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Development and commercialisation of a polymer/ceramic bone graft

Development and commercialisation of a polymer/ceramic bone graft. Team. Dr. Gouher Rabani - Project lead Prof. Mark Bradley - Professor at The University of Edinburgh Dr Ian Muirhead - Commercial Champion. Presentation Outline . Vision Background Market Technology

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Development and commercialisation of a polymer/ceramic bone graft

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  1. Development and commercialisation of a polymer/ceramic bone graft

  2. Team • Dr. GouherRabani - Project lead • Prof. Mark Bradley - Professor at The University of • Edinburgh • Dr Ian Muirhead - Commercial Champion

  3. Presentation Outline • Vision • Background • Market • Technology • In Vitro and In Vivo testing • Ageing studies • Next Steps

  4. Vision To commercialise a unique bone graft substitute, which will be marketed under the name Osteoconnex, through the spin-out of a Scottish based high-growth company

  5. Background • PoC project focused on a bone forming scaffold (Osteoconnex) • Marketing activities conducted to define optimal market requirements and commercialisation drivers • Refined product specifications to fit market requirements and end-user needs

  6. The Market

  7. Bone Graft Substitute (BGS) Market • Global market worth over $1.9B set to increase to $3.3B by 2017 • US Market worth over $1.3B set to increase to $2.2B by 2017 • European market is estimated to be worth$500M

  8. BGSMarket Segmentation 26% 6% 16% Allograft 40% Synthetic 20% 8% 9% 13% Demineralised Bone Matrix 40% 10% 12% 23%

  9. Failings of Current Products • Allograft & Demineralised Bone Matrix: • Reliant on donated tissue • Quality variation • Risk of disease transmission • Synthetic: • Fracture or extrusion • Difficult to cut & Shape • Delayed union or non-union of defect site • Slow rate of Resorption • Autograft: • Patient morbidity/Severe side effects • Double operation required

  10. Competitor Analysis and Current Needs

  11. End-user Requirements • Product must resorb in 9 - 12 months • Must be wettable • Good handling and shapability is a must • Structurally sound and robust material • Require no time limits in which the BGS is usable

  12. Technology A polymer/glass-based fully resorpable scaffold that promotes fast bone growth and is easy to cut & shape

  13. Incorporation of glass improves or maintains: • Handlability (easy to cut & shape) • Porosity (70 – 80%) • Compression resistance • Bone forming properties • Ease of manufacture Overview

  14. Mechanical Properties

  15. Corglaes 151 (Powder)

  16. Corglaes 101 (Powder)

  17. Corglaes 107 (Fibre, F2)

  18. In Vitro Testing

  19. Background- Osteoblast differentiation In vitro stem cells can be induced to differentiate into bone forming cells (osteoblasts), using a combination of chemicals: Osteogenic media commonly contains: Dexamethasone Beta glycerophosphate L ascorbic acid In vitro, these substances are capable of promoting gene expression, in a manner that results in osteogenesis. Runx2Collagen type I osteocalcin Growth Differentiation MSC Osteoprogenitor mature osteoblasts

  20. Experimental set up • All experiments were carried out over 21 days and analysed at days 1,7,14 and 21. • All experiments were carried out in 24 well plates and appropriate media replaced every 2 days. • Cells used were adipose derived mesenchymal stem cells, which have previously been shown to form osteoblasts within 21 days.

  21. Nomenclature • NOR Cells cultured on tissue culture plastic without osteogenic media • OS Cells cultured on tissue culture plastic with osteogenic media • HA Cells cultured on commerical hydroxyapatite with osteogenic media • BL Cells cultured on BLANK scaffolds with osteogenic media • 5% Cells cultured on scaffolds containing 5% phosphate fibres with osteogenic media

  22. Viability – live dead staining BL 5% Green: live cells (Calcein AM) Red: dead cells (propidium iodide ) CONTROL

  23. RUNX2 – early osteogenic marker Day 7

  24. COLLAGEN TYPE I -mid/early osteogenic protein Day 14

  25. OSTEOCALCIN- late stage osteogenic protein Day 14

  26. Gene expression

  27. Alkaline Phosphatase Day 14

  28. Alizarin Red (Calcium)

  29. Von Kossa (Phosphate)

  30. Von Kossa (x10) BL 5% HA PL

  31. In Vivo Studies

  32. Stability & Storage testing • Accelerated ageing • 40 °C /75% RH for 130 days • Further studies (GMP) • Accelerated ageing at 25/60,30/75, 40/75 • Photostability • Real time study (24 months) • Materials will be tested at various time points:

  33. Further work • Accelerated ageing • Full in vivo study (7 -9 months) • Further In Vitro studies • GMP Manufacturing • Clinical trial • Fund raising

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