Neovasc squeaks by Q2, positive on Tiara trial

Neovasc (NASDAQ:NVCN) reported 2nd quarter sales ahead of estimates, though down from 2014 and marked by growing losses, but rallied around the progress of its Tiara transcatheter mitral valve implant feasibility trial.

The company’s 30-patient Tiara 1 trial has 2 study patients implanted, in addition to 5 patients implanted through compassionate use regulations.

Of the 3 compassionate use patients still alive, there have been no reports of paravalvular leak, left ventricular tract obstruction or thrombosis issues. To date, no mechanical failures of the Tiara device have been reported, Neovasc said.

The progression of this trial outweighs the losses the company posted, Leerink Partners analyst Danielle Antalffy said in a report released today.

Neovasc said it plans to add a 40mm Tiara valve to the trial, which Antallfy said would increase device coverage to 80% of all mitral valve regurgitation patients, up from around 33%.

The market opportunity for the transcatheter mitral valve repair market is approximately $9 billion, Antalffy said, and Neovasc is positioned to potentially be 1 of the 1st, if not the 1st, to bring their device to the market.

For the quarter, Vancouver-based Neovasc posted losses of $8.3 million, or 12¢ per share, on sales of $3.6 million for the 30 days ending June 30. That amounts to a 28.3% increase in losses on an 18.3% sales slide compared to the 2nd quarter last year.

“With steady activity in our tissue business, Reducer’s European launch going well, and with additional successful Tiara implantations, the second quarter was constructive across all facets of our company. We are taking steps to accelerate patient recruitment in the Tiara-I study and during the quarter we made crucial adjustments towards this objective. Specifically, we have made revisions to the trial protocol to enhance enrollment and have increased the number of participating sites.  We are now expecting to have eight centres recruiting patients by the end of Q3.  More importantly, we are adding a second valve size to the Tiara-I study, a 40mm Tiara to complement our existing 35mm device, significantly increasing the population of eligible patients.  We anticipate first use of the 40mm size in Q4 of this year. Development of the 45mm Tiara is also well underway to provide further treatment options to patients.  To date, the 35mm Tiara is performing very well, meeting our expectations and clearly demonstrating its potential to greatly improve the quality of life for patients suffering from severe mitral regurgitation through a minimally invasive, catheter-based valve replacement procedure,” CEO Alexei Marko said in a press release.

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