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Stem Cell Meeting on the Mesa 2013
Stem Cell Meeting on the Mesa 2013
Stem Cell Meeting on the Mesa 2013
Stem Cell Meeting on the Mesa 2013
Stem Cell Meeting on the Mesa 2013
Stem Cell Meeting on the Mesa 2013
Stem Cell Meeting on the Mesa 2013
Stem Cell Meeting on the Mesa 2013
Stem Cell Meeting on the Mesa 2013
Stem Cell Meeting on the Mesa 2013
Stem Cell Meeting on the Mesa 2013
Stem Cell Meeting on the Mesa 2013
Stem Cell Meeting on the Mesa 2013
Stem Cell Meeting on the Mesa 2013
Stem Cell Meeting on the Mesa 2013
Stem Cell Meeting on the Mesa 2013
Stem Cell Meeting on the Mesa 2013
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Stem Cell Meeting on the Mesa 2013

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SVP of Operations Doug Arm presents at the 2013 Stem Cell Meeting on the Mesa on October 15, 2013.

SVP of Operations Doug Arm presents at the 2013 Stem Cell Meeting on the Mesa on October 15, 2013.

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  • 1. Cytori Corporate Overview NASDAQ: CYTX October 2013
  • 2. Safe Harbor Statement This presentation contains certain ‘forward-looking statements’ about Cytori Therapeutics, Inc. 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 involve known and unknown risks that relate to Cytori’s future events or future financial performance and the actual results could differ materially from those discussed in this presentation. Risks and uncertainties that may cause Cytori's actual results to differ materially from those discussed in the presentation can be found in the "Risk Factors" section of Cytori’s Form 10-K, Forms 10-Q and other filings with the United States Securities and Exchange Commission. We would advise reading our most recent annual report on Form 10-K and quarterly report on Form 10-Q filed with the United States Securities and Exchange Commission for a more detailed description of these risks. The forward-looking statements contained in this presentation represent Cytori’s estimates and assumptions only as of the date of this presentation and Cytori undertakes no duty or obligation to update or revise publicly any forward-looking statements contained in this presentation as a result of new information, future events or changes in Cytori’s expectations.
  • 3. Cytori Technology Therapeutic, Regulated as a Device • • • • Regulatory Path: US PMA Device (CBER), EU-Device (Notified body) Per treatment consumable MSRP $2,000 - $10,000 Cells processed available at bedside in about 1 hour Adipose tissue yields unique mixed cell population
  • 4. Cytori Priorities: Leverage Transformative Technology Platform Cardiac • Completed proof-of-concept trial • Enrolling US Phase II Heart Failure trial USA / BARDA New opportunities leveraging the platform • Up to $106 in development funding • Commercial preparedness contract with US Government • Potential to fully fund PMA for burns Commercial • Japan approval • EU ‘Vascular’ approval • Clinical experience in thousands of patients
  • 5. Cytori’s Cardiac Cell Therapy • Completed proof-of-concept trial • Enrolling ATHENA I & II US Phase 2 heart failure trials
  • 6. Cytori Cardiac Cell Therapy Mechanism of Action in Ischemic Heart Disease Cell Sub Type • • • • • • ADRC Mixed Cell Population ADSCs EPCs Mø Endo VSMCs Pericytes • • • ADSCs Mø T cells • • • Mø EPCs Endo ADSCs Mediator Mechanism  VEGF, PlGF, bFGF  Vessel density  NOS,  ROS  Endothelial dysfunction Vessel stabilization & expansion Clinical Effect & Patient Benefit Pericyte differentiation & recruitment, SDF-1, PlGF  IL-10,  IL-6  PGE2  MMP1, TGFβ,  TIMP1  SDF-1, IGF-1  HGF, IGF-1  WBC recruitment & activation Mø switch to M2  Perfusion  Inflammation  Scar remodeling  Recruitment of cardiac stem cells  Myocardial apoptosis  Fibrosis Disease (VO2 Max) Stabilization. QOL Benefit
  • 7. Cardiac Cell Therapy PRECISE Pilot Showed Proof-of-Concept Proof-ofObjective: • safety and feasibility of ADRCs delivered via intramyocardial injections in patients with chronic myocardial ischemia not amenable to revascularization Study Design: • double-blind, randomized, parallel group, placebo-controlled Sample Size • 27 subjects (Spain, The Netherlands, Denmark) (21 ADRC, 6 Placebo) Procedure • electromechanical mapping (NOGASTAR®) • ≤ 15 intramyocardial injections in the area with inducible ischemia via the MYOSTAR® Injection Catheter : – ADRCs (n=21, median dose of ADRCs 42 x 106 per subject) – Placebo (n=6: indistinguishable solution)
  • 8. Cardiac Cell Therapy PRECISE Trial: Exercise Tolerance
  • 9. Cardiac Cell Therapy PRECISE Trial: Data Summary Results • Holter: no adverse effects on rhythm at 6 and 18 months • VO2max: improvement (p<0.05 vs. placebo) – Supported by NYHA improvement trend • MRI: reduction in infarct size (p<0.05 vs. placebo) • No safety issues • Mortality [36 months]: placebo 33% (2/6) , ADRC 14% (3/21)
  • 10. Cardiac Cell Therapy ATHENA I & II US Heart Failure Trials • Heart failure due to ischemic heart disease • Phase II Trials based on EU Pilot (PRECISE) • Prospective, double-blind, placebo-controlled trials – 90 patients: 45 patients at low dose, 45 patients at high dose – Up to 10 centers • First data readout targeted for 2014 • Potential for pivotal trial initiation in 2015
  • 11. Cardiac Cell Therapy ATHENA Endpoints • Safety • Treatment emergent Serious Adverse Events (SAEs) • Arrhythmia assessment via 24-hour Holter monitoring • MACE defined as Cardiac Death or Hospitalization for Heart Failure • Efficacy • • • • VO2 max (treadmill) (6 mo) LVEF, LVESV/LVEDV assessed by Echo (6 mo) Perfusion defect by Rest/Pharmacologic Stress SPECT (6 mo) Heart failure symptoms, angina, and quality of life (3, 6, 12 mo): • NYHA and CCS classifications • Minnesota Living with Heart Failure Questionnaire (MLHFQ) • SF-36 Health Survey
  • 12. BARDA Contract Discussions Begin 2010 Award 3 Proof-of-concept Objectives Announcement Ongoing Fall, 2012 Cell viability Pre-Award, White Papers, Proposal, Negotiation 3 Objectives Trigger Option 1 & 3 Q1, 2014 Option 1 Objective Triggers Option 2 Q4, 2015 $32.6 M Option 1 Animal model POC $45.5M Option 2 Next Gen device feasibility $4.7M Phase 1 Proof of Concept $23.4M Option 3 Commercial Acquisition at BARDA’s Discretion
  • 13. Commercial • Emphasis: Currently selling systems and consumables primarily for researchers conducting independently funded clinical studies. • Rationale: Expand Cytori’s bandwidth to validate new indications; Build brand presence with leading physicians; Offset burn as revenues grow. • Driving Growth: Japan Class I designation / pending legislation; Approval in Australia; Intravase (cardiac reagent) approval in Europe; Ischemic tissue and muscle CE Mark claim expansion.
  • 14. Commercial Research Customers Worldwide 50+ investigator studies (in process or completed) SUI data published Aug. 2013 USA EU AP 3 34 11 Positive scleroderma data Sep 2013 Diabetic ulcer data published May 2013 Soft Tissue Wound Ischemia Ortho/Sport Vital Organ Australian approval July 2013 based on extensive clinical case work EM 3
  • 15. Cytori Cell Therapy: Intellectual Property Meg 64 Patents Issued Worldwide; More than 75 Pending Applications DEVICES CURRENT DEVICES NEXT 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) US: (1) CELUTION & FUTURE GENERATIONS (‘075) EUROPE: (2) ADRCS FOR CARDIAC (‘382) OPPOSED DEVICE FOR RESTORING BLOOD FLOW (‘575) OPPOSED US: (4) CELUTION FOR BONE (‘043) CELUTION OUTPUT PLUS AUSTRALIA: (1) ADRCS FOR CARDIAC (‘858) ADRCS FOR REMODELING (‘046) (‘716) CELUTION FOR TREATING WOUND HEALING (‘580) ADRC’S FOR RENAL (‘229) INDIA: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘529) US: (7) 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) CURRENT CELUTION DEVICE PLUS FAT (‘947) ADRC’S PLUS FAT PLUS BUFFER (‘834) AUSTRALIA: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘937) JAPAN: (1) CELUTION AND NEXT GEN DEVICES FOR MIXING ADRCS PLUS FAT (‘041) HONG KONG: (1) ADRCS FOR RESTORING BLOOD FLOW (‘085) INDIA: (1) CELUTION DEVICE (‘706) SINGAPORE: (1) CELUTION & FUTURE GENERATIONS (‘683) RUSSIA: (1) CELUTION FOR RESTORING BLOOD FLOW (‘924) AUSTRALIA: (2) CELUTION DEVICE (‘135) STEMSOURCE DEVICE (‘901) ISRAEL: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘800) KOREA: (3) ADRCS PLUS FAT (‘454) CELUTION OR NEXT GEN DEVICES FOR SOFT TISSUE DEFECTS (‘508) ADRCS PLUS FAT METHOD (‘666) CHINA: (1) CELUTION DEVICE (‘689) MEXICO: (1) CELUTION & FUTURE GENERATIONS (‘348) JAPAN: (2) CELUTION DEVICE (‘952) CELUTION FOR CLINICALLY SAFE OUTPUT (‘556) KOREA: (3) CELUTION DEVICE (‘995) STEMSOURCE DEVICE (‘812) CELUTION DEVICE (‘139) OLYMPUS-CYTORI PATENTS NEXT GENERATION DEVICE - JAPAN CENTRIFUGAL CONTAINER (‘020) DIGESTIVE ENZYMES (‘861) CHINA: (1) CELUTION & FUTURE GENERATIONS (‘241) HONG KONG (1) CELUTION & FUTURE GENERATIONS (‘322) KOREA: (1) CELUTION WITH CENTRIFUGE OR FILTER (‘305) JAPAN: (1) CELUTION BUSINESS METHOD SINGAPORE: (1) ADRCS FOR RESTORING BLOOD FLOW(‘309) CHINA: (1) ADRCS FOR RESTORING BLOOD FLOW (‘104) SOUTH AFRICA: (1) ADRCS FOR CARDIAC (‘446) MEXICO: (1) CELUTION FOR RESTORING BLOOD FLOW (‘775) ISRAEL: (1) ADRCS FOR CARDIAC (‘354) CANADA: (1) ADRCS FOR RESTORING BLOOD FLOW(‘510) JAPAN: (2) RESTORING BLOOD FLOW(‘787) CELUTION FOR REMODELING (‘155) CELUTION FOR PROSTHETIC FOR BONE RELATED DISORDERS EUROPE: (2) CELUTION FOR ACUTE TUBULAR NECROSIS (‘834) ADRCS FOR WOUND HEALING (‘833) JAPAN: (3) ADRCS FOR WOUND HEALING (‘699) CELUTION OUTPUT PLUS PROSTHETIC FOR BONE RELATED DISORDERS (‘119) CELUTION FOR PERIPHERAL VASCULAR DISEASE (‘511) INDIA: (1) ADRCS FOR WOUND HEALING (‘580) KOREA: (1) ADRCS FOR WOUND HEALING (‘909) CARDIAC CONTINUED KOREA (1) ADRCS FOR VENTRICULAR DILATION (‘170)
  • 16. Upcoming Milestones • Achieve BARDA proof-of-concept objectives – Qualify for up to $56 MM in further development funding • Complete enrollment in the US ATHENA trial • Report six-month outcomes from the US ATHENA trial • Publish 3-year data from the EU PRECISE chronic ischemic heart failure trial • Accelerate growth in product and contract revenues • Additional international approvals and patents
  • 17. Thank You

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