NASDAQ, TSX: NVCN
VANCOUVER, April 17, 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 the International Journal of Cardiology (the "IJC")
has published a peer reviewed article demonstrating that coronary
sinus ("CS") narrowing through the use of the Neovasc Reducer™ (the
"Reducer") improves diastolic function and relaxation of the heart.
The article title is: "The impact of coronary sinus narrowing on
diastolic function in patients with refractory angina."
"We are pleased to report evidence that CS narrowing may also
improve diastolic function in patients with chronic refractory
angina and proven myocardial ischemia. We believe this study has
the potential to further encourage cardiologists to treat
refractory angina patients with coronary sinus narrowing without
the concern of adverse effects on the relaxation properties of the
heart," commented Dr. Shmuel Banai,
Medical Director of Neovasc.
The purpose of the study was to evaluate the impact of CS
narrowing on stiffness and relaxation abilities of the left
ventricle (diastolic function) in patients with myocardial ischemia
and severe refractory angina treated with the Reducer. The study
demonstrated that treatment with the Reducer may lead to
improvement in diastolic function and echocardiographic parameters
of left ventricular relaxation. The results of this trial may
preclude the speculation that coronary sinus narrowing might
adversely affect relaxation of the heart muscle. The study clearly
indicates the opposite, and demonstrates that the Reducer not only
improved angina status and quality of life of these patients, but
also resulted in a significant improvement in mean diastolic
function. The observed improvement in the relaxation properties of
the heart are most probably secondary to the improvement in blood
perfusion to ischemic territories of the heart muscle which is
known to be the effect of the Reducer.
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 medical therapy. 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 improving 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.
While the Reducer is widely used in Europe, it is not yet approved for commercial
use in the United States. The U.S.
Food and Drug Administration ("FDA") granted Breakthrough Device
designation to the Neovasc Reducer in October 2018. This designation is granted by the
FDA in order to expedite the development and review of a device
that demonstrates compelling potential to provide a more effective
treatment or diagnosis for life-threatening or irreversibly
debilitating diseases. In addition, there must be no FDA
approved treatments presently available, or the technology must
offer significant advantages over existing approved alternatives
for the FDA to grant Breakthrough Device designation.
Refractory angina, resulting in continued symptoms despite
maximal medical therapy and without revascularization options, is
estimated to affect 600,000 to 1.8 million Americans, with 50,000
to 100,000 new cases per year.1
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, beliefs or
expectations as to the IJC article having the potential to further
encourage cardiologists to treat refractory angina patients with
coronary sinus narrowing without the concern of adverse effects on
the relaxation properties of the heart, coronary sinus narrowing
not adversely affecting relaxation of the heart muscle, the
likelihood that the observed improvement in the relaxation
properties of the heart are most probably secondary to the
improvement in blood perfusion to ischemic territories of the heart
muscle, 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 senior secured convertible
notes (the "Notes") issued pursuant to the November 2017 private placement (the "2017
Financing"), 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 Notes issued pursuant to the 2017
Financing, 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 conversion of Notes issued pursuant to the 2017 Financing,
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 conclusion that it did not have
effective internal control over financial reporting as at
December 31, 2018; 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 Notes 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 Management's Discussion and
Analysis for the year ended December 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.
1T. J. Povsic, S. Broderick, K. J. Anstrom et al.,
"Predictors of long‐term clinical endpoints in patients with
refractory angina," Journal of the American Heart Association, vol.
4, no. 2, article e001287, 2015.
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SOURCE Neovasc Inc.