Edwards Lifesciences (NYSE:EW) last week said it agreed to pay $400 million for CardiAQ Valve Technologies and its transcatheter mitral valve implant, saying it also reached a deal to revise the protocol for restarting a trial of its own Fortis mitral valve.
The deal for CardiAQ Valve, which like Edwards is based in Irvine, Calif., calls for an up-front payment of $350 million in cash and another $50 million pegged to “achievement of a European regulatory milestone,” Edwards said. The deal is expected to be “slightly dilutive” to 2015 earnings, the company said.
“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,” chairman & CEO Michael Mussallem said in prepared remarks. “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.”
“CardiAQ is proud of our pioneering efforts in the early development of this transcatheter mitral valve therapy conceived by cardiac surgeon Dr. Arshad Quadri. We believe our technology, which incorporates multiple delivery approaches with a single valve, shows great promise for patients,” added CardiAQ CEO Rob Michiels.
In April, CardiAQ won an investigational device exemption from the FDA for a 20-patient feasibility trial of its as-yet-unnamed TMVI candidate, with a protocol calling for 10 subjects to be treated transfemorally and another 10 treated via the transapical approach.
“We look forward to joining Edwards, whose experience and leadership as a developer of breakthrough therapies for heart valve disease will advance our work,” co-founder, president & COO Brent Ratz said in a statement.
Edwards also said it reached a deal with the investigators in its Fortis trial for changes to study’s protocol, after blood clots in some of the 20 patients implanted with the device prompted a temporary halt for the trial.