Vancouver-based Neovasc, which is looking to be the 1st to market with a transcatheter mitral valve implant, put up losses of -$7.4 million, or -11 per share, on sales of $2.2 million for the 3 months ended Dec. 31, 2015. Losses grew 10.0% and sales fell -24.7% compared with Q4 2014.
Full-year losses grew 55.6% to -$26.7 million,or -41,on sales growth of 90.1% to $9.9 million, compared with 2o14.
Neovasc is hoping its Tiara TMVR device will be the 1st such device to make it to market. The company also makes the Reducer device, which is designed to treat refractory angina.
“Our chief priority for 2016 is to complete all the necessary regulatory and clinical activity to begin a CE Mark trial for Tiara, while continuing to expand Reducer’s commercial footprint in Europe,” CEO Alexei Marko said in prepared remarks.
“2016 will be our first full year of commercial sales for Reducer, and with distributors now in multiple European countries including Italy and Germany, we expect this base of business to grow,” added CFO Chris Clark. “As we continue transitioning revenue from our legacy businesses to our own proprietary products, our balance sheet remains very strong, entering 2016 with more than $55 million in cash.”
Neovasc added another patient to its clinical trial program for the Tiara device this year, taking the total to 12, and has “multiple” more patients scheduled for implantation, CEO Alexei Marko told analysts during a conference call yesterday. In January the company won FDA approval to add the 40mm size of the Tiara device to the trial, which could further accelerate enrollment.
The company plans to release data from the trial at the EuroPCR meeting in May, Marko said, according to a Seeking Alpha transcript. That will be an eventful month for the company, as the trial in a trade theft lawsuit brought by rival CardiAQ Valve Technologies (now a part of Edwards Lifesciences) is slated to go to trial May 2.
Investors, likely reacting to the increasing momentum for Tiara’s clinical program, sent NVCN shares up 2.4% to $4.32 apiece in mid-day trading today.