NASDAQ, TSX: NVCN
VANCOUVER, Sept. 30, 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 were featured in
multiple presentations at the Transcatheter Cardiovascular
Therapeutics (TCT) 2019 scientific symposium, which took
place September 25-29, 2019, in San Francisco.
"We continue to build a comprehensive portfolio of clinical
evidence in support of Tiara and Reducer," said Fred Colen, President and Chief Executive
Officer of Neovasc. "Moreover, the continued use of our
products by some of the world's leading cardiologists and cardiac
surgeons, further validates their significant potential. We look
forward to continuing to advance our development program for Tiara
and our efforts to expand our commercial efforts with Reducer."
Select Presentations:
Tiara
During a presentation at TCT on Saturday, September 28,
2019, titled, "Tiara: Device Description, Results, and Ongoing
Studies," 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, provided an update on the
Tiara development program. There have been 79 patients treated
worldwide with the Tiara mitral valve replacement device. Dr.
Cheung provided an overview of data from 71 patients, including 26
patients in the TIARA-II European CE Mark Clinical Study, 23
patients in the TIARA-I Early Feasibility Clinical Study and 22
patients treated via Special Access/Compassionate Use. The
presentation included data on Tiara's excellent procedural safety,
improvement in mitral regurgitation and significant improvement in
Quality of Life as determined by the New York Heart Association
Classification.
Reducer
On Friday, September 27, 2019, Dr. Carlo
Zivelonghi from Ziekenhuis Netwerk Antwerpen, Belgium, presented a poster, titled
"Efficacy of Coronary Sinus Reducer in Patients with
non-revascularized Chronic Total Occlusions." In this multicenter
retrospective study, 205 patients were divided in two groups
according to the presence or absence of chronic total occlusion
(CTO) lesions. Clear benefit in angina reduction was demonstrated
in both CTO and non-CTO patients, with improvement in CCS Class, a
clinical tool used to assess the degree of severity of a patient's
angina, at six-month follow-up (144 /205, 74%, p-value 0.03)
following Reducer therapy. Dr. Zivelonghi concluded that there was
a significantly greater improvement in the CTO group and that the
Reducer implantation should be considered a valid complementary
therapy to CTO percutaneous coronary intervention.
Also on Friday, September 27, Prof. Matjaz
Bunc of Ljubljana University Medical Centre in Slovenia presented a complex case, during his
presentation on "Multimodal Treatment of Refractory Angina
Pectoris With Coronary Flow Reducer Implantation." Prof. Bunc noted
the growing number of refractory angina patients due to the aging
population and the corresponding increase in "no-option" patients
who experience severe debilitating angina, despite optimal medical
therapy, and current treatment guidelines. He presented a complex
case of a 65-year old male who, despite 2 CABG procedures and
multiple PCIs, as well as optimal medical therapy, continued to be
CCS Class IV. Reducer was implanted, and the patient is now at CCS
Class II. Prof. Bunc concluded that Reducer therapy may provide
additional symptomatic improvement for resistant angina and could
have additional clinical indications.
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 not commercially available and 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 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, beliefs and expectations relating to the clinical
results of the Tiara and Reducer, including statements that the
Reducer implantation should be considered a valid complementary
therapy to CTO percutaneous coronary intervention and that the
Reducer therapy may provide additional symptomatic improvement for
resistant angina and could have additional clinical indications,
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.