Cytori Therapeutics7th International Conference on Cell Therapy for Cardiovascular Disease

Focus on Acute Injury Technologies

25 January 2012

Alex Milstein, M.D.

VP, Clinical Development

Real-Time Access to Autologous Regenerative Cells

Cardiovascular

Disease

Soft Tissue Repair

< 2 hours

Cytori Celution® Regenerative cells

Versatile technology; focus on cardiac & soft tissue repair

CE Mark approval in Europe for soft tissue; Seeking CMI in 1H 2012

36+ patents, 100 + filed on device & cells

Celution™ System is not available in the US

Acute Myocardial Infarction – The APOLLO Trial

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)

• Co-Principal Investigators: Drs. H.J. Duckers

and P.W. Serruys

Perfusion defect in LAD territory:

Reduction in perfusion defect in patients treated with ADRC compared

to placebo patients as analyzed by MIBI SPECT (TSS scores)

MIB

I SP

EC

T TS

S c

ha

ng

e (

ma

tch

ed

pa

irs)

10ximprovement

9ximprovement

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

Cell Treated: Better Perfusion of the Heart6 & 18 month follow-up

p=NSSlide: Courtesy

HJ Duckers, MD, PhD

p=NS

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

Percent of Left Ventricle Infarcted (%LVI):Greater improvement in %LVI in ADRC patients vs. to Placebo control patients (late enhancement cMRI)

all pts baseline 6 mo

Placebo 24,7% 24,7%

ADRC 31,6% 15,4%

Matched-pair analysis

Means for treatment groups

Reduction of > 50% in Infarct Size seen with ADRCs6 & 18 month follow-up

ch

an

ge

in r

el.in

farc

t si

ze (

I/LV

) (m

atc

he

d p

airs)

Slide: Courtesy

HJ Duckers, MD, PhD

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

ch

an

ge

in E

SV

(c

c, 2

D T

TE)

Preservation of End-Systolic Volume with ADRCs6 & 18 month follow-up

24,4 ccimprovement

(-72,2%)

Change in ESV ESV was markedly reduced in ADRC patients as compared to placebo control patients

Slide: Courtesy

HJ Duckers, MD, PhD

APOLLO: Arrhythmias

More ventricular arrhythmias observed in Control patients

More Significant Ventricular Arrhythmias in control patients

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

Higher number of VPBs per recording

in Controls

50%

30%

0%

10%

20%

30%

40%

50%

60%

Placebo Group1

PercentofPa entswithSignifica ntVentricularArrhythmias

0

100

200

300

400

500

600

700

0.5 1 2 3 4 8 12 16 25 52 77

PrematureVentricularContrac ons-MeanCountperPa ent

control

ADRC

0

500

1000

1500

2000

2500

3000

0.5 1 2 3 4 8 12 16 25 52 77

PrematureVentricularContrac ons-MeanCumula veCount

control

ADRC

APOLLO: Summary

ADRCs are safe in the treatment of STEMI No safety concerns

Cell administration is safe

No new MACE/SAEs

No Deaths

Feasibility 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

Cytori Cardiac Program: Present and Future

Celution™ System is CE Marked in the EU

Acute Myocardial Infarction:

• European APOLLO Trial – completing 36-mo FU• Pivotal European ADVANCE Trial – ramping up

• US trial in AMI – to follow ADVANCE

Chronic Myocardial Ischemia:• European PRECISE Trial – completing 36-mo FU

• US ATHENA Trial – IDE filed

AMI - THE ADVANCE TRIAL

• Primary endpoint: cMRI infarct size at 6 months

• Randomized, Double-blind, Placebo-controlled

• N ≤ 360, at up to 35 sites in the EU

• 23 sites selected & committed

• Various states of regulatory process by country

• Co-PIs Drs. H.J. Duckers and G. Pompilio

• Independent blinded core labs will evaluate all imaging data

• Independent DMC provides safety oversight

• Independent CEC will adjudicate all germane events

• Currently enrolling & treating patients

18-mo data from Apollo support trial design for ADVANCE

Thank you