Edwards Lifesciences to Acquire Valtech Cardio for $690 Million to Expand Transcatheter Mitral Valve Repair Portfolio

Edwards Lifesciences, the Irvine, California-based medical device company, has been increasingly doubling down on transcatheter therapies for the mitral valve.Edwards Focused on structural heart disease, it dominates the U.S. transcatheter valve replacement device market and recently announced the acquisition of the Israeli company Valtech Cardio for $690 million. Valtech possesses a technology called “Cardioband”^TMThe “System” product repairs heart valves via transcatheter therapy.

Cardioband, Valtech’s Technology Acquired by Edwards Lifesciences^TMSystem

Transcatheter cardiac therapy is a technique that involves inserting catheters through peripheral vessels to reach various chambers of the heart and major blood vessels, enabling minimally invasive treatment for structural heart diseases. It is even regarded as a “non-surgical” approach. CardiAQ, a company previously acquired by Edwards Lifesciences, developed the world’s first self-aligning and self-anchoring technology for transcatheter mitral valve implantation (TMVI).

By early 2017, Edwards will pay Valtech $340 million in stock and cash, with the remaining $350 million to be paid out over the next decade through milestone-based payments. The specific structure of these milestone payments has not been disclosed; however, companies like Edwards Lifesciences typically conduct periodic post-acquisition assessments of the acquired entity, evaluating factors such as regulatory approvals for new products and market revenue. Each subsequent tranche of funding is contingent upon the outcomes of these evaluations.

“We are delighted to see that Edwards, a global leader in medical devices, has set its sights on the field of transcatheter therapies for structural heart disease. We believe this collaboration will enable Valtech’s Cardioband product to fully realize its potential in treating mitral regurgitation,” said Amir Gross, CEO of Valtech Cardio.

Left ventricular enlargement in patients with mitral regurgitation leads to papillary muscle dysfunction, thereby impairing the function of the mitral valve and the mitral annulus. This can ultimately result in restricted leaflet motion and blood regurgitation, which may even lead to heart failure in severe cases. For patients with functional mitral regurgitation, Valtech’s Cardioband^TMThe therapeutic approach of this system differs from traditional cardiac surgery, employing a transcatheter method for implant-based reconstruction.

Cardioband^TMThe system employs a femoral vein puncture technique, in which the catheter is inserted via the femoral vein, traverses the diaphragm, and enters the heart. A distinctive feature is that the device for repairing the mitral annulus is customized for each patient.

Cardiac valve therapy can be performed via femoral vein puncture.

“Throughout our ongoing exploration of treatment options for related diseases, we have found that Valtech’s products can complement our comprehensive portfolio of heart valve repair and replacement devices,” said Michael Mussallem, Chairman and CEO of Edwards Lifesciences. “We are currently advancing multiple internal projects with promising progress and prospects, and we are confident that Valtech’s talented team and heart valve technologies will bring us additional opportunities.”

Last year, after spending approximately $400 million to acquire CardiAQ, Edwards launched its own transcatheter heart valve replacement program. This is one of the in-house projects mentioned by Mussallem. Valve replacement using the CardiAQ system can be performed via two approaches: one is the retrograde approach, accessing the ventricle through the femoral vein in the thigh; the other is the antegrade approach, entering directly via the cardiac apex.

Edwards Lifesciences had not initially intended to acquire a company specializing solely in mitral valve replacement technology. However, since Valtech could optimize CardiAQ’s valve and Edwards was indeed determined to accumulate resources in the heart valve sector, it decided to proceed with another acquisition, this time of Valtech. Prior to the completion of the acquisition transaction, Valtech will temporarily delay its early-stage research program on transcatheter mitral valve replacement.

Valtech Cardio, founded in 2005, is a private company specializing in the repair and replacement of the mitral and tricuspid valves, with more than 150 patents granted or pending. In addition to Cardioband, which attracted the interest of Edwards Lifesciences,^TMBeyond their system, they also have a surgical valve repair portfolio and Cardiovalve, which is currently under development.^TMTranscatheter Valve Replacement System. Valtech Cardio possesses its own resources throughout the entire process of research and development, manufacturing, and clinical studies.