MassMedic Presentation Innovation Accelerated SM

CorNova, Inc. Company Overview Offices  Corporate Headquarters – Burlington, MA  CorNova GmbH – Munich, Germany  CorNova Latin America – Buenos Aires, Argentina Public Partners

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

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

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

Innovation Accelerated SM CorNova, Inc. Drug-Eluting Stents Stent Thrombosis Milan/Siegburg Experience (Lakovou et al, JAMA 2005;293: )

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

Innovation Accelerated SM CorNova, Inc. Drug-Eluting Stents “The Pitiful Polymer”, John Orniston, MD, Dec 6, 2005 TaxusCypher

Innovation Accelerated SM CorNova, Inc. Drug-Eluting Stents Taxus “The Pitiful Polymer”, John Orniston,MD, Dec 6, 2005

Innovation Accelerated SM CorNova, Inc. Drug-Eluting Stents “The Pitiful Polymer”, John Orniston,MD, Dec 6, 2005 Balloon Expansion

Innovation Accelerated SM CorNova, Inc. Drug-Eluting Stents “The Pitiful Polymer”, John Orniston,MD, Dec 6, 2005 Bifurcation

Innovation Accelerated SM CorNova, Inc. Drug-Eluting Stents CorNova’s DES

Innovation Accelerated SM CorNova, Inc. EU Regulatory Competent Authority (country specific under EN guidelines) Notified Body (engaged by company) Company (ISO 13485)

Innovation Accelerated SM CorNova, Inc. Regulatory

Innovation Accelerated SM CorNova, Inc. Regulatory

Innovation Accelerated SM CorNova, Inc. Company Overview ISO Certification December 2005

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?

Innovation Accelerated SM CorNova, Inc. Regulatory Drug Authority (country specific) Notified Body Company Dossier Approval / Response Consultation!!!

Innovation Accelerated SM CorNova, Inc. Regulatory FDA Company Dossier Notified Body Design History File ISO vs Design Control Guidance & Good Manufacturing Practice

Innovation Accelerated SM CorNova, Inc. Company Overview Thank You