Cytori Therapeutics                    (NASDAQ:                    (NASDAQ CYTX)Lazard Capital Markets 8th Annual Healthca...
Safe Harbor StatementThis presentation may contain certain ‘forward-looking statements’. Allstatements, other than stateme...
Investment Summary•   Large pipeline opportunity     – EU chronic ischemia approval     – EU acute heart attack pivotal tr...
Investment Opportunity          Regenerative cells in the operating room in real‐time                                     ...
Adipose Tissue: Ideal Source for Cell Therapy   Adipose Tissue: Richest source of regenerative cells in the body          ...
Adipose Tissue: Ideal Source for Cell TherapyImplication: Real-time access to a patient’s own regenerative cells is possib...
Soft Tissue Repair                     7
Soft Tissue Repair: RESTORE Procedure                       Celution® approved in EU for breast reconstruction            ...
Soft Tissue Repair: RESTORE 2 Trial Outcomes                                 High satisfaction rates & safety to support r...
Soft Tissue Repair: Building Toward Launch                           Breast Reconstruction Path to Market Access          ...
Soft Tissue Repair: Global Development StatusEU Breast Reconstruction                                                     ...
Soft Tissue Repair: Near-Term European Market                         Breast reconstruction in Europe on its own          ...
Soft Tissue Repair: Global Revenue Potential                                                     Celution® Consumable cart...
Cardiovascular Disease                         Dr. Fernandez-Aviles                         Principal Investigator        ...
Cardiac Repair: Global Development StatusEU Chronic Myocardial Ischemia     Clinical Data                        Regulator...
Cardiac Repair: PRECISE CMI Trial                           Change in Max Volume of Oxygen (MV02) from Baseline to 6 & 18 ...
Cardiac Repair: PRECISE CMI Trial                                                            28 Month Mortality Rate      ...
Cardiac Repair: U.S. CMI Trial              Confirmed device designation by FDA              Pursuing IDE/PMA clinical tri...
Cardiac Repair: APOLLO Acute MI Trial                                          Potential new approach for treatment of hea...
Cardiac Repair: APOLLO Acute MI Trial                            Lower abnormal ventricular beat rate in cell group       ...
Cardiac Repair: Significant Market Need                                Estimated Market Size for Europe Alone             ...
Current Commercial Business                              22
Current Commercial BusinessBuild for profitable growth• Manage regions as distinct operating units• Establish beach head c...
Current Commercial Business• Revenue growth year over year• Q  Quarters variable      t       i bl• Systems driving revenu...
Our Business               25
Partners           Astellas Pharmaceuticals           • $10 mm equity investment at $7.00           • Potential for future...
Intellectual Property: Foundation for Protection30+ Patents Issued Worldwide with 100 + PendingNorth America/Europe       ...
FinancialsCash (Q3, 2011)                             $41 millionGE L   Loan                                     $25 milli...
Potential Near-Term CatalystsCelution® One CE MarkCE Mark for Chronic myocardial ischemiaInitiate hI iti t chronic myocard...
Cytori Therapeutics                    (NASDAQ:                    (NASDAQ CYTX)Lazard Capital Markets 8th Annual Healthca...
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Cytori Lazard Healthcare Conf. Presentation

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Overview of Cytori's business as presented at the Lazard Healthcare Investor

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Cytori Lazard Healthcare Conf. Presentation

  1. 1. Cytori Therapeutics (NASDAQ: (NASDAQ CYTX)Lazard Capital Markets 8th Annual Healthcare Conference November 16, 2011 16 Mark E. Saad, Chief Financial Officer 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 and trends, conditions,other factors they believe to be appropriate.The forward looking statements included in this presentation are also subject forward-lookingto 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 thd i ti f these risks. ik 2
  3. 3. Investment Summary• Large pipeline opportunity – EU chronic ischemia approval – EU acute heart attack pivotal trial – US chronic ischemia pilot trial – EU breast reconstruction reimbursement – Japan breast reconstruction approval• Near term commercial business potential – Building for profitable growth – Soft tissue and translational research – Grow in select emerging markets• Established partnerships and potential future licensing – $100 MM + in funding to Cytori – Multiple development and commercialization partnership prospects• Patent protection into mid-2020s and beyond 3
  4. 4. Investment Opportunity Regenerative cells in the operating room in real‐time Soft Tissue Repair f p About one hourCytori Celution® System Regenerative cells Cardiovascular Disease Celution currently approved in Europe Scalable platform System/Consumable model y 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 M lti t t ll • Multipotent cells M lti t t ll • 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. Soft Tissue Repair 7
  8. 8. Soft Tissue Repair: RESTORE Procedure Celution® approved in EU for breast reconstruction Significant unmet medical need $73 Two completed clinical t i l T l t d li i l trials $126 $ 26 $163Soft Tissue RepairSoft Tissue Repair Safe and effective Clinical Soft Tissue Repair Soft Tissue Repair Reimbursable Partner ‘Cell‐ ‘Cell‐Enriched  $43 Graft’ Cells Fat 8
  9. 9. Soft Tissue Repair: RESTORE 2 Trial Outcomes High satisfaction rates & safety to support reimbursement efforts $73 $126 $ 100%Soft Tissue RepairSoft Tissue Repair 6-Mo 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 9
  10. 10. Soft Tissue Repair: Building Toward Launch Breast Reconstruction Path to Market Access 2006 – Present Soft Tissue Repair Soft Tissue Repair Soft Tissue Repair Soft Tissue Repair 2006 2007 2008 2009 2010 2011• RESTORE 1  • CE Mark for   •Cytori begins  • RESTORE 2  • Breast  • UK NIC Initiated in  l general  RESTORE 2 trial  ll enrollment  reconstruction  d f identifies cost‐Japan processing in EU complete added to CE  effective‐ness • RESTORE 1  Mark  • Complete  data reported RESTORE 2  data reported 10
  11. 11. Soft Tissue Repair: Global Development StatusEU Breast Reconstruction Reimbursement Regulatory R l Clinical Data Cli i l D Early Adoption E l Ad i (2013)Japan Breast Reconstruction Regulatory Reimbursement Clinical Data Adoption (2012) (2012/2013)US Parry Romberg Clinical Data Regulatory Reimbursement Adoption Regulatory Clinical Data Stages of Market Access Adoption Reimbursement 11
  12. 12. Soft Tissue Repair: Near-Term European Market Breast reconstruction in Europe on its own can get Cytori to p g y profitability y • Target hospitalsSoft Tissue RepairSoft Tissue Repair Soft Tissue Repair • Focus on G5 Soft Tissue Repair • Breast recon as entry into Operating Room Indication Status Next Milestones Market Size General processing Approved 2008;  Continued hospital  Tens of millions $8.4 MM 2010 sales adoption @ KOL sites Breast cancer cancer  Approved July 2010 July 2010 UK reimbursement  UK reimbursement $300 400 MM    $300‐400 MM reconstruction 2013 followed by G5  coverage Wounds Approved July 2010 Initiation of  $500 + MM Independent  I d d t reimbursement trial 12
  13. 13. Soft Tissue Repair: Global Revenue Potential Celution® Consumable cartridgeSoft Tissue RepairSoft Tissue Repair Soft Tissue RepairRevenue Potential on Consumables aloneAssumption: One Consumable per dayCustomer universe: 15,000 hC t i 15 000 hospitals who buy capitall equipment it l h b it i tSoft tissue est. price per consumable - $2,500 ± Installed Cartridges per Price per Annual Revenue Systems Year Cartridge Potential 100 260 $2,500 $65 MM 1,000 260 $2,500 $650 MM 10,000 260 $2,500 $6.5 Bil 13
  14. 14. Cardiovascular Disease Dr. Fernandez-Aviles Principal Investigator for the PRECISE trial Hosp. G H Gregorio M i Maranon Madrid, Spain 14
  15. 15. Cardiac Repair: Global Development StatusEU Chronic Myocardial Ischemia Clinical Data Regulatory g y CE Mark Application  Early Adoption E l Ad i Reimbursement R i b (2012) Filed Q2 2011EU Acute Myocardial Infarction Clinical Data Pilot complete Regulatory Reimbursement Adoption Pivotal began 2011 Pi t l b 2011US Chronic Myocardial Ischemia Clinical Data PRE‐IDE Q3 ‘11 Regulatory Reimbursement Adoption Initiate 2012  Regulatory Clinical Data Stages of Market Access Adoption Reimbursement 15
  16. 16. Cardiac Repair: PRECISE CMI Trial Change in Max Volume of Oxygen (MV02) from Baseline to 6 & 18 months 20 0 20.0Soft Tissue RepairSoft Tissue Repair 19.0 Soft Tissue Repair P<0.05 P<0.05 18.0 17.2 17.1 16.0 16.6 15.5 15.3 15 3 14.0 Transplant ListN = 27 pts(6 placebo/21 treated) ADRC’s Baseline 6 Mos 18 Mos Standard of Care 16
  17. 17. 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 17
  18. 18. 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 Randomized, double blind placebo-controlled • 1o Endpoints: Safety & Efficacy Next Steps: • Submit IDE application by end of year • Initiate 1H 2012 18
  19. 19. 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 iin reduction of iinfarct size iis maintained iin cell-t Diff d ti f f t i i t i d cell-treated patients ll t d ti t p<0.05 for change in infarct size for cell-treated patients at 6 and 18 months (paired t-test cell- comparing baseline and follow up for same patients) 19
  20. 20. Cardiac Repair: APOLLO Acute MI Trial Lower abnormal ventricular beat rate in cell group abnormal 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 20
  21. 21. Cardiac Repair: Significant Market Need Estimated Market Size for Europe Alone CMI AMI $ 20 Billion* $ 7 Billion # of Patients # of Pts (10-YrRegion Annual Heart Attack Incidence (EU) 1.9 1 9 million (Incidence) Prevalence)United 40,000 400,000Kingdom % STEMI (large heart attacks) 38%Italy 40,000 400,000 Target Addressable Procedures 720,000Germany 55,000 550,000France 40,000 400,000 Est. Price per cardiac consumable p $ 10,000 ,Spain 30,000 300,000Total G5 205,000 2,050,000 Potential Healthcare Savings for CMI LVAD + Procedure > $200 000 $200,000 Celution Consumable + Procedure < $50,000 21
  22. 22. Current Commercial Business 22
  23. 23. Current Commercial BusinessBuild for profitable growth• Manage regions as distinct operating units• Establish beach head customers beach-headNear-term catalysts• Additional country approvalsCE Mark can get Cytori to profitability• Multi-hundred million dollar markets accessible with current approvalsEnter/grow in emerging marketsE t / i i k t• India and Apollo Hospital as example• Other countries to follow 23
  24. 24. Current Commercial Business• Revenue growth year over year• Q Quarters variable t i bl• Systems driving revenue• EU focus on reconstruction• Emerging markets & Asia: - Aesthetics - Reconstruction - Translational research - StemSource® cell & tissue banks 24
  25. 25. Our Business 25
  26. 26. Partners Astellas Pharmaceuticals • $10 mm equity investment at $7.00 • Potential for future liver disease partnership p p Green Hospital Supply p pp y • Co-selling StemSource® Cell Banks in Asia GE Healthcare • Co-distributer in select countries • Lead lender Olympus (Japan): Manufacturing Joint Venture • Next-generation Celution® One System •ADVANCE trial 26
  27. 27. 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) ( 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: CELUTION FOR CARDIOVASCULAR (‘924)CELLS PLUS FAT PLUS ADDITIVES (‘795) Japan: pCELLS 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) 27
  28. 28. FinancialsCash (Q3, 2011) $41 millionGE L Loan $25 million illiShares Outstanding 55 millionWarrants (W t (average price $ 3.80) i 3 80) 12 million illiVested Options (average price $5) 5 millionQ3 N New cash used iin operating activities h d ti ti iti $7.9 $7 9 28
  29. 29. Potential Near-Term CatalystsCelution® One CE MarkCE Mark for Chronic myocardial ischemiaInitiate hI iti t chronic myocardial ischemia trial in U.S. i di l i h i ti li USBreast reconstruction technology evaluation in UK (reimbursement)Celution® System approval in additional major countriesAdditional partnerships 29
  30. 30. Cytori Therapeutics (NASDAQ: (NASDAQ CYTX)Lazard Capital Markets 8th Annual Healthcare Conference November 16, 2011 16 Mark E. Saad, Chief Financial Officer 30

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