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CYTX Conference on Cell Therapy for Cardiovascular Disease

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Dr. Alex Milstein, VP of Clinical at Cytori presents on the Acute Injury Technology Panel at the Cardiovascular Research Foundation's Conference on Cell Therapy for Cardiovascular Disease on January 25, 2012

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CYTX Conference on Cell Therapy for Cardiovascular Disease

  1. 1. Cytori Therapeutics7th International Conference on Cell Therapy for Cardiovascular Disease Focus on Acute Injury Technologies 25 January 2012 Alex Milstein, M.D. VP, Clinical Development
  2. 2. Real-Time Access to Autologous Regenerative Cells Cardiovascular Disease < 2 hours Cytori Celution® Regenerative cells Soft Tissue RepairVersatile technology; focus on cardiac & soft tissue repairCE Mark approval in Europe for soft tissue; Seeking CMI in 1H 201236+ patents, 100 + filed on device & cells Celution™ System is not available in the US
  3. 3. Acute Myocardial Infarction – The APOLLO Trial 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) • Co-Principal Investigators: Drs. H.J. Duckers and P.W. Serruys
  4. 4. Cell Treated: Better Perfusion of the Heart 6 & 18 month follow-up Perfusion defect in LAD territory: Reduction in perfusion defect in patients treated with ADRC compared to placebo patients as analyzed by MIBI SPECT (TSS scores) MIBI SPECT TSS change (matched pairs) 10x 9x improvement improvementp=NS Slide: CourtesyAll SPECT images were assessed by an independent, blinded core lab (CCL, Boston, MA) HJ Duckers, MD, PhD
  5. 5. Reduction of > 50% in Infarct Size seen with ADRCs 6 & 18 month follow-up Percent of Left Ventricle Infarcted (%LVI): Greater improvement in %LVI in ADRC patients vs. to Placebo control patients (late enhancement cMRI) change in rel.infarct size (I/LV) (matched pairs) all pts baseline 6 mo Placebo 24,7% 24,7% ADRC 31,6% 15,4% Means for treatment groupsp=NS Matched-pair analysis Slide: CourtesyAll MRI images were assessed by an independent, blinded core lab (CCL, Boston, MA) HJ Duckers, MD, PhD
  6. 6. Preservation of End-Systolic Volume with ADRCs 6 & 18 month follow-up Change in ESV ESV was markedly reduced in ADRC patients as compared to placebo control patients change in ESV (cc, 2D TTE) 24,4 cc improvement (-72,2%) Slide: CourtesyAll TTE images were assessed by an independent, blinded core lab (CCL, Boston, MA) HJ Duckers, MD, PhD
  7. 7. APOLLO: Arrhythmias Percent of Pa ents with Signific nt a More ventricular arrhythmias observed in Ventricular Arrhythmias Control patients60%  More Significant Ventricular Arrhythmias in50% 50% control patients  Higher frequency of recordings with40% 30% Ventricular Premature Bits (VPB) in Controls Higher number of VPBs per recording30% 20% in Controls10% 0% 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
  8. 8. APOLLO: Summary ADRCs are safe in the treatment of STEMI  No safety concerns  Cell administration is safe  No new MACE/SAEs  No Deaths Feasibility  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
  9. 9. Cytori Cardiac Program: Present and FutureCelution™ System is CE Marked in the EUAcute Myocardial Infarction: • European APOLLO Trial – completing 36-mo FU • Pivotal European ADVANCE Trial – ramping up • US trial in AMI – to follow ADVANCEChronic Myocardial Ischemia: • European PRECISE Trial – completing 36-mo FU • US ATHENA Trial – IDE filed
  10. 10. AMI - THE ADVANCE TRIAL• Primary endpoint: cMRI infarct size at 6 months• Randomized, Double-blind, Placebo-controlled• N ≤ 360, at up to 35 sites in the EU• 23 sites selected & committed• Various states of regulatory process by country• Co-PIs Drs. H.J. Duckers and G. Pompilio• Independent blinded core labs will evaluate all imaging data• Independent DMC provides safety oversight• Independent CEC will adjudicate all germane events• Currently enrolling & treating patients18-mo data from Apollo support trial design for ADVANCE
  11. 11. Thank you

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