NASDAQ, TSX: NVCN
Accompanying editorial comment also published by the journal
VANCOUVER, Oct. 16, 2018 /CNW/ - Neovasc Inc. ("Neovasc" or the
"Company") (NASDAQ: NVCN) (TSX:NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement
technologies and in the development of minimally invasive devices for the treatment of refractory angina, today announced that an
original article was published in Circulation: Cardiovascular Interventions titled 'Transcatheter Mitral Valve Replacement
in Patients With Previous Aortic Valve Replacement', which reports for the first time ever the experience of transcatheter mitral
valve replacement ("TMVR") using Neovasc's Tiara™ ("Tiara") valve in patients with previous aortic valve replacement. The Tiara
is a self-expanding mitral bioprosthesis for transcatheter implantation in patients with Mitral Regurgitation ("MR"), one of the
most prevalent valvular heart diseases in western countries. Tiara is not currently approved for commercial sale in any
geographies.
The article describes the periprocedural and short-term outcomes of patients with severe MR and previous surgical aortic valve
prosthesis replacement treated with the Tiara. The article describes procedural success rate of 100% with no death, myocardial
infarction, stroke, major bleeding, or access site complications at 30 days. In addition, MR was eliminated in patients
immediately after implantation. The authors of the article conclude that, "transapical mitral valve replacement with the Tiara
valve in high-risk patients with severe MR and aortic valve prostheses is technically feasible and can be performed safely." The
article is currently available for download at the American Heart Association Journals website, https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.118.006412
The editorial comment titled 'Taking Transcatheter Mitral Valve Replacement to the Next Level' written by Mayra Guerrero and Charanjit Rihal concludes that: "The investigators, are
taking the field of TMVR to the next level where both prosthetic aortic valves and transcatheter mitral prosthesis coexist, and
should be congratulated for their contribution." The article is currently available for download at the American Heart
Association Journals website, https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.118.007369.
About Tiara
Tiara is a self-expanding mitral bioprosthesis specifically designed to treat mitral valve regurgitation (MR) by
replacing the diseased valve. Conventional surgical treatments are only appropriate for about half of MR patients, who number an
estimated four million in the U.S. with a similar number of patients affected throughout Europe.
Tiara is implanted in the heart using a minimally invasive, transapical transcatheter approach without the need for open-heart
surgery or use of a cardiac bypass machine.
The Tiara is currently being evaluated in 2 ongoing investigational clinical trials: TIARA-I—an early feasibility trial
in the United States, Canada, and Belgium—and TIARA-II—a
European Conformité Européenne Mark Trial in Germany,
Italy, and the United Kingdom. In addition, patients have also
been treated under compassionate programs in Canada, Italy,
Germany, Israel, and Switzerland.
About Neovasc Inc.
Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing
cardiovascular marketplace. Its products include the Neovasc Reducer ™ ("Reducer"), for the treatment of refractory angina, which
is not currently commercially available in the United States and has been commercially available
in Europe since 2015, and the Tiara, for the transcatheter treatment of mitral valve disease,
which is currently under clinical investigation in the United States, Canada and Europe. For more information, visit: www.neovasc.com.
This news release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act
of 1995 and applicable Canadian securities laws regarding the growth of the cardiovascular marketplace. Words and phrases such as
"continue", "strategy", "would", "may", "could", "should", "expect" and "will", and similar words or expressions, are intended to
identify these forward-looking statements. Forward-looking statements are based on estimates and assumptions made by the Company
in light of its experience and its perception of historical trends, current conditions and expected future developments, as well
as other factors that the Company believes are appropriate in the circumstances. Many factors and assumptions could cause the
Company's actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking
statements, including, without limitation, the substantial doubt about the Company's ability to continue as a going concern;
risks relating to the warrants (the "Warrants") and senior secured convertible notes (the "Notes") issued pursuant to the
November 2017 underwritten public offering and concurrent private placement (together, the "2017
Financings"), resulting in significant dilution to the Company's shareholders; risks relating to the Company's need for
significant additional future capital and the Company's ability to raise additional funding; risks relating to cashless exercise
and adjustment provisions in the Warrants and Notes issued pursuant to the 2017 Financings, which could make it more difficult
and expensive for the Company to raise additional capital in the future and result in further dilution to investors; risks
relating to the sale of a significant number of common shares of the Company; risks relating to the exercise of Warrants or
conversion of Notes issued pursuant to the 2017 Financings, which may encourage short sales by third parties; risks relating to
the possibility that the Company's common shares may be delisted from the Nasdaq Capital Market or the Toronto Stock Exchange,
which could affect their market price and liquidity; risks relating to the Company's common share price being volatile; risks
relating to the influence of significant shareholders of the Company over the Company's business operations and share price;
risks relating to the Company's significant indebtedness, and its effect on the Company's financial condition; risks relating to
claims by third parties alleging infringement of their intellectual property rights; risks relating to lawsuits that the Company
is subject to, which could divert the Company's resources and result in the payment of significant damages and other remedies;
the Company's ability to establish, maintain and defend intellectual property rights in the Company's products; risks relating to
results from clinical trials of the Company's products, which may be unfavorable or perceived as unfavorable; the Company's
history of losses and significant accumulated deficit; risks associated with product liability claims, insurance and recalls;
risks relating to use of the Company's products in unapproved circumstances, which could expose the Company to liabilities; risks
relating to competition in the medical device industry, including the risk that one or more of the Company's competitors may
develop more effective or more affordable products; risks relating to the Company's ability to achieve or maintain expected
levels of market acceptance for the Company's products, as well as the Company's ability to successfully build its in-house sales
capabilities or secure third-party marketing or distribution partners; the Company's ability to convince public payors and
hospitals to include the Company's products on their approved products lists; risks relating to new legislation, new regulatory
requirements and the efforts of governmental and third-party payors to contain or reduce the costs of healthcare; risks relating
to increased regulation, enforcement and inspections of participants in the medical device industry, including frequent
government investigations into marketing and other business practices; risks associated with the extensive regulation of the
Company's products and trials by governmental authorities, as well as the cost and time delays associated therewith; risks
associated with post-market regulation of the Company's products; health and safety risks associated with the Company's products
and industry; risks associated with the Company's manufacturing operations, including the regulation of the Company's
manufacturing processes by governmental authorities and the availability of two critical components of the Reducer; risk of
animal disease associated with the use of the Company's products; risks relating to the manufacturing capacity of third-party
manufacturers for the Company's products, including risks of supply interruptions impacting the Company's ability to manufacture
its own products; risks relating to the Company's dependence on limited products for substantially all of the Company's current
revenues; risks relating to the Company's exposure to adverse movements in foreign currency exchange rates; risks relating to the
possibility that the Company could lose its foreign private issuer status under U.S. federal securities laws; risks relating to
breaches of anti-bribery laws by the Company's employees or agents; risks associated with future changes in financial accounting
standards and new accounting pronouncements; risks relating to the Company's dependence upon key personnel to achieve its
business objectives; the Company's ability to maintain strong relationships with physicians; risks relating to the sufficiency of
the Company's management systems and resources in periods of significant growth; risks associated with consolidation in the
health care industry, including the downward pressure on product pricing and the growing need to be selected by larger customers
in order to make sales to their members or participants; risks relating to the Company's ability to successfully identify and
complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances;
risks relating to the Company's ability to successfully enter into fundamental transactions as defined in the Series C warrants
issued pursuant to the 2017 Financings; anti-takeover provisions in the Company's constating documents which could discourage a
third party from making a takeover bid beneficial to the Company's shareholders; and risks relating to conflicts of interests
among the Company's officers and directors as a result of their involvement with other issuers. These risk factors and others
relating to the Company are discussed in greater detail in the "Risk Factors" section of the Company's Annual Report on Form 20-F
and in Management's Discussion and Analysis for the quarter ended June 30, 2018 (copies of which
may be obtained at www.sedar.com or www.sec.gov). The Company has no intention and undertakes no obligation to update or revise any forward-looking
statements beyond required periodic filings with securities regulators, whether as a result of new information, future events or
otherwise, except as required by law.
View original content:http://www.prnewswire.com/news-releases/neovasc-announces-publication-of-a-peer-reviewed-article-on-tiara-cases-in-circulation-cardiovascular-interventions-300731607.html
SOURCE Neovasc Inc.
View original content: http://www.newswire.ca/en/releases/archive/October2018/16/c3043.html