Edwards Lifesciences has announced that it has agreed to acquire CardiAQ Valve Technologies, a privately held company and developer of a transcatheter mitral valve implantation (TMVI) system. CardiAQ has received a FDA investigational device exemption (IDE) approval to conduct an early feasibility study of its TMVI system of up to 20 patients, and also plans to initiate a CE Mark study in Europe.
The purchase price is up to US$400 million, including US$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.
“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,” says Michael A Mussallem, Edwards’ chairman and chief executive officer. “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.”
As an update to the temporary pause in the Fortis programme, working closely with its global clinical investigators, Edwards recently completed its review and has reached agreement on protocol revisions to re-start enrolment.