2011 annual shareholder meeting presentation

Cell Therapy

Cytori Cell TherapyShareholder Presentation

August 16, 2011

Cell Therapy

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

To improve the quality and length of life

by providing innovative cell therapy for patients

Our Company Mission

CYTORI - The Leader in Cell Therapy.

Cytori Restored my Life . . .

Gary’s Story

Cell Therapy

Pathway to Market Access

Reimbursement

Indications for Use

Clinical Data / Trials

Translational Studies

Growing Data on Fistulas

> 100 wound pts treated

High success rate

Most difficult cases

CE Mark Claims for

fistula - 2010

Expansion of claims for

wounds in process

Healthcare economic

evaluation in process

Innovation funding

Specific DRGs over time

Dr. BorowskiNorth Tees, UK

North Tees & Hartlepool NHS Foundation Trust

is looking for scientific appreciation through peer

review and has not yet confirmed a significant

benefit in a study that Involved sufficient

numbers of patients

Pioneers: Translational Medicine

Cell Therapy

~ 4,000 Patients Treated

Cardiovascular

F O C U S

Soft Tissue

Cell Therapy

Chronic Myocardial Ischemia

Dr. AvilesMadrid, Spain

PRECISE TRIAL• Prospective European Multicenter• Randomized (3:1) • Double Blind • Placebo controlled• Blinded independent core labs• Safety & Feasibility Trial• n= 27 (6 placebo, 21 treated)

Cell Therapy

Change in Max Volume of Oxygen (MV02) from Baseline to 6 & 18 monthsThe Precise Trial

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

Cell Therapy


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

• MVO2 ≤ 14 = 47% 1 yr survival rate

METS: significant change at 18 months

Infarct size: 8.2% change at 6 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

* On-site Review completed in MayInitiating US IDE Clinical Trial: ATHENA

* Successful pre-IDE meeting with FDA

Cell Therapy

Chronic Heart Failure

What Really Matters For Patients

ImprovedHeart

Condition

Improved Activity

Reduced Mortality

Cell Therapy

“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

G5 Market $ 20 Billion*

* Estimated price per treatment: $ 10,000

Cell Therapy

Acute Heart Attack

Eric Duckers, MD, PhDRotterdam, The Netherlands

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)

p=NS

All MRI images were assessed by an independent, blinded core lab (CCL, Boston, MA)

Percent of Left Ventricle Infarcted:

Infarct size normalized to ventricle size (%LVI) improved more in ADRC patients

compared to placebo control patients (late enhancement cMRI): +5,1% abs. and +59% rel. improvement compared to placebo control, PTE)

all pts baseline 6 mo

control

Tx24,7% 24,7%

ADRC

Tx31,6% 15,4%

matched pairs

all patients

The APOLLO trial6 & 18 month follow-up

ch

an

ge in

re

l.in

farc

t s

ize

(I/

LV

) (m

atc

he

d p

air

s)

Slides & Data provided by:Eric Duckers, MD, PhD

p=NS

All SPECT images were assessed by an independent, blinded core lab (CCL, Boston, MA)

Perfusion defect: Reduction in perfusion defect in patients treated with ADRC

compared to placebo control patients (3,5-fold improvement) as analyzed by MIBI SPECT (visual rest scores, PTE)

MIB

I S

PE

CT

TS

S c

ha

ng

e (

ma

tch

ed

pair

s)

+253%

improvement

+87%

improvement



Perfusion defect in LAD territory: Reduction in perfusion defect in patients treated with ADRC

compared to placebo patients (9,7-fold improvement in LAD perfusion territory) as analyzed by MIBI SPECT (TSS scores)

MIB

I S

PE

CT

TS

S c

ha

ng

e (

ma

tch

ed

pair

s)

+867%

improvement

+800%

improvement

All SPECT images were assessed by an independent, blinded core lab (CCL, Boston, MA)


p=NSSlides & Data provided by:Eric Duckers, MD, PhD

All TTE images were assessed by an independent, blinded core lab (CCL, Boston, MA)

ch

an

ge in

ES

V (

cc, 2

D T

TE

)


24,4 ccimprovement

(-72,2%)

Change in ESV

ESV was markedly reduced in ADRC patients as compared to placebo control patients (as measured by 2D TTE, cMRI and SPECT, PTE)



All TTE images were assessed by an independent, blinded core lab (CCL, Boston, MA)

ch

an

ge in

ED

V (

cc, 2

D T

TE

)

Change in EDV i.c.c. post-AMI adverse remodeling

EDV was significantly reduced in ADRC patients compared to placebo-control patients (as measured by 2D TTE, cMRI and SPECT, PTE), indicating a significant reduction of adverse post-AMI adverse cardiac remodeling

39,1 ccimprovement

(-56,9%)


The APOLLO trialVentricular Tachyarrhythmias and Ventricular Extra Systoles

as manifestations of developing post-AMI Cardiomyopathy up to 18 mo

Continuous telemetric/ holter registration in first 6 days post AMI

48 hr holter registrations weekly in first month

24 hr holter registrations monthly in first 6 months

Analysis by Student-t- tests

All Holter registrations were assessed by an independent, blinded core lab

Post hoc analysis by Thoraxcenter/ MCL

Placebo

(n=4)

ADRC

(n=9)P-value

Ventricular TachyArrhythmia

patients w documented VT 2 / 4 (50%) 3 / 10 (30%) NS

total episodes of VT 11 5 < 0.05

average episodes/ patient 2.8 0.5 < 0.05

Placebo

(n=4)

ADRC

(n=9)P-value

Premature Contractions (PVC)

patients w > 10 PVC/ hr 3 / 4 (75%) 0 / 10 (0%) < 0.05

total PVC / patient at 18 mo FU 1607 284 < 0.001

average PVC / 24 hr / patient 146 24 < 0.05


The APOLLO trialVentricular ectopy in post-AMI patients

as manifestations of developing cardiomyopathy

Analysis by Student-t-test

All Holter registrations were assessed by an independent, blinded core lab

Post hoc analysis by Thoraxcenter/ MCL

cu

m. v

en

tric

ula

r e

cto

py

per

24 h

r re

gis

tra

tio

n

Weeks after AMI

P < 0.001


Cell Therapy

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

Long-term data indicates slowing progression toward heart failure

Positive impact on arrhythmia in cell-treatment patents

Cell Therapy

Acute Heart Attack


“We show if you protect the muscle in the acute phase of MI

you will indeed have sustained improvement”

Cell Therapy

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

Cell Therapy

Acute Myocardial Infarction

Estimated Market Size for AMI Patients in Europe

EU AMI Market$ 7.2 Billion

Annual Heart Attack Incidence (EU) 1.9 million

% STEMI (large heart attacks) 38%

Target Addressable Procedures 720,000

Estimated Price per Treatment $ 10,000

Cell Therapy

Lumpectomy Reconstruction

Eva Weiler-Mithoff, MDGlasglow, United Kingdom

RESTORE II TRIAL• Prospective European Multicenter Trial• ‚No Option‛ Partial Mastectomy patients• 1 year primary follow up • Blinded independent core labs• 71 Patients treated

Cell Therapy


Eva Weiler-Mithoff, MDGlasglow, United Kingdom

Clinical:• Safe & Persistent Therapy• 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

Cell Therapy


6 months

12 monthsPre-treatment

Pat

ien

t B

Pat

ien

t A

Cell Therapy


“The use of lipomodelling for reconstruction after breast cancer surgery has become a common technique. However, in the radiation injured patient, repeat procedures are often required. Cytori's Celution System supplements a fat graft with a patient's own adipose-derived regenerative cells to improve graft take and help regenerate damaged tissue. This minimally invasive treatment approach could reduce or eliminate the practice of repeat procedures, leading to significant cost savings for the NHS.”

Brian WinnHead of Technology & Product InnovationNHS National Innovation Centrewww.nic.nhs.uk

Cell Therapy

Breast Reconstruction

Estimated Market Size for Breast Reconstruction in Europe

EU Lumpectomy Reconstruction Market: $ 3.7 Billion

Annual Breast Cancer Incidence - Europe 332,000

% Lumpectomy eligible ~70%

Target Addressable Market (Incidence) 230,000

Target Addressable Market (Prevalence) > 1,000,000

* Estimated price per treatment: $ 3,000 (USD)

Cell Therapy

Soft Tissue / Breast Reconstruction

Progress Toward Market Access (EU)

Reimbursement

Indications for Use


Chronic Heart Disease

Acute Heart

Cell Therapy

Current Opportunities

Market Access Today

Private Pay / Grants

Indications for Use

Pre-Clinical / Clinical Data

• Aesthetics Market• Translational Research Market• StemSource Cell Banks

Cell Therapy

Current Opportunities

Market Access Today

• Aesthetics Market• Translational Research Market• StemSource Cell Banks

• Revenue growth yr / yr• Quarters remain lumpy• Steady growth of Celution

installed base• No annuity sales growth• Shifting sales focus:

Soft Tissue Reconstruction

Cell Therapy

REGENERATIVE MEDICINE MARKET

Driving Toward Market Inflection Point

Reimbursement

Indications for Use


Market Inflection PointDrive Consumable UtilizationEfficiency of Sales & Service

Cell Therapy

EU Regulatory

STRATEGYPART I: Tool ClaimsPART II: Therapeutic Claims

CE Mark ProcessFoundational Device: Approved 2007Claims Expansion: Approved 2010

Breast Reconstruction Breast Augmentation Crohn’s Fistula

Claims Expansion: In ProcessChronic “No Option” Myocardial Ischemia

Pivotal Clinical Trial: In ProcessADVANCE: Acute Myocardial Infarction

Cell Therapy

Japan Regulatory

STRATEGYPART I: Tool ClaimsPART II: Therapeutic Claims

Japan MHLW / PMDAApplication for Device Approval in process

Application for Breast Reconstruction in process- based on Restore I & Restore II data

Various investigator led translational studies* including: Radiation wounds Incontinence Fistula /wounds

* Translational studies in Japan require MHLW approval

Cell Therapy

US Regulatory

STRATEGYPath I: Therapeutic ClaimsPath II: Humanitarian Use Path III: Tool Claims

Cell Therapy

US Regulatory

US FDA in Process

US IDE Trial for Cardiovascular: ATHENAChronic Ischemia pre-IDE meeting successfulFile IDE in Fall ’11Plan to begin enrollment in mid-2012

Ultimately FDA’s IDE – PMA process: provides clinical trial data specific indications for use supports applications for reimbursement

MOST IMPORTANT PROCESS WITH FDA

Cell Therapy

US Regulatory

US FDA in Process

US HUD: Perry Rombergs DiseaseStep 1: Humanitarian Use Designation

Currently Negotiating HUD with FDAStep 2: Humanitarian Device ExemptionSmall trial, reimbursement usually availableClinical label in a soft tissue indication Restricted indications for use / marketOrphan Indication

Cell Therapy

US Regulatory

US FDA in Process

• Multiple 510(k) apps pending / in process of submission• These include various predicates / indications• FDA status quo remains negative on 510(k) pathway• We believe the pathway is appropriate• 2 applications are currently under appeal• Potential to utilize Circuit Courts • Cost effective, efficient, independent

Cell Therapy

Patents: 35 Issued, 100+ Pending

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)

*PATENTS ISSUED IN 2011 IN RED

Cell Therapy

Financial Information

Cash (Q2, 2011) $ 33 millionAdditional cash post Q2 6 million

Shares Outstanding 52 millionWarrants (average price $ 3.80) 12 millionOptions (vested; average price $5) 5 million

GE Loan (maturity 2013) $ 17 million

Operating cash loss average ~ $7 million / quarter over last 6 quartersTrended higher over the past 2 quartersExpect operating cash loss to move back down toward average 2H ’11Actively reducing costs, narrowing focus, improving efficiency, investing in our future

Additional partnership is a near term corporate goal

Cell Therapy

Strong Partners Supporting Growth of Business

Olympus Corporation (Japan): Manufacturing Joint Venture (2004)• Co-design & manufacture next-generation Celution® One • Available for ADVANCE heart attack trial• Manufacturing expertise & service infrastructure• Committed Partner: invested $55+mm

Green Hospital Supply (2007)• Co-selling StemSource® Cell Banks in Asia

GE Healthcare (2008)• Co-distribute Celution & StemSource in select countries

Astellas Pharmaceuticals (2010)• Equity investment ($10 mm)• Received right-of-first refusal for liver disease partnership

Future Partnerships Opportunities• 10 Individual processes ongoing• 6 distinct therapeutic areas

Cell Therapy

• Chronic myocardial ischemia indications-for-use in Europe

• Celution One - CE Mark approval

• PureGraft approval in Japan

• Revenue growth for the full year 2011

Report of 18-month outcome data from APOLLO acute heart attack trial

• Publish and Present complete RESTORE 2 trial 12-month data

• US FDA clearance or trial approval

• Design and prepare to begin ATHENA

• Growth in targeted emerging markets

• Establish a meaningful corporate partnership

Many Near Term Value Drivers

43

Thank You !

Cell Therapy

2011 annual shareholder meeting presentation

Health & Medicine