NASDAQ, TSX: NVCN
VANCOUVER, July 12, 2019 /CNW/ - 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 Food and Drug Administration ("FDA") has
provided guidance to the Company following its Sprint Discussion on
June 26, 2019, together with the
Company's consultants and supporting U.S. cardiologists to review
the clinical evidence collected to date for the Neovasc Reducer™
(the "Reducer"), to determine the most expedient pathway to
potentially gaining regulatory approval in the United States and the quickest path to the
U.S. market for these patients with an unmet need.
In its guidance, the FDA has recommended that the Company
consider potential alternate approaches such as: the Humanitarian
Device Exemption ("HDE") pathway for class IV refractory angina
patients and/or alternate clinical trial designs for a broader
refractory angina patient population.
Based on the FDA's feedback, the Company has decided to explore
a two-pronged approach. First, the Company will work with the FDA
to pursue the option for the Reducer to be classified as a
Humanitarian Use Device ("HUD") seeking an HDE approval pathway in
order to bring this treatment option to those patients in the U.S.
with the worst (class IV) angina symptoms as soon as possible.
Second, the Company, in close consultation with the FDA and key
opinion leaders, will evaluate an alternate investigational device
exemption ("IDE") clinical trial design for class III and IV
patients.
"We are encouraged by the outcome of our discussions with the
FDA on the clinical evidence and the potential pathway to the U.S.
market for the Reducer," said Fred
Colen, President and Chief Executive Officer of Neovasc.
"The FDA's proposed alternative approaches, including a potential
HDE pathway, would provide a meaningful treatment option for those
patients suffering from the worst angina symptoms and who are
desperate for a novel treatment in the fastest possible manner.
This guidance from the FDA represents a potential substantial
improvement over the original timeline we expected to bring this
novel breakthrough medical device therapy for the treatment of
refractory angina to the U.S. market."
A HUD designation and approval of a HDE for class IV refractory
angina patients would allow the Reducer device to be sold in the
U.S. for profit as a medical device intended to benefit such
patients in the treatment or diagnosis of a disease or condition
that affects or is manifested in not more than 8,000 individuals in
the U.S. per year. There can be no assurance that the Company will
be successful in attaining such an HUD designation or approval of
such an HDE for the Reducer.
In addition, the Company will explore an alternate IDE study
design, in conjunction with our supportive U.S. cardiologists, with
the intent to further expand the patient population and to
eliminate the above-mentioned market restrictions over time. There
can be no assurance that such an IDE study can be financed, will be
approved by the FDA, will be completed, or if such a study is
completed, that U.S approval will follow based on the results of
that study.
While the guidance provided by the FDA is not intended to
change, there can be no guarantee that a submission by the Company
on the basis of such guidance will be accepted by the FDA.
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.
While the Reducer is not approved for commercial use in the
USA, the 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.
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.
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
potential pathways and timelines to accessing the U.S. market with
respect to the Reducer, including the Company's ongoing discussions
with the FDA and guidance provided by the FDA, the Company's
intention to pursue HUD designation and a HDE for the Reducer with
respect to class IV refractory angina patients, and the Company's
intention to explore an alternate IDE study design with the intent
to further expand the patient population and eliminate market
restrictions over time, the growing incidence of refractory angina
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.
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.