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CYTX Jefferies 2011 Global Healthcare Conference
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CYTX Jefferies 2011 Global Healthcare Conference

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CEO Chris Calhoun presents at the Jefferies 2011 Global Healthcare Conferece on Wednesday, June 8, 2011.

CEO Chris Calhoun presents at the Jefferies 2011 Global Healthcare Conferece on Wednesday, June 8, 2011.

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CYTX Jefferies 2011 Global Healthcare Conference CYTX Jefferies 2011 Global Healthcare Conference Presentation Transcript

  • Cell TherapyJefferies 2011 Global Healthcare Conference New York City June 8, 2011
  • 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
  • Our Company Mission To improve the quality and length of life by providing innovative cell therapies for patients CYTORI - The Leader in Cell Therapy. Cell Therapy
  • Company Summary Product RevenueGlobal leader in emerging Cell Therapy market $9 $8.3 with more than 3,000 patients treated $8 $7 $5.8 $6Management team comprised of proven innovators $5 $4.5 with significant equity stake $4 $3Revenues primarily from consumable sales $2 $0.8 $1Significant market opportunities with multiple $0 novel first-in-class indications 2007 2008 2009 2010Financial stability with $44 million cash (pro forma – Q1, 2011)Well positioned to help shape the future of cell-based Regenerative Medicine fieldStrong corporate partnerships: Olympus, GE, Astellas, GHS Cell Therapy
  • Our Development ApproachWe are developing a Platform rather than a single productWe Target Ischemia rather than tissue differentiationWe focus on “World’s Firsts” & “No Option” indicationsWe bring innovation to Global markets PLATFORM TARGET WORLD’S GLOBAL TECHNOLOGIES ISCHEMIA FIRST Cell Therapy
  • Our InnovationReal-time Access to a Patient’s Own Regenerative Cells Syringe of Your Own Cells Regenerative Cells Derived from Adipose Tissue (Fat) ≈1 Hour Cell Therapy
  • Cell Therapy via Device Multiple Cells = Multiple Mechanisms of Action Adipose contains the richest source of Stem & Regenerative cells in the body Stem Cells (CFU-F) 1-5% 500,000 Endothelial cell 7% 400,000 Smooth muscle cell 9% 300,000 Blood cell 22% 200,000 Tissue Macrophage 23% 100,000 CD34+/CD31-/CD45- 38%(100 cc Tissue) Bone Adipose Marrow Tissue Cell Therapy
  • Cell Therapy via Device Multiple Cells = Multiple Mechanisms of Action Adipose contains the richest source of Stem & Regenerative cells in the body Stem Cells (CFU-F) 1-5% 500,000 Endothelial cell 7% 400,000 Smooth muscle cell 9% 300,000 Blood cell 22% 200,000 Tissue Macrophage 23% 100,000 CD34+/CD31-/CD45- 38%(100 cc Tissue) Bone Adipose Marrow Tissue Blood Wound Prevent Home Immune Paracrine Tissue Supply Remodeling Cell Death To Injury Modulation SignalingRegeneration Cell Therapy
  • Cell Therapy via Device 3,000+ Patients TreatedAcute Heart Attack Breast ReconstructionChronic Heart Failure Breast AugmentationPeripheral Vascular Burn ReconstructionLiver Insufficiency Facial WastingUrinary Incontinence Tendon InjuryChronic Wounds Vocal Cord ParalysisRadiation Necrosis Facial TraumaBone Regeneration Periodontal DiseaseStroke Soft Tissue DefectsAcute Kidney Injury Cell Therapy
  • Cell Therapy via Device 3,000+ Patients TreatedAcute Heart Attack Breast ReconstructionChronic Heart Failure Breast Augmentation F O C U S Cell Therapy
  • Acute Heart Attack 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) Eric Duckers, MD, PhD Rotterdam, The Netherlands Cell Therapy
  • APOLLO – 18 Month Data 100% Pa ent Follow up Number of Pa ents with MACCE to 18 Months 12 12 10 10 8 Started Liposuc on 8 Randomized 6 Placebo 6 Completed 6 mo visit Group 1 4 4 Completed 18 mo visit 2 2 0 0 Placebo Group 1 6 MO 18 MO SAE Rate to 18 Months 100%  100% patient follow up 90% 80% 75%  No new MACCE events 70% 60% 50% 44%  No Deaths 40% 30%  No Re-infarctions 20% 10%  Higher SAE rate in 0% Placebo Group 1 Controls Cell Therapy
  • APOLLO: Arrhythmias Percent of Pa ents with Signific nt a Abnormal ventricular beats occur more Ventricular Arrhythmias often in Control patients60% 50%  More Significant Ventricular Arrhythmias50% in control patients40%  Higher frequency of recordings with 30%30% Ventricular Premature Bits (VPB) in20% Controls10%  Higher number of VPBs per recording0% in Controls Placebo Group 1 Premature Ventricular Contrac ons - Mean Count per Pa ent Premature Ventricular Contrac ons - Mean Cumula ve Count700 3000600 2500500 2000400 control 1500 control300 ADRC ADRC 1000200 500100 0 0 0.5 1 2 3 4 8 12 16 25 52 77 0.5 1 2 3 4 8 12 16 25 52 77 Cell Therapy
  • APOLLO: Infarct Size Absolute Difference in Infarct Size, ITT 0.0 BL -> 6 MO BL -> 18 MO P < 0.05 for change from BL for ADRCs -2.0 P > 0.05 for change from BL for Placebo -4.0 -4.4 -6.0 Placebo -6.1 -8.0 Group 1 -10.0 -12.0 -11.2 -11.7 -14.0  Difference in reduction of infarct size is maintained in cell-treated patients  p<0.05 for change in infarct size for cell-treated patients at 6 and 18 months (paired t-test comparing baseline and follow up for same patients) Cell Therapy
  • APOLLO: Perfusion by SPECT Mean Change in Visual Rest Score (SPECT), PTE 0 2-4D -> 6MO 2-4D -> 18MO P < 0.05 for change from BL for ADRCs -1 P > 0.05 for change from BL for Placebo -2 -1.7 -3 Placebo -3 -4 Group 1 -5 -6 -5.6 -6 -7  Sustained improvement in ischemia (VRS) from baseline to 6 and 18 months as measured by SPECT core laboratory  p<0.05 for change in VRS and TSS for cell-treated patients at 6 and 18 months (paired t-test comparing baseline and follow up for same patients) 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 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 Eric Duckers, MD, PhD Rotterdam, The Netherlands Cell Therapy
  • Acute Myocardial Infarction Estimated Market Size for AMI Patients in Europe Annual Heart Attack Incidence (EU) 1.9 million % STEMI (large heart attacks) 38% Target Addressable Procedures 720,000 Estimated Price per Treatment $ 10,000 EU AMI Market $ 7.2 Billion Cell Therapy
  • Chronic Myocardial Ischemia 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) Patrick Serruys, MD, PhD Rotterdam, The Netherlands Cell Therapy
  • Chronic Myocardial Ischemia Change in Mass Volume of Oxygen (MV02) from Baseline to 6 & 18 months The Precise Trial 20.0 19.0 P<0.05 P<0.05 18.0 17.2 17.1 16.0 16.6 15.5 15.3 14.0 Transplant List Baseline 6 Mos 18 Mos ADRC’s Standard of Care Cell Therapy
  • Chronic Myocardial Ischemia MVO2:significant change at 18 months 28 Month Mortality Rate • MVO2 correlates to improved survival • MVO2 ≤ 14 = 47% 1 yr survival rate METS: significant change at 18 months Treated Infarct size: 8.2% change at 6 months Placebo Cytori procedure safe and feasible through 18-months 0% 10% 20% 30% 40% 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 May Initiating US IDE PMA Clinical Trial * Applied for pre-IDE meeting with FDA 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 * Estimated price per treatment: $ 10,000 G5 Market $ 20 Billion* Cell Therapy
  • Lumpectomy Reconstruction RESTORE II TRIAL • Prospective European Multicenter Trial • ‚No Option‛ Partial Mastectomy patients • 1 year primary follow up • Blinded independent core labs • 71 Patients treated Eva Weiler-Mithoff, MD Glasglow, United Kingdom Cell Therapy
  • Lumpectomy Reconstruction Clinical: • Safe • 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 Eva Weiler-Mithoff, MD Glasglow, United Kingdom Cell Therapy
  • Lumpectomy ReconstructionPatient APatient B Pre-treatment 6 months 12 months Cell Therapy
  • Breast Reconstruction Estimated Market Size for Breast Reconstruction in Europe Annual Breast Cancer Incidence - Europe 332,000 % Lumpectomy eligible ~70% Target Addressable Market (Incidence) 230,000 Target Addressable Market (Prevalence) > 1,000,000EU Lumpectomy Reconstruction Market: $ 3.7 Billion * Estimated price per treatment: $ 3,000 (USD) Cell Therapy
  • EU RegulatorySTRATEGYPART I: Tool ClaimsPART II: Therapeutic ClaimsCE Mark for Device: 2007Claims Expansion: 2010 Breast Reconstruction Breast Augmentation Crohn’s FistulaClaims Expansion: In Process Chronic “No Option” Myocardial IschemiaPivotal Clinical Trial: In Process ADVANCE: Acute Myocardial Infarction Cell Therapy
  • US RegulatorySTRATEGYPART I: Tool ClaimsPART II: Therapeutic ClaimsUS FDA in ProcessUS IDE Trial for Cardiovascular: Chronic IschemiaUS HUD: Perry Rombergs DiseaseMultiple 510(k) device applications (Tool Claims)US IDE Trial for Cardiovascular: Heart Attack to follow European Advance Trial Cell Therapy
  • Japan RegulatorySTRATEGYPART I: Tool ClaimsPART II: Therapeutic ClaimsJapan MHLW / PMDAApplication for Device Approval in processApplication for Breast Reconstruction in process - based on Restore I & Restore II data Cell Therapy
  • Barriers-to-Entry: 34 Patents, 100 + Pending North America/Europe Asia Pacific Emerging Markets US (12): Japan (2): India (3): CELUTION DEVICE (‘706) CELUTION DEVICE (‘952) CELUTION FUTURE GENERATIONS (‘529) DEVICES DEVICES FOR CELLS PLUS FAT (‘041) CELUTION DEVICE WOUND HEALING (‘580) CELUTION DEVICE (‘484) CELUTION PLUS ADDITIVES (‘420) Korea (3): China (2): CELUTION FOR CRS (‘488) CELUTION DEVICE (‘689) STEMSOURCE DEVICE (‘115) CELUTION DEVICE (‘995) CELUTION FOR CARDIAC (‘104) CELUTION FUTURE GENERATIONS (‘075) STEMSOURCE DEVICE (‘812) CELUTION PLUS SENSORS/SAFE OUTPUT (‘670) CELUTION DEVICE (‘139) Mexico (2): CELUTION FOR BONE (‘043) CELUTION FUTURE GENERATIONS (‘348) CELUTION FOR SOFT TISSUE DEFECTS (‘684) CELUTION FOR CARDIAC (‘775) BEDSIDE COMPREHENSIVE DEVICE (‘059) Singapore (2): CELUTION OUTPUT PLUS PROSTHETIC CELUTION DEVICE & FUTURE FOR BONE RELATED DISORDERS (‘716) GENERATIONS (‘683) Australia (4): CELUTION FOR CARDIOVASCULAR CELUTION DEVICE (‘135) (‘590) STEMSOURCE DEVICE (‘901) METHODS CELUTION FOR CARDIOVASCULAR (‘858) CELLS PLUS FAT (‘672) CELUTION DEVICE WITH CENTRIFUGE OR CELLS PLUS FAT PLUS ADDITIVES (‘795) FILTER (‘937) MIDDLE EAST ISRAEL (1): South Africa (1): EUROPE (1): CELUTION DEVICES WITH CENTRIFUGE CELUTION FOR CARDIOVASCULAR (‘446) DEVICES FOR TREATING ACUTE TUBULAR OR FILTER (‘800) NECROSIS (‘834) Russia (1): CELUTION FOR CARDIOVASCULAR (‘924) Cell Therapy
  • Strong Partners Supporting Growth of BusinessOlympus Corporation (Japan): Manufacturing Joint Venture (2004)• Co-design & manufacture next-generation Celution® One o Ideal hospital-based device o Reside in OR, cath lab, or cell & tissue bank facility• Available for ADVANCE heart attack trial• Manufacturing expertise & service infrastructure• Committed Partner: invested $55+mm• Board observer seatAstellas Pharmaceuticals (2010)• Equity investment ($10 mm)• Received right-of-first refusal for liver disease partnership• Board observer seatGreen Hospital Supply (2007)• Co-selling StemSource® Cell Banks in AsiaGE Healthcare (2008)• Co-distribute Celution & StemSource in select countries Cell Therapy
  • Upcoming Catalysts Many Near Term Drivers  Report 18-month outcome data from APOLLO acute heart attack trial • Chronic myocardial ischemia indications-for-use in Europe • Celution One - CE Mark approval • PureGraft approval in Japan • Accelerated revenue growth for the full year 2011 • Publish and Present complete RESTORE 2 trial 12-month data • Celution System US FDA 510(k) clearance • Humanitarian Use Device Designation by FDA • Finalize US HDE soft tissue defect repair trial • Design and prepare to begin a US chronic myocardial ischemia trial • Growth in targeted emerging markets, including India Cell Therapy
  • Cell TherapyJefferies 2011 Global Healthcare Conference New York City June 10, 2011