Glomerular Filtration rate and its determinants.pptx
2012 Stem Cell Meeting on the Mesa
1. NASDAQ: CYTX
Douglas Arm, Ph.D.
Senior Vice President, Operations
Meeting on the Mesa
October 29, 2012
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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. i. Business and Technology Overview
ii. Recent Development: BARDA Contract
iii. Scientific Leadership
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5. Cytori Cell Therapy: Unique Attributes
• Autologous
• Virtual ‘off the shelf’
• Mixed population
• Multiple mechanisms
0.5
0.25
0
Multipotent Cells in Adipose
Multipotent Cells in BM
6. Cytori Cell Therapy: Multiple Applications
Proprietary Indication:
• US refractory heart failure trial Heart
• EU heart attack trial Disease
Proprietary Indication: Thermal
• US Govt. Contract Burns &
• EU approval: Breast recon/soft tissue Tissue
Injury
Other
Licensing/Translational Medicine: Ischemic
• Co-development partnerships Conditions
• Academic ctrs explore new Rx apps
7. Outcomes from PRECISE European RHF Trial
20.0 Change in Peak Oxygen Consumption (V02 Max) from Baseline to 6 & 18 months
19.0
P<0.05 P<0.05
Soft Tissue Repair
Soft Tissue Repair
18.0
Soft Tissue Repair 28 Month Mortality Rate
17.2 17.1
Treated 5%
16.0 16.6 33%
Placebo
0% 10% 20% 30% 40%
15.5 15.3
14.0 Transplant List
Baseline
7 6 Mos 18 Mos
ADRC’s N = 27 pts
Standard of Care (6 placebo/21 treated)
8. i. Business and Technology Overview
ii. Recent Development: BARDA Contract
iii. Scientific Leadership
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9. BARDA Mission and Contract Focus
BARDA
• Biomedical Advanced Research and Development Authority
• Mission: To develop and procure advanced medical countermeasures
against public health threats such as pandemic influenza, emerging
diseases, and CBRN agents
Thermal Burn and Combined Injury
• Detonation of an Improvised Nuclear Device could lead to as many as
10,000 patients in need specialist burn care
• However, there are only 1,850 burn beds in 126 burn units across the USA
• Approximately 40% of these beds are occupied at any given time
• Many of these burns will be complicated by simultaneous radiation
exposure
10. Burn and Radiation Injury Experience
90% cells to circular area around sore
Exposed Sacrum
Note sig. inflammation, redness, swelling 10% cells to sore itself
Immediate Pre Op Intra Op, Debrided Intra Op, Post-Cell Rx 27 wks Post Op
Chronic burn injury: Pre-Op Chronic burn injury: Post-Op 18-mo
11. Thermal Burns: Up to $106 million from BARDA
U.S. Govt. contract: Thermal burns combined with radiation injury
• National preparedness to counter radiological bomb
• Funds complete development: preclinical to FDA submission
• New soft tissue pipeline application in U.S.
• Procurement potential above and beyond contract
Options 1 & 2
• $4.7 MM in funding • Up to $45 MM
• Preclinical model • Pivotal trial
• Up to $55 MM
• Next-gen product • FDA submission
• Development
development
including clinical
• ≤ 2 years
• Govt. has
Proof-of-
Proof-of- procurement ability Option 3
Concept
12. i. Business and Technology Overview
ii. Recent Development: BARDA Contract
iii. Scientific Leadership
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14. miRNA Characterization of ADRCs
Objectives
Establish scientific leadership in novel
characterization strategies for ADRC identity
and potency determination
Demonstrate capacity to execute cutting-edge
science, thereby establishing a higher bar for
competitors to claim equivalence
15. miRNA Characterization Results
Each sample tested for expression of >1100 miRNA miRNA fingerprints were assessed for relative
sequences. A total of 279 different miRNAs were abundance of miRNA groups associated with
observed in at least one of the 7 donor samples. different cellular processes. A striking concordance
233 miRNAs were detected in every sample. with preclinical MOA was observed.
16. Stromal Vascular Cells: Sorting Fact from Fiction
Non-Enzymatic Methods to Obtain ADRCs: Possible?
Objectives:
Advance leadership position by definitively reporting our
efforts to determine the basic truths about ADRCs (i.e.
how many, what they are and are not, etc.)
Establish protease isolation as gold standard and only
method proven clinically safe for generating efficacious
ADRCs
Discredit emergent competitors’ claims for isolation of
ADRCs using mechanical (ultrasound) or non-enzymatic
chemical (emulsifier) methods
17. How Many SVF Cells Are There? What is SVF?
1 cc3 = 1 x 1012 µm3
Endothelial Vascular
CD34+/CD31- Cells Smooth
1 cm
37% 7% Muscle Cells
9%
1 cm
Tissue
Macrophages
Stem Cells
WBCs 23%
2%
22%
• Excerpt from Online Cosmetic Surgery blog:
Cytori… estimated the maximum theoretical number of adipose stem (and regenerative) cells
to be equal to 4 Million cells/cc. In a jab to exaggerated stem cell count claims by competitors,
“anybody reporting cell counts higher than that number is ‘creating life’”.
18. Celution versus Emulsification:
Cell Output Composition & Viable Yield
Celution
Emulsification
• Output from emulsification kits contains two logs more red blood cells
• Enzymatic digestion method generated ~10X more viable nucleated cells/g tissue
• NO stem cells detected with emulsification method based on CFU-F
19. Celution versus Ultrasound Processing:
Viable Nucleated Cell Recovery and Content
Ultrasound
Celution
• Ultrasound yields NO more viable nucleated cells than the “no power” control
• Yield from enzymatic processing is ~10X greater than that from ultrasound processing
• More ultrasound power less nucleated cells, more tissue debris
• Majority of the nucleated cells in ultrasound samples are granulocytic WBCs
20. Result: Technology Protected to mid-2020s
49 WORLDWIDE ISSUED PATENTS; MORE THAN 75 PENDING
DEVICES DEVICES COSMETIC & CARDIOVASCULAR THERAPIES PIPELINE THERAPIES
CURRENT NEXT GENERATION RECONSTRUCTIVE SURGERY
US: (6) US: (1) US: (5) EUROPE: (2) US: (3)
CELUTION DEVICE (‘484) CELUTION OR FUTURE CELUTION FOR MIXING ADRCS FOR CARDIAC (‘382) CELUTION FOR BONE
CELUTION DEVICE PLUS ADDITIVES (‘420) GENERATIONS (‘075) ADRCS PLUS FAT OPPOSED (‘043)
STEMSOURCE DEVICE (‘115) CHINA: (1) (‘488) DEVICE FOR RESTORING BLOOD FLOW CELUTION OUTPUT PLUS
CELUTION DEVICE PLUS SENSORS FOR CELUTION OR FUTURE CELUTION OR NEXT GEN (‘575) PROSTHETIC
CLINICALLY SAFE OUTPUT (‘670) GENERATIONS (‘241) DEVICES FOR SOFT OPPOSED FOR BONE RELATED
BEDSIDE COMPREHENSIVE INDIA: (1) TISSUE DEFECTS(‘684) AUSTRALIA: (1) DISORDERS (‘716)
DEVICE (‘059) CELUTION OR FUTURE ADRCS PLUS FAT PLUS ADRCS FOR CARDIAC (‘858) ADRCS FOR WOUND
CELUTION DEVICE CD31 POSITIVE CELLS GENERATIONS (‘529) ADDITIVES (‘795) SINGAPORE: (1) HEALING (‘580)
(‘276) AUSTRALIA: (1) ADRCS PLUS FAT ADRCS FOR RESTORING BLOOD EUROPE: (2)
JAPAN: (2) CELUTION WITH CENTRIFUGE (‘672) FLOW(‘309) CELUTION FOR ACUTE
CELUTION DEVICE (‘952) OR ADRCS PLUS FAT CHINA: (1) TUBULAR NECROSIS
CELUTION FOR CLINICALLY SAFE OUTPUT FILTER (‘937) COMPOSITION (‘121) ADRCS FOR RESTORING BLOOD FLOW (‘834)
(‘556) SINGAPORE: (1) JAPAN: (1) (‘104) ADRCS FOR WOUND
KOREA: (3) CELUTION OR FUTURE CELUTION AND NEXT HONG KONG: (1) HEALING (‘833)
CELUTION DEVICE (‘995) GENERATIONS (‘683) GEN DEVICES FOR ADRCS FOR RESTORING BLOOD FLOW JAPAN: (2)
STEMSOURCE DEVICE (‘812) ISRAEL: (1) MIXING ADRCS PLUS (‘085) ADRCS FOR WOUND
CELUTION DEVICE (‘139) CELUTION WITH CENTRIFUGE FAT (‘041) RUSSIA: (1) HEALING (‘699)
INDIA: (1) OR KOREA: (2) CELUTION FOR RESTORING BLOOD FLOW CELUTION OUTPUT PLUS
CELUTION DEVICE (‘706) FILTER (‘800) ADRCS PLUS FAT (‘924) PROSTHETIC FOR BONE
AUSTRALIA: (2) MEXICO: (1) (‘454) SOUTH AFRICA: (1) RELATED DISORDERS
CELUTION DEVICE (‘135) CELUTION OR FUTURE CELUTION OR NEXT GEN ADRCS FOR CARDIAC (‘446) (‘119)
STEMSOURCE DEVICE (‘901) GENERATIONS (‘348) DEVICES FOR SOFT MEXICO: (1) INDIA: (1)
CHINA: (1) KOREA: (1) TISSUE DEFECTS (‘508) CELUTION FOR RESTORING BLOOD FLOW ADRCS FOR WOUND
CELUTION DEVICE (‘689) CELUTION WITH CENTRIFUGE (‘775) HEALING (‘580)
OR FILTER (‘305) ISRAEL: (1)
ADRCS FOR CARDIAC (‘354)
21. Summary
Scientific and Clinical Leadership
Processing and characterization of 3000+ human tissue samples
Deep understanding of ADRC content, and safety requirements
5000+ patients treated, primarily in soft tissue and translational
49 Patents WW; 75+ Pending
Recognized by BARDA through thermal burn contract
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22. NASDAQ: CYTX
Douglas Arm, Ph.D.
Senior Vice President, Operations
Meeting on the Mesa
October 29, 2012
22