The News

Corevalve reports it has certified its Irvine, Calif., clean room operations to be used in manufacturing company's Revalving™ system for percutaneous aortic valve replacement (PAVR)

16/05/2005

IRVINE, Calif., and PARIS, May 16, 2005—CoreValve (www.corevalve.com) announced today that it has completed the certification of the Company’s two ‘clean rooms’ at its R&D and manufacturing facility based in Irvine, Calif.

The 8,500-square-foot Irvine operation is a state-of-the-art research, development and manufacturing facility—with microbiology, biochemical, tissue fixation, and tissue-heart valve production capabilities. CoreValve is focusing its proprietary development and manufacturing programs—i.e., its ReValving™ frame, its tissue heart valve and valveto-frame assembly, as well as its loading and delivery catheter systems assembly—in this specialized facility. The Irvine ‘clean rooms’ are to be used for separate prosthesis and catheter production.

“We are in the final stage of completing our proprietary design of a novel pericardial valve, specifically intended for percutaneous delivery. The importance of this event to the interventional cardiology community is that our upcoming European clinical trial will be initiated with this new valve design—which will reduce the diameter of our delivery catheter to less than 21French size. This facility certification is the first step toward fabricating our second-generation ReValving System for clinical trial use,” said Rob Michiels, President of CoreValve USA.

“This milestone keeps CoreValve on schedule to commence a Phase II clinical trial later this year to meet our European CE-Marking objective,” added Dr. Jacques Séguin, founder, chairman and CEO of CoreValve. “The decision to design our own tissue valve and build it in-house on CoreValve’s patented frame is to optimize design and mounting so as to enhance valve durability—and make it comparable, if not superior, to surgical prostheses.”

About CoreValve
Privately held CoreValve, with U.S. headquarters in Irvine, Calif., has developed a proprietary delivery system for percutaneous aortic heart valve replacement (PAVR), 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.

Contact:
Ronald Trahan, APR,
Ronald Trahan Associates Inc
781-762-9782, x18