NASDAQ, TSX: NVCN
VANCOUVER, June 15, 2017 /CNW/ - Neovasc Inc.
("Neovasc" or the "Company") (NASDAQ, TSX: NVCN)
today announced its Tiara™ technology, developed to treat severe
Mitral Regurgitation (MR), is being featured in a video recorded
procedure to be presented at the 10th Annual Transcatheter Valve
Therapies (TVT) Conference. TVT is being held from
June 14th -
17th, 2017 in Chicago, Illinois.
The video recording is being presented by Dr. Shmuel Banai, Director of Interventional
Cardiology in the Cardiology Department at the Tel Aviv Medical
Center and Neovasc's Medical Director.
The case presented was completed in Lugano, Switzerland, where a 35mm Tiara™
transcatheter mitral valve was successfully implanted in a
79-year-old male with a complex cardiovascular history, which
included ischemic cardiomyopathy, poor left ventricular
function, calcified mitral ring, with severe mitral valve
regurgitation, chronic atrial fibrillation, previous mechanical
aortic surgical valve placement, CABG, aortic aneurysm, and a
biventricular pacemaker and defibrillator implantation. The
Tiara™ implantation was successfully completed in 30
minutes. Implantation of the Tiara™ valve resulted in
the complete resolution of the patient's MR. At 7-week follow
up the patient is at home and is doing well. Of note, prior
to the Tiara™ procedure, several alternative treatments were
considered, including MitraClip, redo surgery and other implantable
devices currently under investigation, however due to the
anatomical challenges and poor cardiac function of this patient and
the presence of a mechanical aortic valve, they were not considered
to be viable options.
"This case highlights two critical aspects of the Tiara.
One, it clearly demonstrates the Tiara's medical role in very
damaged and sick heart that simply are not candidates for
conventional surgery, a patient pool that is unfortunately already
large and growing," said Alexei Marko, CEO of Neovasc.
"Two, the audience witnessed the elegant simplicity of this
implantation procedure. Combined, these two themes underscore the
Tiara's potential for the medical community and patients suffering
from mitral regurgitation."
The Tiara™ has now been used to treat 30 patients under early
feasibility, compassionate use and clinical study protocols
across North America and Europe. Results using
the device continue to be encouraging with good technical success,
and positive patient outcomes. One of the first patients
treated with the Tiara™ is now over three years post implant.
The Company has begun enrolling patients into its European CE Mark
trial, with an initial case performed in Italy and
additional cases anticipated
in Germany and Italy over the coming
months. Implantation is completed through a short
trans-apical procedure and typically results in complete resolution
of the patient's MR without significant residual leaks or
obstruction of the ventricular outflow tract.
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 Neovasc
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 its business, and other
matters, including the Company's expectations on the number of
patients that will not be candidates for conventional surgery, and
the Company's intentions and expectations with regard to patient
enrollment and additional cases to be performed in the TIARA II CE
Mark study. Words and phrases such as "growing", "begun" and
"anticipated", 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, risks relating to the
Company's litigation with CardiAQ, including the Company's ability
to successfully appeal the validity of the awards as well as the
ruling on inventorship, which create material uncertainty and which
cast substantial doubt on the Company's ability to continue as a
going concern; 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 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;
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" section of the Company's Annual
Information Form and in the Company's Management's Discussion and
Analysis of Financial Condition and Results of Operations (copies
of which filings may be obtained at www.sedar.com or www.sec.gov,
each of which are included in the Company's Annual Report on Form
40-F). 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.