Neovasc Provides Tiara TA Update
April 16 2021 - 9:05AM
via NewMediaWire -- Neovasc Inc. ("Neovasc" or the "Company")
(NASDAQ, TSX: NVCN), today announced that the Tiara Transapical
system (“Tiara TA”) will be unable to receive a European CE mark
under the current Medical Device Directive regulations (“MDD”)
ending on May 26, 2021. The Company is collaborating with its
European Notified Body (the “Notified Body”) on potential next
steps.
Neovasc has been working with its Notified Body for more than a
year to obtain a decision on a CE Mark for Tiara TA, including an
ongoing exchange of additional information beyond the original
submission. The Company has determined that it will be unable to
provide the additional information required by the Notified Body,
which includes further testing data, before the current MDD
regulations end next month.
The MDD is set to be replaced by the newer Medical Device
Regulation (“MDR”) on May 26, 2021. A CE Mark under either
the MDD or MDR regulations would allow the Company to commercialize
the Tiara TA system in Europe.
“We are disappointed that the MDD regulations are going to be
replaced before we are able to gain CE Mark approval for the Tiara
TA system,” said Fred Colen, Chief Executive Officer Neovasc. “We
believe that the Tiara valve has shown to be a remarkable device
and we are pleased with the safety and efficacy profile the device
has displayed in clinical trials to date. Our team has worked
tirelessly, and we believe we have made meaningful progress with
our notified body during COVID-19 lockdowns to advance the approval
process, but we have run out of time to complete the review before
the transition to MDR next month, our previously announced target
date for a CE mark decision.”
The Company expects to provide an update at, or around, the
upcoming Q1 2021 Earnings Call scheduled for early May.
The transition from MDD to MDR does not impact the Tiara
transfemoral program (“Tiara TF”). The Company has always
anticipated that Tiara TF’s CE Mark submission would be assessed
under MDR.
About Neovasc Inc.
Neovasc is a specialty medical device company that develops,
manufactures and markets products for the rapidly growing
cardiovascular marketplace. The Company is a leader in the
development of minimally invasive transcatheter mitral valve
replacement technologies, and minimally invasive devices for the
treatment of refractory angina. Its products include 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 Tiara™, for the
transcatheter treatment of mitral valve disease, which is currently
under clinical investigation in the United States, Canada, Israel
and Europe. For more information, visit: www.neovasc.com.
Investors
Mike Cavanaugh
Westwicke/ICR
Phone: +1.646.877.9641
Mike.Cavanaugh@westwicke.com
Media
Sean Leous
Westwicke/ICR
Phone: +1.646.866.4012
Sean.Leous@westwicke.com
Forward-Looking Statement Disclaimer
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. When used herein,
the words "expect", "anticipate", "estimate", "may", "will",
"should", "intend," "believe", and similar expressions, are
intended to identify forward-looking statements. Forward-looking
statements may involve, but are not limited to expectations as to
the growing cardiovascular marketplace, the safety and efficacy
profile of the Tiara TA, the Company’s plans to evaluate all
feedback from the notified body and strategic alternatives, and the
anticipated submission and assessment of the Tiara TF under the MDR
rules at the time of submission. 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
doubt about the Company’s ability to continue as a going concern;
risks related to the recent COVID-19 coronavirus outbreak or other
health epidemics, which could significantly impact the Company’s
operations, sales or ability to raise capital or enroll patients in
clinical trials and complete certain Tiara development milestones
on the Company’s expected schedule; risks relating to the Company’s
need for significant additional future capital and the Company’s
ability to raise additional funding; risks relating to the sale of
a significant number of Common Shares; risks relating to the
possibility that the Company’s common shares (the “Common Shares”)
may be delisted from the Nasdaq or the TSX, which could affect
their market price and liquidity; risks relating to the Company’s
conclusion that it did have effective internal control over
financial reporting as of December 31, 2020 but not at December 31,
2019 and 2018; risks relating to the Common Share price being
volatile; risks relating to the possibility that the Common Shares
may be delisted from the Nasdaq or the TSX, which could affect
their market price and liquidity; risks relating to the Company’s
significant indebtedness, and its effect on the Company’s financial
condition; 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; risks relating
to claims by third-parties alleging infringement of their
intellectual property rights; risks relating to 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
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; risks relating to 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 relating to the extensive regulation of the
Company’s products and trials by governmental authorities, as well
as the cost and time delays associated therewith; risks relating to
post-market regulation of the Company’s products; risks relating to
health and safety concerns associated with the Company’s products
and industry; risks relating to 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; risks relating to the
possibility 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 the possibility that the Company could be treated
as a "passive foreign investment company"; risks relating to
breaches of anti-bribery laws by the Company’s employees or agents;
risks relating to 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;
risks relating to 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 relating to 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
conflicts of interests among the Company's officers and directors
as a result of their involvement with other issuers; and risks
relating to 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. These risk
factors and others relating to the Company are discussed in greater
detail in the "Risk Factors" section of the Company's Annual
Information Form and in the Management's Discussion and Analysis
for the year ended December 31, 2020 (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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