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Edwards Makes Significant Moves in the Mitral Valve Space

As the Irvine, CA-based company strengthens its mitral valve portfolio, it also faces a lawsuit from Abbott Laboratories over the Pascal system.

Edwards Lifesciences bolstered its presence in the mitral valve space through a pair of transactions it announced Monday. The Irvine, CA based company invested $35 million in an exclusive right to acquire Corvia Medical and in addition the firm obtained certain assets of Mitralign for an undisclosed sum.

Edwards investments come on the heels of Boston Scientific exercising its option to acquire the remaining shares of Millipede Inc. for $325 million. In addition, the Marlborough, MA-based company said a $125 million payment becoming available upon achievement of a commercial milestone.

Tewksbury, MA-based Corvia Medical’s InterAtrial Shunt Device is designed to provide continuous and dynamic decompression of the left atrium, which may reduce symptoms and slow the progression of heart failure. The therapy has received CE Mark and is being studied as part of an FDA pivotal clinical trial. In August, the company reported strong one-year follow-up data from the REDUCE LAP-HF I clinical study of the Interatrial Shunt Device.

In the Mitralign deal, Edwards said the assets including intellectual property and associated clinical and regulatory experience. Tewksbury, MA-based Mitralign is developing an investigational transcatheter annuloplasty system designed to treat functional mitral and tricuspid regurgitation.

Edwards made a big splash in the mitral valve space back in 2015. During this time, the firm spent up to $400 million to acquire CardiAQ Valve Technologies and its transcatheter mitral valve replacement system.

Also in 2016, Edwards would go on to acquire Yehuda, Israel-based Valtech Cardio Ltd. for about $340 million, with about $350 million in milestone payments.

During Edwards’ most recent earnings call, the company’s CEO spoke about the success the firm was having in the mitral valve space.

“Turning to our Transcatheter Mitral and Tricuspid therapies, or TMTT,” Mussallem said according to a transcript from Seeking Alpha. “We remain enthusiastic about the opportunities to treat the many patients suffering from these deadly heart valve diseases. As we previously outlined, we continued to invest aggressively in our portfolio and plan to achieve significant milestones in 2019.”

However, it hasn’t been smooth sailing for Edwards on the mitral valve front. Earlier this year, Abbott Laboratories said it had filed a lawsuit against Edwards saying the Irvine, CA-based company’s Pascal System for repairing a damaged mitral valve infringes on five patents for (Abbott’s) the MitraClip.

During Edwards’ most recent earnings call, Mussallem addressed the lawsuit.

“We were disappointed to learn earlier this week that Abbott is pursuing patent litigation regarding our Pascal system in the U.S., UK and Germany,” Mussallem said according to a Seeking Alpha Transcript. Pascal represents the culmination of 20 years of innovation by Edwards to develop a novel differentiated and more advanced platform for patients in need. The IP landscape for transcatheter mitral therapies is complex and crowded. In fact, Edwards owns an impressive portfolio of intellectual property in this space. We plan to vigorously defend ourselves and are currently evaluating a range of responses.”

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