Cytori Therapeutics, Inc. <br />NASDAQ: CYTX<br />BioCentury Future Leaders<br />Marc H. Hedrick, MD, President<br />April...
Safe Harbor Statement<br />This presentation may contain certain ‘forward-looking statements’. All statements, other than ...
<ul><li>Business Overview
Cardiovascular Pipeline
Customers Developing New “Apps”
Cosmetic & Reconstruction Commercialization
Barriers to Entry
Summary</li></li></ul><li>Cytori Regenerative Medicine Platform Technology<br />Real-time Access to a Patient’s Own Regene...
Device Business Model: Regenerative Cells from Fat<br />Key Attributes of Adipose Derived Regenerative Cells<br />Mixed Ce...
Multipotent cells
Endothelial cells
Vasc. smooth muscle cells
Tissue resident macrophages
Perivascular cells</li></li></ul><li>Key Business Driver:  Consumable Cartridge Sales <br />Cardiovascular Disease<br />Pl...
Strong Partnerships & Commercial Network<br />Olympus (Japan): Manufacturing Joint Venture<br /><ul><li> Next-generation C...
 Available for ADVANCE trial
 Invested $55 + mm</li></ul>SHIP Holding (Green Hospital Supply)<br /><ul><li> Co-selling StemSource® Cell Banks in Asia</...
 Right-of-first refusal for hepatic disease partnership</li></li></ul><li>Current Global Commercial Activity<br />Frankfur...
<ul><li>Business Overview
Cardiovascular Pipeline
Customers Developing New “Apps”
Cosmetic & Reconstruction Commercialization
Barriers to Entry
Summary</li></li></ul><li>Cardiac Repair Overview<br />CV Trial Design<br />Multi-center, double-blind, placebo-control  <...
No Option Chronic Myocardial Ischemia<br />PRECISE Pilot: Intramuscular injection using JNJ Noga Star catheter<br />MVO2:s...
MVO2≤ 14 = 47% 1 yr survival rate</li></ul>METS: significant change at 18 months<br />Infarct size: 8.2% change at 6 month...
No Option Chronic Myocardial Ischemia<br />Potentially sufficient functional improvement for limited  ‘no-option’ indicati...
Notified body submission- H1 2011 </li></ul>Patient criteria<br /><ul><li>No option- not eligible for revascularization, p...
Leverage 30+ ADVANCE trial sites
Build targeted network of regional centers, NOGA sites</li></ul>Economics<br /><ul><li>Cartridge & procedure cost lower th...
Initial: self pay, open coding, new technology payments
Future: Precise + registry = DRG
Upcoming SlideShare
Loading in...5
×

CYTX BioCentury Future Leaders in the Biotech Industry Presentation

668

Published on

Dr. Marc Hedrick's presentation at the BioCentury Future Leaders in the Biotech Industry presentation on April 15, 2011

Published in: Health & Medicine, Technology
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
668
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
0
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide
  • The Celution system is originally being marketed to 2 areas of regenerative medicine: reconstructive and aesthetic.The distinction of these two areas is in the location of the procedure and the general reimbursement of the procedure.
  • CYTX BioCentury Future Leaders in the Biotech Industry Presentation

    1. 1. Cytori Therapeutics, Inc. <br />NASDAQ: CYTX<br />BioCentury Future Leaders<br />Marc H. Hedrick, MD, President<br />April 15, 2011<br />
    2. 2. Safe Harbor Statement<br />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. <br />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. <br />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.<br />
    3. 3. <ul><li>Business Overview
    4. 4. Cardiovascular Pipeline
    5. 5. Customers Developing New “Apps”
    6. 6. Cosmetic & Reconstruction Commercialization
    7. 7. Barriers to Entry
    8. 8. Summary</li></li></ul><li>Cytori Regenerative Medicine Platform Technology<br />Real-time Access to a Patient’s Own Regenerative Cells<br />Unique ‘Scalable’ Source<br />Powerful Cell Mixture <br />Point-of-Care Platform<br />Regenerative Cells from Adipose Tissue (Fat)<br />≈1 Hour<br />
    9. 9. Device Business Model: Regenerative Cells from Fat<br />Key Attributes of Adipose Derived Regenerative Cells<br />Mixed Cell Population<br />Potency<br />High Cell Number<br />million/100cc<br /><ul><li>No Adipocytes
    10. 10. Multipotent cells
    11. 11. Endothelial cells
    12. 12. Vasc. smooth muscle cells
    13. 13. Tissue resident macrophages
    14. 14. Perivascular cells</li></li></ul><li>Key Business Driver: Consumable Cartridge Sales <br />Cardiovascular Disease<br />Plastic and Reconstructive Surgery<br />Single Use Consumable<br />18K potential customers<br />1 consumable per day <br />6 mm + consumables/year<br />Cell & Tissue Storage<br />Open Op System: ID new “Apps” and Fuel Pipeline<br />
    15. 15. Strong Partnerships & Commercial Network<br />Olympus (Japan): Manufacturing Joint Venture<br /><ul><li> Next-generation Celution
    16. 16. Available for ADVANCE trial
    17. 17. Invested $55 + mm</li></ul>SHIP Holding (Green Hospital Supply)<br /><ul><li> Co-selling StemSource® Cell Banks in Asia</li></ul>GE Healthcare<br /><ul><li> Co-distribute Celution & StemSource in select countries </li></ul>AstellasPharmaceuticals <br /><ul><li> $10 mm equity investment at market premium    
    18. 18. Right-of-first refusal for hepatic disease partnership</li></li></ul><li>Current Global Commercial Activity<br />Frankfurt(logistics)<br />Tokyo(sales)<br />San Diego(HQ)<br />Zug (sales)<br />North America<br />PureGraft<br />StemSource<br />Planned clinical trials<br />Europe & ME<br />Celution System <br />PureGraft<br />Celution CV<br />ADVANCE Acute MI trial<br />Japan & A/P<br />StemSource<br />Celution<br />PureGraft<br />10+ investigator studies<br />
    19. 19. <ul><li>Business Overview
    20. 20. Cardiovascular Pipeline
    21. 21. Customers Developing New “Apps”
    22. 22. Cosmetic & Reconstruction Commercialization
    23. 23. Barriers to Entry
    24. 24. Summary</li></li></ul><li>Cardiac Repair Overview<br />CV Trial Design<br />Multi-center, double-blind, placebo-control <br />Intracoronary and myocardial cell injections safe<br />Strong and consistent efficacy signals <br />Predictors of long-term outcomes improved<br />Two Completed Celution® pilot studies in Europe<br />Chronic myocardial ischemia: PRECISE Trial<br />Seeking CE Mark in “no-option” patients<br />Acute MI(Heart Attack): APOLLO Trial<br />Pivotal EU approval study underway<br />
    25. 25. No Option Chronic Myocardial Ischemia<br />PRECISE Pilot: Intramuscular injection using JNJ Noga Star catheter<br />MVO2:significant change at 18 months<br /><ul><li>MVO2 correlates to improved survival
    26. 26. MVO2≤ 14 = 47% 1 yr survival rate</li></ul>METS: significant change at 18 months<br />Infarct size: 8.2% change at 6 months<br />Lower cardiac mortality rate<br /><ul><li>At avg. follow up of 28 months: </li></ul> - 2/6 placebo pts died of cardiac causes <br /> - 1/21 treated pts died of cardiac causes<br />
    27. 27. No Option Chronic Myocardial Ischemia<br />Potentially sufficient functional improvement for limited ‘no-option’ indication<br /><ul><li>Approx. 200,000 new CMI patients each year in Europe
    28. 28. Notified body submission- H1 2011 </li></ul>Patient criteria<br /><ul><li>No option- not eligible for revascularization, pre transplant</li></ul>Market introduction<br /><ul><li>Patient registry for post-market data and reimbursement
    29. 29. Leverage 30+ ADVANCE trial sites
    30. 30. Build targeted network of regional centers, NOGA sites</li></ul>Economics<br /><ul><li>Cartridge & procedure cost lower than assist devices
    31. 31. Initial: self pay, open coding, new technology payments
    32. 32. Future: Precise + registry = DRG
    33. 33. $200 MM annual est. market (10% of market @ $10,000/cartridge (Est. $5k-10k/cartridge) </li></li></ul><li>ADVANCE: Pivotal EU Trial for Transmural AMI<br />‘Virtual off the shelf’ @ point-of-care<br />APOLLO- Reduced infarct size<br /><ul><li>LV infarct size cut in half in treated group
    34. 34. LVEF difference of 5.7% (SPECT)
    35. 35. 3.5x improvement perfusion
    36. 36. No change in placebo</li></ul>ADVANCE- European pivotal study<br /><ul><li>Approx. 350 patients
    37. 37. Three arms: 20 MM cells, 30 MM cells, & placebo
    38. 38. Up to 35 centers
    39. 39. Enrolling as of Jan 2011 (est.18-24 mo enrollment)</li></li></ul><li><ul><li>Business Overview
    40. 40. Cardiovascular Pipeline
    41. 41. Customers Developing New “Apps”
    42. 42. Cosmetic & Reconstruction Commercialization
    43. 43. Barriers to Entry
    44. 44. Summary</li></li></ul><li>Celution: Discovering New Applications<br />Sold systems/cartridges to researchers to develop new “apps” <br />Cytori selects most promising applications to develop/commercialize <br />- First example is breast reconstruction<br />Current investigator-sponsored trials<br /><ul><li>Radiation injury
    45. 45. SUI
    46. 46. Liver
    47. 47. Renal
    48. 48. Malignant wounds
    49. 49. Cardiomyopathy
    50. 50. Vocal cord paralysis
    51. 51. HIV therapy-induced soft tissue atrophy
    52. 52. Others </li></ul>Common theme: Acute or chronic ischemic tissue<br />
    53. 53. Celution: Discovering New Applications<br />Two Investigator-Initiated Studies<br />Radiation Injury<br />Urinary Incontinence<br />Urethral Lumen<br />Pre-Celution<br />Treatment<br /><ul><li>5 males post radical prostatectomy
    54. 54. Moderate to severe Incontinence
    55. 55. Single treatment
    56. 56. All improved</li></ul>10 weeks<br />Post-Celution<br />Treatment<br />Nagoya & Nagasaki, Japan<br />
    57. 57. <ul><li>Business Overview
    58. 58. Cardiovascular Pipeline
    59. 59. Customers Developing New “Apps”
    60. 60. Cosmetic & Reconstruction Commercialization
    61. 61. Barriers to Entry
    62. 62. Summary</li></li></ul><li>Cytori Technology for Breast Reconstruction<br />RESTORE Procedure<br />Breast conservation = std of care<br />Reconstruction post BCT = un-met need<br />Favorable economics<br />Strong record clinical success<br />Cells in graft counteract radiation effects<br />‘Cell-Enriched <br />Graft’<br />Cells<br />Fat<br />$43<br />$73<br />$128<br />$163<br />$76<br />$126<br />Clinical<br />Clinical<br />Clinical<br />Partner<br />Partner<br />Partner<br />
    63. 63. RESTORE II- 6 and 12 Month Data<br />Post-Marketing Study Design<br /><ul><li>Prospective 71 patient study</li></ul>Co-Primary Endpoints<br /><ul><li>Physicians and patient satisfaction with functional and cosmetic results and improvement in overall breast deformity</li></ul>Results<br /><ul><li>85% phys satisfaction (12-mo)
    64. 64. 75% pt satisfaction on (12-mo)
    65. 65. Improvement in scar, pigmentation, symmetry and defect index (6-Mo):
    66. 66. 2.8 to 3.9 in ptassessment (0-5 scale)
    67. 67. 3.1 to 4.1 in phys. assessment (0-5 scale)</li></ul>Binary patient and physician satisfaction with treatment results at 6- and 12-months <br />19<br />
    68. 68. EU Market Analysis for Restore Procedure<br />Ex. 1- Based on EU Hospital Penetration<br />Ex. 2- Based on UK Patient Adoption<br />2,000<br />Procedures/Year<br />Number of Hospitals<br />Note- Backlog: 2 mm patients<br />1 System in 10% of hospitals using 1 consumable/day = $146 MM <br />UK only- 10% penetration of incidence = $25 MM/year<br />
    69. 69. EU Breast Reconstruction Commercialization<br />Approved Therapy in Europe<br /><ul><li>Regulatory- clinical indication for reconstruction in July 2010
    70. 70. RESTOREII, phase IV trial- full 6 month and top-line 12 month data</li></ul>Favorable market dynamics and economics<br /><ul><li>Unmet need
    71. 71. Minimally invasive , out-patient
    72. 72. Cost savings</li></ul>Targeted Launch coincidence with Celution ONE Approval<br /><ul><li>Q2 2011
    73. 73. NICE evaluation
    74. 74. France, Germany, Italy, Spain, Switzerland, and UK
    75. 75. Pursue reimbursement on regional basis
    76. 76. Marketed under name RESTORE Procedure
    77. 77. Support patient awareness/education (www.cellreconstruct.eu)
    78. 78. Directed efforts toward surgeons (Cytori Exchange) </li></li></ul><li>Natural Breast Augmentation<br />Initial product introduction early 2008 in Europe and Asia Pacific<br />
    79. 79. Supplemental Product: PureGraft™ Natural Fill<br />Fat grafting market growth<br />100K fat-graft cases/yr in US, EU each<br />Product attributes <br />Optimizes, dialyzes fat graft (for non-cell enriched) <br />Complements Celution (EU)<br />Celution lead qualifier (EU)<br />US and European approval <br />Low cost consumer awareness campaign<br /><ul><li>TV, print and radio outreach around customers</li></ul>Distributor model <br /><ul><li>Sound Surgical is first in the US
    80. 80. Multiple in Europe
    81. 81. Minimal training requirements </li></ul> units shipped in 2010 since Q2 launch (1,000 + in Q4)<br />
    82. 82. Commercial Performance: Systems and Consumables<br />Consumable Growth<br />Growing Installed Base<br />
    83. 83. Commercial Performance: Revenue<br />
    84. 84. <ul><li>Business Overview
    85. 85. Cardiovascular Pipeline
    86. 86. Customers Developing New “Apps”
    87. 87. Cosmetic & Reconstruction Commercialization
    88. 88. Barriers to Entry
    89. 89. Summary</li></li></ul><li>Barriers-to-Entry<br />Knowledge-based barriers to entry:<br /><ul><li>31 issued patents/100 pending
    90. 90. Intellectual Property: patents, trade secrets, know-how </li></ul>Economics-based barriers to entry:<br /><ul><li>Exclusive supply chains for critical components, e.g., Celase
    91. 91. Long-term partnerships: fund development enforce IP, e.g., Olympus</li></ul>Commercial based-barriers to entry:<br /><ul><li>Set the standard/establish operating ecosystem
    92. 92. Branding
    93. 93. Create customer loyalty with quality product and service
    94. 94. Protect, use and enforce trademarks
    95. 95. Marketing support </li></ul>27<br />
    96. 96. <ul><li>Business Overview
    97. 97. Cardiovascular Pipeline
    98. 98. Customers Developing New “Apps”
    99. 99. Cosmetic & Reconstruction Commercialization
    100. 100. Barriers to Entry
    101. 101. Summary</li></li></ul><li>Celution One: Next Generation Product<br />Commercially available in Europe in 2011<br />Hospital-based system- Restore Procedure<br />ADVANCE Study, CV therapy<br />Recon<br />Formula transfer price<br />Cardiac<br />Other Apps<br />Manufacturing JV<br />Commercial rights<br />
    102. 102. Strengthened Balance Sheet, Growing Business<br />Cash: $52.7 million (12/31)<br /><ul><li>Includes $10 MM strategic equity deal with AstellasPharma (Dec. 10)</li></ul>Long-term Debt: $20 million (GE/SVB/Oxford term loan)<br />Shares Outstanding: 52 million<br />Revenue Growth<br />
    103. 103. Near Term Catalysts<br />Growth in commercial reconstructive and aesthetics business<br />Full RESTORE 2 data set presented<br />Breast augmentation investigator study publication, ENHANCE<br />Celution ONE- EU launch into Breast Recon/ OR market<br />Expanded sales team and reimbursement <br />PG approval Japan<br />Growing sales and device placements<br />Celgraft launch<br />Development Pipeline<br /><ul><li>Initiate ADVANCE and site activation</li></ul>Report 18-Mo APOLLO data<br />Potential approval and launch Celution ONE for no-option ischemia<br />US clinical and regulatory milestones<br />Partner expansion<br />
    104. 104. Thank You<br />

    ×