Vericel Corporation · NASDAQ:VCEL
Vericel — Aastrom Biosciences — Investor Presentation (January 2010)
20 slides from Vericel's investor presentation, Jan 8, 2010
Slide 1: Investor Slide Presentation January 2010
Investor Slide Presentation January 2010 Developing Regenerative Medicine Therapies to Treat Severe Chronic Cardiovascular Diseases
Slide 2: Safe Harbor
2 2 Safe Harbor This presentation contains forward-looking statements, including, without limitation, statements concerning product-development objectives, clinical trial strategies, clinical trial timing and expected results, market data, potential market opportunities, market development plans, an
Slide 3: Aastrom Overview
3 3 Aastrom Overview Cardiac Phase II Clinical Development Regenerative medicine company developing personalized cell-based therapies to slow or reverse the course of severe, chronic cardiovascular diseases Vascular Dilated Cardiomyopathy (DCM) Critical Limb Ischemia (CLI)
Slide 4: Aastrom Cell Products
4 Aastrom Cell Products Personalized cell-based therapies 4 2 - Cells produced in centralized GMP manufacturing facility 3 - Patient-specific cell products with significantly increased stem and progenitor cells 4 - Personalized cell therapy injected into the patient based on target indication Cardia
Slide 5: Aastrom's Expansion of Stem and Progenitor Cells
5 5 5 Hematopoietic and Endothelial Stem Cells Macrophages Autologous Bone Marrow Endothelial Precursor Cells Aastrom's TRC-Based Products Mesenchymal Stem Cells Aastrom's Expansion of Stem and Progenitor Cells
Slide 6: Aastrom's Mixed Cell Population
6 Aastrom's Mixed Cell Population Most promising opportunity for near-term success Source: Leerink Swann KOL interviews Tissue-Specific Stem Cells "Skeletal myoblasts to date have failed miserably in clinical trials" Isolate tissue-specific stem cells of interest Difficult to isolate and expand due
Slide 7: Clinical Development Pipeline
7 7 Clinical Development Pipeline Driving cardiovascular therapies to market RESEARCH PRECLINICAL PHASE II (2007-2010) PHASE III PIVOTAL Critical Limb Ischemia DCM - Catheter CARDIAC DCM - Surgical Vascular
Slide 8: Dilated Cardiomyopathy Opportunity
Dilated Cardiomyopathy Opportunity Largest growing segment of heart failure population; significant unmet need due to limited therapeutic options 8 8 Cardiac Regeneration for Severe Heart Failure 5.5 million Americans with heart failure (Class I - IV), the largest medical expenditure in the U.S. 120
Slide 9: Cardiac Regeneration
9 9 Cardiac Regeneration Need for therapy to reverse disease progression Source: Aastrom; EU compassionate use case and U.S. IMPACT-DCM clinical trial Normal Heart Cardiac Repair Cell (CRC) Treatment Approach Dilated Cardiomyopathy Heart typically size of fist Enlarged heart and reduced pump functio
Slide 10: IMPACT-DCM Surgical Clinical Trial
Status: Enrollment initiated Nov 2008; 37 patients enrolled by end of Dec 2009; enrollment completion expected Jan 2010 10 10 IMPACT-DCM Surgical Clinical Trial U.S. Phase II Dilated Cardiomyopathy Trial 40 patient, randomized, controlled, open-label study 20 patients with ischemic DCM; 20 patients
Slide 11: IMPACT-DCM - Early Findings
11 IMPACT-DCM - Early Findings American Heart Association Meeting November 2009 Data from patients who have completed 6-month follow-up visit (n=10) These patients (ischemic and non-ischemic) entered treatment as NYHA Class III NYHA Class I (best) to Class IV (worst) Part of presentation by Dr. Amit
Slide 12: IMPACT-DCM Patient Case Study
12 12 58 year old male patient diagnosed with ischemic dilated cardiomyopathy 22 year U.S. Air Force Veteran Cardiac left ventricular ejection fraction (LVEF) of ~20%; NYHA class III heart failure Suffered from lack of energy and reduced stamina Profile Patient #1 - Thomas Clegg Treated with CRCs in
Slide 13: Catheter DCM Clinical Trial
13 13 Catheter DCM Clinical Trial U.S. Phase II Dilated Cardiomyopathy Trial 24 patient, randomized, controlled, open-label study 12 patients with ischemic DCM; 12 patients with non- ischemic DCM Randomized 2:1 treatment vs. control Up to 4 treatment centers planned CRCs delivered as monotherapy Tra
Slide 14: Critical Limb Ischemia Opportunity
14 14 Critical Limb Ischemia Opportunity Vascular Regeneration for Severe Critical Limb Ischemia Source: Allie, Herbert. Vascular Disease Management. 2006; Barzilay et al. Diabetes Care. 2001; Bianchi et al. Diabetes Research and Clinical Practice. 2007; Jensen et al. Eur J Vasc Endovasc. 2006; The
Slide 15: RESTORE-CLI Clinical Trial
15 RESTORE-CLI Clinical Trial U.S. Phase IIb Critical Limb Ischemia Trial Up to 150 patients in a prospective, controlled, randomized, double-blind study Randomized 2:1 treatment vs. control Up to 30 treatment centers Vascular Repair Cells (VRCs) delivered as monotherapy Direct injection of VRCs int
Slide 16: Vascular Regeneration (Patient I)
16 Patient Profile Pre-Vascular Repair Cell (VRC) Treatment 44 Weeks Post-VRC Treatment VRC Intramuscular Injection into Calf Muscle 69 year old male patient; co-morbidities: coronary heart disease, chronic heart failure, hyperlipidemia, hypertension; previous treatment methods failed to heal ulcers
Slide 17: Vascular Regeneration (Patient II)
17 Vascular Regeneration (Patient II) Diabetic Foot Wound Patient Treatment Source: Stratmann, Kirana, Tschope, Diabetes Center at the Heart and Diabetes Center in North Rhine-Westphalia, Bad Oeynhausen, Germany Critical limb ischemia and serious gangrene Forefoot amputation followed by VRC administ
Slide 18: Aastrom Advantages
18 Minimizes risk of cell rejection Potential for long-term engraftment TRC technology based on mixed cell populations Regenerate multiple tissue types Expansion of stem and early progenitor cell populations Therapeutic advantage with increased numbers of early stage cells U.S. and EU GMP cell manuf
Slide 19: Clinical Milestones
19 Clinical Milestones History of achieving clinical milestones 2009 Report preliminary 6-month interim data on all 40 IMPACT-DCM patients once all patients have completed 6- month follow-up visit Report RESTORE-CLI trial interim data (Q1 2010) 2010 Report interim data from the IMPACT- DCM surgical
Slide 20: Developing Regenerative Medicine Therapies to Treat Severe Cardiovascular Diseases
Nasdaq:ASTM Developing Regenerative Medicine Therapies to Treat Severe Cardiovascular Diseases 1/10-IR-V2
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