NASDAQ, TSX: NVCN
VANCOUVER, Sept. 19, 2018 /PRNewswire/ - Neovasc, Inc.
("Neovasc" or the "Company") (NASDAQ: NVCN) (TSX: NVCN), a leader
in the development of minimally invasive transcatheter mitral valve
replacement technologies and in the development of minimally
invasive devices for the treatment of refractory angina, announced
today that a Neovasc Reducer™ (the "Reducer") has now been
implanted in 100 patients in Germany. The Reducer is a wire mesh implanted
into a vein in the heart which treats patients with refractory
angina.
A growing number of patients suffer from significant angina
despite optimal medication and prior revascularisations (via
percutaneous coronary intervention or coronary artery bypass
graft), or when revascularization is not feasible or when the risks
is too great. Refractory angina can lead to significant disability,
limited quality of life, multiple medications and frequent hospital
admissions.
"This important milestone in Germany was reached earlier than originally
anticipated, thanks in large part to the Reducer being awarded
NUB-status 1 earlier this year. With awareness of the Reducer
therapy continuing to build among cardiologists, we are well on our
way to tripling the number of implants in Germany for 2018 as compared to last year,"
stated Fred Colen, President and
Chief Executive Officer of Neovasc.
Dr. Steffen Schnupp, Klinikum
Coburg, Germany, commented "We see
a growing number of patients presenting with refractory angina,
despite optimal medical treatment and revascularization therapies.
The Reducer therapy is a welcome option for these patients in my
center."
Dr. Schnupp and his colleague, Dr. Ashraf Salem, implanted the 100th Reducer in
Coburg, Germany. The procedure was
uneventful and lasted less than 30 minutes.
"We have treated over 25 patients with the Reducer and observe a
high success rate. Ninety percent of our patients have reported a
relief of symptoms and an improved quality of life," said Dr.
Salem.
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 usually 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 commercially available in the United States and has been commercially
available in Europe since 2015,
and the Tiara™ (the "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 tripling
of the number of Reducer implants in Germany for 2018 as compared to last year, the
growing incidence of refactory angina and the rapidly growing
cardiovascular marketplace. Words and phrases such as "expected"
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, the substantial doubt
about the Company's ability to continue as a going concern; risks
relating to the warrants (the "Warrants") and senior secured
convertible notes (the "Notes") issued pursuant to the November 2017 underwritten public offering and
concurrent private placement (together, the "2017 Financings"),
resulting in significant dilution to the Company's shareholders;
risks relating to the Company's need for significant additional
future capital and the Company's ability to raise additional
funding; risks relating to cashless exercise and adjustment
provisions in the Warrants and Notes issued pursuant to the 2017
Financings, which could make it more difficult and expensive for
the Company to raise additional capital in the future and result in
further dilution to investors; risks relating to the sale of a
significant number of Common Shares; risks relating to the exercise
of Warrants or conversion of Notes issued pursuant to the 2017
Financings, which may encourage short sales by third parties; risks
relating to the possibility that the 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
the Company's common share price being volatile; risks relating to
the influence of significant shareholders of the Company over the
Company's business operations and share price; risks relating to
the Company's significant indebtedness, and its effect on the
Company's financial condition; risks relating to claims by third
parties alleging infringement of their intellectual property
rights; risks relating to lawsuits that the Company is subject to,
which could divert the Company's resources and result in the
payment of significant damages and other remedies; 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 use of
the Company's products in unapproved circumstances, which could
expose the Company to liabilities; risks relating to competition in
the medical device industry, including the risk that one or more of
the Company's 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 its 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 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 the Company's dependence on limited
products for substantially all of the Company's current revenues;
risks relating to the Company's exposure to adverse movements in
foreign currency exchange rates; risks relating to the possibility
that the Company could lose its foreign private issuer status under
U.S. federal securities laws; 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 its 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; risks relating to the Company's
ability to successfully identify and complete corporate
transactions on favorable terms or achieve anticipated synergies
relating to any acquisitions or alliances; risks relating to the
Company's ability to successfully enter into fundamental
transactions as defined in the Series C warrants issued pursuant to
the 2017 Financings; 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; and
risks relating to conflicts of interests among the Company's
officers and directors as a result of their involvement with other
issuers. These risk factors and others relating to the Company are
discussed in greater detail in the "Risk Factors" section of the
Company's Annual Report on Form 20-F and in Management's Discussion
and Analysis for the quarter ended June 30,
2018 (copies of which may be obtained at www.sedar.com or
www.sec.gov). The Company has no intention and undertakes no
obligation to update or revise any forward-looking statements
beyond required periodic filings with securities regulators,
whether as a result of new information, future events or otherwise,
except as required by law.
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SOURCE Neovasc Inc.