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Tepha at forefront of U.S. Opportunities in Heart Valve Disease Management

Health Research International/Medtech Insight Forecasts Nearly 11% Annual Growth in Heart Valve Market Through 2010 as Transcatheter Technologies Begin to Expand Treated Population

Hundreds of thousands of patients in the U.S., including a large share with congestive heart failure, could potentially benefit from heart valve repair or replacement. However, because both are currently performed as open heart procedures requiring cardiopulmonary bypass, less than 94,000 individuals underwent heart valve surgery in 2001 due to its invasiveness, risks and cost.

This situation is expected to change dramatically over the next decade as the emergence of minimally invasive and transcatheter heart valve repair techniques significantly reduces the risks and costs associated with heart valve procedures. Collapsible and compressible valve prostheses, transcatheter valve repair technologies, anticalcification treatments, and innovative valve suturing technologies are among the key developments that will enable this trend, and their impact is expected to be felt as soon as 2005, contributing to the 6.4% annual growth in heart valves and related products, from $420 million in 2001 to $573 million in 2006. This initial expansion will be followed by dramatic gains in the ensuing four-year period ending in 2010 as the transcatheter segment alone — primarily repair products used to treat congestive heart failure — potentially exceeds $500 million. Tissue-engineered heart valves are expected to become a clinical reality only after 2006; however, their impact, too, will be significant. In the interim, tissue valve prostheses will continue to gain share from mechanical prostheses, and improved products and protocols for valve repair, including minimally invasive surgical repair performed without cardiopulmonary bypass, will increase their share of the total procedure caseload.

These are among the findings of Health Research International’s comprehensive new report, “U.S. Opportunities in Heart Valve Disease Management,” which will be marketed by Medtech Insight. Products covered in the report include: tissue, mechanical, autograft and allograft valve prostheses; valve repair products; mechanical valved grafts and conduits (including in-depth discussions of both the Ross and Rastelli procedures), balloon valvuloplasty catheters, new valve suturing technologies, tissue- engineered valves, and emerging percutaneous valve repair and replacement technologies. Supplier shares are provided for each major product type, and the market forecasts incorporate intensive econometric analysis of leading indicators, penetration rates and product usage per procedure, as well as the important clinical and cost considerations driving usage.

Companies whose products and strategies are detailed in the report include: 3F Therapeutics, Advanced Tissue Sciences, AorTech International, ATS Medical, Autogenics, Axya Medical, Boston Scientific Corporation, CardioMend, Cleveland Clinic Foundation, Corazon Technologies, Cryolife, Edwards Lifesciences, Evalve, Genzyme Biosurgery, JOMED, Medical Carbon Research Institute, Medical CV, Medtronic, Mitralife, Percutaneous Valve Technologies, Sorin Biomedica, St. Jude Medical, Sulzer Carbomedics, TEI Biosciences, Tepha, Toray Industries (America) and Triflo Medical, among others.

“U.S. Opportunities in Heart Valve Disease Management” is part of a comprehensive new series being rolled out over a six-month period that will be marketed as part of an exclusive arrangement with Medtech Insight. Other series reports cover: Interventional Coronary Revascularization, Surgical Revascularization, Nontraditional Revascularization Technologies, Management of Atrial Fibrillation, Adjunctive and Ancillary Transcatheter Technologies, Cardiac Assist Technologies and Rhythm Management, among others. Each report ranges from 200 to 500 pages and contains up to 100 exhibits that present detailed market forecasts, analyses, product offerings, key clinical outcomes and companies. Additional details for all reports, including tables of contents are available upon request by contacting Scott Pantel of Medtech Insight at 714-596-5353 or via fax 714-596-3838, toll free in the U.S. 888-290-2225, or by email at scott@medtechinsight.com or by visiting http://www.medtechinsight.com/reports.html.