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Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Sr. VP of Operations Doug Arm at the Stem Cell Meeting on the Mesa 2011
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1 Cytori Therapeutics (NASDAQ: CYTX) Stem Cell Meeting on the Mesa December 1, 2011 Doug Arm, Ph.D Sr. VP, Operations
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Page 1: Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Cytori Therapeutics(NASDAQ: CYTX)

Stem Cell Meeting on the Mesa

December 1, 2011

Doug Arm, Ph.D

Sr. VP, Operations

Page 2: Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Safe Harbor Statement

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.

Page 3: Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Our Mission

To improve the quality and length of life

by providing innovative cell therapy for patients

Page 4: Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Technology

Regenerative cells in the operating room in real-time

• Celution currently approved in Europe

• Scalable platform• System/Consumable model

• 35+ issued patents

Soft Tissue RepairAbout one hour

Cardiovascular DiseaseCytori Celution® System Regenerative cells

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Adipose Tissue: Ideal Source for Cell Therapy

Soft Tissue RepairSoft Tissue Repair

• Adipocytes

• Multipotent cells

• Endothelial cells

• Vasc. smooth muscle cells

• Tissue resident macrophages

• Perivascular cells

Adipose Derived Regenerative Cells

• Adipocytes

• Multipotent cells

• Endothelial cells

• Vasc. smooth muscle cells

• Tissue resident macrophages

• Perivascular cells

Adipose Tissue

Liposuction

Processing

Adipose Tissue: Richest source of regenerative cells in the body

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Adipose Tissue: Ideal Source for Cell Therapy

Number of Cells (millions) per 100 mL of tissue (1/2 cup)

Implication: Real-time access to a patient’s own regenerative cells is possible

(No lengthy and expensive cell culture or manufacturing involved)

0

0.25

0.5

Multipotent Cells in AdiposeMultipotent Cells in BM

0

15

30

45

Total Nucleated Cells in Adipose

Page 7: Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Multiple Mechanisms at Work

Immune-modulation

Wound remodeling

Prevention of cell death

Blood Supply

Paracrine signaling

Differentiation

Page 8: Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Intellectual Property: Foundation for Protection

North America/Europe Asia Emerging Markets

US:CELUTION DEVICE (‘484)CELUTION PLUS ADDITIVES (‘420)CELUTION FOR CRS (‘488)STEMSOURCE DEVICE (‘115)CELUTION FUTURE GENERATIONS (‘075)CELUTION PLUS SENSORS FOR CLINICALLY SAFE OUTPUT

(‘670)CELUTION FOR BONE (‘043)CELUTION OR CELGRAFT FOR SOFT TISSUE DEFECTS

(‘684)BEDSIDE COMPREHENSIVE

DEVICE (‘059)CELUTION OUTPUT PLUS PROSTHETIC

FOR BONE RELATED DISORDERS (‘716)CELLS PLUS FAT PLUS ADDITIVES (‘795)CELLS PLUS FAT (‘672)

Europe:CELUTION FOR ACUTE

TUBULAR NECROSIS (‘834)

Korea:CELUTION DEVICE (‘995)STEMSOURCE DEVICE (‘812)CELUTION DEVICE (‘139)

Singapore:CELUTION DEVICE & FUTURE GENERATIONS

(‘683)CELUTION FOR CARDIOVASCULAR (‘590)

China:CELUTION DEVICE (‘689)CELUTION FOR

CARDIOVASCULAR (‘104)

Japan:CELUTION DEVICE (‘952)DEVICES FOR CELLS PLUS FAT (‘041)CLINICALLY SAFE (‘556)

Australia:CELUTION DEVICE (‘135)STEMSOURCE DEVICE (‘901)CELUTION FOR CARDIOVASCULAR (‘858)CELUTION DEVICE WITH CENTRIFUGE OR

FILTER (‘937)

South Africa:CELUTION FOR CARDIOVASCULAR (‘446)

Mexico:CELUTION FUTURE GENERATIONS (‘348)CELUTION FOR CARDIOVASCULAR (‘775)

Russia:CELUTION FOR CARDIOVASCULAR (‘924)

India:CELUTION DEVICE (‘706)CELUTION FUTURE GENERATIONS (‘529)CELUTION DEVICE FOR TREATING WOUND

HEALING (‘580)

Israel:CELUTION DEVICE WITH CENTRIFUGE OR

FILTER (‘800)

30+ Patents Issued Worldwide with 100 + Pending

Page 9: Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Soft Tissue Repair

Page 10: Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Soft Tissue Repair: RESTORE Procedure

Soft Tissue RepairSoft Tissue Repair

Soft Tissue RepairSoft Tissue Repair

Celution® approved in EU for breast reconstruction

Significant unmet medical need

Two completed clinical trials

Safe and effective

Reimbursable

$43

$73

$126 $163

Clinical

Partner

Cells Fat

‘Cell-Enriched Graft’

Page 11: Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Soft Tissue Repair: RESTORE 2 Trial Outcomes

Soft Tissue RepairSoft Tissue Repair

Soft Tissue RepairSoft Tissue Repair

$73

$126

Post-Marketing Study Design

• Prospective 71 patient study

Co-Primary Endpoints

• Physicians and patient satisfaction with functional and cosmetic results &improvement in overall breast deformity

0%

20%

40%

60%

80%

100%

Patient SatisfactionPhysician

Satisfaction

6-Mo

12-Mo

High satisfaction rates & safety to support reimbursement efforts

Page 12: Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Cardiovascular Disease

Dr. Fernandez-Aviles

Principal Investigator

for the PRECISE trial

Hosp. Gregorio Maranon

Madrid, Spain

Page 13: Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Cardiac Repair: PRECISE CMI Trial

Soft Tissue RepairSoft Tissue Repair

Soft Tissue Repair

Change in Max Volume of Oxygen (MV02) from Baseline to 6 & 18 months

Baseline 6 Mos 18 Mos

Transplant List

20.0

18.0

16.0

14.0

19.0

15.5 15.3

16.6

17.117.2

ADRC’sStandard of Care

P<0.05 P<0.05

N = 27 pts

(6 placebo/21 treated)

Page 14: Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Cardiac Repair: PRECISE CMI Trial

MVO2:significant change at 18 months• MVO2 correlates to improved survival

• MVO2 ≤ 14 = 47% 1 yr survival rate

METS: significant change at 18 months

Cytori procedure safe and feasible through 18-months

Lower cardiac mortality rate:• At avg. follow up of 28 months:

- 2/6 placebo

- 1/21 treated

Next Steps:

Applying for European Approval

Initiating US IDE Clinical Trial: ATHENA • Completed pre-IDE meeting with FDA

0% 10% 20% 30% 40%

Placebo

Treated

33%

5%

28 Month Mortality Rate

Page 15: Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Cardiac Repair: U.S. CMI Trial

Confirmed device designation by FDA

Pursuing IDE/PMA clinical trial

Pre-IDE meeting with FDA Q3 2011

Proposed design for “ATHENA” trial:

• Approx. 50 patient pilot

• Randomized, double-blind, placebo-controlled

• 1o Endpoints: Safety & Efficacy

Next Steps:

• Submit IDE application by end of year

• Initiate 1H 2012

Page 16: Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Cardiac Repair: APOLLO Acute MI Trial

Potential new approach for treatment of heart attacks

Strong signals of safety & efficacy

Higher SAE rate in Controls

Initiated pivotal European clinical trial, ADVANCE

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)

P < 0.05 for change from BL for ADRCs

P > 0.05 for change from BL for Placebo

Page 17: Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Cardiac Repair: APOLLO Acute MI Trial

Lower abnormal ventricular beat rate in cell group

More significant Ventricular Arrhythmias in

placebo

Higher frequency of recordings with Ventricular Premature Beats (VPB) in Controls

Higher number of VPBs per recording in placebo

Page 18: Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Post-Op 18 mo8 cc cell-enriched fat

Single Session

Pre-Op

Dr. Tunc TiryakiIstanbul, Turkey

Soft Tissue Repair: Defect Filling

Page 20: Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Dr. AkitaNagasaki University, Japan

Immediate Preop Intraop post-debride

25 Days Post Op 41 Days Post Op

Intraop after Cell Tx

Exposed Sacrum

Note sig. inflammation, redness, swelling

90% cells to circular area around sore

10% cells to sore itself

20 wks Post Op

27 wks Post Op

Soft Tissue Repair: Radiation Necrosis

Page 21: Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Immune-modulation

Wound remodeling

Preventioncell death

AngiogenesisParacrine signaling

Differentiation

0

0.1 M

0.2 M

0.3 M

0.4 M

0.5 M

Bone Marrow Adipose Tissue

1. Real-time therapy,No cell culture

2. ‘Consumables’Business model

3. Multiple mechanisms, multiple opportunities

Cytori Platform: 3 Key Differentiators

Page 22: Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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• Revenue growth year over year

• Quarters variable

• Systems driving revenue

• EU focus on reconstruction

• Emerging markets & Asia:

- Aesthetics- Reconstruction

- Translational research

- StemSource® cell & tissue banks

Current Commercial Business

Page 23: Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Global Cell Therapy Market

$ 3.5 B

CRS $ 5.0 B

Wounds

$ 16 B

Urology$ 33 B

AMI

$ 200 B

Chronic Heart Failure

Page 24: Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Thank You


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