2. Safe Harbor
This presentation may contain certain ‘forward-looking statements’. All statements,
other than statements of historical fact, that address activities, events or
developments that we intend, expect, project, believe or anticipate will or may
occur in the future are forward-looking statements. Such statements are based upon
certain assumptions and assessments made by our management in light of their
experience and their perception of historical trends, current conditions, expected
future developments and other factors they believe to be appropriate.
The forward-looking statements included in this presentation are also subject to a
number of material risks and uncertainties. We caution investors not to place undue
reliance on the forward-looking statements contained in this presentation.
We would advise reading our annual report filed with the United States Securities
and Exchange Commission on Form 10-K for a more detailed description of these
risks.
Cell Therapy
3. Our Company Mission
To improve the quality and length of life
by providing innovative cell therapies for patients
CYTORI - The Leader in Cell Therapy.
Cell Therapy
4. Company Summary
Product Revenue
Global leader in emerging Cell Therapy market $9 $8.3
with more than 3,000 patients treated $8
$7
$5.8
$6
Management team comprised of proven innovators
$5 $4.5
with significant equity stake
$4
$3
Revenues primarily from consumable sales
$2
$0.8
$1
Significant market opportunities with multiple $0
novel first-in-class indications
2007 2008 2009 2010
Financial stability with $44 million cash (pro forma – Q1, 2011)
Well positioned to help shape the future of cell-based Regenerative Medicine field
Strong corporate partnerships: Olympus, GE, Astellas, GHS
Cell Therapy
5. Our Development Approach
We are developing a Platform rather than a single product
We Target Ischemia rather than tissue differentiation
We focus on “World’s Firsts” & “No Option” indications
We bring innovation to Global markets
PLATFORM TARGET WORLD’S GLOBAL
TECHNOLOGIES ISCHEMIA FIRST
Cell Therapy
6. Our Innovation
Real-time Access to a Patient’s Own Regenerative Cells
Syringe of Your Own Cells
Regenerative Cells
Derived from
Adipose Tissue (Fat)
≈1 Hour
Cell Therapy
7. Cell Therapy via Device
Multiple Cells = Multiple Mechanisms of Action
Adipose contains the richest source of Stem & Regenerative cells in the body
Stem Cells (CFU-F) 1-5%
500,000 Endothelial cell 7%
400,000 Smooth muscle cell 9%
300,000 Blood cell 22%
200,000 Tissue Macrophage 23%
100,000
CD34+/CD31-/CD45- 38%
(100 cc Tissue) Bone Adipose
Marrow Tissue
Cell Therapy
8. Cell Therapy via Device
Multiple Cells = Multiple Mechanisms of Action
Adipose contains the richest source of Stem & Regenerative cells in the body
Stem Cells (CFU-F) 1-5%
500,000 Endothelial cell 7%
400,000 Smooth muscle cell 9%
300,000 Blood cell 22%
200,000 Tissue Macrophage 23%
100,000
CD34+/CD31-/CD45- 38%
(100 cc Tissue) Bone Adipose
Marrow Tissue
Blood Wound Prevent Home Immune Paracrine Tissue
Supply Remodeling Cell Death To Injury Modulation SignalingRegeneration
Cell Therapy
10. Cell Therapy via Device
3,000+ Patients Treated
Acute Heart Attack Breast Reconstruction
Chronic Heart Failure Breast Augmentation
F O C U S
Cell Therapy
11. Acute Heart Attack
APOLLO TRIAL
• Prospective European Multicenter Trial
• Randomized (3:1)
• Double Blind
• Placebo controlled
• Blinded independent core labs
• Safety & Feasibility Trial
• n = 14 (4 placebo, 10 treated)
Eric Duckers, MD, PhD
Rotterdam, The Netherlands
Cell Therapy
12. APOLLO – 18 Month Data
100% Pa ent Follow up Number of Pa ents with MACCE to 18 Months
12 12
10 10
8 Started Liposuc on 8
Randomized 6 Placebo
6
Completed 6 mo visit Group 1
4 4
Completed 18 mo visit
2 2
0 0
Placebo Group 1 6 MO 18 MO
SAE Rate to 18 Months
100% 100% patient follow up
90%
80% 75%
No new MACCE events
70%
60%
50% 44%
No Deaths
40%
30%
No Re-infarctions
20%
10%
Higher SAE rate in
0%
Placebo Group 1
Controls
Cell Therapy
13. APOLLO: Arrhythmias
Percent of Pa ents with Signific nt
a Abnormal ventricular beats occur more
Ventricular Arrhythmias often in Control patients
60%
50%
More Significant Ventricular Arrhythmias
50% in control patients
40% Higher frequency of recordings with
30%
30% Ventricular Premature Bits (VPB) in
20% Controls
10% Higher number of VPBs per recording
0% in Controls
Placebo Group 1
Premature Ventricular Contrac ons - Mean Count per Pa ent Premature Ventricular Contrac ons - Mean Cumula ve Count
700 3000
600
2500
500
2000
400
control 1500 control
300 ADRC ADRC
1000
200
500
100
0 0
0.5 1 2 3 4 8 12 16 25 52 77 0.5 1 2 3 4 8 12 16 25 52 77
Cell Therapy
14. APOLLO: Infarct Size
Absolute Difference in Infarct Size, ITT
0.0
BL -> 6 MO BL -> 18 MO P < 0.05 for change from BL for ADRCs
-2.0
P > 0.05 for change from BL for Placebo
-4.0
-4.4
-6.0 Placebo
-6.1
-8.0 Group 1
-10.0
-12.0 -11.2
-11.7
-14.0
Difference in reduction of infarct size is maintained in cell-treated
patients
p<0.05 for change in infarct size for cell-treated patients at 6 and 18
months (paired t-test comparing baseline and follow up for same
patients)
Cell Therapy
15. APOLLO: Perfusion by SPECT
Mean Change in Visual Rest Score (SPECT), PTE
0
2-4D -> 6MO 2-4D -> 18MO P < 0.05 for change from BL for ADRCs
-1
P > 0.05 for change from BL for Placebo
-2 -1.7
-3 Placebo
-3
-4 Group 1
-5
-6 -5.6
-6
-7
Sustained improvement in ischemia (VRS) from baseline to 6 and 18 months
as measured by SPECT core laboratory
p<0.05 for change in VRS and TSS for cell-treated patients at 6 and 18 months
(paired t-test comparing baseline and follow up for same patients)
Cell Therapy
16. APOLLO: Summary
ADRCs are safe in the treatment of STEMI
No safety concerns
No new Major Adverse Cardiac Events
No Deaths
Efficacy
Concordant improvement in infarct and ischemia:
Mean reduction in Infarct Size is maintained to 18 months
Improvement in cardiac perfusion is maintained to 18 months
May have positive impact on arrhythmia in cell-treatment
patents
ADVANCE
No changes to ADVANCE trial design are needed
Cell Therapy
17. Acute Heart Attack
ADVANCE TRIAL
• European Pivotal Trial
• Prospective
• Randomized (2:2:1)
• Double Blind
• Placebo controlled
• Blinded independent core labs
• Up to 370 patients for STEMI
• Currently enrolling & treating
Eric Duckers, MD, PhD
Rotterdam, The Netherlands
Cell Therapy
18. Acute Myocardial Infarction
Estimated Market Size for AMI Patients in Europe
Annual Heart Attack Incidence (EU) 1.9 million
% STEMI (large heart attacks) 38%
Target Addressable Procedures 720,000
Estimated Price per Treatment $ 10,000
EU AMI Market
$ 7.2 Billion
Cell Therapy
20. Chronic Myocardial Ischemia
Change in Mass Volume of Oxygen (MV02) from Baseline to 6 & 18 months
The Precise Trial
20.0
19.0
P<0.05 P<0.05
18.0
17.2 17.1
16.0 16.6
15.5 15.3
14.0 Transplant List
Baseline 6 Mos 18 Mos
ADRC’s
Standard of Care
Cell Therapy
21. Chronic Myocardial Ischemia
MVO2:significant change at 18 months 28 Month Mortality Rate
• MVO2 correlates to improved survival
• MVO2 ≤ 14 = 47% 1 yr survival rate
METS: significant change at 18 months Treated
Infarct size: 8.2% change at 6 months
Placebo
Cytori procedure safe and feasible through
18-months
0% 10% 20% 30% 40%
Lower cardiac mortality rate:
• At avg. follow up of 28 months:
- 2/6 placebo
- 1/21 treated Next Steps:
Applying for European Approval
* On-site Review completed in May
Initiating US IDE PMA Clinical Trial
* Applied for pre-IDE meeting with FDA
Cell Therapy
22. “No Option” Heart Failure
Estimated Market Size for No Option Patients in Europe
Region # of Patients (Incidence) # of Patients (10-Yr
Prevalence)
United Kingdom 40,000 400,000
Italy 40,000 400,000
Germany 55,000 550,000
France 40,000 400,000
Spain 30,000 300,000
Total G5 205,000 2,050,000
* Estimated price per treatment: $ 10,000
G5 Market
$ 20 Billion*
Cell Therapy
23. Lumpectomy Reconstruction
RESTORE II TRIAL
• Prospective European Multicenter Trial
• ‚No Option‛ Partial Mastectomy patients
• 1 year primary follow up
• Blinded independent core labs
• 71 Patients treated
Eva Weiler-Mithoff, MD
Glasglow, United Kingdom
Cell Therapy
24. Lumpectomy Reconstruction
Clinical:
• Safe
• 85% Investigator Satisfaction
• 75% Patient Satisfaction
36% (24/66) patients underwent 2nd procedure
MRI – independent core laboratory:
• High rate of improvement in breast shape
• High rate of improvement in defect shape
Eva Weiler-Mithoff, MD
Glasglow, United Kingdom
Cell Therapy
26. Breast Reconstruction
Estimated Market Size for Breast Reconstruction in Europe
Annual Breast Cancer Incidence - Europe 332,000
% Lumpectomy eligible ~70%
Target Addressable Market (Incidence) 230,000
Target Addressable Market (Prevalence) > 1,000,000
EU Lumpectomy Reconstruction Market: $ 3.7 Billion
* Estimated price per treatment: $ 3,000 (USD)
Cell Therapy
27. EU Regulatory
STRATEGY
PART I: Tool Claims
PART II: Therapeutic Claims
CE Mark for Device: 2007
Claims Expansion: 2010
Breast Reconstruction
Breast Augmentation
Crohn’s Fistula
Claims Expansion: In Process
Chronic “No Option” Myocardial Ischemia
Pivotal Clinical Trial: In Process
ADVANCE: Acute Myocardial Infarction
Cell Therapy
28. US Regulatory
STRATEGY
PART I: Tool Claims
PART II: Therapeutic Claims
US FDA in Process
US IDE Trial for Cardiovascular: Chronic Ischemia
US HUD: Perry Rombergs Disease
Multiple 510(k) device applications (Tool Claims)
US IDE Trial for Cardiovascular: Heart Attack to follow
European Advance Trial
Cell Therapy
29. Japan Regulatory
STRATEGY
PART I: Tool Claims
PART II: Therapeutic Claims
Japan MHLW / PMDA
Application for Device Approval in process
Application for Breast Reconstruction in process
- based on Restore I & Restore II data
Cell Therapy
30. Barriers-to-Entry: 34 Patents, 100 + Pending
North America/Europe Asia Pacific Emerging Markets
US (12): Japan (2): India (3):
CELUTION DEVICE (‘706)
CELUTION DEVICE (‘952)
CELUTION FUTURE GENERATIONS (‘529)
DEVICES DEVICES FOR CELLS PLUS FAT (‘041)
CELUTION DEVICE WOUND HEALING (‘580)
CELUTION DEVICE (‘484)
CELUTION PLUS ADDITIVES (‘420)
Korea (3): China (2):
CELUTION FOR CRS (‘488)
CELUTION DEVICE (‘689)
STEMSOURCE DEVICE (‘115) CELUTION DEVICE (‘995) CELUTION FOR CARDIAC (‘104)
CELUTION FUTURE GENERATIONS (‘075) STEMSOURCE DEVICE (‘812)
CELUTION PLUS SENSORS/SAFE OUTPUT (‘670) CELUTION DEVICE (‘139) Mexico (2):
CELUTION FOR BONE (‘043) CELUTION FUTURE GENERATIONS (‘348)
CELUTION FOR SOFT TISSUE DEFECTS (‘684) CELUTION FOR CARDIAC (‘775)
BEDSIDE COMPREHENSIVE DEVICE (‘059) Singapore (2):
CELUTION OUTPUT PLUS PROSTHETIC CELUTION DEVICE & FUTURE
FOR BONE RELATED DISORDERS (‘716) GENERATIONS (‘683) Australia (4):
CELUTION FOR CARDIOVASCULAR CELUTION DEVICE (‘135)
(‘590) STEMSOURCE DEVICE (‘901)
METHODS
CELUTION FOR CARDIOVASCULAR (‘858)
CELLS PLUS FAT (‘672)
CELUTION DEVICE WITH CENTRIFUGE OR
CELLS PLUS FAT PLUS ADDITIVES (‘795) FILTER (‘937)
MIDDLE EAST
ISRAEL (1): South Africa (1):
EUROPE (1): CELUTION DEVICES WITH CENTRIFUGE CELUTION FOR CARDIOVASCULAR (‘446)
DEVICES FOR TREATING ACUTE TUBULAR OR FILTER (‘800)
NECROSIS (‘834) Russia (1):
CELUTION FOR CARDIOVASCULAR (‘924)
Cell Therapy
31. Strong Partners Supporting Growth of Business
Olympus Corporation (Japan): Manufacturing Joint Venture (2004)
• Co-design & manufacture next-generation Celution® One
o Ideal hospital-based device
o Reside in OR, cath lab, or cell & tissue bank facility
• Available for ADVANCE heart attack trial
• Manufacturing expertise & service infrastructure
• Committed Partner: invested $55+mm
• Board observer seat
Astellas Pharmaceuticals (2010)
• Equity investment ($10 mm)
• Received right-of-first refusal for liver disease partnership
• Board observer seat
Green Hospital Supply (2007)
• Co-selling StemSource® Cell Banks in Asia
GE Healthcare (2008)
• Co-distribute Celution & StemSource in select countries
Cell Therapy
32. Upcoming Catalysts
Many Near Term Drivers
Report 18-month outcome data from APOLLO acute heart attack trial
• Chronic myocardial ischemia indications-for-use in Europe
• Celution One - CE Mark approval
• PureGraft approval in Japan
• Accelerated revenue growth for the full year 2011
• Publish and Present complete RESTORE 2 trial 12-month data
• Celution System US FDA 510(k) clearance
• Humanitarian Use Device Designation by FDA
• Finalize US HDE soft tissue defect repair trial
• Design and prepare to begin a US chronic myocardial ischemia trial
• Growth in targeted emerging markets, including India
Cell Therapy