The News

Corevalve names Jack Lips as "European clinical manager"

03/10/2005

Seasoned medical device executive will oversee clinical trials in Europe, including the current Feasibility Trials as well as the CE Mark international clinical trial, of CoreValve’s minimally invasive
ReValving™ System for percutaneous aortic valve replacement (PAVR) as a successful alternative to open-heart surgery

IRVINE, Calif., and PARIS, Oct. 3, 2005—CoreValve announced today that it has appointed Jacobus (“Jack”) H. M. Lips as European Clinical Manager, effective immediately. In this position, Mr. Lips is responsible for overseeing current Feasibility Trials as well as initiating and managing the definitive international CE Mark clinical trial for the purpose of seeking marketing approval in Europe of the Company’s proprietary ReValving™ System for percutaneous aortic valve replacement (PAVR).

With CoreValve’s breakthrough ReValving™ System, heart valve replacement can be performed ‘non-surgically’ 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 compared with open-heart surgery to replace diseased heart valves. The CE Mark international clinical trial will use CoreValve’s second-generation ReValving™ System, consisting of its own proprietary porcine pericardium aortic heart valve, delivered via CoreValve’s 21-French-sized catheter. This secondgeneration ReValving™ System—thanks to its reduced overall catheter size—eases the delivery manipulation and therefore requires less time to implant—under 15 minutes in the last four patients.

“The start of our definitive European clinical trial for CE Marking in late 2006 will be a very significant milestone for CoreValve in the process of clinically validating our ReValving System,” said Jacques Séguin, M.D., Ph.D., chairman, CEO, and founder of CoreValve. “Consequently, we are delighted that Jack has joined our team. His tremendous experience and expertise in interventional cardiology devices make him the ideal individual to spearhead the execution of this momentous clinical trial, as well as other critically important clinical programs that will be launched shortly thereafter. We fully expect that Jack Lips will play a key role in sustaining CoreValve as the clear leader in percutaneous aortic valve replacement (PAVR).”

Mr. Lips, who is fluent in several languages, has more than two decades of experience in the clinical aspects of medical specialty device applications, both from cath lab and industry perspectives. His professional background includes nursing, clinical teaching (with a focus on intensive and coronary care), cardiology research, catheterization laboratory management, and interventional cardiology product clinical and sales management. Prior to joining CoreValve, he held similar responsibilities at InterVentional Technologies (BSC), Novoste and, more recently, at St Jude Medical. Prior to joining the medical device industry, Mr. Lips served in a variety of clinical and managerial positions at the Medical Centre De Klokkenberg and St. Ignatius Hospital in Breda, The Netherlands. He started his career in a nursing capacity at the Mathijssen Military Hospital (Utrecht, The Netherlands).

About CoreValve
Founded in 2001, privately held CoreValve—which is headquartered in Paris and has R&D and manufacturing facilities in Irvine, California—has developed a proprietary delivery system for percutaneous heart valve replacement, based on a novel catheter-and-self-expanding-frame 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.