CollEngin, Inc

Cell-Guiding Bridge for Ligament

Repair & Reconstruction

www.CollEngin.comSunnyvale, CA

June 2009

Seeking Equity Financing

PROBLEM: Ligament Injury & Tear

Source: U.S. Bancorp Piper Jaffray EquityResearch, Orthopedic Overview, 1999

Tissue Annual injuries (US)

Wrist/Hand ligament 200,000

Rotator Cuff Tendon 400,000

ACL 550,000

THUMB UCL (ULNARCOLLATERAL LIGAMENT)

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

STANDARD FIXATION METHODS USED

PHALANX

FEMUR

METACARPAL

TIBIA

KNEE ACLTEAR

THUMBUCLTEAR

CollEngin

CollEnginRibbon FORM

LOOP

ORIENTATION - STRENGTH - CELLS

CollEnginSheet

SOLUTION: Cell Guiding Bridge

Ligament

Nano-structure

Medical Grade

Collagen

Proprietary Low-cost Mfg Process

Bio-equivalent Scaffold

Native Scaffold

Reconstitution

Fibrils

Patented Deposition Machine

SCAFFOLD FILM (12” X 12” max)

CE FIBER

~ SizeBreaking Strength

125 um Dia 60 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

~ equalmaterialstrength

Proof of Concept

Ligament-like high mechanical strength

Cell Guidance: Migration & Proliferation

Small Animal Study

Platelet Rich Plasma Controlled Delivery

Stem Cell Seeded Scaffolds

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

CELL GUIDED SCAFFOLDSMesenchymal Stem Cells

Allograft Cell Bridge

Strength (kg)

50 15 thru 70

Tol. (kg)

±10 ±1

EUP ($) 1600 325 - 1600

Repair time Slow Fast

Specs None Tight

Quality Variable Consistent

Infection Some risk None

Competitive Profile

Allograft Market: RTI, Arthrex, Lifenet, Allosource

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

$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

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

• 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

“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

12 Month Plan

2009 - 2010Jul Aug S O N D Jan F Mar Apr May Jun

Cross-link processProduct Prototype

Bio-mechanical TestingCell Culture Tests

Animal studyToxicity & other tests

510k process

MILESTONES1) Product prototype2) Results of BioMechanical tests3) Results of Animal tests4) 510k Entry

1

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

Initial Prototype & Animal Tests

File 510KSuture/ Matrix

File 510KSuture/ Matrix

$5 M - 2 yrs$1.5 M - 1 yr

FDA Timeline

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

Summary

Proprietary Technology

Proof of Concept

Large Market

Strong Team

Great Funding Opportunity