CYTX Corporate Presentation, Biotech Showcase

Cell Therapy

CytoriCorporate Presentation

January 2012

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 products

Our Company Mission

Cell Therapy

Real-time Access to a Patient’s Own Regenerative Cells

Our Innovation

Regenerative Cells Derived from

Adipose Tissue (Fat)

Syringe of Patient’s Own Cells

http://www.facebook.com/photo.php?pid=126828&id=122693987772201

Cell Therapy

2011 : Year in Review March Shareholder Letter – 12 month milestones

• Expand CE Mark Claims to include NO-CMI

On track for early 2012 claims expansion

• Report 18 month APOLLO data

Reported highly positive long-term Data

• Expand number of sites & ongoing enrollment of ADVANCE

Initiated ADVANCE, 4 sites on-line & 23 in process

• Define & prepare to initiate a US clinical trial for CMI

Successful pre-IDE meeting & IDE for CMI filed in Q4

• Expand efforts with FDA to gain approval or clearance for Celution

3 - 510ks, 2 appeals, pre-IDE, IDE filing, 3 HUD rounds, ++mtgs

• CE Mark & European commercial launch for Celution One

CE Mark for Celution One received in November

• Complete development of next generation aesthetics device

- Development on hold to focus on cardiac pipeline

Cell Therapy

2011 : Year in Review March Shareholder Letter – 12 month milestones

• Increase system installed base & consumable usage rates

Grew installed based of systems, shifted sales to hospitals

• Increase hospital-based customers, with emphasis on breast recon

More than half the systems went to hospital based customers

• Pursue payment for breast reconstruction in Europe

NIC support UK, Italy grant Breast recon, NICE filing Q1

• Grow PureGraft product sales

More than doubled PG; anticipate ongoing growth in 2012

• Expand selectively into emerging markets

Opened India, Australia, So. Africa, Bulgaria & Russia

Cell Therapy

2012 : Key steps to increase shareholder value

• Commercial Business

• Product Pipeline

• Corporate

Cell Therapy


Commercial Business

1. Manage into a profitable segment in near term

2. 20+% annual revenue growth until inflection point

3. Focus reimbursement efforts in UK

4. Building market access for NO-CMI

5. Japan – cell therapy guidelines & help dev approved studies for translational applications; MHLW approval for breast reconstruction

Cell Therapy


Product Pipeline

1. No-option CMI CE Mark (EU)

2. Focus on ADVANCE centers: 30 Centers on-line by year-end

3. Publish results of Apollo, Precise & Restore II

4. Initiate Athena (U.S. Chronic Ischemia)

Cell Therapy


Corporate

1. Bring in non-dilutive / strategic funding

2. Average Cash Operating Loss to $7 mm / qtr

3. Continue to expand global regulatory approvals

Cell Therapy

Cell Therapy via Device

Acute Heart Attack

4,000+ Patients Treated

Chronic Heart Failure

Cardiovascular Soft Tissue

Breast Reconstruction

Wounds, Fistula

Cell Therapy

Chronic Myocardial Ischemia

Patrick Serruys, MD, PhDRotterdam, The Netherlands

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

Cell Therapy


MVO2: statistically significant change at 18 months

METS: statistically 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:

- 1 of 21 treated vs. 2 of 6 placebo

0% 10% 20% 30% 40%

Placebo

Treated

28 Month Mortality Rate

Under review by Notified BodyFor CE Mark claims expansion

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

ATHENA Trial

US FDA Trial


• IDE Filed Q4, 2011

• Trial design under negotiation with FDA

• Anticipate IDE approval Summer, 2012

Emerson Perin, MDTexas Heart Institute

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)

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

han

ge

(m

atc

he

d p

airs)

+867%

improvement

+800%

improvement

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

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

Cell Treated: Reduced Damage by > 50%6 & 18 month follow-up

ch

an

ge

in r

el.in

farc

t siz

e (

I/L

V)

(ma

tch

ed

pairs)

Slides & 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

)

Cell Treated – Not going into Heart Failure6 & 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 (as measured by 2D TTE, cMRI and SPECT, PTE)

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

Cell Therapy

APOLLO: Arrhythmias

Abnormal ventricular beats occur more often 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

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

May have positive impact on arrhythmia in cell-treatment patents

ADVANCE No changes to ADVANCE trial design are needed

Cell Therapy

Acute Heart Attack

Eric Duckers, MD, PhDRotterdam, The Netherlands

ADVANCE TRIAL• Currently enrolling & treating• 30 – 35 sites to treat up to 360 patients• 60 sites identified & interested; ½ in G-5• 23 sites selected & committed• Various states of regulatory process by country• Focus in 2012 to bringing sites online by YE

Cell Therapy

Advance Trial Timeline in EU

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

US Regulatory

US IDE Trial for Cardiovascular: IDE Filed

US IDE Trial for Cardiovascular: Heart Attack to follow European Advance Trial

US HUD: Parry Rombergs Disease: Ongoing Process

Multiple 510(k) device applications filed in 2011

Filed 2 appeals on 510(k) NSE: Now to Merits Panel

Cell Therapy

38 Worldwide Issued Patents, > 100 pending

DevicesNext Generation

DevicesNext Generation

Cosmetic & ReconstructiveSurgery (CRS)

Cardiovascular Therapies Pipeline Therapies

US: (1)CELUTION FUTURE

GENERATIONS (‘075)

India: (1)CELUTION FUTURE


Australia: (1)CELUTION WITH CENTRIFUGE

OR

FILTER (‘937)

Singapore: (1)CELUTION & FUTURE


Israel: (1)CELUTION WITH CENTRIFUGE

OR

FILTER (‘800)

Mexico: (1)CELUTION FUTURE

GENERATIONS

US: (1)CELUTION FUTURE


India: (1)CELUTION FUTURE


Australia: (1)CELUTION WITH

CENTRIFUGE OR

FILTER (‘937)

Singapore: (1)CELUTION & FUTURE


Israel: (1)CELUTION WITH

CENTRIFUGE OR

FILTER (‘800)

Mexico: (1)CELUTION FUTURE

GENERATIONS

US: (4)CELUTION FOR MIXING

ADRCS PLUS FAT (‘488)CELUTION OR NEXT GEN

DEVICES FOR SOFT TISSUE

DEFECTS (‘684)ADRCS PLUS FAT PLUS

ADDITIVES (‘795)ADRCS PLUS FAT (‘672)

Japan: (1)CELUTION AND NEXT GEN

DEVICES FOR MIXING ADRCS

PLUS FAT (‘041)

Europe: (1)ADRCS FOR CARDIAC

(‘382) <Opposition filed>

Australia: (1)CELUTION FOR

CARDIOVASCULAR (‘858)

Singapore: (1)CELUTION FOR


China: (1)CELUTION FOR


Russia: (1)CELUTION FOR


South Africa: (1)CELUTION FOR


Mexico: (1)CELUTION FOR


US: (2)CELUTION FOR BONE

(‘043)CELUTION OUTPUT

PLUS PROSTHETIC

FOR BONE RELATED

DISORDERS (‘716)

Europe: (2)CELUTION FOR ACUTE

TUBULAR NECROSIS

(‘834)ADRCS FOR WOUND

HEALING (‘833)

Japan: (1)ADRCS FOR WOUND

HEALING (‘699)

India: (1)ADRCS FOR WOUND

HEALING (‘580)

Thank You !

Cell Therapy

CYTX Corporate Presentation, Biotech Showcase

Health & Medicine

Transcript of CYTX Corporate Presentation, Biotech Showcase