Participating Hospitals in Germany Now Eligible to Negotiate
Reimbursement for Reducer Procedure
NASDAQ, TSX: NVCN
VANCOUVER, Feb. 1, 2018 /CNW/ - Neovasc, Inc. ("Neovasc" or
the "Company") (NASDAQ, TSX: NVCN), a leader in the development of
minimally invasive transcatheter mitral valve technologies, today
announced that the "Institut für das Entgeltsystem im Krankenhaus"
("InEk"), the German Institute for the Hospital Remuneration
System, has awarded its Neovasc Reducer™ ("Reducer"), a CE-Marked
medical device for the treatment of refractory angina, NUB status 1
designation for 2018.
InEK, is responsible for prioritizing new therapies in
Germany through the NUB process.
Yesterday, InEK upgraded the status of the Neovasc Reducer from
status 4 to status 1 - the highest priority designation
available.
A NUB decision is valid for one year and can be renewed
annually. The NUB process opens the path for negotiations
between hospitals and health insurances on the reimbursement of new
medical treatments in the German system. Based on the new NUB
status 1 for the Neovasc Reducer, 107 German hospitals can now
negotiate reimbursement coverage for the Neovasc Reducer therapy
under the German health insurance system.
Fred Colen, CEO of Neovasc
commented "This significant upgrade to the highest level in the
German NUB status is an exciting development for the Reducer
therapy in Europe. For many
patients Angina remains a significant issue and many of them have
limited treatment options today. This positive NUB development will
allow additional patients suffering from refractory angina to be
treated with the Reducer in Germany."
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 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™ ("Tiara"),
for the transcatheter treatment of mitral valve disease, which is
currently under clinical investigation in the United States, Canada and Europe. 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 possible future
renewals of NUB decisions, the treatment of additional patients
suffering from refractory angina in Germany with the Reducer, and the growing
incidence of refractory angina. Words and phrases such as
"will", "can be" and "growing", 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.