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MassMedic Presentation 03-28-06 Innovation Accelerated SM
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CorNova, Inc. Company Overview Offices Corporate Headquarters – Burlington, MA CorNova GmbH – Munich, Germany CorNova Latin America – Buenos Aires, Argentina Public Partners
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Innovation Accelerated SM CorNova, Inc. Drug-Eluting Stents > $5 Billion Market (~4.5M DES deployed) DES 10x price of bare stent system in Europe Cypher (Cordis) & Taxus (Boston Scientific) only currently approved devices in US 2 nd Gen in Europe - Cypher-Select (Cordis) Taxus Liberte (Boston Scientific) Host of others (“-limus family”) Issues for current DES (especially in certain subsets) - Remaining Restenosis - Stent Thrombosis - Unapproved Indications
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Innovation Accelerated SM CorNova, Inc. Drug-Eluting Stents Restenosis (TLR) Combined Cypher Studies At 36 months Cypher 6.4% Bare 23.2% Combined Taxus Studies At 36 months Taxus 9.4% Bare 19.9% “Evidence-based medicine guidelines for drug-eluting stent use”, Greg Stone, Cardiovascular Research Foundation
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Innovation Accelerated SM CorNova, Inc. Drug-Eluting Stents Stent Thrombosis Combined Cypher Studies At 36 months Cypher 1.1% Bare 0.6% Combined Taxus Studies At 36 months Taxus 1.3% Bare 0.8% “Evidence-based medicine guidelines for drug-eluting stent use”, Greg Stone, Cardiovascular Research Foundation
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Innovation Accelerated SM CorNova, Inc. Drug-Eluting Stents Stent Thrombosis Milan/Siegburg Experience (Lakovou et al, JAMA 2005;293:2126-2130)
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Innovation Accelerated SM CorNova, Inc. Drug-Eluting Stents Unapproved Indications Bifurcations Long lesions Chronic total occlusions Left main disease In-stent restenosis Multivessel disease Acute MI “Evidence-based medicine guidelines for drug-eluting stent use”, Greg Stone, Cardiovascular Research Foundation
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Innovation Accelerated SM CorNova, Inc. Drug-Eluting Stents “The Pitiful Polymer”, John Orniston, MD, Dec 6, 2005 TaxusCypher
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Innovation Accelerated SM CorNova, Inc. Drug-Eluting Stents Taxus “The Pitiful Polymer”, John Orniston,MD, Dec 6, 2005
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Innovation Accelerated SM CorNova, Inc. Drug-Eluting Stents “The Pitiful Polymer”, John Orniston,MD, Dec 6, 2005 Balloon Expansion
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Innovation Accelerated SM CorNova, Inc. Drug-Eluting Stents “The Pitiful Polymer”, John Orniston,MD, Dec 6, 2005 Bifurcation
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Innovation Accelerated SM CorNova, Inc. Drug-Eluting Stents CorNova’s DES
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Innovation Accelerated SM CorNova, Inc. EU Regulatory Competent Authority (country specific under EN guidelines) Notified Body (engaged by company) Company (ISO 13485)
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Innovation Accelerated SM CorNova, Inc. Regulatory
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Innovation Accelerated SM CorNova, Inc. Regulatory
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Innovation Accelerated SM CorNova, Inc. Company Overview ISO 13485 Certification December 2005
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Innovation Accelerated SM CorNova, Inc. EU Regulatory Drug Authority (country specific) Notified Body Company Prior 2006 Dossier (I, Is, IIa, IIb, III device) Approval / Response Consultation?
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Innovation Accelerated SM CorNova, Inc. Regulatory Drug Authority (country specific) Notified Body Company Dossier Approval / Response Consultation!!!
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Innovation Accelerated SM CorNova, Inc. Regulatory FDA Company Dossier Notified Body Design History File ISO 13485 vs Design Control Guidance & Good Manufacturing Practice
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Innovation Accelerated SM CorNova, Inc. Company Overview Thank You
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