NASDAQ, TSX: NVCN
VANCOUVER, Sept. 12, 2017 /PRNewswire/ - Neovasc Inc.
("Neovasc" or the "Company") (NASDAQ, TSX: NVCN)
today provided an update on the study progress and clinical
performance of the TiaraTM valve, a self-expanding
mitral bioprosthesis for transcatheter implantation in patients
with Mitral Regurgitation ("MR"), one of the most prevalent
valvular heart diseases in western countries. MR is often
severe and can lead to heart failure and death.
To date, 34 patients have been treated with the
TiaraTM valve at ten different medical centers across
the United States, Canada,
Germany, Italy, Belgium, Switzerland and Israel. The technical success rate in
these implantations is 31/34 or 91.1%. 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 33 patients who have reached 30 days post
implant with TiaraTM is 12.1% (4/33). The
remaining patient treated within the last 30 days is recovering
well. To date, the longest surviving patient has passed 3.5
years post implant.
"Transcatheter implantation of the Tiara mitral valve resulted
in immediate elimination of MR and improved the performance of the
heart, without the need for any cardiac support device and with no
procedural complications," commented Professor Dr. Ulrich Schafer, an Interventional Cardiologist
from the Cardiology Department at the University Heart Center
Hamburg and one of the CE Mark trial's principal investigators.
"The results we see so far are very encouraging in this very
sick and high-risk patient population. These patients with
severe MR and severe heart failure tolerate the Tiara implantation
procedure without any major issues, and most of them are discharged
home 3-5 days after the valve implantation."
Implantations of the TiaraTM are being performed
under 3 parallel clinical/investigational programs: 1) a
European pivotal CE Mark trial, TIARA-II; 2) an FDA Early
Feasibility trial, TIARA-I; and 3) compassionate use/special access
treatment. To date, the Company has received regulatory
approval in Italy, Germany and the UK to conduct the TIARA-II
study at 10 centers (5 in Italy, 3
in Germany and 2 in the UK).
The TIARA-II study, which is the primary focus of the Tiara
program, is a 115 patient, non-randomized, prospective clinical
study evaluating Tiara's safety and performance. It is
expected that data from this study will be used to file for CE Mark
approval.
In addition, the Company has recruited two new U.S. centers to
participate in its TIARA-I study, and is actively recruiting in 4
centers in the U.S., 1 center in Belgium, and 3 centers in Canada. TIARA-I is an international,
multicenter early feasibility study being conducted to assess the
safety and performance of the Tiara™ mitral valve system and
implantation procedure in high-risk surgical patients suffering
from severe mitral regurgitation.
Upcoming Presentations
TiaraTM results and
data continue to be presented at major medical conferences,
including on September
9th, when Dr. Paulo
Denti, principal investigator at San Raffaele Hospital,
Milan, Italy presented a
TiaraTM case example at CSI-UCSF 2017, a conference
hosted by the CSI Foundation in association with the University of California, San Francisco (UCSF);
and, on September 25th,
Dr. Anson Cheung, a principal
investigator of the TIARA-I study, will be presenting an update on
the Neovasc TiaraTM program at PCR London Valves 2017
conference, an annual meeting of the European Association for
Percutaneous Cardiovascular Interventions.
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. TiaraTM 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 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 to use data from the TIARA-II
study to file for CE Mark approval and to continue to present
TiaraTM results and data at major medical conferences.
Words and phrases such as "expected", "continue" 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, 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.