NASDAQ, TSX: NVCN
VANCOUVER, May 6, 2019 /CNW/ - 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 1,000 patients diagnosed with refractory angina have
been treated with the Neovasc Reducer™ ("Reducer"). These
patients have been treated in Europe, the Middle
East, Canada, and
the United States (the two
patients treated in the U.S. were treated under compassionate use).
Three patients were treated simultaneously by Dr.
Francesco Giannini and Prof.
Antonio Colombo at the Maria Cecilia
Hospital in Cotignola, Italy,
Prof. Marco Valgimigli at the Inselspital Universitätsspital
Bern, Switzerland and Prof. Javier
Escaned at the Hospital Clinico San Carlos in Madrid, Spain.
"Regular bouts of angina can significantly impact a patient's
quality of life. This is especially true when these people suffer
from refractory angina, which is angina that persists despite
optimal drug therapy and revascularization. For many of these
patients, angina changes their life unexpectedly and the prospect
of living with this pain for the rest of their lives is difficult
to bear," says Prof. Banai, Director Division of Cardiology at the
Tel Aviv Medical Center and Medical Director for Neovasc.
"We are pleased to have treated the 1,000th patient to receive
the Reducer therapy at the Inselspital Universitätsspital
Bern". The procedure was performed
by Prof. Marco Valgimigli and is expected to offer symptomatic
relief from invalidating angina after coronary artery bypass
surgery 19 years ago and multiple percutaneous coronary
interventions afterwards.
The Reducer therapy now totals medical evidence spanning 1,000
patients and 14 years of follow up. This substantial evidence
demonstrates that the Reducer alleviates refractory angina symptoms
in about 80% of the treated patients. The procedure lasts about 20
minutes and has been shown to be very safe and straightforward.
"It is important to note that the clinical results obtained in a
randomized trial have been replicated in 'real life' hospital
settings across several countries," stated Dr. Giannini. "The fact
that the Reducer therapy is effective and safe is very important
for refractory angina patients, as this chronic condition
significantly impairs their quality of life and they have very
limited treatment options."
"I have been following the development of the Reducer therapy
for many years. I am pleased to see how its clinical data has
continued to build. With the 1,000th patient treated
milestone, I believe it is time we encourage our colleagues and
societies to inform their refractory angina patients that there may
be a treatment option available to them today," says Prof.
Colombo.
"There is great interest in the cardiology community for the
Reducer device. Published data from real-world experience, which
has now reach 1000 patients, supports the very solid evidence
obtained in the randomized, sham-controlled COSIRA trial on the
value of coronary sinus reduction in patients with refractory
angina. this is particularly important for this group of patients
with limited options", stated Prof. Escaned.
"We are pleased to reach this milestone and view the increasing
use of the Reducer to treat refractory angina patients around the
world as a testament to the positive impact the device has had on
patients compared to other treatment options. This momentum
is mostly attributable to the commercialization strategy that we
have implemented for the Reducer in Europe, which has generated growing interest
among leading cardiologists," stated Fred
Colen, CEO of Neovasc.
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. The
Reducer is not commercially available in the United States, the FDA however granted the
Reducer the Breakthrough Device Designation in October of last
year. Refractory Angina 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 commercially available in the United States and has been commercially
available in Europe since 2015,
and 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.
Certain statements in this news release contain forward-looking
statements within the meaning of the U.S. Private Securities
Litigation Reform Act of 1995 and applicable Canadian securities
laws that may not be based on historical fact, including
without limitation statements containing the words "believe",
"may", "plan", "will", "estimate", "continue", "anticipate",
"intend", "expect" and similar expressions. Forward-looking
statements may involve, but are not limited to, beliefs or
expectations regarding the growing interest for the Reducer among
leading cardiologists, the growing incidence of refractory angina
and the rapidly growing cardiovascular marketplace. 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
senior secured convertible notes (the "Notes") issued pursuant to
the November 2017 private placement
(the "2017 Financing"), 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 Notes issued pursuant to the 2017
Financing, 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 of the Company; risks relating
to the conversion of Notes issued pursuant to the 2017 Financing,
which may encourage short sales by third parties; risks relating to
the possibility that the common shares of the Company 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 conclusion that it did not have
effective internal control over financial reporting as at
December 31, 2018; 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 Notes 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 the Management's Discussion and
Analysis for the year ended December 31,
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.
View original
content:http://www.prnewswire.com/news-releases/neovasc-announces-treatment-of-1-000th-refractory-angina-patient-with-neovasc-reducer-300844227.html
SOURCE Neovasc Inc.