Neovasc shares tumble on 2018 earnings release

Neovasc

Shares in Neovasc (NSDQ:NVCN) have fallen nearly 10% today after the medical device maker posted full year 2018 earnings that showed losses growing to more than triple what it reported in 2017.

The Vancouver-based company posted losses of $109.1 million, or $7.63 per share, on sales of $1.7 million, seeing losses grow 338.7% while sales shrunk 67.5% compared with the previous fiscal year.

“After achieving a steady flow of positive operational and development milestones throughout 2018, we have entered 2019 with significant momentum in the business which is driving increased awareness among cardiologists for both the Tiara and Reducer. Our sales and marketing team continues to make steady progress ramping up sales for the Reducer through our partners and distributors across the EU and Middle East and through direct sales activities in Germany. The clinical data that we have generated for the Reducer as a treatment for chronic refractory angina continues to build support among some of the leading cardiologists around the world. As a result, we have already generated a number of peer reviewed articles and presentations at medical conferences in 2019 that are putting us in front of an ever larger number of cardiologists and other treating physicians. This new data is going further in showcasing patients’ responses to the Reducer, by utilizing new technologies to measure its performance, including dipyridamole stress perfusion cardiac magnetic resonance. While still in clinical trials, the Tiara truly is a leading edge, ground-breaking device that is expected to be able to treat more patients with a larger amount of co-existing conditions. Our clinical data continues to support our efforts to further develop the Tiara as we look to bring it to market. The positive momentum we built up in 2018 for patient enrollment through the addition of several new clinical sites will support the ongoing TIARA-II study in 2019. We recently received regulatory approval in Germany and the UK to proceed with the second phase of the study,” prez &CEO Fred Colen said in a press release.

Shares in Neovasc have fallen approximately 9.3% so far today, at approximately 43¢ as of 10:44 a.m. EDT.

Yesterday, Neovasc claimed a win in its patent infringement war with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve Technologies, saying a German appeals court dismissed a case there.

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Neovasc claims win in German TMVR patent case against Edwards unit CardiAQ Valve

Edwards Lifesciences, CardiAQ Valve, NeovascNeovasc (NSDQ:NVCN) today claimed a win in its patent infringement war with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve Technologies, saying a German appeals court dismissed a case there.

In June 2017 the District Court in Munich ruled that CardiAQ Valve contributed to the creation of Neovasc’s Tiara transcatheter mitral valve replacement, awarding”co-entitlement” rights to the patent in Europe. Both sides appealed that ruling, in the course of which CardiAQ withdrew its total ownership claim but asserted partial ownership, Vancouver-based Neovasc said today.

Munich’s Higher Regional Court dismissed the remaining claims, finding that CardiAQ “had not contributed to the invention of the Tiara” and ruling “Neovasc to be the rightful inventor and owner of all rights to the disputed Tiara European patent application,” according to Neovasc.

“We are pleased that after full consideration of the evidence, the German courts have now recognized that CardiAQ made no contribution to the invention or development of the Tiara,” CEO Fred Colen said in prepared remarks. “With this decision, which we strongly believe would be confirmed, even if appealed to and accepted as a case by the German Supreme Court, Neovasc is free to pursue its European patent application and has the sole right to commercialize the Tiara in Europe and help treat patients suffering from debilitating mitral valve disease. We will continue to vigorously defend our intellectual property against any attempts by third parties to infringe on these rights.”

The German case is only one front in the companies’ TMVR war. In the U.S., a jury in May 2016 awarded $70 million to CardiAQ after finding that Neovasc misappropriated trade secrets in developing Tiara. A federal judge in Massachusetts added $21 million in enhanced damages to the decision that November; in January 2017 the Boston court added another $21 million to the judgment.

Edwards, which inherited the beef when it acquired CardiAQ Valve for $400 million in August 2014, did not immediately reply to a request for comment.

Earlier this month Neovasc inked an exchange deal for the last of the warrants it issued as part of a $65 million funding round to cover the litigation damages.

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Neovasc retains EC Marking after EU surveillance audit

Neovasc

Updated to correct from CE Marking to EC Marking.

Neovasc (NSDQ:NVCN) said yesterday that it successfully completed its 2019 mandatory surveillance audit with its notified body in the European Union.

The Vancouver-based company said that as a result of the successful audit, and its maintenance of the ISO 13485: 2016 certification of its quality management system, it retained its EC Marking certification in the region.

“The quality system surveillance audits enables us to continue to advance our Reducer and Tiara programs by ensuring the safety, effectiveness and fitness for use of our devices, through risk-based effective and efficient processes and controls across the Total Product Life Cycle. The maintenance of the regulatory and quality certifications allows the team to be laser focused on achieving the 2019 goals and objectives for Reducer and Tiara programs,” quality VP John Panton said in a press release.

Neovasc said that its second surveillance audit is slated to occur next year.

On Monday, Neovasc priced an upcoming offering looking to raise $5 million to support its Tiara and Reducer devices.

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Neovasc prices $5m offering

Neovasc

Neovasc (NSDQ:NVCN) today priced an upcoming offering looking to raise $5 million to support its Tiara and Reducer devices.

In the round, the Vancouver-based company will look to float approximately 11.1 million shares of its common stock at a price of 45¢ per share. The offering is expected to close on March 15, the company said.

After expenses, Neovasc said that it expects to receive net proceeds of approximately $4.3 million, which it plans to use to support continued development of its Tiara transcatheter mitral valve replacement and the development and commercialization of its Neovasc Reducer.

H.C. Wainwright & Co. is acting as the sole book-runner for the offering, according to a press release.

Last month, Neovasc closed a separate $5 million offering and said that it inked a $3 million settlement agreement with Micro Interventional Devices to resolve undisclosed allegations related to Neovasc’s transcatheter mitral valve replacement technology, including its flagship Tiara device.

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Neovasc advances warrant exchange from CardiAQ case

Neovasc

Neovasc (NSDQ:NVCN) said today that it inked an exchange deal for the last of the warrants it issued as part of a $65 million funding round to cover the damages from litigation with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve.

The Vancouver-based replacement heart valve developer said it plans to exchange the Series A and Series E warrants it issued in November 2017 to cover the $42 million balance from its loss in the CardiAQ lawsuit. The deals call for Neovasc to issue more than 496,000 shares in exchange for nearly 58.4 million warrants, which works out to 0.0085 shares per warrant.

“We are delighted to be able to continue our stepwise approach to clearing the remaining elements of the 2017 financings,” CEO Fred Colen said in prepared remarks.

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.

Last month Neovasc priced a $5 million offering, saying it plans to use the $4.1 million in net proceeds for continued development of its Reducer device and Tiara valve, and settled a spat with Micro Interventional Devices for $3 million.

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Neovasc prices $5m offering

Neovasc

Neovasc (NSDQ:NVCN) today priced a $5 million offering of its common stock slated to support its Reducer device and Tiara transcatheter mitral valve.

The Vancouver-based company said it plans to float approximately 11.1 million shares of its common stock at a price of 45¢ per share, expecting to bring in approximately $5 million in gross proceeds.

Neovasc said that it expects to receive net proceeds of approximately $4.1 million, and that proceeds will support continued development of its Reducer device and Tiara valve, as well as for general corporate and working capital purposes.

The offering is expected to close on February 28, with H.C. Wainwright & Co. acting as the sole book-running manager, according to an SEC filing.

Earlier this month, Neovasc said that it inked a $3 million settlement agreement with Micro Interventional Devices to resolve undisclosed allegations related to Neovasc’s transcatheter mitral valve replacement technology, including its flagship Tiara device, and added that it raised approximately $1.2 million.

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Neovasc inks $3m settlement deal with MID, raises $1m

Neovasc

Neovasc (NSDQ:NVCN) said today that it inked a $3 million settlement agreement with Micro Interventional Devices to resolve undisclosed allegations related to Neovasc’s transcatheter mitral valve replacement technology, including its flagship Tiara device, and added that it has raised approximately $1.2 million.

The agreement includes payments totally approximately $3 million to be made by Neovasc to MID over the next two and a half years, Neovasc said in a press release.

The settlement deal includes a 1.3% royalty to be paid to MID on the annual net sales of the Tiara, Neovasc said. The agreement also includes a buy-out clause that allows Neovasc, or anyone who purchases the company or its Tiara assets, to buy-out the royalty obligations.

As part of the agreement, charges levied by MID against Neovasc will be dismissed without prejudice, MID said in a prepared statement..

“We are delighted to announce the resolution of yet another legal challenge from the past, via a reasonable settlement agreement with MID, which will remove further uncertainty for the company moving forward,” Neovasc CEO Fred Colen said in a press release.

Neovasc also announced that it has raised $1.2 million in proceeds from investor-initiated exercises of the last of its Series C warrants.

“We are also glad to announce that all of the Series C warrants and more importantly all of the underlying Series B warrants from the 2017 financings have now been exercised, leaving only Series A warrants and Series E warrants from the 2017 financings outstanding. These outstanding warrants are minimally dilutive; they convert into 1/100th of a common share, irrespective of the current share price; finally, we are now down to US$10.8 million of debt notes outstanding, of which, only US $2 million is held by the only debt note holder who, to date, has been converting debt notes into common shares; I see more light at the end of the tunnel,” Colen said in a prepared release.

Late last month, Neovasc said that it won approval to advance a clinical trial for its Tiara transcatheter mitral valve replacement, sending its share price up on Wall Street.

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Neovasc jumps on Tiara trial news

NeovascNeovasc (NSDQ:NVCN) said today that it won approval to advance a clinical trial for its Tiara transcatheter mitral valve replacement, sending its share price up on Wall Street.

The Vancouver-based company said it closed out the Phase I requirements for the 115-patient Tiara-II trial in the U.K. and Germany, after several reviews. The Clinical Events Committee looked at adverse events, the Data & Safety Monitoring Board reviewed the data and government regulatory and ethics committees reviewed the interim clinical report on 20 patients.

Neovasc said the approval means Tiara-II can proceed in those countries with no restrictions.

“The Neovasc team is excited about the positive news from the governmental healthcare authorities in Germany and the U.K., as well as from the independent ethics committees in both countries. After their review of the submitted, detailed results of the first 20 Tiara implants, we received all required approvals to continue this Tiara-II clinical study into the second and final phase of full enrollment, without further restrictions,” president & CEO Fred Colen said in prepared remarks.

NVCN shares were up 7.5% to 72.92¢ today in mid-afternoon trading.

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Neovasc touts Reducer study

NeovascNeovasc (NSDQ:NVCN) this week touted a newly-published article that described the use of dipyridamole stress perfusion cardiac magnetic resonance to evaluate its Reducer device.

The Vancouver-based company’s device is designed to treat refractory angina. The article, published in the Journal of the American College of Cardiology: Cardiovascular Interventions, featured a 66 year old man with angina who was treated with anti-ischemic therapy.

Four months after being implanted with the Reducer, the patient was asymptomatic for angina and reported improved quality of life, according to Neovasc.

A four-month dipyridamole stress perfusion CMR revealed an ischemic burden of 13.3%, down from 22.9%, and a global myocardial perfusion reserve index of 1.61, up from 1.25.

“The authors of this article point to objective evidence available via stress perfusion CMR, providing insights into the potential impact of the Reducer on the ischemic burden, suggesting a physiological rationale as to how the Reducer reduces a perfusion defect in this patient,” Neovasc’s president & CEO, Fred Colen, said in prepared remarks.

“Stress perfusion CMR is emerging as the noninvasive gold standard for the assessment of ischemia. We believe the use of a reliable, non-operator-dependent imaging tool, such as stress perfusion CMR, will allow for greater insights into the potential impact of the Reducer on the ischemic burden of patients with refractory angina with coronary artery disease,” Colen added.

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Edwards Lifesciences settlement with Boston Scientific lets Neovasc off the hook

Boston Scientific, NeovascLast week’s legal win for Boston Scientific (NYSE:BSX) in its years-long patent battle with Edwards Lifesciences (NYSE:EW) was also a win for Neovasc (NSDQ:NVCN), that company said today.

As part of a settlement deal worked out between Irvine, Calif.-based Edwards and Marlborough, Mass.-based Boston Scientific, the Federal Court of Canada dismissed a lawsuit brought by Edwards against Boston, in which Neovasc and LivaNova (NSDQ:LIVN) were named as co-defendants.

Litigation over patent ownership between Edwards and Neovasc is not a part of the dismissal, Edwards said.

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