CYTX Corporate Presentation, Biotech Showcase

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CYTX Corporate Presentation at the Biotech Showcase 2012 - 1.9.12

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CYTX Corporate Presentation, Biotech Showcase

  1. 1. Cell Therapy CytoriCorporate Presentation January 2012
  2. 2. Safe Harbor 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. Cell Therapy
  3. 3. Our Company Mission To improve the quality and length of life by providing innovative cell therapy products Cell Therapy
  4. 4. Our InnovationReal-time Access to a Patient’s Own Regenerative Cells Syringe of Patient’s Own Cells Regenerative Cells Derived from Adipose Tissue (Fat) Cell Therapy
  5. 5. 2011 : Year in ReviewMarch Shareholder Letter – 12 month milestones • Expand CE Mark Claims to include NO-CMI  On track for early 2012 claims expansion • Report 18 month APOLLO data  Reported highly positive long-term Data • Expand number of sites & ongoing enrollment of ADVANCE  Initiated ADVANCE, 4 sites on-line & 23 in process • Define & prepare to initiate a US clinical trial for CMI  Successful pre-IDE meeting & IDE for CMI filed in Q4 • Expand efforts with FDA to gain approval or clearance for Celution  3 - 510ks, 2 appeals, pre-IDE, IDE filing, 3 HUD rounds, ++mtgs • CE Mark & European commercial launch for Celution One  CE Mark for Celution One received in November • Complete development of next generation aesthetics device - Development on hold to focus on cardiac pipeline Cell Therapy
  6. 6. 2011 : Year in ReviewMarch Shareholder Letter – 12 month milestones • Increase system installed base & consumable usage rates  Grew installed based of systems, shifted sales to hospitals • Increase hospital-based customers, with emphasis on breast recon  More than half the systems went to hospital based customers • Pursue payment for breast reconstruction in Europe  NIC support UK, Italy grant Breast recon, NICE filing Q1 • Grow PureGraft product sales  More than doubled PG; anticipate ongoing growth in 2012 • Expand selectively into emerging markets  Opened India, Australia, So. Africa, Bulgaria & Russia Cell Therapy
  7. 7. 2012 : Key steps to increase shareholder value • Commercial Business • Product Pipeline • Corporate Cell Therapy
  8. 8. 2012 : Key steps to increase shareholder valueCommercial Business 1. Manage into a profitable segment in near term 2. 20+% annual revenue growth until inflection point 3. Focus reimbursement efforts in UK 4. Building market access for NO-CMI 5. Japan – cell therapy guidelines & help dev approved studies for translational applications; MHLW approval for breast reconstruction Cell Therapy
  9. 9. 2012 : Key steps to increase shareholder valueProduct Pipeline 1. No-option CMI CE Mark (EU) 2. Focus on ADVANCE centers: 30 Centers on-line by year-end 3. Publish results of Apollo, Precise & Restore II 4. Initiate Athena (U.S. Chronic Ischemia) Cell Therapy
  10. 10. 2012 : Key steps to increase shareholder valueCorporate 1. Bring in non-dilutive / strategic funding 2. Average Cash Operating Loss to $7 mm / qtr 3. Continue to expand global regulatory approvals Cell Therapy
  11. 11. Cell Therapy via Device 4,000+ Patients Treated Cardiovascular Soft TissueAcute Heart Attack Breast ReconstructionChronic Heart Failure Wounds, Fistula Cell Therapy
  12. 12. Chronic Myocardial Ischemia PRECISE TRIAL • Prospective European Multicenter Trial • Randomized (3:1) • Double Blind • Placebo controlled • Blinded independent core labs • Safety & Feasibility Trial • n= 27 (6 placebo, 21 treated) Patrick Serruys, MD, PhD Rotterdam, The Netherlands Cell Therapy
  13. 13. Chronic Myocardial Ischemia MVO2: statistically significant change at 18 months METS: statistically significant change at 18 months Under review by Notified Body For CE Mark claims expansion Infarct size: 8.2% change at 6 months Cytori procedure safe and feasible through 18-months Lower cardiac mortality rate: • At avg. follow up of 28 months: - 1 of 21 treated vs. 2 of 6 placebo 28 Month Mortality Rate Treated Placebo 0% 10% 20% 30% 40% Cell Therapy
  14. 14. ‚No Option‛ Heart Failure Estimated Market Size for No Option Patients in Europe Region # of Patients (Incidence) # of Patients (10-Yr Prevalence) United Kingdom 40,000 400,000 Italy 40,000 400,000 Germany 55,000 550,000 France 40,000 400,000 Spain 30,000 300,000 Total G5 205,000 2,050,000 * Estimated price per treatment: $ 10,000 G5 Market $ 20 Billion* Cell Therapy
  15. 15. ATHENA Trial US FDA Trial Chronic Myocardial Ischemia • IDE Filed Q4, 2011 • Trial design under negotiation with FDA • Anticipate IDE approval Summer, 2012 Emerson Perin, MD Texas Heart Institute Cell Therapy
  16. 16. Acute Heart Attack APOLLO TRIAL • Prospective European Multicenter Trial • Randomized (3:1) • Double Blind • Placebo controlled • Blinded independent core labs • Safety & Feasibility Trial • n = 14 (4 placebo, 10 treated) Eric Duckers, MD, PhD Rotterdam, The Netherlands Cell Therapy
  17. 17. Cell Treated: Better Perfusion of the Heart 6 & 18 month follow-up Perfusion defect in LAD territory: Reduction in perfusion defect in patients treated with ADRC compared to placebo patients (9,7-fold improvement in LAD perfusion territory) as analyzed by MIBI SPECT (TSS scores) MIBI SPECT TSS change (matched pairs) +867% +800% improvement improvementp=NS Slides & Data provided by:All SPECT images were assessed by an independent, blinded core lab (CCL, Boston, MA) Eric Duckers, MD, PhD
  18. 18. Cell Treated: Reduced Damage by > 50% 6 & 18 month follow-up Percent of Left Ventricle Infarcted: Infarct size normalized to ventricle size (%LVI) improved more in ADRC patients compared to placebo control patients (late enhancement cMRI): +5,1% abs. and +59% rel. improvement compared to placebo control, PTE) change in rel.infarct size (I/LV) (matched pairs) all pts baseline 6 mo control Tx 24,7% 24,7% ADRC Tx 31,6% 15,4% all patientsp=NS matched pairs Slides & Data provided by:All MRI images were assessed by an independent, blinded core lab (CCL, Boston, MA) Eric Duckers, MD, PhD
  19. 19. Cell Treated – Not going into Heart Failure 6 & 18 month follow-up Change in ESV ESV was markedly reduced in ADRC patients as compared to placebo control patients (as measured by 2D TTE, cMRI and SPECT, PTE) change in ESV (cc, 2D TTE) 24,4 cc improvement (-72,2%) Slides & Data provided by:All TTE images were assessed by an independent, blinded core lab (CCL, Boston, MA) Eric Duckers, MD, PhD
  20. 20. APOLLO: Arrhythmias Percent of Pa ents with Signific nt a Abnormal ventricular beats occur more Ventricular Arrhythmias often in Control patients60% 50%  More Significant Ventricular Arrhythmias50% in control patients40%  Higher frequency of recordings with 30%30% Ventricular Premature Bits (VPB) in20% Controls10%  Higher number of VPBs per recording0% in Controls Placebo Group 1 Premature Ventricular Contrac ons - Mean Count per Pa ent Premature Ventricular Contrac ons - Mean Cumula ve Count700 3000600 2500500 2000400 control 1500 control300 ADRC ADRC 1000200 500100 0 0 0.5 1 2 3 4 8 12 16 25 52 77 0.5 1 2 3 4 8 12 16 25 52 77 Cell Therapy
  21. 21. APOLLO: Summary ADRCs are safe in the treatment of STEMI  No safety concerns  No new Major Adverse Cardiac Events  No Deaths Efficacy  Concordant improvement in infarct and ischemia:  Mean reduction in Infarct Size is maintained to 18 months  Improvement in cardiac perfusion is maintained to 18 months  May have positive impact on arrhythmia in cell-treatment patents ADVANCE  No changes to ADVANCE trial design are needed Cell Therapy
  22. 22. Acute Heart Attack ADVANCE TRIAL • Currently enrolling & treating • 30 – 35 sites to treat up to 360 patients • 60 sites identified & interested; ½ in G-5 • 23 sites selected & committed • Various states of regulatory process by country • Focus in 2012 to bringing sites online by YE Eric Duckers, MD, PhD Rotterdam, The Netherlands Cell Therapy
  23. 23. Advance Trial Timeline in EU Cell Therapy
  24. 24. Acute Myocardial Infarction Estimated Market Size for AMI Patients in Europe Annual Heart Attack Incidence (EU) 1.9 million % STEMI (large heart attacks) 38% Target Addressable Procedures 720,000 Estimated Price per Treatment $ 10,000 EU AMI Market $ 7.2 Billion Cell Therapy
  25. 25. US RegulatoryUS IDE Trial for Cardiovascular: IDE FiledUS IDE Trial for Cardiovascular: Heart Attack to follow European Advance TrialUS HUD: Parry Rombergs Disease: Ongoing ProcessMultiple 510(k) device applications filed in 2011Filed 2 appeals on 510(k) NSE: Now to Merits Panel Cell Therapy
  26. 26. 38 Worldwide Issued Patents, > 100 pending Devices Devices Cosmetic & Reconstructive Cardiovascular Therapies Pipeline Therapies Next Generation Next Generation Surgery (CRS) US: (1) US: (1) US: (4) Europe: (1) US: (2) CELUTION FUTURE CELUTION FUTURE CELUTION FOR MIXING ADRCS FOR CARDIAC CELUTION FOR BONE GENERATIONS (‘075) GENERATIONS (‘075) ADRCS PLUS FAT (‘488) (‘382) (‘043) CELUTION OR NEXT GEN <Opposition filed> CELUTION OUTPUT India: (1) India: (1) DEVICES FOR SOFT TISSUE PLUS PROSTHETIC CELUTION FUTURE CELUTION FUTURE DEFECTS (‘684) Australia: (1) FOR BONE RELATED GENERATIONS (‘529) GENERATIONS (‘529) ADRCS PLUS FAT PLUS CELUTION FOR DISORDERS (‘716) ADDITIVES (‘795) CARDIOVASCULAR (‘858) Australia: (1) Australia: (1) ADRCS PLUS FAT (‘672) Europe: (2) CELUTION WITH CENTRIFUGE CELUTION WITH Singapore: (1) CELUTION FOR ACUTE OR CENTRIFUGE OR Japan: (1) CELUTION FOR TUBULAR NECROSIS FILTER (‘937) FILTER (‘937) CELUTION AND NEXT GEN CARDIOVASCULAR (‘590) (‘834) DEVICES FOR MIXING ADRCS ADRCS FOR WOUND Singapore: (1) Singapore: (1) PLUS FAT (‘041) China: (1) HEALING (‘833) CELUTION & FUTURE CELUTION & FUTURE CELUTION FOR GENERATIONS (‘683) GENERATIONS (‘683) CARDIOVASCULAR (‘104) Japan: (1) ADRCS FOR WOUND Israel: (1) Israel: (1) Russia: (1) HEALING (‘699) CELUTION WITH CENTRIFUGE CELUTION WITH CELUTION FOR OR CENTRIFUGE OR CARDIOVASCULAR (‘924) India: (1) FILTER (‘800) FILTER (‘800) ADRCS FOR WOUND South Africa: (1) HEALING (‘580) Mexico: (1) Mexico: (1) CELUTION FOR CELUTION FUTURE CELUTION FUTURE CARDIOVASCULAR (‘446) GENERATIONS GENERATIONS Mexico: (1) CELUTION FOR CARDIOVASCULAR (‘775) Cell Therapy
  27. 27. Cell Therapy Thank You !

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