CollEngin, Inc CellGuiding Bridge for Ligament Repair

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CollEngin, Inc Cell-Guiding Bridge for
Ligament Repair Reconstruction
www.CollEngin.comSunnyvale, CA

• June 2009

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Seeking Equity Financing
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PROBLEM Ligament Injury Tear
THUMB UCL (ULNAR COLLATERAL LIGAMENT)
Source U.S. Bancorp Piper Jaffray
Equity Research, Orthopedic Overview, 1999
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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

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SOLUTION Cell Guiding Bridge
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Proprietary Low-cost Mfg Process
Fibrils
Ligament Nano-structure
Reconstitution
Bio-equivalent Scaffold
Native Scaffold
Medical Grade Collagen
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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 UCLs for US market

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Proof of Concept

• Ligament-like high mechanical strength
• Cell Guidance Migration Proliferation
• Small Animal Study
• Platelet Rich Plasma Controlled Delivery
• Stem Cell Seeded Scaffolds

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Key Bridge Component
Collagen Fiber

• Bridge Parameters
• Diameter length woven as reqd
• J elasticity similar to ACL
• Advantages
• Ligament-like strength on day one
• Consistent quality
• Accelerated growth and repair
• Patient Platelet / Stem Cell Seeding

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CELL GUIDED SCAFFOLDS
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Competitive Profile
Allograft Market RTI, Arthrex, Lifenet,
Allosource
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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
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385K has bought

• 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

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CollEngin Management Team

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

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Advisors

• James Larrick, M.D., Ph.D Director, Panorama
  Research
• Prof. Vincent Hentz, MD Hand Surgery, Stanford
• Elizabeth Watson, MD Ortho Surgeon, Kaiser Perm.
• Robert Duboc, MBA Senior Business 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, PhD Tissue engineering, Kaiser
  Perm.
• Frank Delustro, PhD VP Collagen Corp., CEO
  Fusion

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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

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12 Month Plan
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FDA Timeline
Initial Prototype Animal Tests
FDA Approval
File 510K Suture/ Matrix

• Primary Clinical Points
• Safety efficacy
• Initial strength of healthy ligament
• Promotes ingrowth repair

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Funding Exit options

• VC / Corporate Funding
• Large, underserved market
• Strategic to large corporations
• Blocking IP
• Large upside potential

• M A
• Orthopedics Stryker, Zimmer, JJ, Smith
  Nephew
• Tissue Regen JJ, Pfizer
• RD Millipore, BD

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Summary

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