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June 2009

CollEngin, Inc Cell-Guiding Bridge for Ligament Repair & Reconstruction www.CollEngin.com Sunnyvale, CA. June 2009. Seeking Equity Financing. PROBLEM: Ligament Injury & Tear. Tissue. Annual injuries (US). Wrist/Hand ligament. 200,000. Rotator Cuff Tendon. 400,000. ACL. 550,000.

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June 2009

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  1. CollEngin, Inc Cell-Guiding Bridge for Ligament Repair & Reconstructionwww.CollEngin.comSunnyvale, CA June 2009

  2. Seeking Equity Financing

  3. PROBLEM: Ligament Injury & Tear Tissue Annual injuries (US) Wrist/Hand ligament 200,000 Rotator Cuff Tendon 400,000 ACL 550,000 THUMB UCL (ULNAR COLLATERAL LIGAMENT) Source: U.S. Bancorp Piper Jaffray Equity Research, Orthopedic Overview, 1999

  4. Problems with Current Implants • Autografts ( $300M ACL market) • Donor site morbidity • Additional incision • Risk of complications • Allografts & Xenografts ( $200M ACL market) • Variable quality • Inconsistent availability • Risk of infection • Slow to heal • High cost

  5. SOLUTION: Cell Guiding Bridge

  6. Proprietary Low-cost Mfg Process Fibrils Ligament Nano-structure Reconstitution Bio-equivalent Scaffold Native Scaffold Medical Grade Collagen

  7. Patented Deposition Machine SCAFFOLD FILM (12” X 12” max) CE FIBER ~ equal material strength UCL ACL • Existing machine: • originally designed for optical manufacturing • can easily produce all UCL’s for US market

  8. Proof of Concept • Ligament-like high mechanical strength • Cell Guidance: Migration & Proliferation • Small Animal Study • Platelet Rich Plasma Controlled Delivery • Stem Cell Seeded Scaffolds

  9. Key Bridge Component Collagen Fiber • Bridge Parameters: • Diameter & length woven as req’d • “J” elasticity similar to ACL • Advantages: • Ligament-like strength on day one • Consistent quality • Accelerated growth and repair • Patient Platelet / Stem Cell Seeding

  10. Mesenchymal Stem Cells CELL GUIDED SCAFFOLDS

  11. Competitive Profile Allograft Market: RTI, Arthrex, Lifenet, Allosource

  12. Market • Ligament Procedures/yr US • Hand / Wrist = 70k • Ankle (sprain) = 350k • Hand / Wrist Reimbursement • $1k avg / device • $70M market Market Penetration Goals Yr 1 – 1% Yr 2 – 3% Yr 3 – 10%

  13. $385K has bought Coated glass Free-standing • Prototype Production: • Collagen coated slides & Petri Dishes • Free-standing collagen film • Advanced Cell Culture Results • Collaboration Agreements • UCSF (3 Labs), Stanford • Navy (CRADA) • Strong Initial Team & Advisors • Blocking IP

  14. George R. Martin, President Pioneer in biomaterials, NIH Director, VP Fibrogen Michael V. Paukshto, CTO Oriented molecular film technology David H. McMurtry, VP Mfg Productdevelopment & manufacturing, IBM Nicholas A. Abidi, CMO Orthopaedic Surgeon (foot & ankle) Dennis R. Riemann, CFO CPA, Management of Finance, IT & HR CollEngin Management Team

  15. Advisors James Larrick, M.D., Ph.DDirector, Panorama Research Prof. Vincent Hentz, MDHand Surgery, Stanford Elizabeth Watson, MD Ortho Surgeon, Kaiser Perm. Robert Duboc, MBA SeniorBusiness Executive David Bagley Pres. Advanced BioMatrix, VP AlIergan Prof. Gerry Fuller Chair, Chemical Eng., Stanford Bill Hyun, PhD GM of 5 cell labs, UCSF Eric Sabelman, PhDTissue engineering, Kaiser Perm. Frank Delustro, PhD VP Collagen Corp., CEO Fusion

  16. Seeking $1.5M for 12 months • “Cell Guiding Bridge” Prototypes • Bovine/Porcine Collagen "in house" • BioMechanical Studies • Mechanical testing “in house & by contract" • BioReactor, Stanford (Prof. R. Hentz, MD) • Platelet Rich Plasma & ECM Production, UCSF • Stem Cell Seeding, Stanford (Prof. J. Cooke) • Animal Study by contract • 510k Application

  17. 12 Month Plan

  18. Primary Clinical Points: Safety & efficacy Initial strength of healthy ligament Promotes ingrowth & repair $1.5 M - 1 yr $5 M - 2 yrs FDA Timeline Initial Prototype & Animal Tests FDA Approval File 510K Suture/ Matrix

  19. Funding & Exit options • VC / Corporate Funding • Large, underserved market • Strategic to large corporations • Blocking IP • Large upside potential • M & A • Orthopedics: Stryker, Zimmer, J&J, Smith & Nephew • Tissue Regen: J&J, Pfizer • R&D: Millipore, BD

  20. Summary • Proprietary Technology • Proof of Concept • Large Market • Strong Team • Great Funding Opportunity

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