2012 stem cell meeting on the mesa
DESCRIPTION
Presented by Doug Arm, Sr. VP of Operations on October 30, 2012TRANSCRIPT
NASDAQ: CYTX
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Douglas Arm, Ph.D.Senior Vice President, Operations
Meeting on the MesaOctober 29, 2012
Safe Harbor Statement
This presentation may contain certain ‘forward-looking statements’. Allstatements, other than statements of historical fact, that address activities, eventsor developments that we intend, expect, project, believe or anticipate will ormay occur in the future are forward-looking statements. Such statements arebased upon certain assumptions and assessments made by our management inlight of their experience and their perception of historical trends, currentconditions, expected future developments and other factors they believe to beappropriate.
The forward-looking statements included in this presentation are also subject to anumber of material risks and uncertainties. We caution investors not to placeundue reliance on the forward-looking statements contained in this presentation.
We would advise reading our annual report filed with the United States Securitiesand Exchange Commission on Form 10-K for a more detailed description of theserisks.
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This presentation may contain certain ‘forward-looking statements’. Allstatements, other than statements of historical fact, that address activities, eventsor developments that we intend, expect, project, believe or anticipate will ormay occur in the future are forward-looking statements. Such statements arebased upon certain assumptions and assessments made by our management inlight of their experience and their perception of historical trends, currentconditions, expected future developments and other factors they believe to beappropriate.
The forward-looking statements included in this presentation are also subject to anumber of material risks and uncertainties. We caution investors not to placeundue reliance on the forward-looking statements contained in this presentation.
We would advise reading our annual report filed with the United States Securitiesand Exchange Commission on Form 10-K for a more detailed description of theserisks.
i. Business and Technology Overviewii. Recent Development: BARDA Contractiii. Scientific Leadership
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i. Business and Technology Overviewii. Recent Development: BARDA Contractiii. Scientific Leadership
Cytori Cell Therapy: Innovative & Affordable
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Celution® System:point-of-care device
Adipose-derived stem ®enerative cells (ADRCs)
Fat (adipose) tissuefrom minor liposuction
Cytori Cell Therapy: Unique Attributes
• Autologous
• Virtual ‘off the shelf’
• Mixed population
• Multiple mechanisms
0
0.25
0.5
Multipotent Cells in AdiposeMultipotent Cells in BM
Cytori Cell Therapy: Multiple Applications
Proprietary Indication:• US refractory heart failure trial• EU heart attack trial
Proprietary Indication:• US Govt. Contract• EU approval: Breast recon/soft tissue
HeartDisease
ThermalBurns &TissueInjury
Proprietary Indication:• US Govt. Contract• EU approval: Breast recon/soft tissue
Licensing/Translational Medicine:• Co-development partnerships• Academic ctrs explore new Rx apps
ThermalBurns &TissueInjury
OtherIschemic
Conditions
Outcomes from PRECISE European RHF Trial
Soft Tissue RepairSoft Tissue RepairSoft Tissue Repair
Change in Peak Oxygen Consumption (V02 Max) from Baseline to 6 & 18 months20.0
18.0
16.0
14.0
19.0
17.117.2
P<0.05 P<0.05
0% 10% 20% 30% 40%
Placebo
Treated
33%
5%
28 Month Mortality Rate
7Baseline 6 Mos 18 Mos
Transplant List
20.0
18.0
16.0
14.015.5 15.3
16.6
ADRC’sStandard of Care
N = 27 pts(6 placebo/21 treated)
0% 10% 20% 30% 40%
Placebo
Treated
33%
5%
28 Month Mortality Rate
i. Business and Technology Overviewii. Recent Development: BARDA Contractiii. Scientific Leadership
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i. Business and Technology Overviewii. Recent Development: BARDA Contractiii. Scientific Leadership
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, emergingdiseases, 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
BARDA• Biomedical Advanced Research and Development Authority• Mission: To develop and procure advanced medical countermeasures
against public health threats such as pandemic influenza, emergingdiseases, 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
Burn and Radiation Injury Experience
Exposed Sacrum
Note sig. inflammation, redness, swelling
90% cells to circular area around sore
10% cells to sore itself
27 wks Post OpImmediate Pre Op Intra Op, Debrided Intra Op, Post-Cell Rx
Chronic burn injury: Pre-Op Chronic burn injury: Post-Op 18-mo
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
• $4.7 MM in funding• Preclinical model• Next-gen product
development• ≤ 2 years
ProofProof--ofof--ConceptConcept
• Up to $55 MM• Development
including clinical• Govt. has
procurement ability
Options 1 & 2Options 1 & 2• Up to $45 MM• Pivotal trial• FDA submission
Option 3Option 3
i. Business and Technology Overviewii. Recent Development: BARDA Contractiii. Scientific Leadership
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i. Business and Technology Overviewii. Recent Development: BARDA Contractiii. Scientific Leadership
Objective
Further advance reputation as industry leader inadipose regenerative cell science
miRNA Characterization of ADRCs
Objectives Establish scientific leadership in novel
characterization strategies for ADRC identityand potency determination Demonstrate capacity to execute cutting-edge
science, thereby establishing a higher bar forcompetitors to claim equivalence
Objectives Establish scientific leadership in novel
characterization strategies for ADRC identityand potency determination Demonstrate capacity to execute cutting-edge
science, thereby establishing a higher bar forcompetitors to claim equivalence
miRNA Characterization Results
Each sample tested for expression of >1100 miRNAsequences. A total of 279 different miRNAs wereobserved in at least one of the 7 donor samples.233 miRNAs were detected in every sample.
miRNA fingerprints were assessed for relativeabundance of miRNA groups associated withdifferent cellular processes. A striking concordancewith preclinical MOA was observed.
Stromal Vascular Cells: Sorting Fact from FictionNon-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 onlymethod proven clinically safe for generating efficaciousADRCs
Discredit emergent competitors’ claims for isolation ofADRCs using mechanical (ultrasound) or non-enzymaticchemical (emulsifier) methods
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 onlymethod proven clinically safe for generating efficaciousADRCs
Discredit emergent competitors’ claims for isolation ofADRCs using mechanical (ultrasound) or non-enzymaticchemical (emulsifier) methods
How Many SVF Cells Are There? What is SVF?
1 cm
1 cm
1 cc3 = 1 x 1012 µm3
EndothelialCells7%
VascularSmooth
Muscle Cells9%
TissueMacrophages
23%Stem Cells
2%
CD34+/CD31-37%
TissueMacrophages
23%WBCs22%
Stem Cells2%
• Excerpt from Online Cosmetic Surgery blog:Cytori… estimated the maximum theoretical number of adipose stem (and regenerative) cellsto 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’”.
Celution versus Emulsification:Cell Output Composition & Viable Yield
CelutionEmulsification
• 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
Celution versus Ultrasound Processing:Viable Nucleated Cell Recovery and Content
Ultr
asou
ndCe
lutio
n
• 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
Celu
tion
Result: Technology Protected to mid-2020s
49 WORLDWIDE ISSUED PATENTS; MORE THAN 75 PENDINGDEVICESCURRENT
DEVICESNEXT GENERATION
COSMETIC &RECONSTRUCTIVE SURGERY
CARDIOVASCULAR THERAPIES PIPELINE THERAPIES
US: (6)CELUTION DEVICE (‘484)CELUTION DEVICE PLUS ADDITIVES (‘420)STEMSOURCE DEVICE (‘115)CELUTION DEVICE PLUS SENSORS FOR
CLINICALLY SAFE OUTPUT (‘670)BEDSIDE COMPREHENSIVE
DEVICE (‘059)CELUTION DEVICE CD31 POSITIVE CELLS
(‘276)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: (2)CELUTION DEVICE (‘135)STEMSOURCE DEVICE (‘901)CHINA: (1)CELUTION DEVICE (‘689)
US: (1)CELUTION OR FUTURE
GENERATIONS (‘075)CHINA: (1)CELUTION OR FUTURE
GENERATIONS (‘241)INDIA: (1)CELUTION OR FUTURE
GENERATIONS (‘529)AUSTRALIA: (1)CELUTION WITH CENTRIFUGE
OR
FILTER (‘937)SINGAPORE: (1)CELUTION OR FUTURE
GENERATIONS (‘683)ISRAEL: (1)CELUTION WITH CENTRIFUGE
OR
FILTER (‘800)MEXICO: (1)CELUTION OR FUTURE
GENERATIONS (‘348)KOREA: (1)CELUTION WITH CENTRIFUGE
OR FILTER (‘305)
US: (5)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)ADRCS PLUS FAT
COMPOSITION (‘121)JAPAN: (1)CELUTION AND NEXT
GEN DEVICES FOR
MIXING ADRCS PLUS
FAT (‘041)KOREA: (2)ADRCS PLUS FAT
(‘454)CELUTION OR NEXT GEN
DEVICES FOR SOFT
TISSUE DEFECTS (‘508)
EUROPE: (2)ADRCS FOR CARDIAC (‘382)OPPOSED
DEVICE FOR RESTORING BLOOD FLOW
(‘575)OPPOSED
AUSTRALIA: (1)ADRCS FOR CARDIAC (‘858)SINGAPORE: (1)ADRCS FOR RESTORING BLOOD
FLOW(‘309)CHINA: (1)ADRCS FOR RESTORING BLOOD FLOW
(‘104)HONG KONG: (1)ADRCS FOR RESTORING BLOOD FLOW
(‘085)RUSSIA: (1)CELUTION FOR RESTORING BLOOD FLOW
(‘924)SOUTH AFRICA: (1)ADRCS FOR CARDIAC (‘446)MEXICO: (1)CELUTION FOR RESTORING BLOOD FLOW
(‘775)ISRAEL: (1)ADRCS FOR CARDIAC (‘354)
US: (3)CELUTION FOR BONE
(‘043)CELUTION OUTPUT PLUS
PROSTHETIC
FOR BONE RELATED
DISORDERS (‘716)ADRCS FOR WOUND
HEALING (‘580)EUROPE: (2)CELUTION FOR ACUTE
TUBULAR NECROSIS
(‘834)ADRCS FOR WOUND
HEALING (‘833)JAPAN: (2)ADRCS FOR WOUND
HEALING (‘699)CELUTION OUTPUT PLUS
PROSTHETIC FOR BONE
RELATED DISORDERS
(‘119)INDIA: (1)ADRCS FOR WOUND
HEALING (‘580)
US: (6)CELUTION DEVICE (‘484)CELUTION DEVICE PLUS ADDITIVES (‘420)STEMSOURCE DEVICE (‘115)CELUTION DEVICE PLUS SENSORS FOR
CLINICALLY SAFE OUTPUT (‘670)BEDSIDE COMPREHENSIVE
DEVICE (‘059)CELUTION DEVICE CD31 POSITIVE CELLS
(‘276)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: (2)CELUTION DEVICE (‘135)STEMSOURCE DEVICE (‘901)CHINA: (1)CELUTION DEVICE (‘689)
US: (1)CELUTION OR FUTURE
GENERATIONS (‘075)CHINA: (1)CELUTION OR FUTURE
GENERATIONS (‘241)INDIA: (1)CELUTION OR FUTURE
GENERATIONS (‘529)AUSTRALIA: (1)CELUTION WITH CENTRIFUGE
OR
FILTER (‘937)SINGAPORE: (1)CELUTION OR FUTURE
GENERATIONS (‘683)ISRAEL: (1)CELUTION WITH CENTRIFUGE
OR
FILTER (‘800)MEXICO: (1)CELUTION OR FUTURE
GENERATIONS (‘348)KOREA: (1)CELUTION WITH CENTRIFUGE
OR FILTER (‘305)
US: (5)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)ADRCS PLUS FAT
COMPOSITION (‘121)JAPAN: (1)CELUTION AND NEXT
GEN DEVICES FOR
MIXING ADRCS PLUS
FAT (‘041)KOREA: (2)ADRCS PLUS FAT
(‘454)CELUTION OR NEXT GEN
DEVICES FOR SOFT
TISSUE DEFECTS (‘508)
EUROPE: (2)ADRCS FOR CARDIAC (‘382)OPPOSED
DEVICE FOR RESTORING BLOOD FLOW
(‘575)OPPOSED
AUSTRALIA: (1)ADRCS FOR CARDIAC (‘858)SINGAPORE: (1)ADRCS FOR RESTORING BLOOD
FLOW(‘309)CHINA: (1)ADRCS FOR RESTORING BLOOD FLOW
(‘104)HONG KONG: (1)ADRCS FOR RESTORING BLOOD FLOW
(‘085)RUSSIA: (1)CELUTION FOR RESTORING BLOOD FLOW
(‘924)SOUTH AFRICA: (1)ADRCS FOR CARDIAC (‘446)MEXICO: (1)CELUTION FOR RESTORING BLOOD FLOW
(‘775)ISRAEL: (1)ADRCS FOR CARDIAC (‘354)
US: (3)CELUTION FOR BONE
(‘043)CELUTION OUTPUT PLUS
PROSTHETIC
FOR BONE RELATED
DISORDERS (‘716)ADRCS FOR WOUND
HEALING (‘580)EUROPE: (2)CELUTION FOR ACUTE
TUBULAR NECROSIS
(‘834)ADRCS FOR WOUND
HEALING (‘833)JAPAN: (2)ADRCS FOR WOUND
HEALING (‘699)CELUTION OUTPUT PLUS
PROSTHETIC FOR BONE
RELATED DISORDERS
(‘119)INDIA: (1)ADRCS FOR WOUND
HEALING (‘580)
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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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
NASDAQ: CYTX
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Douglas Arm, Ph.D.Senior Vice President, Operations
Meeting on the MesaOctober 29, 2012