NASDAQ, TSX: NVCN
VANCOUVER, Sept. 23, 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
announced that its Tiara™ ("Tiara") transcatheter mitral valve
replacement device and its Neovasc Reducer™ ("Reducer") CE-Marked
device for the treatment of refractory angina will be featured in
multiple presentations at the Transcatheter Cardiovascular
Therapeutics (TCT) 2019 scientific symposium, which takes
place September 25-29, 2019, in San Francisco.
"We are excited that our core products, Tiara and Reducer, will
be prominently featured at TCT, the largest and most prestigious
interventional cardiology conference in North America," said Fred Colen, President and Chief Executive
Officer of Neovasc. "Our team looks forward to interacting
with many of the leading cardiologists from around the globe."
Select Presentations:
Tiara
- In Session I, "TMVR Overview and Principle Devices,"
Anson Cheung, M.D., Professor of
Surgery, University of British
Columbia, Canada, and Director of Cardiac Transplant and
Mechanical Circulatory Assist Program of British Columbia, will deliver a presentation
entitled, "Tiara: Device Description, Results, and Ongoing
Studies," on Saturday, September 28,
2019, at 2:27 PM PT.
Reducer
- In a Moderated Poster Session, "Chronic Total Occlusions," on
Friday, September 27, 2019, at
2:30 PM PT, Dr. Carlo Zivelonghi will deliver a presentation
entitled, "Efficacy of Coronary Sinus Reducer in Patients with
non-Revascularized Chronic Total Occlusions: a Multicentre
Experience."
- In an International Complex Case Session, "Featured Complex
Coronary Cases," on Friday, September 27,
2019, at 4:50 PM PT, Prof.
Matjaz Bunc of Ljubljana University Medical Centre in Slovenia will deliver a presentation entitled,
"Multimodal Treatment of Refractory Angina Pectoris With Coronary
Flow Reducer Implantation."
About Tiara
Tiara is a self-expanding mitral
bioprosthesis specifically designed to treat mitral valve
regurgitation ("MR") by replacing the diseased valve. Conventional
surgical treatments are only appropriate for about half of MR
patients, who number an estimated four million in the U.S. with a
similar number of patients affected throughout Europe. Tiara
is implanted in the heart using a minimally invasive, transapical
transcatheter approach without the need for open-heart surgery or
use of a cardiac bypass machine.
The Tiara valve is currently being evaluated in two ongoing
clinical trials: TIARA-I—an early feasibility trial in the
United States, Canada, and Belgium; and TIARA-II—a
European Conformité Européenne Mark
Trial in Germany, Italy, Spain, and
the United Kingdom. In addition, patients have also been
treated under compassionate programs
in Canada, Italy, Germany, Israel,
and Switzerland.
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 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.
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
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, statements regarding 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, risks relating to the possibility that the
Company's common shares may be delisted from the Nasdaq Capital
Market or the Toronto Stock Exchange, including Nasdaq's
discretionary public interest authority to apply more stringent
criteria for continued listing or suspend or delist securities,
which could affect their market price and liquidity; 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 the senior secured
convertible Notes issued pursuant to the 2017 Financing, which may
encourage short sales by third parties; 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 three and
six months ended June 30, 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.