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INVESTOR PRESENTATION JUNE 2010 INVESTOR PRESENTATION: CLINICAL RESEARCH AND COMMERICIALIZATION PLANS Excellagen Formulated Collagen-Based Topical Gel m Therapeutics, Inc. © 2010 Cardium

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Page 1: Document

INVESTOR PRESENTATION

JUNE 2010

INVESTOR PRESENTATION:

CLINICAL RESEARCH AND COMMERICIALIZATION PLANS

Excellagen Formulated Collagen-Based Topical Gel

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INVESTOR PRESENTATION:

Forward Looking Statement

This presentation contains forward-looking statements, including

d d ldiscussions and plans concerning clinical trials and product development

programs, regulatory and commercialization plans, evaluation of

potential opportunities, anticipated levels of corporate expenditures, the

assessment of Cardium’s technology by potential corporate partnersassessment of Cardium s technology by potential corporate partners,

capital market conditions, timing of events, cash consumption and other

subjects. Actual results could differ materially from these forward-looking

statements for many reasons, including the risks described under "Risk

Factors" in the Company’s Annual Report on Form 10-K and Quarterly

Reports on Form 10-Q as filed with the Securities and Exchange

Commission. No guarantee about future results, performance or

achievements can be made. Neither Cardium nor its agents intend toac e e e ts ca be ade e t e Ca d u o ts age ts te d to

update any of the forward-looking statements made after the date of this

presentation to conform them to actual results or to changes in

expectations.

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Tissue Engineering l f

Spinal Fusion

Diabetic Foot

PlatformFusion Ulcers

GENE ACTIVATED

MATRIX

Orthobiologics Osteorate

[Ad5PDGF-B]

Wound Healing

ExcellarateCustom Formulation

[Ad5PDGF-B/Collagen 2.6%]

TECHNOLOGY[Ad5chBMP4] ExcellagenCustom Formulation

[Collagen 2.6%]

Non-Union Bone

Fractures

Periodontal Tissue

Engineering Acute &Pressurem T

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EngineeringExcellarate

[Ad5PDGF-B]Surgical Wounds

Pressure Ulcers

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Healing for Diabetic Foot Ulcers

Wound

Standard of Care:

Dressings & Bandages

Living Skin Equivalents

Healing

Diabetic Foot

Ulcers

Negative Pressure Topical

Excellagen™ essu e

Vacuum Pumps

Topical Gel

Collagen-Based Dressings and Therapies

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EXCELLAGEN©20

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EXCELLAGEN

Commercial Opportunity Overview

Excellagen is a highly-refined fibrillar bovine Type I collagen-based gelthat is formulated to include structural stabilizers, hydrolytic enzymeinhibitors and bacteriostatic agents

Commercial Opportunity Overview

inhibitors, and bacteriostatic agents

⎯ Initially developed by Cardium, and its Tissue Repair Company subsidiary, as aflowable matrix to support, preserve and promote advanced DNA-basedregenerative medicine biologics

Designed to be an easy-to-use, pre-formulated product. Excellagen willbe supplied as pre-filled sterile, single-use syringes that are refrigeratedat 2°C to 8°C. The product is initially intended for use by health careprofessionals, but this market opportunity could be expanded as a directto consumer product with additional clinical experience and appropriatesupply chain logistics

⎯ The initial labeling will recommend that Excellagen be applied to the woundsurface immediately following a surgical debridement procedure and thaty g g ppatients receive a treatment administration three to four times during a 12week period

Unlike most collagen dressings, Excellagen has been evaluated in a multi-center controlled study. Cardium’s recently completed Matrix Phase 2bm

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center controlled study. Cardium s recently completed Matrix Phase 2bclinical study (n=124) evaluated Excellagen as one of two comparatorarms with standard of care (SOC) in patients with chronic non-healingdiabetic foot ulcers at 23 U.S.-based medical centers©

2010

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EXCELLAGEN

Commercial Opportunity Overview

Patients treated with one or two doses of Excellagen in the Matrix clinicalstudy showed increased frequency of wound closure, increased woundarea reductions and statistically significant increases in wound closure

Commercial Opportunity Overview

area reductions, and statistically significant increases in wound closurerate immediately following application compared to SOC. These findingscompare favorably to other treatments requiring more frequent or dailyapplications (which introduce patient compliance issues).

⎯ Based on data from the Matrix study, the company's clinical research advisorsbelieve that increasing treatment frequency from one or two administrations to3 to 4 treatments over a 12 week period will further accelerate healing andoverall closure rates compared to standard of care therapy and otherpreparationspreparations

Cardium has filed a 510 (k) application for U.S. marketing clearance withthe FDA, and is now completing final manufacturing activities, packagingand other final release requirements.q

MedPodium is a premium-priced, podiatry-focused, advanced skin-careproduct line that has been developed to complement planned Excellagenpromotional activities. Provides a capital-free, low-effort, revenue-

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generating practice development tool for physicians and boutiques.

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Collagen Based PlatformEXCELLAGEN

Collagen-Based Platform

ExcellagenCustom Formulation

[Collagen 2.6%]

Product Line Extensions

ExcellagenFxExcellagenXL

Gel for Topical Wounds

ExcellagenAGTopical Gel with

Antimicrobial Formulation

ExcellagenFxFlowable

Tunneled / Undermined

WoundsCoveredm

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Covered by Initial

510(k) Submission

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Collagen-Based Dressing OpportunitiesU.S. Incidence of Major Wound Types

Medical Condition

Wound Type Incidence

V Ul 1 625 000

Illness

Venous Ulcers 1,625,000

Arterial ulcers 1,725,000

Diabetic foot ulcers 1,260,0001

Immobility Pressure Ulcers 2,500,000

SurgicalSurgical Wounds: Major 36,000,000

Surgical Wounds: Moderate/Minor 31,000,000

Trauma

Burn injuries 1,285,000

Amputations 150,000

Traumatic Wounds/Lacerations2 16,250,000

TOTAL 91,795,000

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Source: Medtech Insight1Source: American Diabetes Association2Traumatic wounds/lacerations consist of open wounds (approx. 8.7 million), superficial wounds

(approx. 1.7 million), and contusions (approx. 5.8 million) seen in emergency rooms. EXCELLAGEN

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Product FormulationEXCELLAGEN

Product Formulation

Cardium Supplemental

Fibrillar Type I

FormulationBovineCollagen Structural Stabilizers

Hydrolytic Enzyme Inhibitors, and Bacteriostatic

Agents

EXCELLAGEN

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Product FormulationEXCELLAGEN

Product Formulation

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Fibrillar Collagen Scanning Electron Microscopic Image

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Proposed Product SpecificationEXCELLAGEN

Intended

Excellagen formulated collagen gel is indicated for the management of wounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/ undermined wounds, surgical wounds (donor sites/ grafts,

Proposed Product Specification

Use, / , g ( / g ,

post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. This device is packaged for one-time use at the physician’s office.

MechanismProvides favorable environment for effective wound management by providing

ff ldi f ll i ti d ill i th b i ll ti ti th hMechanism of Action

scaffolding for cell migration and capillary in-growth, by causing cell activation through adhesion signaling and by providing a moist protective barrier.

Excellagen is an advanced wound care device composed of soluble bovine dermal collagen (Type I). The collagen is enzymatically modified to reduce immunogenicity and purified using a specialized process that eliminates impurities (including endotoxins)

Device Description

purified using a specialized process that eliminates impurities (including endotoxins), removes denatured molecules and collagen fragments. Excellagen consists exclusively of high molecular weight, intact, fibrillar collagen and is formulated at a concentration of 2.6% in an isotonic solution that has buffering capacity, stabilizing agents, enzymatic inhibitors, and bacteriostatic agents. Excellagen is supplied sterile, in a single use syringe. Excellagen is supplied in kits containing four 1cc syringes and four sterile, fl ibl li t 10 i d t il fl ibl li t E ll iflexible applicators or one 10cc syringe and one sterile flexible applicator. Excellagen is stored at standard refrigeration temperature (2°-8°C).

Treatment

Initially Excellagen is a physician use only product. It is suggested that the product be applied at two to four week intervals following the initial treatment as part of a standard of care treatment regimen (including off loading and debridement) or anytimem

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Treatment of care treatment regimen (including off loading and debridement) or anytime immediately following a surgical debridement procedure. The wound should be covered with Excellagen and bandaged following application.

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DescriptionEXCELLAGEN

Type I Bovine Fibrillar Dermal Collagen (collagen is a natural and, essential component of healing wounds)

Triple helical fibrils (structural/functional mimic of collagen made

p

Triple helical fibrils (structural/functional mimic of collagen made by cells)

Biocompatible and bioresorbable/biodegradable

E l i il d (l i id f b i ll i i i )Evolutionarily conserved (low incidence of bovine collagen sensitivity)

Primary antigenic determinants (telopeptides) removed

Manufactured according to cGMPs

Physiologic, buffered, sterile formulation⎯Optimized for ease of application, and complete

wound coverage without dripping

Single use, pre-filled syringes⎯Eliminates risk of wound contamination

Apply post debridement

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Store refrigerated (2°-8°C)

Cover with non-adherent dressing

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Mechanism of Action1EXCELLAGEN

Collagen is a critical component for every phase of wound healing

Provisional matrix jump-starts healing

Substrate (scaffold) for repair cell adhesion, migration and proliferation

Cond ci e to gran lation tiss e formation and epitheliali ationConducive to granulation tissue formation and epithelialization

Localizes and stabilizes growth factors (depot effect)

Promotes balanced healing environmentPromotes balanced healing environment

⎯Substrate for excess proteases (MMPs), commonly found in chronic wounds, that inhibit cellular proliferation and healing

M i t ilib i⎯Moisture equilibrium

⎯Formulation buffer contributes bacteriostatic and hydrolytic enzyme-inhibiting activities

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1 Brett D., Wounds 2009. A Review of Collagen and Collagen-Based Wound Dressings.

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The Four Requirements of h d lChronic Wound Healing

DebridementPhysician

Procedure

Bioburden Increased Bl d V lManagement

Classic Antibiotics

Blood Vessel Growth &

Circulation

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Cellular Stimulation Focus of

EXCELLAGEN

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EXCELLAGEN

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Proposed PackagingEXCELLAGEN

Proposed Packaging

Highly-refined Fibrillar Type I Bovine Collagen

Structural Stabilizers, Hydrolytic Enzyme Inhibitors, and Bacteriostatic agents added

Initially for Professional Use and Broadened to DTC with Enhanced Logistics

Three to Four Applications over 12 Weeks Following Surgical Debridement Procedures

Pre-Formulated Plug-N-Play

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Pre-filled Single Use Sterile Syringe

Refrigerated Storage

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Proposed PackagingEXCELLAGEN

Proposed Packaging

ExcellagenXL Gel for Topical Wounds

ExcellagenFX Flowable Tunneled / Undermined Wounds

Covered by Initial

510(k) Submission

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Matrix Phase 2b Clinical StudyEXCELLAGEN

Bio-Metric

Wound Size Reduction (n = 47)

ExcellagenStandard

f C P

y

Bio Metric Excellagenof Care Percent

Improvement(n = 31) (n = 16)

Wound Size RadiusWound Size Radius Reduction @ Week 1

0.213 cm 0.078 cm + 173%

Wound Size Radius Reduction @ Week 2

0.137 cm/wk 0.063 cm/wk + 117%Reduction @ Week 2

/ /

Wound Area Size Reduction @ 2 Weeks 61% 31% + 97%

≥ 50%

Wound Area Size Reduction @ 2 Weeks 39% 19% + 105%m

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Reduction @ 2 Weeks ≥ 75%

39% 19% + 105%

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EXCELLAGEN

Matrix Phase 2b Clinical Study

Healing Response:Reduction in Wound Size Radius

y

0.25

cm

(n = 47)

0.213

0 cm

Standard of Care Therapy

0.078

0

(p = 0.018)

change @ 1 week

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E ll f d ll t l t d d h d t ti ti ll i ifi t 173%

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Excellagen was safe and well tolerated and showed a statistically significant 173%relative improvement in the acceleration of wound healing (reduction in wound size)during the first week following a one-time application (generally applied followingsurgical debridement) compared to patients receiving standard of care therapy.

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EXCELLAGEN

Matrix Phase 2b Clinical Study

Healing Response:Reduction in Wound Size Radius

m m

y

0.25

cm

EXCELLAGEN

0.25

cm

(n = 47) (n = 47)

0.213

EXCELLAGEN

0 cm

SOC0.078

0 cm

SOC0.137

0.063

(p = 0.018)

change @ 1 week

(p = 0.032)

change @ 2 weeks

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A single application of Excellagen resulted in a statistically significant reduction in wound radius

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(accelerated healing) at one week post-treatment (left) and over the first two weeks post-treatment (right) when compared to Standard of Care. Excellagen was safe and well tolerated andshowed a statistically significant 173% relative improvement in the acceleration of wound healing(reduction in wound size) during the first week following a one-time application (generally appliedfollowing surgical debridement) compared to patients receiving standard of care therapy.

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Phase 2b Clinical Study

EXCELLAGEN

Case Study

yMeasuring Reduction in Wound Size

Case Study

Patient #01-001

radius

Determination of Radius from Wound Area

√ wound Area Wound

Radius=π

Blinded Photo Tracings

π

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Source: Journal of Diabetes and Its Complications 16 (2002) 327 - 332Determinants and estimation of healing times in diabetic foot ulcers

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Matrix Phase 2b Clinical Study

EXCELLAGEN

Wound Healing Metric at 12 Weeks (n = 47)

y

Bio-Metric

Wound Healing Metric at 12 Weeks (n 47)

Excellagen1 Standard of Care

Percent Improvement

All Wound Closures

45% 31% + 45%

Reductions in Wound Size 74% 44% + 68%in Wound Size

≥ 90%74% 44% + 68%

Closure of Large Size Wounds 33% 0% ∞Size Wounds

(> 3cm2)33% 0% ∞

1Based on one or two treatments.

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EXCELLAGEN

Matrix Phase 2b Clinical Study

Healing Response of Wound Size > 3 cm2

y

Bio-Metric ClosureArea Reduction in 12 Weeks

≥ 50% ≥ 75% ≥ 90%

Excellagen1

33% 75% 58% 50%(n = 12)

33% 75% 58% 50%

Standard of Care0% 50% 33% 17%

(n = 6)0% 50% 33% 17%

1Based on one or two treatments pursuant to MATRIX study protocol.

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Standard of CareMulti-Study Clinical Validation for Treatment of

N H li Di b i F Ul 1Non-Healing Diabetic Foot Ulcers1

(n = 672)50% 50%

nd

clo

sure

25% 25%om

ple

te w

ou

12

weeks

25% 25%Apligraf®

Study2

Dermagraft®

Promogran®

Study2

tien

ts w

ith

co

at

1

Margolis Meta-

Analysis Study3

MATRIX

Standard of Care

37.5%

n = 96

gStudy2

18.0%

n = 115

28.0%

n = 138

% p

at Study

19.9% - 28.8%

n = 323m T

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31%

n = 47

0% 0%n = 96 n = 115 n = 138 n = 323

1 Only includes studies with a 12-week treatment period.2 Package insert (Apligraf®, Dermagraft® and Promogram® are trademarks of their respective

owners, information regarding which can be found in their corresponding product inserts)3 Diabetes Care, Vol 22, 5 1999 (692-695).

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n = 47

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Wound Closure RatesRegranex and Excellageng g

Week

Wound Closure Incidence

N = 250 N = 47Week

Placebo Gel Regranex Gel10.01%

Matrix Phase 2b Clinical Study

ExcellagenSOC

2 0% 1% 3% 0%2 0% 1% 3% 0%

4 2% 6% 6% 13%

6 6% 9% 23% 19%

8 14% 16% 29% 25%

10 18% 23% 39% 25%

12 25% 34% 45% 31%

Applications N/A168

Patient1 – 2

Physician N/Am T

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& Cleansings N/A Patient Administrations

Physician Administration(s)

N/A

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241 Regranex® is a trademark of its respective owner, information

regarding which can be found in their corresponding product inserts)

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Regranex® Gel(becaplermin)

f 1

Week

Wound Closure Rate (n = 250)

Pl b G lRegranex Gel

Summary of Clinical Study1

Placebo GelRegranex Gel

0.01% (%)

2 0% 1%

4 2% 6%4 2% 6%

6 6% 9%

8 14% 16%

10 18% 23%

12 25% 34%

14 28% 37%8% 3 %

16 33% 43%

18 34% 46%Excellagen’s

Phase 2b Study

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20 37% 50%

1 Source: Table 1: Regranex Gel (0.01%) product insert (635-20-240-6) revised May 2008. Regranex® is a trademark of its respective owner, information regarding which can be found in their corresponding product inserts).

Endpoint

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Regranex® TreatmentProtein-Based Therapy

Drug Therapy

Wound CleansingDays

# Treatments

1 1 2 3 4 5 6 7 8 9 10 11 12 13 14

2 15 16 17 18 19 20 21 22 23 24 25 26 27 28

3 29 30 31 32 33 34 35 36 37 38 39 40 41 42

4 43 44 45 46 47 48 49 50 51 52 53 54 55 56Weeks

4 43 44 45 46 47 48 49 50 51 52 53 54 55 56

5 57 58 59 60 61 62 63 64 65 66 67 68 69 70

6 71 72 73 74 75 76 77 78 79 80 81 82 83 84

7 85 86 87 88 89 90 91 92 93 94 95 96 97 98

8 99 100 101 102 103 104 105 106 107 108 109 110 111 112

9 113 114 115 116 117 118 119 120 121 122 123 124 125 126

10 127 128 129 130 131 132 133 134 135 136 137 138 139 140

11 141 142 143 144 145 146 147 148 149 150 151 152 153 15411 141 142 143 144 145 146 147 148 149 150 151 152 153 154

12 155 156 157 158 159 160 161 162 163 164 165 166 167 168

13 169 170 171 172 173 174 175 176 177 178 179 180 181 182

14 183 184 185 186 187 188 189 190 191 192 193 194 195 196

15 197 198 199 200 201 202 203 204 205 206 207 208 209 210

16 211 212 213 214 215 216 217 218 219 220 221 222 223 224

17 225 226 227 228 229 230 231 232 233 234 235 236 237 238

18 239 240 241 242 243 244 245 246 247 248 249 250 251 252m T

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19 253 254 255 256 257 258 259 260 261 262 263 264 265 266

20 267 268 269 270 271 272 273 274 275 276 277 278 279 280

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1 Regranex® is a trademark of its respective owner, information regarding which can be found in their corresponding product inserts)

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Days

EXCELLAGEN

Proposed Treatment FrequencyR d d Cli i l U

EXCELLAGEN

Days

Weeks 1 #1

2

3

Recommended Clinical Usage

W 3

4 #2

5

6

7 #3

8

9

10 #410 #4

11

12

13

14

15

16

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19

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EXCELLAGEN

Predictive Wound HealingPredictive Wound HealingClosure Model

0.8

1

m)

ExcellagenMatrix Phase 2b SOCPublished SOC Rate1

0.4

0.6

0.8

d R

adiu

s (c

m Published SOC Rate

0

0.2

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

Wou

nd

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0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

Weeks

Time to complete closure

3.0 cm2 wound

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281 Assuming three Excellagen doses included following debridement procedure at week 0, week 4 and week 8.

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H li I d M d l B d

Predictive Wound HealingClosure Model

3.0 cm2 wound size

WeekHealing Index Model Based on

Matrix Phase 2b DataZimny et. al.2

Standard of Care ModelExcellagen1 Standard of Care

0 1.003 1.00 1.001 0 79 0 92 0 941 0.79 0.92 0.942 0.65 0.86 0.893 0.62 0.80 0.834 0.583 0.73 0.775 0 37 0 67 0 725 0.37 0.67 0.726 0.23 0.61 0.667 0.20 0.54 0.608 0.163 0.48 0.549 0 00 0 42 0 499 0.00 0.42 0.49

10 0.36 0.4311 0.29 0.3712 0.23 0.3213 0 17 0 2613 0.17 0.2614 0.10 0.2015 0.04 0.1516 0.00 0.0917 0 03m

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17 0.0318 0.00

1 Assuming three Excellagen doses included following debridement procedure at week 0, week 4 and week 8.2 Zimny et al. Experimental and Clinical Endocrinology and Diabetes 112: 191-194 (2003). (n = 120).3 Excellagen dosing.

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N M dP di P d LiNew MedPodium Product Line

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MedPodiumAffinity Marketing and Sales Program

Premium-priced, podiatry-focused, boutique-style, advanced skincare line that currently has six foot care products, includingexfoliants moisturizers soak/scrubs and conditioning oil for

y g g

exfoliants, moisturizers, soak/scrubs and conditioning oil fornails

⎯ Intended to complement planned Excellagen promotional activities

W b i di (DTC) k i d lWeb-centric, direct-to-consumer (DTC) marketing and salesplatform that provides capital-free, low-effort, revenue generatingpractice development tools initially for podiatrists with plans toexpand into other distribution channelsexpand into other distribution channels

Patient may receive discounts on MedPodium products andparticipating physicians could earn commissions on all web-based purchases by their patients

⎯Participating physicians will be provided product brochures, productsamples as well as web tools to promote the MedPodium line andtheir practice

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Expanding product line to include an alcohol-free and fragrance-free foot spray sanitizer and additional products planned. Web-based celebrity spokesperson under consideration.©

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Matrix Wound HealingPhase 2b Clinical StudyPhase 2b Clinical Study

A prospective, randomized, double-blind,

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controlled, U.S.-based multi-center study for thepotential treatment of patients with non-healingdiabetic neuropathic, lower extremity ulcers.©

2010

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Diabetic Foot Ulcers are the Leading Cause of Non-Traumatic

Li b A t ti i th U it d St tLimb Amputation in the United States

Diabetic foot ulcers are extremely expensive to the U.S. healthcare system.

When compared to Type-II diabetics without foot ulcers over the first two years after diagnosis, patients with diabetic foot ulcers:

⎯ had additional $28 000 in healthcare costshad additional $28,000 in healthcare costs

⎯ had 36 more outpatient visits and 8 more inpatient days

Cost of treating diabetic foot ulcer (DFU) can be substantial: ⎯Weekly treatment cost of uncomplicated DFU $200

⎯With osteomyelitis weekly cost $900

Ulcers are number one cause of amputation⎯ 84% of lower extremity amputations preceded by ulcer

C t f t ti b t ti lCost of amputations are substantial:⎯With $23,000 for toe, $43,000 for a foot, and $51,000

for a below knee amputation

Survival after amputation is bleak.

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*Ref.: Gordois et al. Diabetes Care. Volume 26, Number 26, June 2003.

Lavery et al 1997 Am J Med Vol 103 383-388.

⎯ 3 year survival rate after amputation is 50%

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U.S. Market Facts: Neuropathic Diabetic Foot Ulcers

Elements Amount

Estimated Diabetic Population in the U.S. 24,000,000

Percent Patients Who will Develop a Foot Ulcer During Lifetime 15%

Total Number of Patients 3,600,000

Estimated Annual Diabetic Foot Ulcers 1,260,000

Source: American Diabetes Association12005 Medtech Insight

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EXCELLAGEN

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Matrix Phase 2b Clinical Study

EXCELLAGEN

Matrix Phase 2b Clinical Study

Patients Evaluated

Per Protocol Analysis Patients1 Percent

EXCELLAGEN:

One Treatment

Two Treatments

13

18

28%

38%

Total 31 66%

Standard of Care 16 34%

TOTAL 47 100%

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1Does not include 66 patients treated with DNA-based therapeutic.

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Matrix Phase 2b Clinical Study

EXCELLAGEN

Patient Demographics

Subjects Enrolled1 47

Subjects Completing Study100% Completed Treatment Phase

Age (years)Range

5630 - 86

Sex (Male/Female) 74% / 26%Sex (Male/Female) 74% / 26%

Mean area (cm2)Range1 (cm2)

3.0cm2

1 5 – 6 5Range (cm ) 1.5 – 6.5

Median duration prior to treatment (wks)Range (wks)

69

6 - 651m T

hera

peut

ics,

Inc.

Range (wks) 6 651

1Does not include 66 patients treated with DNA-based therapeutic.

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Page 37: Document

Matrix Phase 2b Clinical Study

EXCELLAGEN

Preclinical Toxicology

A GLP study in a rabbit excisional wound model revealed no toxicological

Safety

relationship between clinical observations, clinical pathology, hematology, and grossor microscopic pathology following four applications of Excellagen given at oneweek intervals. No significant anti-collagen antibody responses were detected

Clinical

Clinical safety was assessed by AEs, clinical laboratory measurements, vital signs,concomitant medications, physical examination findings, and serum antibodyconcentrations to collagen

There were no treatment-related AEs and no obvious or concerning safety trendsThere were no treatment related AEs and no obvious or concerning safety trends.Individual abnormalities were consistent with the with the patient population

Excellagen did not cause an antibody response to bovine Type I collagen

⎯ The only positive collagen antibody titers were in two patients (one Excellagen and one SOC)that were also positive at screeningthat were also positive at screening

⎯ A positive collagen antibody titer did not inhibit healing

m T

hera

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ics,

Inc.

Excellagen (n = 31)

SOC(n = 16)

Patients with positive collagen antibody titer 1 1

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Patients with positive collagen antibody titer (at Week 5 and at screening)

1 1

Ulcer Area at Screening 3.3 cm2 6.5 cm2

Healing Response at 12 weeks Closed Week 5 52% reduction

Page 38: Document

Continuing Clinical ResearchNext Generation: G

Excellarate

Fibrillar Type I Bovine Collagen

[Ad5PDGFB]Platelet-Derived Growth Factor

DNA

Cardium Supplemental Formulation

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DNA

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Gene Activated MATRIX (GAM)TECHNOLOGY PLATFORM

Page 39: Document

Comparative Healing Following Administration:Weekly Reduction in Wound Radius (mm/week)

Standard ExcellagenF l t d Excellarate

yvs. Run-in Period

Standard of Care Formulated

Collagen GelExcellarate

[Ad5.PDGF-B]

BaselineRun-in 0.06 ± 0.32 0.08 ± 0.61 0.02 ± 0.58

Week 1 0.78 ± 1.53 1.97 ± 1.77p< 0.01

1.46 ± 1.37p< 0.01

Week 2 0.48 ± 0.90 0.81 ± 0.85p< 0.01

0.63 ± 1.05p< 0.01

Week 3 0 68 ± 1 16 0 29 ± 0 83 0.44 ± 0.89Week 3 0.68 ± 1.16 0.29 ± 0.83 p< 0.01

Week 4 0.01 ± 0.94 0.34 ± 1.14 0.72 ± 1.29p< 0.01

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Patient Wound Closure Rates EXCELLAGEN

PatientDiabetic Foot Ulcer % closure

at 12 weeksArea Duration

Based on a one or two treatment application only

Area Duration

EXC-001 2.6 cm2 64 weeks Closed at week 2

EXC-002 1.8 cm2 194 weeks Closed at week 4

EXC-003 3.3 cm2 10 weeks Closed at week 5

EXC-004 3.4 cm2 11 weeks Closed at week 5

EXC-005 1.8 cm2 28 weeks Closed at week 6

EXC-006 2.7 cm2 31 weeks Closed at week 6

EXC-007 3.7 cm2 10 weeks Closed at week 6

EXC-008 1.5 cm2 94 weeks Closed at week 7

EXC-009 2.9 cm2 28 weeks Closed at week 7

EXC-010 1 9 cm2 92 weeks Closed at week 9EXC-010 1.9 cm 92 weeks Closed at week 9

EXC-011 4.1 cm2 52 weeks Closed at week 9

EXC-012 2.3 cm2 119 weeks Closed at week 10

EXC-013 2.1 cm2 42 weeks Closed at week 11

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EXC-014 4.6 cm2 26 weeks Closed at week 12

EXC-015 2.0 cm2 190 weeks 99%

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Patient Wound Closure Rates EXCELLAGEN

PatientDiabetic Foot Ulcer % closure

at 12 weeksArea Duration

Based on a one or two treatment application only

EXC-016 4.1 cm2 52 weeks 98%

EXC-017 2.2 cm2 12 weeks 98%

EXC-018 2.8 cm2 9 weeks 97%

EXC-019 4.6 cm2 15 weeks 95%

EXC-020 2.1 cm2 21 weeks 95%

EXC-021 2.5 cm2 174 weeks 90%

EXC-022 3 5 cm2 6 weeks 88%EXC 022 3.5 cm 6 weeks 88%

EXC-023 1.7 cm2 136 weeks 80%

EXC-024 1.6 cm2 61 weeks 78%

EXC-025 3.1 cm2 16 weeks 71%

EXC-026 3.5 cm2 9 weeks 70%

EXC-027 2.8 cm2 52 weeks 32%

EXC-028 2.5 cm2 651 weeks 31%

C 2 %m T

hera

peut

ics,

Inc.

EXC-029 1.8 cm2 56 weeks 27%

EXC-030 3.7 cm2 111 weeks 26%

EXC-031 6.4 cm2 30 weeks 1%©20

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Standard of CarePatient Wound Closure Rates

PatientDiabetic Foot Ulcer % closure

at 12 weeksArea Duration

SOC-001 2 5 cm2 16 weeks Closed at week 3SOC-001 2.5 cm 16 weeks Closed at week 3

SOC-002 1.9 cm2 30 weeks Closed at week 4

SOC-003 2.7 cm2 11 weeks Closed at week 6

SOC-004 2.5 cm2 23 weeks Closed at week 8

SOC-005 1.6 cm2 10 weeks Closed at week 12

SOC-006 2.5 cm2 16 weeks 94%

SOC-007 2.6 cm2 67 weeks 93%2SOC-008 5.9 cm2 135 weeks 81%

SOC-009 1.6 cm2 27 weeks 78%

SOC-010 2.5 cm2 28 weeks 76%

SOC-011 2.7 cm2 22 weeks 73%SOC 011 2.7 cm 22 weeks 73%

SOC-012 6.5 cm2 82 weeks 52%

SOC-013 4.1 cm2 220 weeks 42%

SOC-014 4.1 cm2 15 weeks 37%

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SOC-015 1.6 cm2 65 weeks 8%

SOC-016 4.9 cm2 53 weeks 2%

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T t d P ti tEXCELLAGEN

Treated Patients

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Patient PhotosEXCELLAGEN

Patient #EXC-001

Patient Photos

Day 1

Week 1 Week 2 Closure

Patient Demographic DataPatient Demographic Data

Age 48

Sex Male

Ulcer Duration 64 weeksm T

hera

peut

ics,

Inc.

Ulcer Duration 64 weeks

Prior Therapy Regranex

Wound Size 2.6 cm2©20

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Patient PhotosEXCELLAGEN

Patient #EXC-002

Patient Photos

Day 1 Week 1

Week 2 Week 4 Closure

Patient Demographic DataPatient Demographic Data

Age 64

Sex Male

Ulcer Duration 194 weeksm T

hera

peut

ics,

Inc.

Ulcer Duration 194 weeks

Prior Therapy Achilles Tendon Surgery

Wound Size 1.8 cm2©20

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Patient PhotosEXCELLAGEN

Patient #EXC-003

Patient Photos

Day 1 Week 1 Week 4

Week 5 Closure Follow-up Week 4

i hiPatient Demographic Data

Age 61

Sex Female

Ul D i 10 km T

hera

peut

ics,

Inc.

Ulcer Duration 10 weeks

Prior Therapy Not Specified

Wound Size 3.3 cm2©20

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Patient PhotosEXCELLAGEN

Patient #EXC-004

Patient Photos

Day 1 Week 1 Week 2

Week 4 Week 5 Closure

P ti t D hi D tPatient Demographic Data

Age 61

Sex Male

Ulcer D ration 11 eeksm T

hera

peut

ics,

Inc.

Ulcer Duration 11 weeks

Prior Therapy Dressings

Wound Size 3.4 cm2©20

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Patient PhotosEXCELLAGEN

Patient #EXC-005

Patient Photos

Day 1 Week 1 Week 2

Week 3 Week 6 Closure

Patient Demographic DataPatient Demographic Data

Age 37

Sex Male

Ulcer Duration 28 weeksm T

hera

peut

ics,

Inc.

Ulcer Duration 28 weeks

Prior Therapy Standard of Care

Wound Size 1.8 cm2©20

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Patient PhotosEXCELLAGEN

Patient #EXC-006

Patient Photos

Day 1 Week 1 Week 3

Week 5 Week 6 Closure

Patient Demographic DataPatient Demographic Data

Age 63

Sex Male

Ulcer Duration 31 weeksm T

hera

peut

ics,

Inc.

Ulcer Duration 31 weeks

Prior Therapy Debridement and Vac Therapy

Wound Size 2.7 cm2©20

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Patient PhotosEXCELLAGEN

Patient #EXC-007

Patient Photos

Day 1 Week 1 Week 2

Week 4 Week 6 Closed

P ti t D hi D tPatient Demographic Data

Age 59

Sex Male

Ul D ti 10 km T

hera

peut

ics,

Inc.

Ulcer Duration 10 weeks

Prior Therapy Debridement and Silvadene

Wound Size 3.7 cm2©20

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Patient PhotosEXCELLAGEN

Patient #EXC-008

Patient Photos

Day 1 Week 1 Week 3

Week 5 Week 7 Closure

Patient Demographic DataPatient Demographic Data

Age 44

Sex Male

Ulcer Duration 94 weeksm T

hera

peut

ics,

Inc.

Ulcer Duration 94 weeks

Prior Therapy Topical Antibiotics

Wound Size 1.5 cm2©20

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Patient PhotosEXCELLAGEN

Patient #EXC-009

Patient Photos

Day 1 Week 1 Week 4

Week 7 ClosureWeek 6

Patient Demographic DataPatient Demographic Data

Age 51

Sex Male

Ulcer Duration 28 weeksm T

hera

peut

ics,

Inc.

Ulcer Duration 28 weeks

Prior Therapy Debridement

Wound Size 2.9 cm2

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Patient PhotosEXCELLAGEN

Patient #EXC-010

Patient Photos

Day 1 Week 1 Week 4

Week 7 Week 9 Closure

Patient Demographic DataPatient Demographic Data

Age 53

Sex Female

Ulcer Duration 92 weeksm T

hera

peut

ics,

Inc.

Ulcer Duration 92 weeks

Prior Therapy Standard of Care

Wound Size 1.9 cm2©20

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Patient PhotosEXCELLAGEN

Patient #EXC-011

Patient Photos

Day 1 Week 1 Week 3

Week 5 Week 9 Closure

Patient Demographic DataPatient Demographic Data

Age 43

Sex Female

Ulcer Duration 52 weeksm T

hera

peut

ics,

Inc.

Ulcer Duration 52 weeks

Prior Therapy Surgical Procedure to Remove Toes

Wound Size 4.1 cm2

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Patient PhotosEXCELLAGEN

Patient #EXC-012

Patient Photos

Day 1 Week 1 Week 3

Week 5 Week 7 Week 10 ClosureWeek 9

Patient Demographic DataPatient Demographic Data

Age 61

Sex Male

Ulcer Duration 119 weeksm T

hera

peut

ics,

Inc.

Ulcer Duration 119 weeks

Prior Therapy Antibiotics and Standard of Care

Wound Size 2.3 cm2

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Patient PhotosEXCELLAGEN

Patient #EXC-013

Patient Photos

Day 1 Week 1 Week 3

Week 5 Week 11 Closure

Patient Demographic DataPatient Demographic Data

Age 73

Sex Male

Ulcer Duration 42 weeksm T

hera

peut

ics,

Inc.

Ulcer Duration 42 weeks

Prior Therapy Standard of Care

Wound Size 2.1 cm2

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EXCELLAGENPatient #EXC-014

Patient Photos

Day 1 Week 1 Week 5

Week 9 Week 11 Week 12 Closure

Patient Demographic DataPatient Demographic Data

Age 66

Sex Male

Ulcer Duration 26 weeksm T

hera

peut

ics,

Inc.

Ulcer Duration 26 weeks

Prior Therapy Standard of Care

Wound Size 4.6 cm2©20

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Patient PhotosEXCELLAGEN

Patient #EXC-015

Patient Photos

Day 1 Week 1 Week 4

Week 8 Week 12

Patient Demographic DataPatient Demographic Data

Age 37

Sex Male

Ulcer Duration 190 weeksm T

hera

peut

ics,

Inc.

Ulcer Duration 190 weeks

Prior Therapy None Specified

Wound Size 2.0 cm2©20

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Patient PhotosEXCELLAGEN

Patient #EXC-016

Patient Photos

Day 1 Week 1 Week 4

Week 8 Week 12

Patient Demographic DataPatient Demographic Data

Age 57

Sex Female

Ulcer Duration 52 weeksm T

hera

peut

ics,

Inc.

Ulcer Duration 52 weeks

Prior Therapy Antibiotics, Dressings

Wound Size 4.1 cm2

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Patient PhotosEXCELLAGEN

Patient #EXC-017

Patient Photos

Day 1 Week 1 Week 4

Week 8 Week 12

Patient Demographic DataPatient Demographic Data

Age 65

Sex Female

Ulcer Duration 12 weeksm T

hera

peut

ics,

Inc.

Ulcer Duration 12 weeks

Prior Therapy Debridement

Wound Size 2.2 cm2©20

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Patient PhotosEXCELLAGEN

Patient #EXC-018

Patient Photos

Day 1 Week 1 Week 4

Week 12Week 9

Patient Demographic DataPatient Demographic Data

Age 50

Sex Female

Ulcer Duration 9 weeksm T

hera

peut

ics,

Inc.

Ulcer Duration 9 weeks

Prior Therapy Debridement and Dressings

Wound Size 2.8 cm2

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Patient PhotosEXCELLAGEN

Patient #EXC-019

Patient Photos

Day 1 Week 1 Week 4

P ti t D hi D t

Week 6 Week 12

Patient Demographic Data

Age 30

Sex Female

Ulcer D ration 15 eeksm T

hera

peut

ics,

Inc.

Ulcer Duration 15 weeks

Prior Therapy Wet to Dry Dressings

Wound Size 4.6 cm2©20

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Patient PhotosEXCELLAGEN

Patient #EXC-020

Patient Photos

Day 1 Week 1 Week 4

Week 8 Week 12

Patient Demographic DataPatient Demographic Data

Age 83

Sex Male

Ulcer Duration 21 weeksm T

hera

peut

ics,

Inc.

Ulcer Duration 21 weeks

Prior Therapy Betadine

Wound Size 2.1 cm2©20

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