- Clinical updates for both Reducer™ and
Tiara™ also presented at premier event -
NASDAQ, TSX: NVCN
VANCOUVER, Dec. 6, 2017 /CNW/ - Neovasc Inc.
("Neovasc" or the "Company") (NASDAQ, TSX: NVCN)
today reported its Neovasc Reducer™ ("Reducer") medical device was
featured in a "live case" broadcast at the 2017 Innovations in
Cardiovascular Interventions (ICI) conference held in Tel Aviv, Israel. In the live case
broadcast to the conference from the Soroka University Medical
Center in Beersheba Israel, Drs. Koifman and Bazan successfully
implanted a Reducer in the coronary sinus of a patient suffering
from very poor quality of life due to refractory angina pectoris,
chest discomfort felt with even minimal effort, despite previous
bypass surgery and multiple stent implantations.
The minimally invasive procedure took approximately 15 minutes
to complete, and was uneventful. The live Reducer case was
broadcast following a scientific presentation describing current
available clinical data supporting the use of the Reducer as a safe
and effective therapy for patients with refractory angina pectoris.
The scientific presentation was given by Dr. Konigstein from the
Cardiovascular Research Foundation (CRF).
"Since launching Reducer in 2015, clinical interest has
consistently grown across Europe
and the product is now used in more than 80 medical centers,"
commented Neovasc CEO, Alexei Marko.
"With no other alternatives to treat this patient population,
Reducer's safe and straight-forward procedure along with clear
patient benefit is fueling its increasing popularity among
interventional cardiologists for their patients with refractory
angina."
The Company's REDUCER-I Observational Study is collecting long
term data from European patients implanted with the Reducer.
Currently more than 130 patients have been enrolled in 18 centers
across Europe. Enrollment in this
study will continue up to 400 patients.
Also during the ICI conference, a clinical update on the Tiara™
("Tiara") trans catheter mitral valve replacement was presented by
Dr. Shmuel Banai. To date, 42
patients have been implanted with Tiara. The 30-day survival
rate for the first 37 patients (those treated more than 30 days
ago) is 33 of 37 or 89%. There have been 20 Tiara
implantations so far in 2017, with 100% technical success achieved
and a 93% 30-day survival rate for the 15 patients who were
implanted more than 30 days ago.
"Tiara's Clinical enrolment rate is gaining momentum with 8
implantations in the last 2 months, 6 of which were patients
enrolled in the CE-Mark Tiara II study. We continue to be very
encouraged by the performance of Tiara. Implantations are
typically completed quickly and without complications, even by new
operators, and in most cases result in the complete elimination of
mitral regurgitation. We are looking forward to continuing to
expand and accelerate this important program," added Alexei Marko.
In a separate matter, the Company reports that it has paid in
full the damages award mandated by the court in the litigation with
CardiAQ Valve Technologies, Inc. and that the associated General
Security Agreement has been terminated.
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.
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.
About ICI 2017
The Innovations in Cardiovascular
Interventions (ICI) conference was held December 3-5, 2017 at the David Intercontinental
Hotel in Tel Aviv, Israel. This
acclaimed forum for interventional cardiologists, entrepreneurs and
the cardiovascular industry focuses on innovative technology and
therapies and covers all stages of the innovation process, from the
bench to the patient bedside. For more information, visit
2017.icimeeting.com.
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
available in the United States and
has been available in Europe since
2015 and the Tiara, for the transcatheter treatment of mitral valve
disease, which is currently under investigation in the United States, Canada and Europe. The Company also sells a line of
advanced biological tissue products that are used as key components
in third-party medical products including transcatheter heart
valves. 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
Company's plans and expectations concerning clinical interest in
its products, the performance of the Reducer and Tiara, and the
anticipated timing for and enrolment in its European trial for
Tiara and REDUCER-I Observational Study. Words and phrases such as
"increasing", "intends", "expects", "considering",
"continue", "looking forward" 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
Company's need for significant additional future capital and the
Company's ability to raise additional funding; risks relating to
the Warrants and Notes, offered pursuant to the November 2017 public offering of units and
private placement of senior secured convertible notes and warrants
(the "Financings"), resulting in significant dilution to the
Company's shareholders; 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 it being more
expensive for the Company to raise capital in the future and
dilution to investors; risks relating to the Company's Common Share
price being volatile; risks relating to the sale of a significant
number of Common Shares; risks relating to the restrictions on the
Company entering into certain transactions; risks relating to the
exercise of Warrants or conversion of Notes offered pursuant to the
Financings, which may encourage short sales by third parties; risks
relating to claims by third parties alleging infringement of their
intellectual property rights; 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 competition in the
medical device industry, including the risk that one or more
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 the Company's
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 the
Company's 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 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 the Company's 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; the Company's ability to
successfully identify and complete corporate transactions on
favorable terms or achieve anticipated synergies relating to any
acquisitions or alliances; 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; risks relating to conflicts of interests among the
Company's officers and directors as a result of their involvement
with other issuers; and risks relating to the influence of
significant shareholders of the Company over the Company's business
operations and share price. These risk factors and others relating
to the Company are discussed in greater detail in the "Risk
Factors" sections of the Company's Annual Information Form and
Management's Discussion and Analysis of Financial Condition and
Results of Operations, each of which is included in its Annual
Report on Form 40-F, and the Company's Management Discussion and
Analysis for the third quarter of 2017 (copies of which filings may
be obtained at www.sedar.com or www.sec.gov). These factors
should be considered carefully, and readers should not place undue
reliance on the Company's forward-looking statements. The
Company has no intention and undertakes no obligation to update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise, except as required by
law.
SOURCE Neovasc Inc.