ARM Regen Med Investor Day: Cytori Presentation
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President Dr. Marc Hedrick gives a company presentation at the 1st Annual Regen Med Investor Day
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ARM Regen Med Investor Day: Cytori Presentation
- 1. 1st Annual Regen Med Investor Day Platform to Bedside Marc Hedrick, MD President
- 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 Platform: Technology STEP 1 Harvest patient tissue (100cc) STEP 2 Separate & Process STEP 3 Technology for cell Deliver ADRCs to isolation, combination with other factors, Same Patient, ~1 hr. storage and clinical therapy
- 4. Cytori Platform: Model Goal: Leadership in Regenerative Medicine Research & Regulatory Clinical Commercial Development Approval Use Device Safety Self Pay Basic Approvals Science CAPITAL PROFIT Efficacy Reimbursement Product Therapeutic Development Approvals
- 5. Cytori Platform: Case Study Radiation Injury, BARDA Ischemia & Japan EU CV Trials Gen One EU Breast Breast Device Approval Sales Pilot Pivotal Other Approvals & Applications
- 6. Cytori Cell Therapy: US Government Contract Discussions Award 3 Proof-of-concept Objectives 3 Objectives Trigger Option 1 Objective Begin Announcement Ongoing Option 1 & 3 Triggers Option 2 2010 Fall, 2012 Q1, 2014 Q4, 2015 Cell viability $32.6 M Option 1 Pre-Award, White Papers, Animal model POC Proposal, Negotiation $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
- 7. Cytori Platform: Clinical Trials and Studies 43 total: 2 Cytori sponsored trials & 41 investigator studies USA EU AP 1 23 13 Soft Tissue: 18 Wound: 7 Ischemia: 2 EM Ortho/Sport: 8 Vital Organ: 8 6 Total: 43