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Cell Society - CYTX Overview

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Dr. Marc Hedrick presents at the 2nd Annual Cell Society Meeting on February 17, 2012 in Coronado, CA
17
Marc Hedrick, MD President
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Page 1: Cell Society - CYTX Overview

Marc Hedrick, MDPresident

Page 2: Cell Society - CYTX Overview

2

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: Cell Society - CYTX Overview

Cytori- Brief Summary

• Estimated 4-5,000 patients treated world wide

• Completed 3 clinical trials, 2 CV trials in progress

• Growing product portfolio

• Commercial growth

• Expanding regulatory approvals

• Pipeline focus

– Cardiovascular disease

– Soft tissue repair

3

Page 4: Cell Society - CYTX Overview

Adipose Derived, Point of Care Cell Therapy

4

Cell Type Frequency

Endothelial cells

(CD34+/CD31+)

7%

CD34+/CD31-/CD45- cells

(CFU-F)

38%

1-5%

Smooth muscle cells 9%

Leukocytes 22%

Tissue Macrophages 23%

Culture = ADSCs

Adipose Enzymatic Digestion

(no enzyme, no cells)

No Culture = ADRCs/SVF

Page 5: Cell Society - CYTX Overview

Publication Heat Map

5

ADRCs ADSCs

Organ System Preclinical

Clinical Preclinical

Clinical

Cardiovascular 6 3 17 0

Pulmonary 1 2 4 0

Orthopedic 5 1 30 1

Muscular 1 0 6 0

Central Nervous System 0 0 11 0

Peripheral Nervous System 2 1 7 0

Hepatobiliary/Pancreatic 0 0 10 2

Gastrointestinal 0 1 3 5

Immunologic (Autoimmune, GVHD)

0 0 5 7

Genitourinary 1 1 11 0

Renal 1 0 2 0

Subtotal 17 9 106 15

Plastic and Reconstructive 4 9 17 1

Dental 0 0 6 2

Subtotal 4 9 24 3

Grand Total 21 18 130 18

Page 6: Cell Society - CYTX Overview

• No Adipocytes

• Multipotent cells

• Endothelial cells

• Vasc. smooth muscle cells

• Tissue resident macrophages

• Perivascular cells

Key Attributes of Adipose Derived Regenerative Cells

Device & Therapeutic

6

0

15

30

45

Total Nucleated Cells in Adipose

0

0.25

0.5

Multipotent Cells in AdiposeMultipotent Cells in BM

Mixed Cell Population High Cell Number Potency

million/100cc

Page 7: Cell Society - CYTX Overview

Cardiovascular Trials- Effectiveness of ADRCs in Ischemia

7

APOLLO: ST Segment

Elevation Myocardial Infarctions

Objective • Safety and feasibility study in ST-elevation myocardial infarction (STEMI) Cells delivered via intra-

coronary route

Study design • Double-blind, placebo controlled

Sample size • N = 14

Randomization • 3:1 randomization (ADRC: Placebo)

Outcome assessment

• Primary at 6m / Long-term at 36m LVEF, wall thickness, wall motion, perfusion defect, pro-BNP

Patient selection

• STEMI 2- 12 hours duration• Successful PCI• Ejection Fraction 30-50%

Core laboratories

• All SPECT, MRI, 2D-Echo, 3D-Echo images were evaluated by independent, blinded core laboratories

Safety oversight

• An independent, blinded, Data and Safety Monitoring Board conducted scheduled and ad-hoc safety review of the study

PRECISE: No Option Chronic

Myocardial Ischemia

Objective • Safety and feasibility in chronic ischemia patients Cells delivered via a NOGA™ catheter patients not eligible

for percutaneous or surgical revascularization

Study design • Double-blind, placebo controlled

Sample size • N = 27

Randomization • 3:1 randomization within each cohort (21 active, 6 placebo)

Outcome assessment

• Primary at 6m / long-term at 36m LVEF, wall thickness, wall motion, perfusion

defect, VO2 Max, pro-BNP

Patient selection

• NYHA Class II-III

• Ejection Fraction < 45%

• Inducible ischemia on SPECT

Core laboratories

• All SPECT, MRI, 2D-Echo, 3D-Echo images were evaluated by independent, blinded core

laboratories

Safety oversight

• An independent, blinded, Data and Safety Monitoring Board conducted scheduled and ad-hoc safety review of the study

Page 8: Cell Society - CYTX Overview

Cardiovascular Trials- APOLLO (AMI)

8

24.4 cc/ -72.2% improvementTime

Placebo ADRC Tx

Page 9: Cell Society - CYTX Overview

Change in mV02 from baseline to 6 and 18 months

The PRECISE Trial

ADRCs

PlaceboBaseline 6 mo 18 mo

Transplantation

20.0

18.0

16.0

14.0

19.0

15.5 15.3

16.6

17.117.2

P < 0.05 P < 0.05

Cardiovascular Trials- PRECISE (Chronic Ischemia)

9

mV

O2

(L/m

in)

Page 10: Cell Society - CYTX Overview

Cardiac Development Status

10

Clinical Data

PRE-IDE Q4 ‘11

Initiate 2012

Regulatory Reimbursement

Clinical Data

CE Mark Application Filed 2011

Regulatory

(2012)Reimbursement

Clinical Data

Pilot complete

Pivotal began 2011

Regulatory Reimbursement

EU Chronic Myocardial Ischemia

EU Acute Myocardial Infarction

US Chronic Myocardial Ischemia ATHENA

Page 11: Cell Society - CYTX Overview

Cell Enriched Fat Grafting

11

Page 12: Cell Society - CYTX Overview

Cell Enriched Grafting for Breast Reconstruction

12

RESTORE 2: Reconstruction in BCT (lumpectomy and RTx)

Study design • Prospective, single-arm, EU study of cell enriched fat grafting after BCT

• Baseline performance study, no control group• Seven centers, 70 patients

Co-primary

endpoints

• Patient satisfaction with functional and cosmetic results and

improvement in overall breast deformity at 12 mo• Physician satisfaction with functional and cosmetic results and

improvement in overall breast deformity at 12 mo

Secondary endpoints

• Change in breast volume and shape (MRI)• Improvement in breast deformity• Number of treatments required to achieve positive changes in

selected endpoints• Improvement in patient Quality of Life scores

Patient selection

• Quadrantectomy for ≤ T2N0M0, up to 3 cm• Min of 12 mo from last treatment to enrollment, no recurrence• Mild to moderate breast damage with ≥ 2/3 of the breast

mound remaining

Page 13: Cell Society - CYTX Overview

Pre Tx

Cell Enriched Grafting for Breast Reconstruction

12 months

Post Op

13

100cc defect60 GySingle treatment150 cc wet CEFG

150cc defectNo RTTwo treatments

150/100 cc wet CEFG

Page 14: Cell Society - CYTX Overview

Cell Enriched Grafting for Breast Reconstruction

14

Co-primary Endpoints

Endpoint Outcome

Physician and patient satisfaction with overall treatment

• Physician- 78% (6 mo), 85% (12 mo)• Patient- 70% (6 mo), 75% (12 mo)

Secondary Endpoints

Endpoint Outcome

Change in breast volume &

contour (MRI)

• MRI volumetric analysis ineffective in these lesions

• Improved or much improved- 77% (6 mo), 83% (12 mo)

Improvement in soft tissue (Lent Soma and cutaneous scoring)

• Improvement in fibrotic indices but not in pain and coloration

Adverse Event profile • Safe, no cancer recurrences, benign lipid cysts were reported as adverse events in 10 patients (14.9%)

Number of treatments required • 1.35 (24 of 67 had second procedure)

Improvement in patient Quality

of Life scoresNo improvement detected with SF-36. This instrument is now

known to lack sensitivity in breast reconstruction. New instrument (breast-Q) is more sensitive in this population.

Resource utilization Average LOS was 7 hours-2 days, inpatient treatment 41/68 (60%) at baseline 19/24 (79%) at optional 6-month treatment

Page 15: Cell Society - CYTX Overview

Breast Reconstruction Development Status

15

2006

• RESTORE 1 Initiated in Japan

2007

• CE Mark for general processing

• RESTORE 1 data reported

2008

•Cytori begins RESTORE 2 trial in EU

2009

• RESTORE 2 enrollment complete

2010

• Breast reconstruction added to CE Mark

2011

• UK NIC identifies cost-effective-ness

• Complete RESTORE 2 data reported

Page 16: Cell Society - CYTX Overview

Urethral Lumen

• 90 yr old Female

• 2 year chronic wound

• Spine exposure

• Radiation Tx > 40 yrs

• Single treatment

• Complete healing

Dr. AkitaNagasaki, JapanWHO Center for Advanced Nuclear & Radiation Medicine

Pre-Treatment 1 year Post-Treatment

Day 0 Day 14 Day 21 Day 68 Day 89

Wound Healing

Page 17: Cell Society - CYTX Overview

Key Milestones 2012

17

Initiate ATHENA trial in U.S. – done

CE Mark for Chronic myocardial ischemia

Publication of key EU breast and CV data

Breast reconstruction technology evaluation in UK

Japanese and other non US regulatory approvals

Expand our commercial scope via partnerships


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