Boston Scientific picks up Neovasc's tissue processing technology and facility, an acquisition intended to support the manufacture of the Lotus transcatheter aortic valve.

Boston Scientific announced a $75 million cash deal that includes Neovasc's tissue processing and manufacturing capabilities as well as a 15% equity interest in the Canadian cardiovascular company. Boston Scientific has agreed to pay approximately $67.9 million for Neovasc's tissue processing technology and facility and will invest approximately $7.1 million in the company, according to a Neovasc press release.

The acquisition, which is expected to close by the end of 2016, is meaningful to Boston Scientific's structural heart business, as the company anticipates bringing its Lotus Valve System for transcatheter aortic valve replacement (TAVR) to the U.S. market in late 2017, contingent upon regulatory approval.

"We continually seek ways to optimize our manufacturing processes and enhance our product portfolio," Ed Mackey, executive vice president of operations at Boston Scientific, said in the company's press release. "The vertically integrated operational capabilities resulting from this acquisition will strengthen our structural heart pipeline and immediately benefit our Lotus valve platform as we work to increase our market share in Europe and prepare for launch in the U.S., expected in late 2017."

For Neovasc, this transaction allows them continue tissue and valve assembly for its existing customers through a license to the sold assets and access to the sold facilities, according to the company's release. Neovasc is also able to continue its own tissue-related programs.

"Boston Scientific has been a long-term customer of Neovasc, having historically represented a sizeable percentage of our tissue processing revenues," Neovasc CEO Alexei Marko, said in the company's release. "As one of the world's premier device companies, with a global cardiovascular franchise, this investment in Neovasc enables continued development of our lead products, Reducer and Tiara, and strengthens our resolve to revolutionize how structural disease is treated."

Neovasc is developing a transcatheter mitral valve replacement, called Tiara. In late November, Neovasc received regulatory and ethics committee approval to start a 115-patient non-randomized, prospective study in Italy. Patient enrollment is expected to start in early 2017 and the company plans to use data from the study to file for CE Mark approval of Tiara.

Boston Scientific's next-generation TAVR, Lotus Edge, received CE Mark in September 2016. However, commercial implants were paused soon after, as an issue with the locking mechanism for one pin in the valve's commissure was observed in 7 out of about 200 patients (4%) implanted during the European commercial launch The company's management has previously said that a valve redesign is not necessary and product timelines are unchanged, with FDA approval for most sizes of Lotus Edge still anticipated in late 2017.

[Image courtesy of BOSTON SCIENTIFIC]