Neovasc surges on news of appeal, FDA nod for clinical trial

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NeovascNeovasc (NSDQ:NVCN) shares surged today in pre-market trading after the replacement heart valve maker said it’s exhausted the appeals process in its trade secret spat with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve and that it won an FDA nod for a clinical trial.

A jury in May 2016 awarded $70 million to CardiAQ after finding that Neovasc misappropriated trade secrets in developing its Tiara transcatheter mitral valve replacement device (Edwards inherited the lawsuit when it acquired CardiAQ Valve for $400 million in August 2014). A federal judge in Massachusetts added $21 million in enhanced damages to the decision in November 2016.

Vancouver-based Neovasc said Nov. 3 that the U.S. Court of Appeals for the Federal Circuit, which in September upheld the district court ruling, also denied it and its rival’s bids for rehearings.

“In summary, the appeals process is now exhausted,” Neovasc said, noting that it’s holding $70 million in escrow but lacks the cash to cover the remaining $42 million, which comes due Nov. 13. “Neovasc will continue to evaluate all options available to the company relating to the requirement to pay the damages and fund the remaining $42 million not held in escrow, which exceeds the company’s current cash resources.”

In a separate release, Neovasc said the FDA granted an investigational device exemption for a pivotal trial of its Reducer device for treating chest pain. The 380-patient Cosira-II trial is designed as a double-blinded, sham-controlled study to evaluate the safety and effectiveness of the Reducer device ahead of a bid for FDA approval.

“Since its commercial launch in Europe two years ago, Reducer has consistently provided relief of severe symptoms in patients suffering from refractory angina, resulting in significant improvements in their quality of life,” CEO Alexei Marko said in prepared remarks. “We are eager to replicate our European clinical and commercial success in the United States, by introducing this important new therapy for patients who have no other option for managing their chronic, severe chest pain.”

NVCN shares were up 21.4% to $1.59 apiece today in pre-market trading.

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