Stem Cell Meeting on the Mesa 2011: CYTX Presentation

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Sr. VP of Operations Doug Arm at the Stem Cell Meeting on the Mesa 2011

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Stem Cell Meeting on the Mesa 2011: CYTX Presentation

  1. 1. Cytori Therapeutics (NASDAQ: CYTX)Stem Cell Meeting on the Mesa December 1, 2011 Doug Arm, Ph.D Sr. VP, Operations 1
  2. 2. Safe Harbor StatementThis presentation may contain certain ‘forward-looking statements’. Allstatements, other than statements of historical fact, that address activities,events or developments that we intend, expect, project, believe oranticipate will or may occur in the future are forward-looking statements.Such statements are based upon certain assumptions and assessmentsmade by our management in light of their experience and their perceptionof historical trends, current conditions, expected future developments andother factors they believe to be appropriate.The forward-looking statements included in this presentation are also subjectto a number of material risks and uncertainties. We caution investors not toplace undue reliance on the forward-looking statements contained in thispresentation.We would advise reading our annual report filed with the United StatesSecurities and Exchange Commission on Form 10-K for a more detaileddescription of these risks. 2
  3. 3. Our Mission To improve the quality and length of life by providing innovative cell therapy for patients 3
  4. 4. Technology Regenerative cells in the operating room in real-time Soft Tissue Repair About one hourCytori Celution® System Regenerative cells Cardiovascular Disease • Celution currently approved in Europe • Scalable platform • System/Consumable model • 35+ issued patents 4
  5. 5. Adipose Tissue: Ideal Source for Cell Therapy Adipose Tissue: Richest source of regenerative cells in the body LiposuctionSoft 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. 6. Adipose Tissue: Ideal Source for Cell TherapyImplication: 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. 7. Multiple Mechanisms at Work Wound remodeling Differentiation Blood Supply Paracrine signaling Prevention of cell death Immune- modulation 7
  8. 8. Intellectual Property: Foundation for Protection30+ Patents Issued Worldwide with 100 + PendingNorth America/Europe Asia Emerging MarketsUS: 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 ORCELUTION 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 FORCELUTION 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 WOUNDTUBULAR NECROSIS (‘834) HEALING (‘580) Israel: CELUTION DEVICE WITH CENTRIFUGE OR FILTER (‘800) 8
  9. 9. Soft Tissue Repair 9
  10. 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 effectiveSoft Tissue RepairSoft Tissue Repair Clinical Soft Tissue Repair Reimbursable Soft Tissue Repair Partner ‘Cell-Enriched $43 Graft’ Cells Fat 10
  11. 11. Soft Tissue Repair: RESTORE 2 Trial Outcomes High satisfaction rates & safety to support reimbursement efforts $73 $126 100%Soft Tissue Repair 6-MoSoft Tissue Repair Soft Tissue Repair 80% Soft Tissue Repair 12-Mo 60% 40% 20% 0% Patient Satisfaction PhysicianPost-Marketing Study Design Satisfaction• Prospective 71 patient studyCo-Primary Endpoints• Physicians and patient satisfaction with functional and cosmetic results &improvement in overall breast deformity 11
  12. 12. Cardiovascular Disease Dr. Fernandez-Aviles Principal Investigator for the PRECISE trial Hosp. Gregorio Maranon Madrid, Spain 12
  13. 13. Cardiac Repair: PRECISE CMI Trial Change in Max Volume of Oxygen (MV02) from Baseline to 6 & 18 months 20.0Soft Tissue Repair 19.0Soft 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 ListN = 27 pts(6 placebo/21 treated) ADRC’s Baseline 6 Mos 18 Mos Standard of Care 13
  14. 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 ApprovalLower 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. 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. 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, ADVANCEP < 0.05 for change from BL for ADRCsP > 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. 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. 18
  19. 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. 20. Soft Tissue Repair: Radiation Necrosis 90% cells to circular area around sore Exposed SacrumNote 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. 21. Cytori Platform: 3 Key Differentiators0.5 M0.4 M0.3 M0.2 M0.1 M 0 Bone Marrow Adipose Tissue1. 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. 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. 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. 24. Thank You 24

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