Vericel Corporation · NASDAQ:VCEL
Vericel — Aastrom Biosciences — Investor Presentation (August 2005)
26 slides from Vericel's investor presentation, Aug 26, 2005
Slide 1: Proprietary Cell Products for Tissue Regeneration
Proprietary Cell Products for Tissue Regeneration (Nasdaq:ASTM) Investor Presentation August, 2005
Slide 2: Safe Harbor
This presentation contains forward-looking statements, including, without limitation, statements concerning product-development objectives and anticipated timing, clinical trial timing and expected results, potential market opportunities and revenue models, market development plans, anticipated key
Slide 3: Summary
Summary Emerging as a leading tissue regeneration company Proprietary bone marrow stem cell products: Tissue Repair Cells Business model based on clinical experience and ability to apply TRCs to multiple markets In clinic with multiple Phase II-level trials for bone grafting New Phase II-level trial
Slide 4: Capturing the Therapeutic Potential of Bone Marrow Stem Cells
Capturing the Therapeutic Potential of Bone Marrow Stem Cells Regenerate tissues with stem cells grown from bone marrow collected from the patient...
Slide 5: Tissue Repair Cells: Bone Marrow Plus
Tissue Repair Cells: Bone Marrow Plus Small aspirate collected from patient Office procedure Cells go to production lab Centralized facility TRCs generate healthy tissues > 180 patients treated to date TRCs produced in AastromReplicell System Proprietary technology
Slide 6: Aastrom Tissue Repair Cell Product
Aastrom Tissue Repair Cell Product TRCs Multi-Lineage Stem/Progenitor Cells Bone Vascular Others Growth Factor Production BMPs VEGF SCGF Others Bone Marrow Derived Cells Natural Tissue Regeneration Process New Capability in Tissue Regeneration
Slide 7: Aastrom's Business Model
Aastrom's Business Model TRCs Aastrom Core Business Infrastructure Tissue Repair Cell Products Developed for Multiple Indications Patient-Specific Cell Manufacturing and Distribution Development & Marketing Alliances Bone Grafting Fractures Jaw Reconstruction Spine Fusion Limb Ischemia Future Percut
Slide 8: Development Pipeline
Development Pipeline Research Preclinical Clinical Market Comments U.S. Europe Jaw reconstruction - Europe (Sinus lift for dental implants) Spine fusions Long bone fractures Bone Grafting Vascular Tissue Cardiac ischemia Peripheral limb ischemia Trial enrolling at 5 sites Positive results reported R
Slide 9: TRCs in Bone Grafting
TRCs in Bone Grafting Complete Phase I/II trials to establish ability of TRCs to induce bone growth in three bone types (long bone, spine, facial) Select indication to continue Phase III level trials for market registration (FDA in US; EMEA in EU) Explore additional trials to expand market potential
Slide 10: Potential for TRCs in Bone Grafting
Potential for TRCs in Bone Grafting
Slide 11: Bone Graft Market Opportunity
Autograft Allograft & DBM BMPs Synthetics East 0.48 0.27 0.09 0.16 TRCs East 0.05 0.95 Bone Graft Market Opportunity Target the Autograft Segment for Severe Indications Source: Millennium Research Group CY2009 projections (U.S., Europe and Japan) BMP = Bone Morphogenic Proteins DBM = Demineralized B
Slide 12: TRCs for Bone Grafting: Bone Fracture Indications
TRCs for Bone Grafting Bone Fracture Indications
Slide 13: Bone Graft Clinical Plan
Bone Graft Clinical Plan EU Lead proof of concept study initiated in Spain in 2Q CY2004 Long term non-union fractures (failed standard treatment) First phase (6 treatments) completed; positive trial results reported May 2005 Process underway to expand trial United States Phase I/II multi-center tria
Slide 14: TRCs and Matrix
TRCs and Matrix 200mm Combining TRCs and Matrix Micrograph of TRCs in Matrix
Slide 15: Non-Union Fracture Trial
Non-Union Fracture Trial * Clinical Situation: Non-union fracture of humerus which failed fixation and autograft (> 8 months) Candidate Patient X-Rays * Point of Fracture
Slide 16: Non-Union Fracture Trial: Fixation Removed
Non-Union Fracture Trial Fracture Site with Previous Fixation Removed
Slide 17: Non-Union Fracture Trial: New Fixation Applied
Non-Union Fracture Trial Fracture Site with New Fixation Applied
Slide 18: Non-Union Fracture Trial: TRCs and Matrix Applied
Non-Union Fracture Trial TRCs and Matrix Applied at Fracture Site TRCs and Matrix
Slide 19: Non-Union Fracture Trial: Patient Recovery
Non-Union Fracture Trial Patient Recovery (5 Months) Fracture Site
Slide 20: TRCs for Vascular Tissue: Limb Ischemia Indication
TRCs for Vascular Tissue Limb Ischemia Indication
Slide 21: Limb Ischemia (Veins and Arteries)
Limb Ischemia (Veins and Arteries) Large market opportunity, with limited therapeutic competition Diabetic and Buerger's disease patients Targeted 1+ million patients in need of surgery for severe limb ischemia Reimbursement levels are high for interventional treatments Published clinical results su
Slide 22: Limb Ischemia: Effect of Large Volume Bone Marrow
Limb Ischemia Effect of Large Volume Bone Marrow Sources: Lancet 360: 427-435, 2002 (left panel) Eur J. Vasc Endovasc Surg 00, 1-3, 2002 (right panel)
Slide 23: Vascular Tissue Clinical Plan
Vascular Tissue Clinical Plan Lead Trial (Phase II Level) Clinical trial agreement with HDZ in Bad Oeynhausen, Germany Cell manufacturing license process obtained and patient accrual to begin in CY2005 Trial Objectives Evaluate TRCs vs Bone Marrow vs Standard of Care to increase vascularization and
Slide 24: Partnering
Partnering Largest provider of allograft tissue matrix (>$250 million revenue) Companies both contribute to development and clinical expenses for products that combine TRCs and MTF matrix Companies sell their own products and coordinate marketing Targeting other relationship(s) for synthetic matrix
Slide 25: Aastrom Balance Sheet Data
Aastrom Balance Sheet Data (March 31, 2005 *) Cash and Investments $ 35,400,000 Total Assets $ 37,000,000 Shareholders' Equity $ 36,200,000 Average Cash Usage Per Month $ 1,000,000 * Per Aastrom Biosciences, Inc. Form 10-Q for quarter ended March 31, 2005
Slide 26: Proprietary Cell Products for Tissue Regeneration
Proprietary Cell Products for Tissue Regeneration (Nasdaq:ASTM)
Aastrom Biosciences — Investor Presentation (August 2005) on 6ix