NASDAQ, TSX: NVCN
VANCOUVER, Jan. 18, 2018 /PRNewswire/ - Neovasc
Inc. ("Neovasc" or the "Company") (Nasdaq, TSX: NVCN)
today reported its Neovasc Reducer™ ("Reducer") was featured in a
"live case" broadcast to more than 800 participants at
the Kardiologie Symposium 2018 held in Berlin,
Germany. The successful live
case was performed by Dr. Spyrantis and Professor Banai in the
Sana-Klinikum Lichtenberg.
"The patient in this case, like a growing number of patients,
still had significant angina after all medical treatment options
had been exhausted. There is clearly a need to address this
patient population as their quality of life is very poor and the
burden on the healthcare system is significant due to the frequency
of emergency room visits," commented Dr. Olaf Göing, a panelist
during the live case session. "Reducer is an important and
innovative treatment option for patients suffering from refractory
angina."
"The live case and the momentum in the post market study reflect
the continued success of Reducer's performance in Europe," commented Neovasc CEO, Alexei Marko. "As Dr. Göing's
comments suggest, we believe we are only beginning to scratch the
surface of this very serious condition."
The Company's REDUCER-I Observational Study is a multi-center,
multi-country, three-arm study collecting long-term data from
European patients implanted with the Reducer. The study is
expected to enroll up to 400 patients. Currently, 135 patients have
been enrolled across 20 centers that are active in Italy, Germany, Belgium, Netherlands, United
Kingdom, and Switzerland.
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 Kardiologie Symposium 2018
The Kardiologie
Symposium 2018 takes place for the 18th time and is
co-chaired by Dr. Göing from Sana-Klinikum Lichtengerg,
Berlin and by Professor Falk from
the Deutsches Herzzentrum Berlin.
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 future performance of the Reducer, the
anticipated timing for and enrolment in its REDUCER-I Observational
Study, the growing incidence of patients suffering angina and the
growing number of patients still suffering angina after all medical
treatment options are exhausted. Words and phrases such as
"growing", "continued", "only beginning to" and "expected", 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.