Edwards Will Acquire CardiAQ and Restart Fortis Clinical Program

July 10, 2015—Edwards Lifesciences announced that it has agreed to acquire CardiAQ Valve Technologies, Inc., a privately held company. The purchase price is up to $400 million, including $350 million in cash at closing and the remainder payable upon achievement of a European regulatory milestone. The transaction remains subject to customary closing conditions. Both Edwards and CardiAQ are based in Irvine, California.

CardiAQ is the developer of a transcatheter mitral valve replacement system that can be delivered through multiple delivery systems. The device's anchoring mechanism engages and utilizes the patient's native mitral valve anatomy, allowing interventionists to implant a new mitral valve within a beating heart without circulatory support. CardiAQ has received a US Food and Drug Administration investigational device exemption approval to conduct an early feasibility study of up to 20 patients and also plans to initiate a CE Mark study in Europe.

The announcement also advised that Edwards, working closely with its global investigators, has completed its review of the clinical program for its investigational Fortis transcatheter mitral valve and has reached agreement on protocol revisions to restart enrollment. On May 19, the company announced that, in consultation with trial investigators, it had voluntarily implemented a temporary pause on enrollment in the Fortis program.

The CardiAQ and Fortis valve systems are not approved for sale in any country, stated Edwards Lifesciences.

In the company’s press release, Edwards’ Chairman and Chief Executive Officer Michael A. Mussallem commented, “Edwards' primary strategy is to create valuable therapies that transform patient care. We believe the acquisition and integration of CardiAQ will advance our development of a transformational therapy for patients with mitral valve disease who aren't well served today. While still early in the development of this therapy, the progress of the team of employees and clinicians working on our Fortis mitral replacement system has reinforced our confidence in a catheter-based approach. We believe the experiences and technologies of Fortis and CardiAQ are complementary and that this combination will enable important advancements for patients.”

Rob Michiels, Chief Executive Officer of CardiAQ, stated, “CardiAQ is proud of our pioneering efforts in the early development of this transcatheter mitral valve therapy conceived by cardiac surgeon Arshad Quadri, MD. We believe our technology, which incorporates multiple delivery approaches with a single valve, shows great promise for patients.” CardiAQ’s cofounder, President and Chief Operating Officer J. Brent Ratz, added, “We look forward to joining Edwards, whose experience and leadership as a developer of breakthrough therapies for heart valve disease will advance our work.”