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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
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.
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.
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%
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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
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)
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
Endpointm T
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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)
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.
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
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Range (wks) 6 651
1Does not include 66 patients treated with DNA-based therapeutic.
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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
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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
Continuing Clinical ResearchNext Generation: G
Excellarate
Fibrillar Type I Bovine Collagen
[Ad5PDGFB]Platelet-Derived Growth Factor
DNA
Cardium Supplemental Formulation
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Inc.
DNA
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Gene Activated MATRIX (GAM)TECHNOLOGY PLATFORM
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
m T
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Inc.
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%
m T
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Inc.
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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