CYTX Cardiac Cell Therapy Panel Presentation at Biotech Showcase

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Cytori CEO Chris Calhoun presents as part of the "Cardiovascular, AMI & PAD" panel on the Regenerative Medicine Insight Track at the Biotech Showcase on January 10, 2012

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CYTX Cardiac Cell Therapy Panel Presentation at Biotech Showcase

  1. 1. $ 503,000,000,000
  2. 2. $ 1,378,000,000 per day
  3. 3. The Cost of CVD• 37% of Americans have some form of CVD• 32 % of all deaths world-wide• Direct cost $272 B = 17% of health care cost• Projected to triple to $818 B by 2030
  4. 4. Life Style AMI Heart Failure D e a t h
  5. 5. Life StyleHHS :Million Hearts AMIDevices Heart FailureDrugs D e a t h
  6. 6. Life Style RegenerativeHHS : MedicineMillion Hearts AMIDevices Heart FailureDrugs D e a t h
  7. 7. Patient’s cells at Point-of-Care 3. Patient’s own cells in about one hour 2. Point Of Care Tissue Processing Device removes adipocytes1. Small volume Liposuction
  8. 8. Relevance of Heart Damage % Left Ventricle infarct size 40% % of patients 35% in heart failure or death 2 years after AMI 30% 25% 46% of patients 20% 15% 7% of patients 10%
  9. 9. 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
  10. 10. Change in Infarct Size % Left Ventricle infarct size 40% Standard of Care 35% 30% Significantly Higher 25% 25% 25% Rate of MACE 20% 15% Significantly Lower Rate of MACE 10% Baseline 6 Months
  11. 11. Cell Treated reduced damage by 50% ADRC’s % Left Ventricle infarct size 40% Standard of Care 35% 32% 30% Significantly Higher 25% 25% 25% Rate of MACE 20% 15% Significantly Lower 15% Rate of MACE 10% Baseline 6 Months
  12. 12. Change in Infarct Size Persistent to 18 Months change in rel. infarct size (I/LV) (matched pairs) all pts baseline 6 mo control Tx 24,7% 24,7% ADRC Tx 31,6% 15,4% Data provided by: Eric Duckers, MD, PhD
  13. 13. Standard of Care Patients Progressing into Heart Failure 24,4 cc improvement (-72,2%) Data provided by: Eric Duckers, MD, PhDChange in ESV ESV was markedly reduced in ADRC patients as compared to placebo control patients (as measured by 2D TTE, cMRI and SPECT, PTE)
  14. 14. Cell Treated Patients Not Progressing into Heart Failure 24,4 cc improvement (-72,2%) Data provided by: Eric Duckers, MD, PhDChange in ESV ESV was markedly reduced in ADRC patients as compared to placebo control patients (as measured by 2D TTE, cMRI and SPECT, PTE)
  15. 15. Cell Treated Patients Better Perfusion of the Heart MIBI SPECT TSS change (matched pairs) +867% +800% improvement improvement Data provided by: Eric Duckers, MD, PhDPerfusion defect in LAD territory: Reduction in perfusion defect in patients treated with ADRC compared to placebopatients (9,7-fold improvement in LAD perfusion territory) as analyzed by MIBI SPECT (TSS scores)
  16. 16. Cell Treated Patients Experienced Fewer Arrhythmias Lower abnormal ventricular beat rate in cell group  More significant Ventricular Arrhythmias in placebo  Higher frequency of recordings with Ventricular Premature Beats (VPB) in Controls  Higher number of VPBs per recording in placebo Data provided by: Eric Duckers, MD, PhD
  17. 17. 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  Long-term data indicates slowing progression toward heart failure  Positive impact on arrhythmia in cell-treatment patents Apollo data consistent with pre-clinical data
  18. 18. 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
  19. 19. Advance EU AMI Trial• 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• Focus in 2012 to bringing sites online: 30 by YE• Enrollment goal: 1 pt / site / month
  20. 20. Advance EU AMI Trial ADVANCE is a European approval trial
  21. 21. 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
  22. 22. Acute Myocardial Infarction Annual STEMI Heart Attack Incidence (EU) 720,000 Progression to Heart Failure in 24 months (46%) 330,000 Total Annual Cost For New HF patients ($180k / yr) $ 60 Billion Est. Progression to HF in 24 mo w Cell Tx (7%) 50,000 Total Annual Cost for New HF patients (180k / yr) $ 9 Billion EU HF Cost Savings $ 51 Billion Savings would compound over future years
  23. 23. Chronic Myocardial Ischemia PRECISE TRIAL • Prospective European Multicenter • Randomized (3:1) • Double Blind • Placebo controlled • Blinded independent core labs • Safety & Feasibility Trial • n= 27 (6 placebo, 21 treated) Emerson Perin, MD Texas Heart, USA Dr. Aviles Madrid, Spain
  24. 24. Standard of Care Patients Key Heart Function Continued Decline 20.0 Standard of Care 19.0 18.0 % MVO2 16.0 15.5 15.3 14.0 Transplant List Baseline 6 Mos 18 Mos Change in Mass Volume of Oxygen (MV02) from Baseline to 6 & 18 months
  25. 25. Cell Treated Patients Improved in Key Heart Function 20.0 ADRC’s Standard of Care 19.0 P<0.05 P<0.05 18.0 % MVO2 17.2 17.1 16.0 16.6 15.5 15.3 14.0 Transplant List Baseline 6 Mos 18 Mos Change in Mass Volume of Oxygen (MV02) from Baseline to 6 & 18 months
  26. 26. Chronic Myocardial Ischemia 28 Month Mortality RateSafe & Feasible• Harvest procedure (Liposuction) safe• Cell delivery safe TreatedMVO2: significant change at 6 & 18 months Placebo• MVO2 correlates to improved survival• MVO2 ≤ 14 = 47% 1 yr survival rate 0% 10% 20% 30% 40%METS: significant change at 6 & 18 monthsInfarct size: 8.2% change at 6 months Next Steps:Lower cardiac mortality rate: Applying for European Approval• At avg. follow up of 28 months: - 2/6 placebo Initiating US IDE Clinical Trial: ATHENA - 1/21 treated
  27. 27. “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 * Estimated price per treatment: $ 10,000 $ 20 Billion*
  28. 28. 38 Worldwide Issued Patents; > 100 pendingDevices Devices Cosmetic & Reconstructive Cardiovascular Therapies Pipeline TherapiesCurrent Next Generation Surgery (CRS)US: (5) US: (1) US: (4) Europe: (1) US: (2)CELUTION DEVICE (‘484) CELUTION FUTURE CELUTION FOR MIXING ADRCS PLUS ADRCS FOR CARDIAC (‘382) CELUTION FOR BONECELUTION DEVICE PLUS ADDITIVES GENERATIONS (‘075) FAT (‘488) (‘043)(‘420) CELUTION OR NEXT GEN DEVICES FOR Australia: (1) CELUTION OUTPUT PLUSSTEMSOURCE DEVICE (‘115) India: (1) SOFT TISSUE DEFECTS (‘684) CELUTION FOR CARDIOVASCULAR PROSTHETICCELUTION DEVICE PLUS SENSORS FOR CELUTION FUTURE ADRCS PLUS FAT PLUS ADDITIVES (‘858) FOR BONE RELATEDCLINICALLY SAFE OUTPUT (‘670) GENERATIONS (‘529) (‘795) DISORDERS (‘716)BEDSIDE COMPREHENSIVE ADRCS PLUS FAT (‘672) Singapore: (1)DEVICE (‘059) Australia: (1) CELUTION FOR CARDIOVASCULAR Europe: (2) CELUTION WITH CENTRIFUGE Japan: (1) (‘590) CELUTION FOR ACUTEJapan: (2) OR CELUTION AND NEXT GEN DEVICES TUBULAR NECROSIS (‘834)CELUTION DEVICE (‘952) FILTER (‘937) FOR MIXING ADRCS PLUS FAT (‘041) China: (1) ADRCS FOR WOUNDCELUTION FOR CLINICALLY SAFE CELUTION FOR HEALING (‘833)OUTPUT (‘556) Singapore: (1) CARDIOVASCULAR (‘104) CELUTION & FUTURE Japan: (1)Korea: (3) GENERATIONS (‘683) Russia: (1) ADRCS FOR WOUNDCELUTION DEVICE (‘995) CELUTION FOR CARDIOVASCULAR HEALING (‘699)STEMSOURCE DEVICE (‘812) Israel: (1) (‘924)CELUTION DEVICE (‘139) CELUTION WITH CENTRIFUGE India: (1) OR South Africa: (1) ADRCS FOR WOUNDIndia: (1) FILTER (‘800) CELUTION FOR CARDIOVASCULAR HEALING (‘580)CELUTION DEVICE (‘706) (‘446) Mexico: (1)Australia: (1) CELUTION FUTURE Mexico: (1)CELUTION DEVICE (‘135) GENERATIONS CELUTION FOR CARDIOVASCULARSTEMSOURCE DEVICE (‘901) (‘775)China: (1)CELUTION DEVICE (‘689)
  29. 29. Summary• CVD represents a $80+ billion market opportunity• Regenerative Medicine is needed to improve treatment options & outcomes• Cell therapy using the Celution System has shown significant benefit in both acute & chronic heart• First approval for CMI anticipated in 2012
  30. 30. THANK YOU!

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