NASDAQ, TSX: NVCN
VANCOUVER, July 2, 2018 /PRNewswire/ - Neovasc Inc.
("Neovasc" or the "Company") (NASDAQ, TZX: NVCN), a leader in the
development of minimally invasive transcatheter mitral valve
replacement technologies, today announced that its Tiara™
("Tiara"), a transcatheter treatment of mitral valve disease, and
the Neovasc Reducer™ ("Reducer"), a CE-Marked medical devices used
for the treatment of refractory angina, were both featured in
presentations at the CSI Frankfurt 2018 conference held on
June 27-30, 2018 in Frankfurt, Germany. CSI Frankfurt is one of
the leading conferences on congenital, structural and valvar
percutaneous heart interventions worldwide.
"The CSI conference is an important event for us every year, as
it brings together some of the leading cardiologists and cardiac
surgeons from across the world to discuss new innovative
technologies and procedures for transcatheter treatment of
structural heart diseases. This year, new Reducer clinical data was
presented in a scientific session entitled: Structural meets
coronary – Reducer for the treatment of refractory angina. The
clinical data presented again demonstrated the clinical benefits of
the Reducer in improving quality of life of patients suffering from
disabling angina, as well as improving exercise capability.
Moreover, data was also presented demonstrating the cost
effectiveness of the Reducer therapy compared to the current
standard of care," commented Fred
Colen, Neovasc's Chief Executive Officer.
"An update on our Tiara – Transcatheter Mitral Valve clinical
program was also presented in the meeting, emphasizing the
excellent results of the two ongoing clinical trials, the Tiara-I
early feasibility U.S./Canadian trial and the Tiara-II, a European
CE Mark clinical trial," concluded Colen.
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 ReducerTM, 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 TiaraTM, 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 the future
performance of the Reducer and theTiara, the anticipated results of
clinical trials relating to the Tiara, the cost-effectiveness of
the Reducer relative to the current standard of care and growth of
the cardiovascular marketplace. Words and phrases such as
"believes,", "anticipates" "may", "not yet" 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; risks relating to
conflicts of interests among the Company's officers and directors
as a result of their involvement with other issuers; and other
factors referenced in the Company's filings with Canadian and U.S.
securities regulators. 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
March 31, 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.