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CollEngin, Inc Cell-Guiding Bridge for Ligament Repair & Reconstruction www.CollEngin.com Sunnyvale, CAwww.CollEngin.com June 2009.

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Presentation on theme: "CollEngin, Inc Cell-Guiding Bridge for Ligament Repair & Reconstruction www.CollEngin.com Sunnyvale, CAwww.CollEngin.com June 2009."— Presentation transcript:

1 CollEngin, Inc Cell-Guiding Bridge for Ligament Repair & Reconstruction Sunnyvale, CAwww.CollEngin.com June 2009

2 Seeking Equity Financing

3 PROBLEM: Ligament Injury & Tear Source: U.S. Bancorp Piper Jaffray Equity Research, Orthopedic Overview, 1999 TissueAnnual injuries (US) Wrist/Hand ligament200,000 Rotator Cuff Tendon400,000 ACL550,000 THUMB UCL (ULNAR COLLATERAL LIGAMENT)

4  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 Problems with Current Implants

5 SOLUTION: Cell Guiding Bridge

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

7 Patented Deposition Machine SCAFFOLD FILM (12” X 12” max) CE FIBER ~ Size Breaking Strength 125 um Dia60 g (meas) 1 x 5 mm~25 kg 7.5 mm Dia~175 kg Existing machine: originally designed for optical manufacturing can easily produce all UCL’s for US market UCL ACL ~ equal material strength

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 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 Collagen Fiber

10 CELL GUIDED SCAFFOLDS Mesenchymal Stem Cells

11 AllograftCell Bridge Strength (kg)5015 thru 70 Tol. (kg)±10±1 EUP ($) Repair timeSlowFast SpecsNoneTight QualityVariableConsistent InfectionSome riskNone Competitive Profile Allograft Market: RTI, Arthrex, Lifenet, Allosource

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

13 $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 Coated glass Free-standing

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 Product development & 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.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

16  “Cell Guiding Bridge” Prototypes - Bovine/Porcine Collagen "in house"  Animal Study by contract  510k Application  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) Seeking $1.5M for 12 months

17 12 Month Plan

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

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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