NASDAQ, TSX: NVCN
VANCOUVER, March 19, 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 data on the Neovasc Reducer™ ("Reducer") was
featured in session 725, titled, "Refractory Angina: Options for
Patients With "No Options"" at the American College of Cardiology's
("ACC") 68th Annual Scientific Session and Expo ("ACC.19"). The
ACC.19 is taking place from March 16
– 18, 2019, in New Orleans.
"We are pleased that today's ACC.19 session included an overview
of our Reducer and its efficiency in narrowing the coronary sinus
in refractory angina patients, which has resulted in an improvement
in symptoms and quality of life for patients with refractory angina
who were not candidates for revascularization. A portion of
the data discussed during the session was originally published in
the New England Journal of Medicine in February 20151," stated Fred Colen, CEO of Neovasc. "Looking at the
participants in this session, we see growing interest for the
Reducer among leading cardiologists; Professor Thomas Luscher, who has treated patients with
Reducer within his practice in Europe and co-authored a published paper on
the Reducer2, presented the Reducer data at ACC.19 and
Dr. Tim Henry of Cedars-Sinai, who
has been a strong supporter of generating additional data for the
Reducer in the U.S., chaired the session."
Session Details:
Session title: 725 - Refractory Angina: Options for Patients
With "No Options
Date: March 18, 2019,
8:00 AM - 9:30 AM
Location: Room 217
Description: This session describes options for angina that
is resistant to conventional treatment options. While mortality may
be low, morbidity is considerable, leaving clinicians in a quandary
regarding management options.
About ACC.19
ACC.19 features hundreds of educational
sessions and late-breaking clinical research across 11 learning
pathways. Keynotes provided updates on the latest guidelines, and
the latest practice-changing scientific breakthroughs with
Late-Breaking Clinical Trials and Featured Clinical Research. In
addition, there are hundreds of other activities and events taking
place before, during and after ACC.19. To learn more, please visit,
https://accscientificsession.acc.org/
About Reducer
The Reducer is CE-marked in the European
Union for the treatment of refractory angina, a painful and
debilitating condition that occurs when the coronary arteries
deliver an inadequate supply of blood to the heart muscle, despite
treatment with standard revascularization or cardiac drug
therapies. It affects millions of patients worldwide, who typically
lead severely restricted lives as a result of their disabling
symptoms, and its incidence is growing. The Reducer provides relief
of angina symptoms by altering blood flow in the heart's
circulatory system, thereby increasing the perfusion of oxygenated
blood to ischemic areas of the heart muscle. Placement of the
Reducer is performed using a minimally invasive transvenous
procedure that is similar to implanting a coronary stent and is
completed in approximately 20 minutes.
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 growing
support for the Reducer among leading cardiologists, the growing
incidence of refractory angina 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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1 Efficacy
of a Device to Narrow the Coronary Sinus in Refractory Angina, New
England Journal of Medicine 2015; 372:519-527, DOI:
10.1056/NEJMoa1402556. Stefan Verheye, M.D., Ph.D., E. Marc
Jolicœur, M.D., Miles W. Behan, M.D., Thomas Pettersson, M.D., et
al
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2 Coronary
sinus reducer device for patients with refractory angina,
Cardiovascular Medicine 108; 21(04):105-110 Peter C. Kahr et
al
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SOURCE Neovasc Inc.