Marc Hedrick, MD   President
Safe Harbor StatementThis presentation may contain certain ‘forward-looking statements’. Allstatements, other than stateme...
Cytori- Brief Summary• Estimated 4-5,000 patients treated world wide• Completed 3 clinical trials, 2 CV trials in progress...
Adipose Derived, Point of Care Cell Therapy Adipose Enzymatic Digestion     (no enzyme, no cells)No Culture = ADRCs/SVF   ...
Publication Heat Map                                               ADRCs                   ADSCs      Organ System        ...
Device & Therapeutic                Key Attributes of Adipose Derived Regenerative Cells  Mixed Cell Population           ...
Cardiovascular Trials- Effectiveness of ADRCs in IschemiaAPOLLO: ST Segment                                      PRECISE: ...
Cardiovascular Trials- APOLLO (AMI)                                                 Time                                24...
Cardiovascular Trials- PRECISE (Chronic Ischemia)               Change in mV02 from baseline to 6 and 18 months           ...
Cardiac Development StatusEU Chronic Myocardial Ischemia          Clinical Data            Regulatory                     ...
Cell Enriched Fat Grafting11
Cell Enriched Grafting for Breast Reconstruction RESTORE 2: Reconstruction in BCT (lumpectomy and RTx) Study design   • Pr...
Cell Enriched Grafting for Breast Reconstruction             Pre Tx              12 months                                ...
Cell Enriched Grafting for Breast Reconstruction                                   Co-primary EndpointsEndpoint           ...
Breast Reconstruction Development Status     2006           2007              2008              2009            2010      ...
Wound Healing                                                             •   90 yr old Female                            ...
Key Milestones 2012Initiate ATHENA trial in U.S. – doneCE Mark for Chronic myocardial ischemiaPublication of key EU breast...
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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

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Cell Society - CYTX Overview

  1. 1. Marc Hedrick, MD President
  2. 2. Safe Harbor StatementThis presentation may contain certain ‘forward-looking statements’. Allstatements, other than statements of historical fact, that address activities,events or developments that we intend, expect, project, believe oranticipate will or may occur in the future are forward-looking statements.Such statements are based upon certain assumptions and assessmentsmade by our management in light of their experience and their perceptionof historical trends, current conditions, expected future developments andother factors they believe to be appropriate.The forward-looking statements included in this presentation are also subjectto a number of material risks and uncertainties. We caution investors not toplace undue reliance on the forward-looking statements contained in thispresentation.We would advise reading our annual report filed with the United StatesSecurities and Exchange Commission on Form 10-K for a more detaileddescription of these risks. 2
  3. 3. 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 repair3
  4. 4. Adipose Derived, Point of Care Cell Therapy Adipose Enzymatic Digestion (no enzyme, no cells)No Culture = ADRCs/SVF Culture = ADSCs Cell Type Frequency Endothelial cells 7% (CD34+/CD31+)CD34+/CD31-/CD45- cells 38% (CFU-F) 1-5% Smooth muscle cells 9% Leukocytes 22% Tissue Macrophages 23% 4
  5. 5. Publication Heat Map ADRCs ADSCs Organ System Preclinica Clinical Preclinica Clinical l l 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, 0 0 5 7 GVHD) 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 18 130 185
  6. 6. Device & Therapeutic Key Attributes of Adipose Derived Regenerative Cells Mixed Cell Population High Cell Number Potency million/100cc 0.5 • No Adipocytes 45 • Multipotent cells 30 • Endothelial cells 0.25 • Vasc. smooth muscle cells 15 • Tissue resident macrophages 0 • Perivascular cells 0 Multipotent Cells in Adipose Multipotent Cells in BM Total Nucleated Cells in Adipose 6
  7. 7. Cardiovascular Trials- Effectiveness of ADRCs in IschemiaAPOLLO: ST Segment PRECISE: No Option ChronicElevation Myocardial Infarctions Myocardial IschemiaObjective • Safety and feasibility study in ST- Objective • Safety and feasibility in chronic elevation myocardial infarction ischemia patients Cells delivered via a (STEMI) Cells delivered via intra- NOGA™ catheter patients not eligible coronary route for percutaneous or surgical revascularizationStudy design • Double-blind, placebo controlled Study design • Double-blind, placebo controlledSample size • N = 14 Sample size • N = 27Randomization • 3:1 randomization (ADRC: Placebo) Randomization • 3:1 randomization within each cohort (21 active, 6 placebo)Outcome • Primary at 6m / Long-term at 36massessment LVEF, wall thickness, wall motion, Outcome • Primary at 6m / long-term at 36m LVEF, perfusion defect, pro-BNP assessment wall thickness, wall motion, perfusion defect, VO2 Max, pro-BNPPatient • STEMI 2- 12 hours durationselection • Successful PCI Patient • NYHA Class II-III • Ejection Fraction 30-50% selection • Ejection Fraction < 45%Core • All SPECT, MRI, 2D-Echo, 3D-Echo • Inducible ischemia on SPECTlaboratories images were evaluated by Core • All SPECT, MRI, 2D-Echo, 3D-Echo independent, blinded core laboratories images were evaluated by laboratories independent, blinded coreSafety • An independent, blinded, Data and laboratoriesoversight Safety Monitoring Board conducted Safety • An independent, blinded, Data and scheduled and ad-hoc safety review oversight Safety Monitoring Board conducted of the study scheduled and ad-hoc safety review of the study 7
  8. 8. Cardiovascular Trials- APOLLO (AMI) Time 24.4 cc/ -72.2% improvement Placebo ADRC Tx8
  9. 9. Cardiovascular Trials- PRECISE (Chronic Ischemia) Change in mV02 from baseline to 6 and 18 months The PRECISE Trial 20.0 19.0 P < 0.05 P < 0.05 18.0 17.2mVO2 (L/min) 17.1 16.0 16.6 15.5 15.3 14.0 Transplantation ADRCs Placebo Baseline 6 mo 18 mo 9
  10. 10. Cardiac Development StatusEU Chronic Myocardial Ischemia Clinical Data Regulatory Reimbursement CE Mark Application Filed 2011 (2012)EU Acute Myocardial Infarction Clinical Data Pilot complete Regulatory Reimbursement Pivotal began 2011US Chronic Myocardial Ischemia ATHENA Clinical Data PRE-IDE Q4 ‘11 Regulatory Reimbursement Initiate 2012 10
  11. 11. Cell Enriched Fat Grafting11
  12. 12. Cell Enriched Grafting for Breast Reconstruction 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 • Patient satisfaction with functional and cosmetic results and endpoints 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 • Change in breast volume and shape (MRI) endpoints • Improvement in breast deformity • Number of treatments required to achieve positive changes in selected endpoints • Improvement in patient Quality of Life scores Patient • Quadrantectomy for ≤ T2N0M0, up to 3 cm selection • Min of 12 mo from last treatment to enrollment, no recurrence • Mild to moderate breast damage with ≥ 2/3 of the breast mound remaining12
  13. 13. Cell Enriched Grafting for Breast Reconstruction Pre Tx 12 months Post Op100cc defect60 GySingle treatment150 cc wet CEFG150cc defectNo RTTwo treatments150/100 cc wetCEFG 13
  14. 14. Cell Enriched Grafting for Breast Reconstruction Co-primary EndpointsEndpoint OutcomePhysician and patient • Physician- 78% (6 mo), 85% (12 mo)satisfaction with overall • Patient- 70% (6 mo), 75% (12 mo)treatment Secondary EndpointsEndpoint OutcomeChange in breast volume & • MRI volumetric analysis ineffective in these lesionscontour (MRI) • Improved or much improved- 77% (6 mo), 83% (12 mo)Improvement in soft tissue (Lent • Improvement in fibrotic indices but not in painSoma and cutaneous scoring) and colorationAdverse 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 No improvement detected with SF-36. This instrument is nowof Life scores 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 treatment14
  15. 15. Breast Reconstruction Development Status 2006 2007 2008 2009 2010 2011• RESTORE 1 • CE Mark for •Cytori begins • RESTORE 2 • Breast • UK NICInitiated in general RESTORE 2 trial enrollment reconstruction identifies cost-Japan processing in EU complete added to CE effective-ness • RESTORE 1 Mark • Complete data reported RESTORE 2 data reported 15
  16. 16. Wound Healing • 90 yr old Female • 2 year chronic wound • Spine exposure Urethral Lumen • Radiation Tx > 40 yrs • Single treatment • Complete healing Pre-Treatment 1 year Post-Treatment Day 0 Day 14 Day 21 Day 68 Day 89 Dr. Akita Nagasaki, Japan WHO Center for Advanced Nuclear & Radiation Medicine
  17. 17. Key Milestones 2012Initiate ATHENA trial in U.S. – doneCE Mark for Chronic myocardial ischemiaPublication of key EU breast and CV dataBreast reconstruction technology evaluation in UKJapanese and other non US regulatory approvalsExpand our commercial scope via partnerships 17
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