NASDAQ, TSX: NVCN
VANCOUVER, Dec. 21, 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 it
has received ISO 13485:2016 certification, an internationally recognized quality standard specific to the medical device
industry.
"As we continue to ramp up sales of the Neovasc Reducer™ in Europe and continue to execute on
other R&D and clinical research activities, this certification confirms that our quality management system continues to
adhere to the stringent requirements for the consistent design, development, production and delivery of medical devices,"
commented Fred Colen, Neovasc's President and Chief Executive Officer. "We received the ISO
13485:2016 certification in advance of the March 2019 deadline to transition from the 2003 to the
2016 version of the standard, following a successful audit of our quality management system conducted by a notified
body."
The ISO 13485 standard has been authored and influenced by the major medical device regulatory bodies across the world.
As such, ISO 13485 is an internationally agreed upon harmonized and voluntary standard which defines a way to address
common regulatory concepts and is an accepted approach with regulators to provide assurance that a company meets certain quality
management system expectations defined within the standard. The 2016 version of the international standard is a major revision of
the 2003 version, with a heavy focus on risk management and risk-based decision-making processes at both the quality management
system and product levels. The validity of this ISO 13485 certificate is for a period of three years from our last certification
date to April 5, 2021.
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, 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 future sales of the Company's products and the rapidly growing
cardiovascular marketplace. Words and phrases such as "continue", "growing", "ramp up" 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 Neovasc
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 September 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.
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SOURCE Neovasc Inc.
View original content: http://www.newswire.ca/en/releases/archive/December2018/21/c8808.html