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$ 503,000,000,000
$ 1,378,000,000
    per day
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
Life Style
             AMI
                   Heart Failure

              D e a t h
Life Style
HHS :
Million Hearts   AMI
Devices                Heart Failure
Drugs

                  D e a t h
Life Style            Regenerative
HHS :                      Medicine
Million Hearts   AMI
Devices                Heart Failure
Drugs

                  D e a t h
Patient’s cells at Point-of-Care
                  3.   Patient’s own cells
                       in about one hour
                                             2.    Point Of Care
                                                  Tissue Processing Device
                                                  removes adipocytes
1. Small volume
   Liposuction
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%
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
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
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
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
Standard of Care Patients
     Progressing into Heart Failure



                                                                        24,4 cc
                                                                      improvement
                                                                        (-72,2%)




                                                                           Data provided by:
                                                                           Eric Duckers, MD, PhD



Change in ESV
      ESV was markedly reduced in ADRC patients as compared to placebo control patients
      (as measured by 2D TTE, cMRI and SPECT, PTE)
Cell Treated Patients
    Not Progressing into Heart Failure



                                                                        24,4 cc
                                                                      improvement
                                                                        (-72,2%)




                                                                           Data provided by:
                                                                           Eric Duckers, MD, PhD



Change in ESV
      ESV was markedly reduced in ADRC patients as compared to placebo control patients
      (as measured by 2D TTE, cMRI and SPECT, PTE)
Cell Treated Patients
        Better Perfusion of the Heart
             MIBI SPECT TSS change (matched pairs)




                                                       +867%         +800%
                                                     improvement   improvement




                                                                                 Data provided by:
                                                                                 Eric Duckers, MD, PhD



Perfusion defect in LAD territory:
         Reduction in perfusion defect in patients treated with ADRC compared to placebo
patients (9,7-fold improvement in LAD perfusion territory) as analyzed by MIBI SPECT (TSS scores)
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
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
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
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
Advance EU AMI Trial




             ADVANCE is a European approval trial
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
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
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
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
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
Chronic Myocardial Ischemia
                                                        28 Month Mortality Rate
Safe & Feasible
• Harvest procedure (Liposuction) safe
• Cell delivery safe                              Treated

MVO2: 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 months

Infarct 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
“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*
38 Worldwide Issued Patents; > 100 pending
Devices                            Devices                    Cosmetic & Reconstructive          Cardiovascular Therapies      Pipeline Therapies
Current                            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 BONE
CELUTION DEVICE PLUS ADDITIVES     GENERATIONS (‘075)         FAT (‘488)                                                       (‘043)
(‘420)                                                        CELUTION OR NEXT GEN DEVICES FOR   Australia: (1)                CELUTION OUTPUT PLUS
STEMSOURCE DEVICE (‘115)           India: (1)                 SOFT TISSUE DEFECTS (‘684)         CELUTION FOR CARDIOVASCULAR   PROSTHETIC
CELUTION DEVICE PLUS SENSORS FOR   CELUTION FUTURE            ADRCS PLUS FAT PLUS ADDITIVES      (‘858)                        FOR BONE RELATED
CLINICALLY 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 ACUTE
Japan: (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 WOUND
CELUTION 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 WOUND
CELUTION 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 WOUND
India: (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 CARDIOVASCULAR
STEMSOURCE DEVICE (‘901)                                                                         (‘775)

China: (1)
CELUTION DEVICE (‘689)
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
THANK YOU!

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CYTX Cardiac Cell Therapy Panel Presentation at Biotech Showcase

  • 1.
  • 3. $ 1,378,000,000 per day
  • 4. 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
  • 5. Life Style AMI Heart Failure D e a t h
  • 6. Life Style HHS : Million Hearts AMI Devices Heart Failure Drugs D e a t h
  • 7. Life Style Regenerative HHS : Medicine Million Hearts AMI Devices Heart Failure Drugs D e a t h
  • 8. Patient’s cells at Point-of-Care 3. Patient’s own cells in about one hour 2. Point Of Care Tissue Processing Device removes adipocytes 1. Small volume Liposuction
  • 9. 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%
  • 10. 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
  • 11. 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
  • 12. 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
  • 13. 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
  • 14. Standard of Care Patients Progressing into Heart Failure 24,4 cc improvement (-72,2%) Data provided by: Eric Duckers, MD, PhD Change 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. Cell Treated Patients Not Progressing into Heart Failure 24,4 cc improvement (-72,2%) Data provided by: Eric Duckers, MD, PhD Change in ESV ESV was markedly reduced in ADRC patients as compared to placebo control patients (as measured by 2D TTE, cMRI and SPECT, PTE)
  • 16. Cell Treated Patients Better Perfusion of the Heart MIBI SPECT TSS change (matched pairs) +867% +800% improvement improvement Data provided by: Eric Duckers, MD, PhD Perfusion defect in LAD territory: Reduction in perfusion defect in patients treated with ADRC compared to placebo patients (9,7-fold improvement in LAD perfusion territory) as analyzed by MIBI SPECT (TSS scores)
  • 17. 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
  • 18. 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
  • 19. 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
  • 20. 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
  • 21. Advance EU AMI Trial ADVANCE is a European approval trial
  • 22. 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
  • 23. 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
  • 24. 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
  • 25. 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
  • 26. 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
  • 27. Chronic Myocardial Ischemia 28 Month Mortality Rate Safe & Feasible • Harvest procedure (Liposuction) safe • Cell delivery safe Treated MVO2: 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 months Infarct 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
  • 28. “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*
  • 29. 38 Worldwide Issued Patents; > 100 pending Devices Devices Cosmetic & Reconstructive Cardiovascular Therapies Pipeline Therapies Current 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 BONE CELUTION DEVICE PLUS ADDITIVES GENERATIONS (‘075) FAT (‘488) (‘043) (‘420) CELUTION OR NEXT GEN DEVICES FOR Australia: (1) CELUTION OUTPUT PLUS STEMSOURCE DEVICE (‘115) India: (1) SOFT TISSUE DEFECTS (‘684) CELUTION FOR CARDIOVASCULAR PROSTHETIC CELUTION DEVICE PLUS SENSORS FOR CELUTION FUTURE ADRCS PLUS FAT PLUS ADDITIVES (‘858) FOR BONE RELATED CLINICALLY 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 ACUTE Japan: (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 WOUND CELUTION 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 WOUND CELUTION 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 WOUND India: (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 CARDIOVASCULAR STEMSOURCE DEVICE (‘901) (‘775) China: (1) CELUTION DEVICE (‘689)
  • 30. 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