Orthocell Ltd · ASX:OCC
Orthocell — Investor Presentation (September 2014)
28 slides from Orthocell's investor presentation, Sep 2, 2014
Slide 1: Advancing Repair and Regeneration
For personal use only Advancing Repair and Regeneration Investor Presentation ASX: OCC September 2014 Paul Anderson Managing Director
Slide 2: Disclaimer
Disclaimer For personal use only This presentation prepared by Orthocell Pty Ltd ("Company") does not constitute, or form part of, an offer to sell or the solicitation of an offer to subscribe for or buy any securities, nor the solicitation of any vote or approval in any jurisdiction, nor shall ther
Slide 3: Company Information
Company Information For personal use only ASX: OCC Orthocell is a commercial Share price $0.38 Shares on issue 82,500,000 stage regenerative medicine Market cap $31,350 million company. Options outstanding 5,912,500 (exercised @ $0.50) Stone Ridge Entities 12.34% Paul Anderson 8.44% Orthocell’s lead
Slide 4: Investment Highlights
Investment Highlights For personal use only First tendon and ligament regeneration product Approved treatments with approved in a major market and the next generation strong clinical evidence cartilage repair therapy Musculoskeletal conditions are the leading contributor Significant unmet medical to
Slide 5: Experienced leadership team
Experienced leadership team For personal use only Paul Anderson CEO Verigen, Genzyme, Biomet Prof Ming Hao Zheng CSO Verigen, Genzyme, UWA Dr Stewart Washer Exec Chair Cynata, Minomic iCeutica, Glycan Bio, Matt Callahan Director Dimerix, Scanalyse UN Bone & Joint Chair, Prof Lars Lidgren Director Bi
Slide 6: Company History
Company History For personal use only 2006/7 – Incorporation, seed capital, cGMP manufacturing facility completed 2008/9 - TGA license, Ortho-ATI™ tennis elbow clinical study commenced 2010 - Ortho-ATI™ first paying patients treated in Australia 2011 - Ortho-ATI™ European Achilles tendon trial study
Slide 7: Three complementary platforms
Three complementary platforms For personal use only Ortho-ATI™ CelGro™ Ortho-ACI™ Tendon repair and regeneration Collagen scaffold for repair of Cartilage repair and therapy utilizing the patients’ soft tissue injuries or regeneration therapy utilizing Description own cultured tendon stem cells dege
Slide 8: Large market for tendon repair
Large market for tendon repair For personal use only • Tendon injury is very common, particularly in active people: - Over 250,000 rotator cuff injuries need surgery in the US each year - Tennis elbow affects 1%-3% of the population - Over 200,000 Achilles tendon sports injuries in the US each year
Slide 9: Regenerating and repairing tissue - not just treating symptoms
Regenerating and repairing tissue - not just treating symptoms For personal use only 9
Slide 10: Ortho-ATI - tendon regeneration
Ortho-ATI™ - tendon regeneration For personal use only Proprietary method for expanding and cultivating tendon stem cells (Tenocytes) GMP process Re-inject Tendon biopsy to expand and tenocyte cells at from patient cultivate site of tendon patient’s cells injury ATI = autologous tenocyte implantatio
Slide 11: Ortho-ATI - multiple indications
Ortho-ATI™ - multiple indications For personal use only Hamstring Tendon Rotator Cuff Tennis elbow Patellar Tendon Gluteal Tendon Achilles Tendon 11
Slide 12: Ortho-ATI - three trials completed
Ortho-ATI™ - three trials completed For personal use only • ATI Tennis Elbow (2008) - 20 patient prospective study - Published (2013) in the prestigious American Journal Sports Medicine - 3-5 year data published showing successful long-term treatment - Ortho-ATI™ disruptive technology and a disease
Slide 13: Tennis elbow trial data
Tennis elbow trial data 3-5 year update For personal use only Key Findings: • 83% mean improvement in Max Pain score • 87.3% * mean * improvement in DASH score • 64.3% mean improvement in UEFS score • 207% mean improvement in Grip Strength * 13
Slide 14: Tennis elbow trial data: 3-5 yr. Functional outcomes
Tennis elbow trial data 3-5 yr. Functional outcomes For personal use only
Slide 15: Ortho-ATI Data Conclusions
Ortho-ATI™ Data Conclusions For personal use only • Ortho-ATI can structurally repaired tendon tissue in patients with Severe chronic Resistance Lateral Epicondylitis; • The improvement of functional outcomes occurs significantly at 6 month and maintains for at least 3-5 years. • Evidence of durabil
Slide 16: Patient feedback
Patient feedback For personal use only Amanda Redwood 43 year old mother of two with resistant tennis elbow. Before treatment even basic tasks such as lifting a glass of water were painful and required the wearing of a brace. “Now I can do anything that I want as if I never had the injury.” Sean Har
Slide 17: Ortho-ATI - RCT
Ortho-ATI™ - RCT For personal use only Achilles Tendon Trial (completed) - 90 patients double-blinded, placebo controlled randomised trial (1:1) - first placebo controlled, randomised tenocyte trial undertaken globally - half patients receive Ortho-ATI™ injection and half receive saline 15
Slide 18: Ortho-ATI - Marketing Strategy
Ortho-ATI™ - Marketing Strategy For personal use only • Ramp up product sales - already revenue generating in Australia – 200+ patients treated as part of early commercialisation efforts - new channel to radiologists, sports docs and physio’s - sales tools, marketing and referral networks expansion
Slide 19: Three complementary platforms
Three complementary platforms For personal use only Ortho-ATI™ CelGro™ Ortho-ACI™ Tendon repair and regeneration Collagen scaffold for repair of Cartilage repair and therapy utilizing the patients’ soft tissue injuries or regeneration therapy utilizing Description own cultured tendon stem cells dege
Slide 20: CelGro Collagen Scaffold
CelGro™ Collagen Scaffold For personal use only CelGro™ is a collagen derived scaffold that can be used for orthopedic (Ortho- ATI™ or Ortho-ACI™) and other soft tissue regeneration • CelGro™ is manufactured using a proprietary technology that gives it unique properties: - high mechanical strength -
Slide 21: CelGro Collagen Scaffold
CelGro™ Collagen Scaffold For personal use only • Multiple applications: - ear drum – reconstructive - orthopaedic - bio-mechanical support and/or cell delivery - gynaecological / urological – reconstructive - general surgical – reconstructive • Ear drum repair Phase 1 clinical study underway • Appl
Slide 22: Three complementary platforms
Three complementary platforms For personal use only Ortho-ATI™ CelGro™ Ortho-ACI™ Tendon repair and regeneration Collagen scaffold for repair of Cartilage repair and therapy utilizing the patients’ soft tissue injuries or regeneration therapy utilizing Description own cultured tendon stem cells dege
Slide 23: Ortho-ACI - cartilage regeneration
Ortho-ACI™- cartilage regeneration For personal use only Orthocell developed a new process called Ortho-ACI™ - the 3rd generation ACI ACI = autologous chondrocyte implantation 21
Slide 24: Restores cartilage anatomy
Restores cartilage anatomy For personal use only Orthocell founders were instrumental in developing the first generation ACI and gaining TGA approval for the first cell therapy to repair damaged cartilage Damaged Articular Cartilage 9 months post ACI 22
Slide 25: Ortho-ACI - Marketing Strategy
Ortho-ACI™ - Marketing Strategy For personal use only •Ramp up product sales - already revenue generating in Australia – 250+ patients treated - existing strong relationships with key prescribers – orthopaedic surgeons - direct sales capacity expansion in NSW and Victoria planned - pursue reimbursem
Slide 26: TGA approved cGMP facility
TGA approved cGMP facility For personal use only • Two ISO 14644-1 clean rooms for human tissue processing • Manufacturing licence issued by TGA which is subject to annual audit • Quality system regularly reviewed and updated and tech transfer achieved for Chinese licensee • Facility supports commer
Slide 27: Strong IP Portfolio
Strong IP Portfolio For personal use only Patent Family Description Status Tenocyte cell culturing method Method for collecting, Granted – Australia, USA, preparing and culturing NZ, Singapore tendon cells (tenocytes) for Pending – Canada, China, Ortho-ATI™ therapy Europe Tenocyte containing Method
Slide 28: Thank you
For personal use only Advancing Repair and Regeneration Thank you ASX: OCC Paul Anderson Managing Director