Company Joined by Other Industry Leaders as
Part of ISO Cardiac Valves Working Group
NASDAQ, TSX: NVCN
VANCOUVER, July 15, 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 its participation in a round-robin study evaluating
prosthetic heart valve hydrodynamic performance measurements among
the 13 leading participating international laboratories.
Aaron J. Chalekian, Neovasc's Vice
President of Product Development & Manufacturing Engineering,
was as an author on a recently published paper in Cardiovascular
Engineering and Technology highlighting the study. The
paper can be found here:
https://link.springer.com/article/10.1007/s13239-019-00422-5
Hydrodynamic performance testing is one of the core in vitro
assessments required by the ISO 5840 series of standards for all
prosthetic heart valves. A round-robin study carried out in 2005 in
accordance with ISO 5840:2005 revealed significant variabilities in
prosthetic heart valve hydrodynamic performance measurements among
the participating laboratories. In order to re-examine the
interlaboratory variability based on the ''state-of-the-art'' under
ISO 5840-1 and 5840-2:2015, the ISO Cardiac Valve Working Group
decided in 2016 to repeat the round-robin study.
The ISO Cardiac Valves Working Group consists of one academic
laboratory (Helmholtz Institute of the RWTH University, Aachen,
Germany), three testing service
providers (BDC Laboratories; Medical Implant Testing Lab; ViVitro
Laboratories), eight heart valve manufacturers (Boston Scientific;
Edwards Lifesciences, Surgical Heart Valve Therapy; Edwards
Lifesciences, Transcatheter Heart Valves; Medtronic; Neovasc; Sorin
Group Italia s.r.l. (fully owned by LivaNova Plc); St Jude Medical;
W. L. Gore), and the Food and Drug Administration Office of Science
and Engineering Laboratories.
"We are extremely gratified to be setting the stage for the
science in this field, together with such a distinguished
group of industry leaders," said Fred
Colen, CEO of Neovasc. "This important work will help refine
prosthetic heart valve hydrodynamic performance testing.
Neovasc looks forward to continuing to collaborate with the other
members of the ISO Cardiac Valves Working Group to achieve further
advancements in the design of prosthetic heart valves."
The study revealed improved reproducibility when compared to the
previous round-robin study, yet significant variability among
different laboratories still exists. It also revealed that
prosthetic heart valve hydrodynamic performance testing involves
not only ''science,'' but also ''art,'' especially in the tuning of
flow and pressure waveforms. It was determined that it is important
to exercise care in the testing by carefully tuning the pulse
duplicator system in order to minimize the variations and obtain
valid and repeatable measurements. This information allowed the ISO
Working Group to incorporate improved language into the ISO 5840-1,
-2, and -3 standards that are currently under revision. The results
can also be used by the testing laboratories to benchmark pulse
duplicator systems, as well as to train and certify testing
personnel.
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™ (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.
Forward-Looking Statement Disclaimer
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 implications of the
referenced study and the rapidly growing cardiovascular
marketplace. Words and phrases such as "continue", "strategy",
"goal", "would", "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 senior secured convertible notes (the "Notes")
issued pursuant to the November 2017 private placement
(together, 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 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 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 Financing; 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 three months
ended March 31, 2019 (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.