NASDAQ, TSX: NVCN
VANCOUVER, May 25, 2018 /PRNewswire/ - Neovasc Inc.
("Neovasc" or the "Company") (NASDAQ, TSX: NVCN), a leader in the
development of minimally invasive transcatheter mitral valve
replacement technologies, today provided highlights from EuroPCR,
the annual meeting of the European Association of Percutaneous
Cardiovascular Interventions (EAPCI) of the European Society of
Cardiology (ESC), which took place at the Palais des Congrès in
Paris, France May 22-25. Neovasc management held numerous
discussions throughout EuroPCR with European physicians regarding
their interest in either participating in the ongoing Tiara™ (the
"Tiara") clinical trials or in using the Neovasc Reducer™ (the
"Reducer") product for their patients suffering from refractory
angina.
Tiara
"We had a successful and engaging meeting with
investigators in our Tiara-II trial regarding clinical results
to-date, optimal screening process, best practices for
implantation, and a direct comparison of published Tiara clinical
results with results from mitral clipping procedures," commented
Fred Colen, Neovasc's Chief
Executive Officer.
"There was also a presentation of results from our first animal
feasibility study for the trans-septal version of Tiara. We
collected additional input and feedback from investigators, and
these results, along with the updates and discussions in general at
the TIARA-II Investigator meeting, appear to have excited our
implanting physicians," continued Mr. Colen.
Dr. Anson Cheung also presented
the latest clinical results of the Tiara valve during the Mitral
Valve Replacement session, noting that 56 patients had been
implanted to date and the 30-day survival rate was 94%, with trace
or no remaining mitral regurgitation in most cases.
Reducer
Dr. Stefan
Verheye and Dr. Shmuel Banai
hosted a symposium on the Reducer, which included presentations
from physicians on their clinical experience with Reducer,
discussions about potential additional applications for Reducer,
and a cost/benefit analysis of Reducer utilizations for healthcare
systems.
"We were delighted by the interest from physicians in the
Reducer this year, and attendance at the symposium exceeded
capacity. It was an extraordinary experience, and it reconfirmed
our belief in Reducer as a safe and effective product that we
expect to generate improved results now that it is being used more
broadly across Europe. We believe
that for too long this product's value has been heavily discounted
by its stakeholders." concluded Mr. Colen.
The scheduled live case of a Reducer implant did not take place
as planned because the patient was feeling better and withdrew from
the procedure.
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 available in the United
States and has been 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 participation in the
Tiara clinical trials and the results from such trials, the
feasibility of the trans-septal version of the Tiara, future use of
the Reducer for treatment of refractory angina, the ability of the
Reducer to generate improved results and the Reducer's value
relative to its stakeholders' perceptions. Words and phrases such
as "continue", "strategy", "believe", "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 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.