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
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
7. Life Style Regenerative
HHS : Medicine
Million Hearts AMI
Devices Heart Failure
Drugs
D e a t h
8. Patientâs cells at Point-of-Care
3. Patientâs 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%
ADRCâs
% 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
ď§ More significant Ventricular Arrhythmias in
placebo
ď§ Higher frequency of recordings with Ventricular
Premature Beats (VPB) in Controls
ď§ Higher number of VPBs per recording in placebo
Data provided by:
Eric Duckers, MD, PhD
18. Apollo Summary
ď§ ADRCs are safe in the treatment of STEMI
ď§ No safety concerns
ď§ No new Major Adverse Cardiac Events
ď§ No Deaths
ď§ Efficacy
ď§ Concordant improvement in infarct and ischemia
ď§ Mean reduction in Infarct Size is maintained to 18 months
ď§ Improvement in cardiac perfusion is maintained to 18 months
ď§ Long-term data indicates slowing progression toward heart failure
ď§ 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 â 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
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 ADRCâs
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. âNo Optionâ 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 (â484) CELUTION FUTURE CELUTION FOR MIXING ADRCS PLUS ADRCS FOR CARDIAC (â382) CELUTION FOR BONE
CELUTION DEVICE PLUS ADDITIVES GENERATIONS (â075) FAT (â488) (â043)
(â420) CELUTION OR NEXT GEN DEVICES FOR Australia: (1) CELUTION OUTPUT PLUS
STEMSOURCE DEVICE (â115) India: (1) SOFT TISSUE DEFECTS (â684) CELUTION FOR CARDIOVASCULAR PROSTHETIC
CELUTION DEVICE PLUS SENSORS FOR CELUTION FUTURE ADRCS PLUS FAT PLUS ADDITIVES (â858) FOR BONE RELATED
CLINICALLY SAFE OUTPUT (â670) GENERATIONS (â529) (â795) DISORDERS (â716)
BEDSIDE COMPREHENSIVE ADRCS PLUS FAT (â672) Singapore: (1)
DEVICE (â059) Australia: (1) CELUTION FOR CARDIOVASCULAR Europe: (2)
CELUTION WITH CENTRIFUGE Japan: (1) (â590) CELUTION FOR ACUTE
Japan: (2) OR CELUTION AND NEXT GEN DEVICES TUBULAR NECROSIS (â834)
CELUTION DEVICE (â952) FILTER (â937) FOR MIXING ADRCS PLUS FAT (â041) China: (1) ADRCS FOR WOUND
CELUTION FOR CLINICALLY SAFE CELUTION FOR HEALING (â833)
OUTPUT (â556) Singapore: (1) CARDIOVASCULAR (â104)
CELUTION & FUTURE Japan: (1)
Korea: (3) GENERATIONS (â683) Russia: (1) ADRCS FOR WOUND
CELUTION DEVICE (â995) CELUTION FOR CARDIOVASCULAR HEALING (â699)
STEMSOURCE DEVICE (â812) Israel: (1) (â924)
CELUTION DEVICE (â139) CELUTION WITH CENTRIFUGE India: (1)
OR South Africa: (1) ADRCS FOR WOUND
India: (1) FILTER (â800) CELUTION FOR CARDIOVASCULAR HEALING (â580)
CELUTION DEVICE (â706) (â446)
Mexico: (1)
Australia: (1) CELUTION FUTURE Mexico: (1)
CELUTION DEVICE (â135) GENERATIONS CELUTION FOR CARDIOVASCULAR
STEMSOURCE DEVICE (â901) (â775)
China: (1)
CELUTION DEVICE (â689)
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