stem cell meeting on the mesa 2011: cytx presentation
DESCRIPTION
Sr. VP of Operations Doug Arm at the Stem Cell Meeting on the Mesa 2011TRANSCRIPT
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Cytori Therapeutics(NASDAQ: CYTX)
Stem Cell Meeting on the Mesa
December 1, 2011
Doug Arm, Ph.D
Sr. VP, Operations
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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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Our Mission
To improve the quality and length of life
by providing innovative cell therapy for patients
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Technology
Regenerative cells in the operating room in real-time
• Celution currently approved in Europe
• Scalable platform• System/Consumable model
• 35+ issued patents
Soft Tissue RepairAbout one hour
Cardiovascular DiseaseCytori Celution® System Regenerative cells
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Adipose Tissue: Ideal Source for Cell Therapy
Soft Tissue RepairSoft Tissue Repair
• Adipocytes
• Multipotent cells
• Endothelial cells
• Vasc. smooth muscle cells
• Tissue resident macrophages
• Perivascular cells
Adipose Derived Regenerative Cells
• Adipocytes
• Multipotent cells
• Endothelial cells
• Vasc. smooth muscle cells
• Tissue resident macrophages
• Perivascular cells
Adipose Tissue
Liposuction
Processing
Adipose Tissue: Richest source of regenerative cells in the body
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Adipose Tissue: Ideal Source for Cell Therapy
Number of Cells (millions) per 100 mL of tissue (1/2 cup)
Implication: Real-time access to a patient’s own regenerative cells is possible
(No lengthy and expensive cell culture or manufacturing involved)
0
0.25
0.5
Multipotent Cells in AdiposeMultipotent Cells in BM
0
15
30
45
Total Nucleated Cells in Adipose
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Multiple Mechanisms at Work
Immune-modulation
Wound remodeling
Prevention of cell death
Blood Supply
Paracrine signaling
Differentiation
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Intellectual Property: Foundation for Protection
North America/Europe Asia Emerging Markets
US:CELUTION DEVICE (‘484)CELUTION PLUS ADDITIVES (‘420)CELUTION FOR CRS (‘488)STEMSOURCE DEVICE (‘115)CELUTION FUTURE GENERATIONS (‘075)CELUTION PLUS SENSORS FOR CLINICALLY SAFE OUTPUT
(‘670)CELUTION FOR BONE (‘043)CELUTION OR CELGRAFT FOR SOFT TISSUE DEFECTS
(‘684)BEDSIDE COMPREHENSIVE
DEVICE (‘059)CELUTION OUTPUT PLUS PROSTHETIC
FOR BONE RELATED DISORDERS (‘716)CELLS PLUS FAT PLUS ADDITIVES (‘795)CELLS PLUS FAT (‘672)
Europe:CELUTION FOR ACUTE
TUBULAR NECROSIS (‘834)
Korea:CELUTION DEVICE (‘995)STEMSOURCE DEVICE (‘812)CELUTION DEVICE (‘139)
Singapore:CELUTION DEVICE & FUTURE GENERATIONS
(‘683)CELUTION FOR CARDIOVASCULAR (‘590)
China:CELUTION DEVICE (‘689)CELUTION FOR
CARDIOVASCULAR (‘104)
Japan:CELUTION DEVICE (‘952)DEVICES FOR CELLS PLUS FAT (‘041)CLINICALLY SAFE (‘556)
Australia:CELUTION DEVICE (‘135)STEMSOURCE DEVICE (‘901)CELUTION FOR CARDIOVASCULAR (‘858)CELUTION DEVICE WITH CENTRIFUGE OR
FILTER (‘937)
South Africa:CELUTION FOR CARDIOVASCULAR (‘446)
Mexico:CELUTION FUTURE GENERATIONS (‘348)CELUTION FOR CARDIOVASCULAR (‘775)
Russia:CELUTION FOR CARDIOVASCULAR (‘924)
India:CELUTION DEVICE (‘706)CELUTION FUTURE GENERATIONS (‘529)CELUTION DEVICE FOR TREATING WOUND
HEALING (‘580)
Israel:CELUTION DEVICE WITH CENTRIFUGE OR
FILTER (‘800)
30+ Patents Issued Worldwide with 100 + Pending
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Soft Tissue Repair
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Soft Tissue Repair: RESTORE Procedure
Soft Tissue RepairSoft Tissue Repair
Soft Tissue RepairSoft Tissue Repair
Celution® approved in EU for breast reconstruction
Significant unmet medical need
Two completed clinical trials
Safe and effective
Reimbursable
$43
$73
$126 $163
Clinical
Partner
Cells Fat
‘Cell-Enriched Graft’
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Soft Tissue Repair: RESTORE 2 Trial Outcomes
Soft Tissue RepairSoft Tissue Repair
Soft Tissue RepairSoft Tissue Repair
$73
$126
Post-Marketing Study Design
• Prospective 71 patient study
Co-Primary Endpoints
• Physicians and patient satisfaction with functional and cosmetic results &improvement in overall breast deformity
0%
20%
40%
60%
80%
100%
Patient SatisfactionPhysician
Satisfaction
6-Mo
12-Mo
High satisfaction rates & safety to support reimbursement efforts
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Cardiovascular Disease
Dr. Fernandez-Aviles
Principal Investigator
for the PRECISE trial
Hosp. Gregorio Maranon
Madrid, Spain
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Cardiac Repair: PRECISE CMI Trial
Soft Tissue RepairSoft Tissue Repair
Soft Tissue Repair
Change in Max 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
19.0
15.5 15.3
16.6
17.117.2
ADRC’sStandard of Care
P<0.05 P<0.05
N = 27 pts
(6 placebo/21 treated)
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Cardiac Repair: PRECISE CMI Trial
MVO2:significant change at 18 months• MVO2 correlates to improved survival
• MVO2 ≤ 14 = 47% 1 yr survival rate
METS: significant change at 18 months
Cytori procedure safe and feasible through 18-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 • Completed pre-IDE meeting with FDA
0% 10% 20% 30% 40%
Placebo
Treated
33%
5%
28 Month Mortality Rate
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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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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
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)
P < 0.05 for change from BL for ADRCs
P > 0.05 for change from BL for Placebo
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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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Post-Op 18 mo8 cc cell-enriched fat
Single Session
Pre-Op
Dr. Tunc TiryakiIstanbul, Turkey
Soft Tissue Repair: Defect Filling
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Dr. AkitaNagasaki University, Japan
Immediate Preop Intraop post-debride
25 Days Post Op 41 Days Post Op
Intraop after Cell Tx
Exposed Sacrum
Note sig. inflammation, redness, swelling
90% cells to circular area around sore
10% cells to sore itself
20 wks Post Op
27 wks Post Op
Soft Tissue Repair: Radiation Necrosis
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Immune-modulation
Wound remodeling
Preventioncell death
AngiogenesisParacrine signaling
Differentiation
0
0.1 M
0.2 M
0.3 M
0.4 M
0.5 M
Bone Marrow Adipose Tissue
1. Real-time therapy,No cell culture
2. ‘Consumables’Business model
3. Multiple mechanisms, multiple opportunities
Cytori Platform: 3 Key Differentiators
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• 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
Current Commercial Business
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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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Thank You