MassMedicPresentation03-28-06

Innovation Accelerated SM

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

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

2nd 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;293:2126-2130)

0%

1%

2%

3%

4%

5%

6%

All Patients Diabetes Bifurcation Renal Failure

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 13485 CertificationDecember 2005

Innovation Accelerated SM

CorNova, Inc.

EU Regulatory

Drug Authority(country specific)

Notified BodyCompany

Prior 2006

Dossier (I, Is, IIa, IIb, III device)

Approval /Response

Consultation?

Innovation Accelerated SM

CorNova, Inc.

Regulatory

Drug Authority(country specific)

Notified BodyCompany

Dossier

Approval /Response

Consultation!!!

Innovation Accelerated SM

CorNova, Inc.

Regulatory

FDA

Company

Dossier

Notified Body

DesignHistory File

ISO 13485 vs Design Control Guidance & Good Manufacturing Practice

Innovation Accelerated SM

CorNova, Inc.

Company Overview

Thank You