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Stem Cell Meeting on the Mesa 2011: CYTX Presentation
1. Cytori Therapeutics
(NASDAQ: CYTX)
Stem Cell Meeting on the Mesa
December 1, 2011
Doug Arm, Ph.D
Sr. VP, Operations
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2. Safe Harbor Statement
This presentation may contain certain ‘forward-looking statements’. All
statements, other than statements of historical fact, that address activities,
events or developments that we intend, expect, project, believe or
anticipate will or may occur in the future are forward-looking statements.
Such statements are based upon certain assumptions and assessments
made by our management in light of their experience and their perception
of historical trends, current conditions, expected future developments and
other factors they believe to be appropriate.
The forward-looking statements included in this presentation are also subject
to a number of material risks and uncertainties. We caution investors not to
place undue reliance on the forward-looking statements contained in this
presentation.
We would advise reading our annual report filed with the United States
Securities and Exchange Commission on Form 10-K for a more detailed
description of these risks.
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3. Our Mission
To improve the quality and length of life
by providing innovative cell therapy for patients
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4. Technology
Regenerative cells in the operating room in real-time
Soft Tissue Repair
About one hour
Cytori Celution® System Regenerative cells
Cardiovascular Disease
• Celution currently approved in Europe
• Scalable platform
• System/Consumable model
• 35+ issued patents
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6. Adipose Tissue: Ideal Source for Cell Therapy
Implication: Real-time access to a patient’s own regenerative cells is possible
(No lengthy and expensive cell culture or manufacturing involved)
45 0.5
30
0.25
15
0 0
Multipotent Cells in Adipose
Total Nucleated Cells in Adipose
Multipotent Cells in BM
Number of Cells (millions) per 100 mL of tissue (1/2 cup)
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7. Multiple Mechanisms at Work
Wound remodeling
Differentiation
Blood
Supply
Paracrine
signaling
Prevention of
cell death
Immune-
modulation
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8. Intellectual Property: Foundation for Protection
30+ Patents Issued Worldwide with 100 + Pending
North America/Europe Asia Emerging Markets
US: Korea: Australia:
CELUTION DEVICE (‘484) CELUTION DEVICE (‘995) CELUTION DEVICE (‘135)
CELUTION PLUS ADDITIVES (‘420) STEMSOURCE DEVICE (‘812) STEMSOURCE DEVICE (‘901)
CELUTION FOR CRS (‘488) CELUTION DEVICE (‘139) CELUTION FOR CARDIOVASCULAR (‘858)
STEMSOURCE DEVICE (‘115) CELUTION DEVICE WITH CENTRIFUGE OR
CELUTION FUTURE GENERATIONS (‘075) Singapore: FILTER (‘937)
CELUTION PLUS SENSORS FOR CLINICALLY SAFE OUTPUT CELUTION DEVICE & FUTURE GENERATIONS
(‘670) South Africa:
(‘683)
CELUTION FOR BONE (‘043) CELUTION FOR CARDIOVASCULAR (‘446)
CELUTION FOR CARDIOVASCULAR (‘590)
CELUTION OR CELGRAFT FOR SOFT TISSUE DEFECTS
(‘684) Mexico:
China: CELUTION FUTURE GENERATIONS (‘348)
BEDSIDE COMPREHENSIVE CELUTION DEVICE (‘689)
DEVICE (‘059) CELUTION FOR CARDIOVASCULAR (‘775)
CELUTION FOR
CELUTION OUTPUT PLUS PROSTHETIC CARDIOVASCULAR (‘104)
FOR BONE RELATED DISORDERS (‘716)
Russia:
CELLS PLUS FAT PLUS ADDITIVES (‘795) CELUTION FOR CARDIOVASCULAR (‘924)
Japan:
CELLS PLUS FAT (‘672)
CELUTION DEVICE (‘952) India:
DEVICES FOR CELLS PLUS FAT (‘041) CELUTION DEVICE (‘706)
Europe: CLINICALLY SAFE (‘556) CELUTION FUTURE GENERATIONS (‘529)
CELUTION FOR ACUTE CELUTION DEVICE FOR TREATING WOUND
TUBULAR NECROSIS (‘834) HEALING (‘580)
Israel:
CELUTION DEVICE WITH CENTRIFUGE OR
FILTER (‘800)
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10. Soft Tissue Repair: RESTORE Procedure
Celution® approved in EU for breast reconstruction
Significant unmet medical need $73
Two completed clinical trials $126 $163
Safe and effective
Soft Tissue Repair
Soft Tissue Repair Clinical
Soft Tissue Repair
Reimbursable
Soft Tissue Repair Partner
‘Cell-Enriched
$43 Graft’
Cells Fat
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11. Soft Tissue Repair: RESTORE 2 Trial Outcomes
High satisfaction rates & safety to support reimbursement efforts
$73
$126
100%
Soft Tissue Repair 6-Mo
Soft Tissue Repair
Soft Tissue Repair 80%
Soft Tissue Repair 12-Mo
60%
40%
20%
0%
Patient Satisfaction
Physician
Post-Marketing Study Design Satisfaction
• Prospective 71 patient study
Co-Primary Endpoints
• Physicians and patient satisfaction with functional and cosmetic results &improvement in overall breast deformity
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12. Cardiovascular Disease
Dr. Fernandez-Aviles
Principal Investigator
for the PRECISE trial
Hosp. Gregorio Maranon
Madrid, Spain
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13. Cardiac Repair: PRECISE CMI Trial
Change in Max Volume of Oxygen (MV02) from Baseline to 6 & 18 months
20.0
Soft Tissue Repair 19.0
Soft Tissue Repair
Soft Tissue Repair P<0.05 P<0.05
18.0
17.2 17.1
16.0 16.6
15.5 15.3
14.0 Transplant List
N = 27 pts
(6 placebo/21 treated)
ADRC’s Baseline 6 Mos 18 Mos
Standard of Care 13
14. Cardiac Repair: PRECISE CMI Trial
28 Month Mortality Rate
Treated 5%
Placebo 33%
MVO2:significant change at 18 months
• MVO2 correlates to improved survival
• MVO2 ≤ 14 = 47% 1 yr survival rate 0% 10% 20% 30% 40%
METS: significant change at 18 months
Next Steps:
Cytori procedure safe and feasible through
18-months
Applying for European Approval
Lower cardiac mortality rate:
• At avg. follow up of 28 months: Initiating US IDE Clinical Trial: ATHENA
- 2/6 placebo
- 1/21 treated
• Completed pre-IDE meeting with FDA
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15. Cardiac Repair: U.S. CMI Trial
Confirmed device designation by FDA
Pursuing IDE/PMA clinical trial
Pre-IDE meeting with FDA Q3 2011
Proposed design for “ATHENA” trial:
• Approx. 50 patient pilot
• Randomized, double-blind, placebo-controlled
• 1o Endpoints: Safety & Efficacy
Next Steps:
• Submit IDE application by end of year
• Initiate 1H 2012
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16. Cardiac Repair: APOLLO Acute MI Trial
Potential new approach for treatment of heart attacks
Strong signals of safety & efficacy
Higher SAE rate in Controls
Initiated pivotal European clinical trial, ADVANCE
P < 0.05 for change from BL for ADRCs
P > 0.05 for change from BL for Placebo
Difference in reduction of infarct size is maintained in cell-treated patients
p<0.05 for change in infarct size for cell-treated patients at 6 and 18 months (paired t-test
comparing baseline and follow up for same patients)
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17. Cardiac Repair: APOLLO Acute MI Trial
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
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19. Soft Tissue Repair: Defect Filling
Pre-Op
Post-Op 18 mo
8 cc cell-enriched fat
Single Session
Dr. Tunc Tiryaki
Istanbul, Turkey
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20. Soft Tissue Repair: Radiation Necrosis
90% cells to circular area around sore
Exposed Sacrum
Note sig. inflammation, redness, swelling 10% cells to sore itself
Immediate Preop Intraop post-debride Intraop after Cell Tx
27 wks Post Op
25 Days Post Op 41 Days Post Op 20 wks Post Op
Dr. Akita
Nagasaki University, Japan
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21. Cytori Platform: 3 Key Differentiators
0.5 M
0.4 M
0.3 M
0.2 M
0.1 M
0 Bone Marrow Adipose Tissue
1. Real-time therapy, 2. ‘Consumables’
No cell culture Business model
Wound Immune- Prevention Paracrine
Differentiation Angiogenesis
remodeling modulation cell death signaling
3. Multiple mechanisms, multiple opportunities
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22. Current Commercial Business
• Revenue growth year over year
• Quarters variable
• Systems driving revenue
• EU focus on reconstruction
• Emerging markets & Asia:
- Aesthetics
- Reconstruction
- Translational research
- StemSource® cell & tissue banks
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23. Global Cell Therapy Market
$ 3.5 B
CRS $ 5.0 B
Wounds
$ 16 B
Urology
$ 33 B
AMI
$ 200 B
Chronic Heart Failure
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