The News

CoreValve receives German government's approval to initiate clinical trial using its revalving™ system to percutaneously replace diseased aortic heart valves

03/01/2005

“Obtaining local IRB and now the German government’s approval to start our clinical trial represents another giant step forward in substantiating ReValving as the next-generation cath lab therapy for interventional cardiology. We fully expect to start this trial immediately.”
Jacques Séguin, MD, PhD
Chairman, CEO and Founder, CoreValve, S.A.

PARIS, Jan. 3, 2005—CoreValve S.A. announced today that it has received approval from the German government (Bezirksregierung Köln, state of Nordrhein-Westfalen, Cologne) to immediately commence a clinical trial of its proprietary ReValving™ System to non-surgically replace diseased aortic heart valves in 10 patients who are contraindicated for open-heart surgery.

Previously, CoreValve received ‘local’ IRB approval from The Heart Center, Seigburg, Germany, where the clinical trial will take place. The principal investigator will be Eberhard Grube, M.D., chief of cardiology at The Heart Center and a consulting professor of medicine at Stanford University. Professor Grube will perform the ReValving procedure in the cardiac catheterization (“cath”) laboratory at The Heart Center.

“Our recent clinical trial in Asia established the fact that ReValving is, indeed, feasible to non-surgically treat the widest possible range of patients, including traditional surgicalcandidates. Nevertheless, in Germany—and soon in other European countries as well—CoreValve will initially focus these trials on high surgical-risk patients,” said Jacques Séguin, M.D., chairman and CEO of CoreValve, S.A.

“While CoreValve’s strategy is to concentrate on the heart of the market—that is, traditional surgical-candidates for aortic valve replacement—we also will be sensitive to cardiologists’ appeals to treat the high surgical-risk cases, a definitive sub-segment of the percutaneous aortic valve replacement market, which we expect will ultimately fastforward physicians’ adoption of ReValving. Thus, high-surgical-risk cases will be included as we commence trials in different European countries,” said Professor Séguin.

“No doubt, obtaining IRB and government approval in Germany is a significant milestone in confirming ReValving as the next-generation cath lab therapy for interventional cardiology, because inclusion of leading European investigative institutions such as The Heart Center can be expected to accelerate adoption of CoreValve’s ReValving technology,” added Professor Séguin.

“We continue to believe that CoreValve’s ReValving approach has universal applicability to percutaneously treat the two most prevalent diseases of the aortic valve—stenosis and regurgitation—regardless of whether the patient is a regular surgical candidate, or presents with life-threatening co-morbidities, or is a high-risk surgical candidate,” concluded Professor Séguin.

About CoreValve
Privately held CoreValve, S.A., headquartered in Paris, France, has developed a proprietary delivery system for percutaneous heart valve replacement, based on a novel catheter-and-self-expanding-stent approach on a beating heart, thus avoiding open-heart surgery. The CoreValve procedure—with the proprietary CoreValve Percutaneous ReValving System™—can be performed in a cardiac “cath lab” just like angioplasty and stenting, resulting in less trauma to the patient and substantial cost-savings to the healthcare system.

This news release contains certain “forward-looking” statements under the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of CoreValve, are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements. Factors that could cause or contribute to such differences may include, but are not limited to, risks relating to the protection of intellectual property, changes to governmental regulation of medical devices, the FDA’s approval of new products, the impact of competitive products, changes to the competitive environment, the acceptance of new products in the market, conditions of the interventional cardiology industry and the economy and other factors.