SlideShare ist ein Scribd-Unternehmen logo
1 von 24
Downloaden Sie, um offline zu lesen
Cytori Therapeutics
       (NASDAQ: CYTX)
Stem Cell Meeting on the Mesa
      December 1, 2011

       Doug Arm, Ph.D
      Sr. VP, Operations
                                1
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.


                                                                             2
Our Mission


      To improve the quality and length of life
  by providing innovative cell therapy for patients




                                                      3
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
                                                                                   4
Adipose Tissue: Ideal Source for Cell Therapy

   Adipose Tissue: Richest source of regenerative cells in the body



                                  Liposuction
Soft Tissue Repair
 Soft Tissue Repair               Processing




     Adipose Tissue                             Adipose Derived Regenerative Cells

    • Adipocytes                                   • Adipocytes
    • Multipotent cells                            • Multipotent cells
    • Endothelial cells                            • Endothelial cells
    • Vasc. smooth muscle cells                    • Vasc. smooth muscle cells
    • Tissue resident macrophages                  • Tissue resident macrophages
    • Perivascular cells                           • Perivascular cells

                                                                                   5
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)

                                                                                 6
Multiple Mechanisms at Work


                     Wound remodeling

                                                Differentiation


      Blood
      Supply




                                                     Paracrine
                                                     signaling


     Prevention of
     cell death


                                        Immune-
                                        modulation



                                                                  7
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)
                                                                                                                               8
Soft Tissue Repair




                     9
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



                                                                     10
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
                                                                                                                  11
Cardiovascular Disease




                         Dr. Fernandez-Aviles
                         Principal Investigator
                         for the PRECISE trial
                         Hosp. Gregorio Maranon
                         Madrid, Spain

                                          12
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
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




                                                                                             14
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




                                                               15
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)
                                                                                                     16
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




                                                                             17
18
Soft Tissue Repair: Defect Filling




                 Pre-Op




          Post-Op 18 mo
    8 cc cell-enriched fat
           Single Session




  Dr. Tunc Tiryaki
  Istanbul, Turkey
                                     19
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
                                                                                                                             20
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
                                                                                                          21
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




                                       22
Global Cell Therapy Market



     $ 3.5 B
      CRS      $ 5.0 B
               Wounds
                          $ 16 B
                         Urology
                                   $ 33 B
                                    AMI

                                                  $ 200 B
                                            Chronic Heart Failure




                                                             23
Thank You

            24

Weitere ähnliche Inhalte

Mehr von Cytori Therapeutics, Inc.

ARM Regen Med Investor Day: Cytori Presentation
ARM Regen Med Investor Day: Cytori PresentationARM Regen Med Investor Day: Cytori Presentation
ARM Regen Med Investor Day: Cytori PresentationCytori Therapeutics, Inc.
 
ARM Regen Med Investor Day: Clinical Outlook in Cardiovascular Disease Panel
ARM Regen Med Investor Day: Clinical Outlook in Cardiovascular Disease PanelARM Regen Med Investor Day: Clinical Outlook in Cardiovascular Disease Panel
ARM Regen Med Investor Day: Clinical Outlook in Cardiovascular Disease PanelCytori Therapeutics, Inc.
 
Biocentury Future Leaders of the Biotech Industry 2013
Biocentury Future Leaders of the Biotech Industry 2013Biocentury Future Leaders of the Biotech Industry 2013
Biocentury Future Leaders of the Biotech Industry 2013Cytori Therapeutics, Inc.
 
CYTX Conference on Cell Therapy for Cardiovascular Disease
CYTX Conference on Cell Therapy for Cardiovascular DiseaseCYTX Conference on Cell Therapy for Cardiovascular Disease
CYTX Conference on Cell Therapy for Cardiovascular DiseaseCytori Therapeutics, Inc.
 
CYTX Cardiac Cell Therapy Panel Presentation at Biotech Showcase
CYTX Cardiac Cell Therapy Panel Presentation at Biotech ShowcaseCYTX Cardiac Cell Therapy Panel Presentation at Biotech Showcase
CYTX Cardiac Cell Therapy Panel Presentation at Biotech ShowcaseCytori Therapeutics, Inc.
 
CYTX 6th International Conference on Cell Therapy for Cardiovascular Disease ...
CYTX 6th International Conference on Cell Therapy for Cardiovascular Disease ...CYTX 6th International Conference on Cell Therapy for Cardiovascular Disease ...
CYTX 6th International Conference on Cell Therapy for Cardiovascular Disease ...Cytori Therapeutics, Inc.
 

Mehr von Cytori Therapeutics, Inc. (20)

2014 ARM Regen Med Investor Day
2014 ARM Regen Med Investor Day2014 ARM Regen Med Investor Day
2014 ARM Regen Med Investor Day
 
26th Annual Roth Conference
26th Annual Roth Conference26th Annual Roth Conference
26th Annual Roth Conference
 
2014 Biotech Showcase Presentation
2014 Biotech Showcase Presentation2014 Biotech Showcase Presentation
2014 Biotech Showcase Presentation
 
LD Micro Conference
LD Micro ConferenceLD Micro Conference
LD Micro Conference
 
Stem Cell Meeting on the Mesa 2013
Stem Cell Meeting on the Mesa 2013Stem Cell Meeting on the Mesa 2013
Stem Cell Meeting on the Mesa 2013
 
Annual Shareholder Meeting 2013
Annual Shareholder Meeting 2013Annual Shareholder Meeting 2013
Annual Shareholder Meeting 2013
 
JMP Healthcare Conference 2013
JMP Healthcare Conference 2013JMP Healthcare Conference 2013
JMP Healthcare Conference 2013
 
ARM Regen Med Investor Day: Cytori Presentation
ARM Regen Med Investor Day: Cytori PresentationARM Regen Med Investor Day: Cytori Presentation
ARM Regen Med Investor Day: Cytori Presentation
 
ARM Regen Med Investor Day: Clinical Outlook in Cardiovascular Disease Panel
ARM Regen Med Investor Day: Clinical Outlook in Cardiovascular Disease PanelARM Regen Med Investor Day: Clinical Outlook in Cardiovascular Disease Panel
ARM Regen Med Investor Day: Clinical Outlook in Cardiovascular Disease Panel
 
Biocentury Future Leaders of the Biotech Industry 2013
Biocentury Future Leaders of the Biotech Industry 2013Biocentury Future Leaders of the Biotech Industry 2013
Biocentury Future Leaders of the Biotech Industry 2013
 
2012 Stem Cell Meeting on the Mesa
2012 Stem Cell Meeting on the Mesa2012 Stem Cell Meeting on the Mesa
2012 Stem Cell Meeting on the Mesa
 
2012 Annual Shareholder Meeting Presentation
2012 Annual Shareholder Meeting Presentation2012 Annual Shareholder Meeting Presentation
2012 Annual Shareholder Meeting Presentation
 
Jefferies 2012 Global Healthcare Conference
Jefferies 2012 Global Healthcare ConferenceJefferies 2012 Global Healthcare Conference
Jefferies 2012 Global Healthcare Conference
 
Cell Society - CYTX Overview
Cell Society - CYTX OverviewCell Society - CYTX Overview
Cell Society - CYTX Overview
 
CYTX Conference on Cell Therapy for Cardiovascular Disease
CYTX Conference on Cell Therapy for Cardiovascular DiseaseCYTX Conference on Cell Therapy for Cardiovascular Disease
CYTX Conference on Cell Therapy for Cardiovascular Disease
 
CYTX Cardiac Cell Therapy Panel Presentation at Biotech Showcase
CYTX Cardiac Cell Therapy Panel Presentation at Biotech ShowcaseCYTX Cardiac Cell Therapy Panel Presentation at Biotech Showcase
CYTX Cardiac Cell Therapy Panel Presentation at Biotech Showcase
 
CYTX Corporate Presentation, Biotech Showcase
CYTX Corporate Presentation, Biotech ShowcaseCYTX Corporate Presentation, Biotech Showcase
CYTX Corporate Presentation, Biotech Showcase
 
2011 Annual Shareholder Meeting Presentation
2011 Annual Shareholder Meeting Presentation2011 Annual Shareholder Meeting Presentation
2011 Annual Shareholder Meeting Presentation
 
CYTX Phacilitate Cell & Gene Therapy Forum
CYTX Phacilitate Cell & Gene Therapy ForumCYTX Phacilitate Cell & Gene Therapy Forum
CYTX Phacilitate Cell & Gene Therapy Forum
 
CYTX 6th International Conference on Cell Therapy for Cardiovascular Disease ...
CYTX 6th International Conference on Cell Therapy for Cardiovascular Disease ...CYTX 6th International Conference on Cell Therapy for Cardiovascular Disease ...
CYTX 6th International Conference on Cell Therapy for Cardiovascular Disease ...
 

Kürzlich hochgeladen

H2O.ai CEO/Founder: Sri Ambati Keynote at Wells Fargo Day
H2O.ai CEO/Founder: Sri Ambati Keynote at Wells Fargo DayH2O.ai CEO/Founder: Sri Ambati Keynote at Wells Fargo Day
H2O.ai CEO/Founder: Sri Ambati Keynote at Wells Fargo DaySri Ambati
 
Gen AI in Business - Global Trends Report 2024.pdf
Gen AI in Business - Global Trends Report 2024.pdfGen AI in Business - Global Trends Report 2024.pdf
Gen AI in Business - Global Trends Report 2024.pdfAddepto
 
WordPress Websites for Engineers: Elevate Your Brand
WordPress Websites for Engineers: Elevate Your BrandWordPress Websites for Engineers: Elevate Your Brand
WordPress Websites for Engineers: Elevate Your Brandgvaughan
 
"ML in Production",Oleksandr Bagan
"ML in Production",Oleksandr Bagan"ML in Production",Oleksandr Bagan
"ML in Production",Oleksandr BaganFwdays
 
Advanced Computer Architecture – An Introduction
Advanced Computer Architecture – An IntroductionAdvanced Computer Architecture – An Introduction
Advanced Computer Architecture – An IntroductionDilum Bandara
 
Vertex AI Gemini Prompt Engineering Tips
Vertex AI Gemini Prompt Engineering TipsVertex AI Gemini Prompt Engineering Tips
Vertex AI Gemini Prompt Engineering TipsMiki Katsuragi
 
Designing IA for AI - Information Architecture Conference 2024
Designing IA for AI - Information Architecture Conference 2024Designing IA for AI - Information Architecture Conference 2024
Designing IA for AI - Information Architecture Conference 2024Enterprise Knowledge
 
Story boards and shot lists for my a level piece
Story boards and shot lists for my a level pieceStory boards and shot lists for my a level piece
Story boards and shot lists for my a level piececharlottematthew16
 
Ensuring Technical Readiness For Copilot in Microsoft 365
Ensuring Technical Readiness For Copilot in Microsoft 365Ensuring Technical Readiness For Copilot in Microsoft 365
Ensuring Technical Readiness For Copilot in Microsoft 3652toLead Limited
 
From Family Reminiscence to Scholarly Archive .
From Family Reminiscence to Scholarly Archive .From Family Reminiscence to Scholarly Archive .
From Family Reminiscence to Scholarly Archive .Alan Dix
 
CloudStudio User manual (basic edition):
CloudStudio User manual (basic edition):CloudStudio User manual (basic edition):
CloudStudio User manual (basic edition):comworks
 
Developer Data Modeling Mistakes: From Postgres to NoSQL
Developer Data Modeling Mistakes: From Postgres to NoSQLDeveloper Data Modeling Mistakes: From Postgres to NoSQL
Developer Data Modeling Mistakes: From Postgres to NoSQLScyllaDB
 
"Debugging python applications inside k8s environment", Andrii Soldatenko
"Debugging python applications inside k8s environment", Andrii Soldatenko"Debugging python applications inside k8s environment", Andrii Soldatenko
"Debugging python applications inside k8s environment", Andrii SoldatenkoFwdays
 
Leverage Zilliz Serverless - Up to 50X Saving for Your Vector Storage Cost
Leverage Zilliz Serverless - Up to 50X Saving for Your Vector Storage CostLeverage Zilliz Serverless - Up to 50X Saving for Your Vector Storage Cost
Leverage Zilliz Serverless - Up to 50X Saving for Your Vector Storage CostZilliz
 
How to write a Business Continuity Plan
How to write a Business Continuity PlanHow to write a Business Continuity Plan
How to write a Business Continuity PlanDatabarracks
 
Commit 2024 - Secret Management made easy
Commit 2024 - Secret Management made easyCommit 2024 - Secret Management made easy
Commit 2024 - Secret Management made easyAlfredo García Lavilla
 
Merck Moving Beyond Passwords: FIDO Paris Seminar.pptx
Merck Moving Beyond Passwords: FIDO Paris Seminar.pptxMerck Moving Beyond Passwords: FIDO Paris Seminar.pptx
Merck Moving Beyond Passwords: FIDO Paris Seminar.pptxLoriGlavin3
 
Search Engine Optimization SEO PDF for 2024.pdf
Search Engine Optimization SEO PDF for 2024.pdfSearch Engine Optimization SEO PDF for 2024.pdf
Search Engine Optimization SEO PDF for 2024.pdfRankYa
 
Transcript: New from BookNet Canada for 2024: BNC CataList - Tech Forum 2024
Transcript: New from BookNet Canada for 2024: BNC CataList - Tech Forum 2024Transcript: New from BookNet Canada for 2024: BNC CataList - Tech Forum 2024
Transcript: New from BookNet Canada for 2024: BNC CataList - Tech Forum 2024BookNet Canada
 

Kürzlich hochgeladen (20)

H2O.ai CEO/Founder: Sri Ambati Keynote at Wells Fargo Day
H2O.ai CEO/Founder: Sri Ambati Keynote at Wells Fargo DayH2O.ai CEO/Founder: Sri Ambati Keynote at Wells Fargo Day
H2O.ai CEO/Founder: Sri Ambati Keynote at Wells Fargo Day
 
Gen AI in Business - Global Trends Report 2024.pdf
Gen AI in Business - Global Trends Report 2024.pdfGen AI in Business - Global Trends Report 2024.pdf
Gen AI in Business - Global Trends Report 2024.pdf
 
WordPress Websites for Engineers: Elevate Your Brand
WordPress Websites for Engineers: Elevate Your BrandWordPress Websites for Engineers: Elevate Your Brand
WordPress Websites for Engineers: Elevate Your Brand
 
"ML in Production",Oleksandr Bagan
"ML in Production",Oleksandr Bagan"ML in Production",Oleksandr Bagan
"ML in Production",Oleksandr Bagan
 
Advanced Computer Architecture – An Introduction
Advanced Computer Architecture – An IntroductionAdvanced Computer Architecture – An Introduction
Advanced Computer Architecture – An Introduction
 
Vertex AI Gemini Prompt Engineering Tips
Vertex AI Gemini Prompt Engineering TipsVertex AI Gemini Prompt Engineering Tips
Vertex AI Gemini Prompt Engineering Tips
 
Designing IA for AI - Information Architecture Conference 2024
Designing IA for AI - Information Architecture Conference 2024Designing IA for AI - Information Architecture Conference 2024
Designing IA for AI - Information Architecture Conference 2024
 
Story boards and shot lists for my a level piece
Story boards and shot lists for my a level pieceStory boards and shot lists for my a level piece
Story boards and shot lists for my a level piece
 
Ensuring Technical Readiness For Copilot in Microsoft 365
Ensuring Technical Readiness For Copilot in Microsoft 365Ensuring Technical Readiness For Copilot in Microsoft 365
Ensuring Technical Readiness For Copilot in Microsoft 365
 
From Family Reminiscence to Scholarly Archive .
From Family Reminiscence to Scholarly Archive .From Family Reminiscence to Scholarly Archive .
From Family Reminiscence to Scholarly Archive .
 
E-Vehicle_Hacking_by_Parul Sharma_null_owasp.pptx
E-Vehicle_Hacking_by_Parul Sharma_null_owasp.pptxE-Vehicle_Hacking_by_Parul Sharma_null_owasp.pptx
E-Vehicle_Hacking_by_Parul Sharma_null_owasp.pptx
 
CloudStudio User manual (basic edition):
CloudStudio User manual (basic edition):CloudStudio User manual (basic edition):
CloudStudio User manual (basic edition):
 
Developer Data Modeling Mistakes: From Postgres to NoSQL
Developer Data Modeling Mistakes: From Postgres to NoSQLDeveloper Data Modeling Mistakes: From Postgres to NoSQL
Developer Data Modeling Mistakes: From Postgres to NoSQL
 
"Debugging python applications inside k8s environment", Andrii Soldatenko
"Debugging python applications inside k8s environment", Andrii Soldatenko"Debugging python applications inside k8s environment", Andrii Soldatenko
"Debugging python applications inside k8s environment", Andrii Soldatenko
 
Leverage Zilliz Serverless - Up to 50X Saving for Your Vector Storage Cost
Leverage Zilliz Serverless - Up to 50X Saving for Your Vector Storage CostLeverage Zilliz Serverless - Up to 50X Saving for Your Vector Storage Cost
Leverage Zilliz Serverless - Up to 50X Saving for Your Vector Storage Cost
 
How to write a Business Continuity Plan
How to write a Business Continuity PlanHow to write a Business Continuity Plan
How to write a Business Continuity Plan
 
Commit 2024 - Secret Management made easy
Commit 2024 - Secret Management made easyCommit 2024 - Secret Management made easy
Commit 2024 - Secret Management made easy
 
Merck Moving Beyond Passwords: FIDO Paris Seminar.pptx
Merck Moving Beyond Passwords: FIDO Paris Seminar.pptxMerck Moving Beyond Passwords: FIDO Paris Seminar.pptx
Merck Moving Beyond Passwords: FIDO Paris Seminar.pptx
 
Search Engine Optimization SEO PDF for 2024.pdf
Search Engine Optimization SEO PDF for 2024.pdfSearch Engine Optimization SEO PDF for 2024.pdf
Search Engine Optimization SEO PDF for 2024.pdf
 
Transcript: New from BookNet Canada for 2024: BNC CataList - Tech Forum 2024
Transcript: New from BookNet Canada for 2024: BNC CataList - Tech Forum 2024Transcript: New from BookNet Canada for 2024: BNC CataList - Tech Forum 2024
Transcript: New from BookNet Canada for 2024: BNC CataList - Tech Forum 2024
 

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 1
  • 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. 2
  • 3. Our Mission To improve the quality and length of life by providing innovative cell therapy for patients 3
  • 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 4
  • 5. Adipose Tissue: Ideal Source for Cell Therapy Adipose Tissue: Richest source of regenerative cells in the body Liposuction Soft Tissue Repair Soft Tissue Repair Processing Adipose Tissue Adipose Derived Regenerative Cells • Adipocytes • Adipocytes • Multipotent cells • Multipotent cells • Endothelial cells • Endothelial cells • Vasc. smooth muscle cells • Vasc. smooth muscle cells • Tissue resident macrophages • Tissue resident macrophages • Perivascular cells • Perivascular cells 5
  • 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) 6
  • 7. Multiple Mechanisms at Work Wound remodeling Differentiation Blood Supply Paracrine signaling Prevention of cell death Immune- modulation 7
  • 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) 8
  • 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 10
  • 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 11
  • 12. Cardiovascular Disease Dr. Fernandez-Aviles Principal Investigator for the PRECISE trial Hosp. Gregorio Maranon Madrid, Spain 12
  • 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 14
  • 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 15
  • 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) 16
  • 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 17
  • 18. 18
  • 19. Soft Tissue Repair: Defect Filling Pre-Op Post-Op 18 mo 8 cc cell-enriched fat Single Session Dr. Tunc Tiryaki Istanbul, Turkey 19
  • 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 20
  • 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 21
  • 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 22
  • 23. Global Cell Therapy Market $ 3.5 B CRS $ 5.0 B Wounds $ 16 B Urology $ 33 B AMI $ 200 B Chronic Heart Failure 23
  • 24. Thank You 24