CardiAQ Transcatheter Mitral Valve Implantation System image courtesy of CardiAQ Valve Technologies
July 13, 2015 - Edwards Lifesciences Corp. announced that it has agreed to acquire CardiAQ Valve Technologies Inc., a privately held company and developer of a transcatheter mitral valve replacement (TMVR) system.
CardiAQ has received a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to conduct an early feasibility study of up to 20 patients, and also plans to initiate a CE mark study in Europe.
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. Edwards expects that this acquisition will be slightly dilutive to 2015 earnings per share. The company will provide updated financial guidance for 2015 when second quarter earnings are released on July 28.
As an update to the temporary pause in the Fortis program, working closely with its global clinical investigators, Edwards recently completed its review and has reached agreement on protocol revisions to re-start enrollment.
The CardiAQ and Fortis valve systems are not approved for sale in any country.
For more information: www.edwards.com