NASDAQ, TSX: NVCN
VANCOUVER, Sept. 11, 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, has been
made aware of a lawsuit filed by Endovalve Inc. and Micro Interventional Devices, Inc. (the "Plaintiffs") in the U.S. District
Court for the District of New Jersey including certain allegations relating to Neovasc's
transcatheter mitral valve technology, including the Tiara™ ("Tiara") device. The complaint has not yet been served on the
Company. If the Plaintiffs do serve the complaint, Neovasc intends to vigorously defend itself.
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™ (the "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 Company's plans and expectations concerning the lawsuit filed
against the Company, the Company's intention to defend itself vigorously, and the growing cardiovascular marketplace.
Words and phrases such as "intend", "could", "would", "may" 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, 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; 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 the Company's common shares; 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
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). In particular, the outcome of any litigation is inherently uncertain, and if litigation matters were
to be resolved against the Company for amounts in excess of management's expectations or any applicable insurance coverage or
indemnification right, the Company's results of operations and financial condition could be materially adversely affected. Any
litigation to which the Company is a party may result in an onerous or unfavorable judgment that may not be reversed upon appeal,
or in payments of substantial monetary damages or fines, the posting of bonds requiring significant collateral, letters of credit
or similar instruments, or the Company may decide to settle lawsuits on similarly unfavorable terms. Any of these factors,
individually or in the aggregate, could have a material adverse effect on the Company's business, results of operations, cash
flows or liquidity. 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-provides-initial-comments-on-lawsuit-300710178.html
SOURCE Neovasc Inc.
View original content: http://www.newswire.ca/en/releases/archive/September2018/11/c3054.html