Shares in Neovasc (NSDQ:NVCN) have fallen nearly 50% today after the structural heart device maker posted shrinking sales in its 2017 earnings release and updated on progress with its investigational Tiara mitral valve replacement.
The Vancouver-based company posted losses of $22.9 million, or 28¢ per share, on sales of $5.4 million for the full 2017 year, seeing losses shrink 73.5% while sales shrunk 43.3% compared with the previous fiscal year.
Losses per share were just behind the 26¢ consensus on Wall Street, where analysts were expecting to see sales of $4.1 million, which the company handily topped.
NeoVasc said that a total of 50 patients have been treated with its investigational Tiara mitral valve system to date. A total of 12 of those patients come from its 150-patient European Tiara II CE Mark study, with 2 additional patients scheduled for implantation and others “currently under evaluation for eligibility.”
The company said that it has developed a new tool to hasten enrollment in the study, and that it expects the CE Mark trial to be complete by approximately 2020.
NeoVasc said a total of 21 patients were implanted with the Tiara valve in 2017, with a 100% technical success rate and a 90% survival rate at 30 days.
“Since joining Neovasc in late January, I have been evaluating the company’s current clinical and commercial activities, as well as organizational and financial matters. We are making adjustments to these programs and have started to implement a broader turnaround strategy designed to more effectively create value for our patients, customers, shareholders and employees, while bringing our innovative products to market. We still face challenges, however, I believe that our innovative and promising products, as well as the determination of our team, will lead us to long-term success. We have three specific tasks to focus on, in order to recognize the potential of our Tiara and Reducer products. Our goal is to expand on the foundation we established in Europe and on the growing enthusiasm in the market for the Reducer therapy, based on the initial, promising clinical experiences. We also remain pleased with the clinical results to-date from the first 50 Tiara implants, with ongoing enrollment in our Tiara I and II studies, as well as the initiation of the development of the transfemoral, trans-septal version of Tiara,” CEO Fred Colen said in a press release.
Shares in Neovasc are down 50% so far today, at 6¢ as of 1:05 p.m. EDT.
In February, NeoVasc said that it won reimbursement coverage from the German Institute for the Hospital Renumberation System for its Reducer device designed to treat refractory angina.
