRT Manufacturing
For personal use only SMRT Manufacturing DEVELOPING AND MANUFACTURING BIOLOGICAL MEDICAL DEVICES
Slide 9: Collagen medical device platform
Collagen medical device platform Our collagen medical device platform is comprised of a range of acellular, type 1 collagen devices for the For personal use only surgical repair of bone, nerve, tendon and cartilage BONE NERVE TENDON Striate+ membrane Remplir nerve wrap SmrtGraft scaffold Dental bone
Slide 10: SMRT manufacturing
SMRT manufacturing Orthocell develops and manufactures innovative collagen medical devices that deliver the highest quality surgical For personal use only repair of bone, nerve, tendon and cartilage Barrier function prevents infiltration of cells not SMRT manufacturing process involved in tissue rep
Slide 11: Remplir: Redefining Nerve Repair
For personal use only Remplir REDEFINING NERVE REPAIR
Slide 12: Remplir: Nerve repair breakthrough
Remplir : Nerve repair breakthrough Current repair methods can place delicate nerve tissue under tension, causing scarring, fibrosis and neuroma For personal use only formation 1860s 2000s 2020s Suturing Conduits Next generation infl sep Success 50-70% 55% 85% Rates 11
Slide 13: Remplir: Redefining nerve repair
Remplir : Redefining nerve repair Collagen nerve wrap approved and reimbursed in Australia. For personal use only Intended for use in peripheral nerve repair GUIDING PREDICTABLE OUTCOMES IN PERIPHERAL NERVE REPAIR ✓ Exceptional handling characteristics ✓ Mimics epineurium (nerve outer layer) ✓ Reduc
Slide 14: Remplir: indications
Remplir : indications Remplir is the only device that can be used for CONNECT For personal use only either connecting severed nerves, protecting damaged nerves or capping amputated nerves Trauma: motor vehicle, power tool, surgical injuries, sports and military related accidents PROTECT Compression:
Slide 15: Remplir: compelling clinical results
Remplir : compelling clinical results Patients regained voluntary muscle movement within 12 months, For personal use only increasing strength and range of motion at 24 months 100% We are now seeing a consistent return of arm and hand function following nerve transfer surgery with Remplir. 80% Rempli
Slide 16: Successful launch with growing revenue
Successful launch with growing revenue AUS commercial launch1 of Remplir with Device Technologies, reimbursed in the private healthcare system in For personal use only November 2022, with sales unit volumes exceeding expectations Remplir product revenue since AUS market launch • 127% growth in Rempl
Slide 17: US FDA approval expected March / April CY25
US FDA APPROVAL EXPECTED MARCH / APRIL CY25 TO US$1.6 For personal use only BILLION MARKET Annual US nerve reconstructions 6,516 4,475 2,309 Over 700,0001 peripheral nerve repair procedures in the US per year, 90% undertaken 56,700 using suture only method. • Successfully completed the 510(k) Regula
Slide 18: US Sales and Medical Affairs Executives
US Sales and Medical Affairs Executives Orthocell has appointed two experienced US-based executives, John Walker and Phillip Edmondson, to drive the For personal use only market launch and sales of Remplir following the expected US FDA market clearance in March / April 2025 John Walker Phillip Edmon
Slide 19: Remplir: Path to partnering
Remplir : Path to partnering Orthocell is underpinned by a proven business model for innovating, developing, launching and successfully For personal use only partnering medical device products Scale Organisation US Approval Brand Ambassadors Data Package Sales and Marketing Executive team Pilot stud
Slide 20: Remplir: Market Expansion
Remplir : Market Expansion Regulatory approval for Remplir in Singapore achieved in 2H CY24 with a further four applications planned in For personal use only EU, UK & Brazil in the next 6-12 months APPROVED in Australia, New Zealand and Singapore REGULATORY 2024 2025 2026 APPLICATIONS Q4 Q1 Q2 Q3 Q4
Slide 21: Remplir: Large addressable market in nerve reconstruction
Remplir : Large addressable market in nerve reconstruction Remplir is a breakthrough product on track to be the global market leader in peripheral nerve repair – a retail For personal use only market estimated to exceed US$3.5 billion¹ per annum Total Addressable Retail Est. procedures Market (US$m)
Slide 22: Upcoming catalysts
Upcoming catalysts1 Remplir – redefining nerve repair For personal use only US FDA market clearance 1Q / 2Q CY25 Appoint US sales team 1Q CY25 Appoint US distributors 2Q CY25 US first sales 2Q CY25 EU+UK & Brazil submissions lodged 3Q / 4Q CY25 Striate+ – growing better bone Columbia submission lodg
Slide 23: Key Investment Highlights
Key Investment Highlights For personal use only Commercial-stage Best in class Strengthened ~$32.7M cash at Near term value medical device products for Bone, board with the bank, strengthened drivers including company at revenue Nerve and Tendon appointments of register, no royalty Remplir US 510(k)
Slide 24: 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 24