NASDAQ, TSX: NVCN
VANCOUVER, May 23, 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 new data for its Tiara™ ("Tiara") transcatheter
mitral valve replacement device and Neovasc Reducer™ ("Reducer")
device for the treatment of refractory angina were presented in
several presentations at the EuroPCR 2019 Conference held this week
in Paris, France.
Reducer
Several clinical research results were
presented including; statistically significant increase in both the
myocardial perfusion reserve index using stress MRI testing and a
statistically significant improvement in left ventricular ejection
fraction in a 19-patient study; a case report of the successful
retrieval of a dislodged Reducer; a successful Reducer implantation
leading to an angina symptoms free outcome for the patient; and a
19-patient study with a statistically significant increase in the
six minute walk test four months after Reducer implantation, an
improvement of the Canadian Cardiovascular Society classification
in 84% of the patients, and a suggestion that coronary sinus size
may play a role in the success rate.
Neovasc also sponsored a successful, interactive, Reducer
Symposium, titled: "A proven evidence-based therapy when angina
persists", with the following agenda and presenters:
- Session objectives, S. Verheye
- How much do we listen to our patients with Angina? I.
Ajmi
- The role of Reducer therapy in the treatment of CTO patients,
J. Hill
- The challenge of microvascular angina, J. Escaned
- Robust clinical evidence from FIM to 2019, F. Giannini
- Session evaluation and key learnings, S. Banai
Tiara
Dr. Lenard
Conradi delivered a presentation entitled: "Innovative
design of a transcatheter transapical mitral valve and update on
Tiara I and Tiara II clinical data" as part of the main session:
"Early trials and First-in-Man in Mitral valve replacement". Dr.
Conradi presented the latest clinical results of the Tiara I and II
clinical studies. For more detailed information and references, we
refer to the EuroPCR publications. Following the session Dr.
Conradi stated "especially since the Trans-Apical Tiara is one of
the earliest mitral valve platforms, it is remarkable that its
procedural safety profile is excellent, with no procedural
mortality in a high-risk patient population. Also, in this early
stage and compared to other devices, the delivery catheter is
remarkably ergonomic and user-friendly."
"The new data reported at this year's EuroPCR for our Reducer
provides us with exciting insights into the positive impact that
the device has on treating refractory angina pain and other
symptoms they might suffer from. Considering this patient
population has limited therapeutic options, and suffer a serious
impact on their quality of life, the more information we can
provide treating cardiologists on the benefits of the Reducer, the
more likely it is that this therapy will become a new standard of
care for the treatment of refractory angina around the world.
On the Tiara side, we also had an interactive and productive
Tiara II meeting with our clinical investigators and a core-lab
representative, plus we demonstrated our new transfemoral,
trans-septal Tiara system in closed door sessions to invited
interventional cardiologists and surgeons, with many lively
discussions and positive and encouraging feedback. All in all, a
very productive and exciting EuroPCR conference for Neovasc this
year" commented Fred Colen,
Neovasc's President and Chief Executive Officer.
About EuroPCR 2019
EuroPCR 2019 is the world-leading
course in interventional cardiovascular medicine and the official
annual meeting of the European Association of Percutaneous
Cardiovascular Interventions ("EAPCI"), which is taking place from
21 to 24 May 2019 at the Palais des
Congrès in Paris, France. The
detailed Course Programme is available on:
https://www.pcronline.com/Courses/EuroPCR. The mission of PCR is to
serve the needs of each individual patient by helping the
cardiovascular community to share knowledge, experience and
practice. PCR offers a large range of many other educational
meetings and resources for the continuing education of the
interventional cardiovascular community. These include major annual
courses across the globe, e-Learning with high-profile PCR
webinars, courses specifically dedicated to valvular heart disease,
tailor-made PCR Seminars on specific topics, online resources and
medical publications such as EuroIntervention, the official journal
of the EAPCI.
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, beliefs and expectations relating to the future
performance and/or success of the Reducer and the Tiara, including
statements about the Reducer potentially becoming a new standard of
care for the treatment of refractory angina around the world, the
FDA's review of the Reducer and the Tiara's safety profile,
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, 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 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 Notes issued pursuant to the 2017 Financing,
which may encourage short sales by third parties; risks relating to
the possibility that the common shares of the Company 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
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 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.