-Recent results presented at the ICI Meeting
in Israel-
NASDAQ: NVCN
TSX: NVC
VANCOUVER, Dec. 6, 2016 /PRNewswire/ - Neovasc Inc.
("Neovasc" or the "Company") (NASDAQ: NVCN) (TSX:
NVC) today provided an update on the clinical experience with its
Tiara™ transcatheter mitral valve. Tiara™ is a novel
transcatheter device designed to treat mitral regurgitation (MR), a
condition that is often severe and can lead to heart failure and
death.
To date, 22 patients have been treated with the Tiara™ valve at
medical centers in Canada, the
U.S. and Europe with more
implantations scheduled for the coming weeks. The technical
success rate in these implantations was 19/22 or 86%. In
these technically successful implantations, paravalvular leak
levels were reported as mild, trace or absent in 100% of these
cases. All cause 30-day mortality in the 19 patients who have
reached 30 days post implant with Tiara™ is 15.7% (3/19). The
3 remaining patients treated within the last 30 days are recovering
well. Of note, there has been no 30-day mortality reported in
any of the last 8 patients treated over a month
ago.
To date, the longest patient follow up available is nearing 3
years post implant, where the Tiara™ valve remains fully
functional. There have been no reported adverse events related
to the valve performance. There have been no frame fractures,
or any device performance issues observed with the Tiara™ in any
patient follow-up.
The results noted above were presented today by Dr. Shmuel Banai, at the ICI Meeting 2016 (ICI) in
Tel Aviv, Israel. ICI is the
premier International Conference for Innovations in Cardiovascular
Systems.
Tiara has demonstrated the ability to treat a range of different
patient anatomies, including patients with pre-existing prosthetic
aortic valves (both mechanical and biological) and those with prior
mitral repair surgery including mitral rings, which may be contra
indications for other devices.
"Tiara's unique shape and trigonal tab anchoring system enables
the device to be securely implanted with reduced risk of projecting
into the LVOT or potentially interfering with prosthetic aortic
valves which are commonly present in this patient population,"
stated Alexei Marko, Neovasc CEO.
"Furthermore, the Tiara anchoring system does not rely
significantly on the integrity of the native mitral leaflets and
therefore can be suitable for certain degenerative MR patients with
flail leaflets or calcification. It has also been
successfully shown that the design of Tiara makes it suitable for
certain cases where mitral rings have been previously implanted in
patients."
TIARA II, a 115 patient, non-randomized, prospective clinical
study evaluating Tiara's safety and performance, recently
received approval to begin enrolling patients in Italy. 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. It is anticipated
that the first implantations in the TIARA II trial will be
conducted by the medical team at San Raffaele Hospital in
Milan, Italy in the first quarter
of 2017. The Company will be initiating additional
investigational sites in 2017 as required approvals are
obtained.
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 the
potential for contra indications of Tiara for other devices, the
suitability of the Tiara anchoring system for certain degenerative
MR patients with flail leaflets or calcification and the Company's
plans and expectations concerning the TIARA II clinical study in
Italy, including 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 anticipated location and timing of the
implantations in the TIARA II trial and the expected initiation of
additional investigational sites in 2017.The words "expected",
"will", "anticipated", "look forward", "may", "can" 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 andwhich
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.