NASDAQ, TSX: NVCN
VANCOUVER, June 21, 2018 /CNW/ - Neovasc Inc. ("Neovasc" or
the "Company") (NASDAQ, TSX: NVCN), a leader in the development of
minimally invasive transcatheter mitral valve replacement
technologies, today announced that its Tiara™ ("Tiara")
transcatheter mitral valve replacement device was featured in a
"Live Case" broadcast at the 11th Annual Transcatheter Valve
Therapy Conference ("TVT 2018"). TVT 2018 is part of The Structural
Heart Disease Summit held June 20-23
in Chicago, Illinois.
In a live case broadcast to the main arena of the conference,
Dr. Anson Cheung, and Dr.
John G. Webb of St. Paul's Hospital (Vancouver, Canada) successfully implanted a
40mm Tiara transcatheter mitral valve in a patient suffering from
severe mitral regurgitation.
Dr Anson Cheung commented
following the case, "This patient suffered from severe mitral
regurgitation and a number of co-morbidities which made him a very
poor candidate for surgery. The Heart Team weighed in on all
available treatment options and determined the Tiara device was the
best option for this patient. The Tiara case was very
straight-forward, with an implant time of under 20 minutes, with no
procedural complications. Following the Tiara implant the
patient's mitral regurgitation was completely resolved, with a
1mmHg gradient and no paravalvular leak. The patient is
recovering well at this time."
"This live case broadcast reinforced Tiara's potential as a
promising treatment option for patients who are not suitable for
open-heart surgical valve replacement," commented Fred Colen, Neovasc's President and Chief
Executive Officer. "Attending physicians were able to see
first-hand the simplicity of the minimally invasive, transapical
transcatheter approach and resulting complete elimination of the
patient's MR. We look forward to continuing to expand our Tiara
clinical program and ultimately the adoption of Tiara for routine
use in these patients once regulatory approvals are obtained."
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 the
Company's plans and expectations concerning the Tiara's potential
as a promising treatment option, the expansion of the Tiara
clinical program, the Tiara's future performance, regulatory
approval and adoption for routine use and the future growth of the
cardiovascular marketplace. Words and phrases such as "potential",
"look forward", "continue", "ultimately", "once", "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.
View original
content:http://www.prnewswire.com/news-releases/tiara-featured-in-live-case-at-11th-annual-tvt-2018-300670471.html
SOURCE Neovasc Inc.