cytx cardiac cell therapy panel presentation at biotech showcase
DESCRIPTION
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, 2012TRANSCRIPT
$ 503,000,000,000
$ 1,378,000,000per 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
AMI
Heart Failure
D e a t h
HHS : Million Hearts
DevicesDrugs
Life Style
AMI
Heart Failure
D e a t h
HHS : Million Hearts
DevicesDrugs
RegenerativeMedicine
1. Small volume Liposuction
2. Point Of Care Tissue Processing Deviceremoves adipocytes
3. Patient’s own cellsin about one hour
Patient’s cells at Point-of-Care
40%
35%
30%
25%
20%
15%
10%
Relevance of Heart Damage
46% of patients
7% of patients
% L
eft
Ve
ntr
icle
infa
rct
size % of patients
in heart failure or death 2 years after AMI
Eric Duckers, MD, PhDRotterdam, The Netherlands
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)
Acute Heart Attack
Change in Infarct Size
Baseline 6 Months
40%
35%
30%
25%
20%
15%
10%
25% 25%
Standard of Care
Significantly HigherRate of MACE
Significantly LowerRate of MACE
% L
eft
Ve
ntr
icle
infa
rct
size
Cell Treated reduced damage by 50%
Baseline 6 Months
40%
35%
30%
25%
20%
15%
10%
32%
15%
25% 25%
ADRC’sStandard of Care
Significantly HigherRate of MACE
Significantly LowerRate of MACE
% L
eft
Ve
ntr
icle
infa
rct
size
Change in Infarct Size Persistent to 18 Months
all pts baseline 6 mo
control
Tx24,7% 24,7%
ADRC
Tx31,6% 15,4%
Data provided by:Eric Duckers, MD, PhD
ch
an
ge
in r
el. in
farc
t siz
e (
I/L
V)
(ma
tch
ed
pairs)
Standard of Care Patients Progressing into Heart Failure
24,4 ccimprovement
(-72,2%)
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)
Data provided by:Eric Duckers, MD, PhD
Cell Treated Patients Not Progressing into Heart Failure
24,4 ccimprovement
(-72,2%)
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)
Data provided by:Eric Duckers, MD, PhD
Cell Treated Patients Better Perfusion of the Heart
Data provided by:Eric Duckers, MD, PhD
MIB
I S
PE
CT
TS
S c
han
ge
(m
atc
he
d p
airs)
+867%
improvement
+800%
improvement
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)
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
Cell Treated PatientsExperienced Fewer Arrhythmias
Data provided by:Eric Duckers, MD, PhD
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 Summary
Apollo data consistent with pre-clinical data
Acute Heart Attack
Eric Duckers, MD, PhDRotterdam, The Netherlands
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
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
EU AMI Market$ 7.2 Billion
Annual Heart Attack Incidence (EU) 1.9 million
% STEMI (large heart attacks) 38%
Target Addressable Procedures 720,000
Estimated Price per Treatment $ 10,000
Acute Myocardial Infarction
EU HF Cost Savings$ 51 Billion
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
Savings would compound over future years
Chronic Myocardial Ischemia
Dr. AvilesMadrid, Spain
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, MDTexas Heart, USA
Change in Mass Volume of Oxygen (MV02) from Baseline to 6 & 18 months
Baseline 6 Mos 18 Mos
Transplant List
20.0
18.0
16.0
14.0
Standard of Care Patients
Key Heart Function Continued Decline
19.0
15.5 15.3
Standard of Care
% M
VO
2
Change in Mass Volume of Oxygen (MV02) from Baseline to 6 & 18 months
Baseline 6 Mos 18 Mos
Transplant List
20.0
18.0
16.0
14.0
Cell Treated Patients
Improved in Key Heart Function
19.0
15.5 15.3
16.6
17.117.2
ADRC’sStandard of Care
P<0.05 P<0.05
% M
VO
2
Chronic Myocardial Ischemia
Safe & Feasible
• Harvest procedure (Liposuction) safe
• Cell delivery safe
MVO2: significant change at 6 & 18 months• MVO2 correlates to improved survival
• MVO2 ≤ 14 = 47% 1 yr survival rate
METS: significant change at 6 & 18 months
Infarct size: 8.2% change at 6 months
Lower cardiac mortality rate:• At avg. follow up of 28 months:
- 2/6 placebo
- 1/21 treated
Next Steps:Applying for European Approval
Initiating US IDE Clinical Trial: ATHENA
0% 10% 20% 30% 40%
Placebo
Treated
28 Month Mortality Rate
“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 $ 20 Billion*
* Estimated price per treatment: $ 10,000
38 Worldwide Issued Patents; > 100 pendingDevicesCurrent
DevicesNext Generation
Cosmetic & ReconstructiveSurgery (CRS)
Cardiovascular Therapies Pipeline Therapies
US: (5)CELUTION DEVICE (‘484)CELUTION DEVICE PLUS ADDITIVES
(‘420)STEMSOURCE DEVICE (‘115)CELUTION DEVICE PLUS SENSORS FOR
CLINICALLY SAFE OUTPUT (‘670)BEDSIDE COMPREHENSIVE
DEVICE (‘059)
Japan: (2)CELUTION DEVICE (‘952)CELUTION FOR CLINICALLY SAFE
OUTPUT (‘556)
Korea: (3)CELUTION DEVICE (‘995)STEMSOURCE DEVICE (‘812)CELUTION DEVICE (‘139)
India: (1)CELUTION DEVICE (‘706)
Australia: (1)CELUTION DEVICE (‘135)STEMSOURCE DEVICE (‘901)
China: (1)CELUTION DEVICE (‘689)
US: (1)CELUTION FUTURE
GENERATIONS (‘075)
India: (1)CELUTION FUTURE
GENERATIONS (‘529)
Australia: (1)CELUTION WITH CENTRIFUGE
OR
FILTER (‘937)
Singapore: (1)CELUTION & FUTURE
GENERATIONS (‘683)
Israel: (1)CELUTION WITH CENTRIFUGE
OR
FILTER (‘800)
Mexico: (1)CELUTION FUTURE
GENERATIONS
US: (4)CELUTION FOR MIXING ADRCS PLUS
FAT (‘488)CELUTION OR NEXT GEN DEVICES FOR
SOFT TISSUE DEFECTS (‘684)ADRCS PLUS FAT PLUS ADDITIVES
(‘795)ADRCS PLUS FAT (‘672)
Japan: (1)CELUTION AND NEXT GEN DEVICES
FOR MIXING ADRCS PLUS FAT (‘041)
Europe: (1)ADRCS FOR CARDIAC (‘382)
Australia: (1)CELUTION FOR CARDIOVASCULAR
(‘858)
Singapore: (1)CELUTION FOR CARDIOVASCULAR
(‘590)
China: (1)CELUTION FOR
CARDIOVASCULAR (‘104)
Russia: (1)CELUTION FOR CARDIOVASCULAR
(‘924)
South Africa: (1)CELUTION FOR CARDIOVASCULAR
(‘446)
Mexico: (1)CELUTION FOR CARDIOVASCULAR
(‘775)
US: (2)CELUTION FOR BONE
(‘043)CELUTION OUTPUT PLUS
PROSTHETIC
FOR BONE RELATED
DISORDERS (‘716)
Europe: (2)CELUTION FOR ACUTE
TUBULAR NECROSIS (‘834)ADRCS FOR WOUND
HEALING (‘833)
Japan: (1)ADRCS FOR WOUND
HEALING (‘699)
India: (1)ADRCS FOR WOUND
HEALING (‘580)
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
T H A N K Y O U !