Pending U.S. Food and Drug Administration
("FDA") Humanitarian Use Device ("HUD") Classification and Approval
as a HUD, Company Expects to Begin Commercializing Reducer in
U.S. by Early 2020
A potential HUD Reducer designation for
Canadian Cardiovascular Society ("CCS") Class IV would, by statute,
allow the treatment of a limited number of patients per year, which
has the potential to represent an estimated Total Annual
Addressable Market of approximately US$80
Million
NASDAQ, TSX: NVCN
VANCOUVER, July 16, 2019 /PRNewswire/ - Neovasc Inc.
("Neovasc" or the "Company") (NASDAQ, 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
provided a further update on its Neovasc Reducer™ (the "Reducer")
program for the treatment of refractory angina.
As previously announced, following guidance recently received
from the FDA, Neovasc intends to seek the FDA's designation of the
Reducer as a HUD for CCS Class IV refractory angina
patients. If it is possible and if the FDA grants HUD
designation for the Reducer for CCS Class IV patients, and if a
subsequent HDE application is approved by the FDA as well, Neovasc
expects to begin commercializing the Reducer in the U.S. by early
2020. The maximum total U.S. annual addressable market with a
Reducer HDE under a CCS Class IV would be limited, by statute, to a
maximum number of patients per year in the U.S. with the most
severe refractory angina, and is therefore limited to an estimated
US$80 million of potential revenue
per year.
"Should the FDA grant the Class IV HUD designation to the
Reducer, we expect to be in a position to offer treatment to those
patients with CCS Class IV refractory angina in early 2020," said
Fred Colen, CEO of Neovasc.
"We view this as a significant market opportunity for Neovasc.
Concurrently, we will explore an alternate investigational device
exemption clinical study design, in conjunction with our supportive
U.S. cardiologists, with the intent of further expanding the
patient population to CCS Class III patients and to seek full
approval for the CCS Class IV patients over time."
There can be no assurance that the HUD or HDE applications that
Neovasc plans to file will be approved by the FDA, that the FDA
will classify the Reducer for CCS Class IV refractory angina
patients as a HUD, or that such applications will be approved on
the timelines described above. In the event that the HUD and HDE
applications are approved by the FDA, there can be no assurance
that Neovasc will be successful in commencing commercialization of
the Reducer in the U.S. on the timeline described above or at all,
or of the total addressable market size for 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 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 U.S., 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.
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 potential pathways and
timelines to accessing the U.S. market with respect to the Reducer,
including the Company's ongoing discussions with the FDA, the
Company's intention to pursue HUD designation and a HDE for the
Reducer with respect to CCC class IV refractory angina patients,
FDA's potential approval of a Reducer Class IV HUD designation,
FDA's potential approval of Neovasc's HUD and HDE applications, and
the Company's intention to explore an alternate IDE study design
with the intent to further expand the patient population and
eliminate statutory restrictions over time, the potential
addressable market for the Reducer in the U.S., 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.