Edwards Lifesciences, the Irvine, California-based medical device company is betting big on the transcatheter mitral valve therapies.
On Monday, the structural heart company that dominates the transcatheter aortic valve replacement market in the U.S. announced that it is buying Valtech Cardio, an Israeli company for up to $690 million. Valtech Cardio has developed the Cardioband System to repair mitral and tricuspid valves using catheters.
When the transaction closes in early 2017, Edwards will fork up $340 million in cash and stock with the promise to make milestone payments of an additional $350 million over the next decade. Those “pre-specified” milestone payments were not clearly spelled out but, usually, involve regulatory approvals and revenue goals for novel products that acquirers like Edwards hope will be successful in the marketplace.
Instead of surgically repairing the problem, the Cardioband System uses a transcatheter approach to place a reconstruction implant for patients suffering from functional mitral regurgitation. In functional MR, the left ventricle of the heart is enlarged, and that leads to a displacing of the papillary muscles that support the two valve leaflets and the stretching the valve opening known as the annulus. As a result, valve leaflets fail to come together to close the annulus causing blood to flow back into the atrium, a dangerous condition that can cause heart failure.
Through the Cardioband System, a catheter is inserted into the femoral vein and delivered through a transseptal approach across the septum of the heart. The devices that closes the annulus is designed to conform to each patient’s specific annular geometry.
“As we continue to pursue multiple therapies to address the diverse needs of patients affected by heart valve disease, we saw an important opportunity to incorporate Valtech’s technologies into our comprehensive heart valve repair and replacement portfolio,” said Michael Mussallem, Edwards’ chairman and CEO, in the news release. “We recognize that physicians will likely need a toolbox of options to treat their patients most effectively. We are very pleased with the progress and future prospects of the multiple internal programs we have underway, and we believe the addition of Valtech’s talented team and mitral and tricuspid technologies will present even more opportunities to help patients.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Mussallem has previously described the transcatheter mitral valve space as one that would require companies to develop both replacement and repair approaches.
Last year, Edwards shelved its own internal, transcatheter mitral valve replacement program after it acquired CardiAQ Valve Technologies for about $400 million. That is one of the “multiple internal programs” that Mussallem refers to.
Meanwhile, before the transaction closes, Valtech will spin out its early-stage transseptal mitral valve replacement technology program. But although Edwards doesn’t want to buy this particular mitral valve replacement technology, given that it is advancing the CardiAQ valve, it appears to want to have its hands in as many TMVR cookie jars as possible. The press release noted how Edwards will retain the right to acquire that early-stage transseptal mitral replacement device in the future.
The CardiAQ system can be used both transfemorally – through the femoral artery in the leg – and transapically – directly through the apex of the heart.
Photo: Nicol??s Mero??o, Getty Images
