NASDAQ: NVCN
TSX: NVC
VANCOUVER, Nov. 28, 2016 /CNW/ - Neovasc Inc.
("Neovasc" or the "Company") (NASDAQ: NVCN) (TSX:
NVC) today announced it has received both regulatory and ethics
committee approval to initiate the Tiara™ Transcatheter Mitral
Valve Replacement Study (TIARA II) in Italy. TIARA II
is a 115 patient, non-randomized, prospective clinical study
evaluating the safety and performance of the Tiara™ Transcatheter
Mitral Valve with the Tiara™ Transapical Delivery System
(Tiara™).
With these critical approvals now in place, it is expected that
the first Italian TIARA II clinical study site will be initiated
before year end, with first enrollment anticipated early in the new
year. Approvals in additional geographies are expected in the
first quarter of 2017.
"We have been very encouraged by the results to date with the
Tiara device," stated Alexei Marko,
Neovasc CEO. "Tiara has been successfully implanted in a wide range
of patients including those with prosthetic aortic valves in place
(both tissue and mechanical valves) and those with prior mitral
valve surgical repairs, including mitral rings. With this
approval, we look forward to beginning our CE mark study which
offers a less invasive treatment option for patients determined to
be high risk for surgery, suffering from severe MR, and to
eventually have Tiara available as a treatment option for clinical
use to treat this devastating disease."
It is expected that data from this study will be used to file
for CE Mark approval for Tiara™. CE Mark is the European
Union (EU) regulatory approval to commercialize a medical device.
Receiving the CE Mark demonstrates that a product has been assessed
by the EU authorities and conforms to the European essential
requirements for safety and performance.
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 effected throughout Europe. Tiara™
is implanted in the heart using a minimally invasive, transapical
transcatheter approach and is designed to replace the diseased
native mitral valve without the need for open-heart surgery or use
of a cardiac bypass machine.
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 U.S. 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 US,
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 relating to the
Company's plans and expectations concerning the TIARA II clinical
study in Italy, including the
anticipated timing for the study in Italy and the anticipated timing for approvals
in additional geographies, the Company's plans and expectations for
Tiara to be available as a treatment option for routine clinical
use, and the Company's expectation that data from the TIARA II
clinical study in Italy will be
used to file for CE Mark approval for Tiara. The words "expected",
"will", "anticipated", "look forward", "eventually", and similar
words or expressions are intended to identify 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 conduct or possible outcomes of any actual
or threatened legal proceedings; the Company's ability to stay the
payment of the awards in the CardiAQ litigation and its ability to
successfully appeal the validity of the awards as well as the
ruling on inventorship, which are inherently uncertain and which
create material uncertainty and cast substantial doubt on the
Company's ability to continue as a going concern; the potential
impact on the Company's business of an adverse decision in the
appeal on the question of inventorship even if the Company prevails
on its appeal of the awards; potential changes in circumstances
relating to the Company's financing requirements, whether as a
result of the CardiAQ litigation, unforeseen circumstances or
otherwise; the Company's ability to raise additional funding;
the potential benefits of the Neovasc Reducer™ and Tiara™ as
compared with other products; successful enrollment of patients in
studies and trials for the Neovasc Reducer™ and Tiara™; results of
the trials and studies for the Neovasc Reducer™ and Tiara™ that
meet the Company's expectations; the Company's receipt of any
required local and institutional regulatory approvals and the
timing and costs of obtaining such approvals; European enrollment
in our clinical trials, studies and compassionate use cases and the
success of applications in Europe;
the Company's ability to protect its intellectual property; changes
in business strategy or development plans; existing governmental
regulations and changes in, or the failure to comply with,
governmental regulations and general economic and business
conditions, both nationally and in the regions in which the Company
operates. 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, which is included in its Annual
Report on Form 40-F and Management's Discussion and Analysis of
Financial Condition and Results of Operation (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.