NASDAQ, TSX: NVCN
VANCOUVER, March 14, 2019 /PRNewswire/ - 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 successfully completed its 2019 mandatory
Surveillance Audit with its Notified Body, resulting in the
maintenance of the Regulatory Certification (EC marking) and
maintenance of the ISO 13485: 2016 certification of the quality
management system.
"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," commented John Panton, Vice-President Quality. "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."
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 ISO13485:2016
certification has a three year cycle, with certification/
recertification followed by two annual surveillance audits.
Neovasc's second surveillance audit is scheduled to occur in
2020.
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 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.
Certain statements in this news release contain forward-looking
statements within the meaning of the U.S. Private Securities
Litigation Reform Act of 1995 and applicable Canadian securities
laws that may not be based on historical fact, including without
limitation statements containing the words "believe", "may",
"plan", "will", "estimate", "continue", "anticipate", "intend",
"expect" and similar expressions. Forward-looking statements may
involve, but are not limited to, comments with respect to the
advancement of the Reducer and Tiara programs and the growing
cardiovascular marketplace. 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 common
shares of the Company 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 the Amended and Restated 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.