via NewMediaWire ‒ Neovasc Inc. (“Neovasc” or the “Company”)
(NASDAQ, TSX: NVCN) today announced that the first patient has been
enrolled in the
COronary
SInus Reducer for the
Treatment of Refractory
Microvascular
Angina
(“COSIMA”) trial. The enrollment occurred at University Hospital,
Mainz, Germany. The patient is an 82-year-old woman who suffers
from severe Canadian Cardiovascular Society (“CCS”) Class IV angina
on a daily basis despite optimal medical treatment. The study is
being led by Prof. Tommaso Gori, M.D., Ph.D., University Medical
Center, Mainz, Germany.
COSIMA is a randomized controlled trial, supported by Neovasc,
investigating the Neovasc Reducer™ (“Reducer”) for the treatment of
Microvascular Angina. The study will enroll up to 144 patients
across multiple centers in Germany. The primary endpoint of the
study is change in CCS angina class, a measure of chest pain
severity and limitation, by two or more classes. Patients enrolled
in the trial will be randomized to one of two groups: the treatment
arm will receive the Reducer and continue with their optimized
medications; the control arm will not receive the Reducer but will
continue with their optimized medications. Patients will be
followed for an initial period of six months to determine the
outcomes of the two treatment strategies.
“Microvascular Angina is a common condition that affects
millions of patients worldwide, and it disproportionately affects
women,” stated Helen Ullrich, M.D., University Medical Center,
Mainz, Germany, who enrolled the first patient in the trial.
“Preliminary case reports have suggested Reducer may be a
beneficial treatment for microvascular angina. The COSIMA Trial is
important because it will provide robust data on the performance of
the Reducer in this important, underserved population.”
There are millions of angiograms performed worldwide per year on
patients experiencing angina symptoms. Studies suggest that up to
50% of the angiograms reveal no significant blockages in the large
blood vessels of the heart, and of those patients without
significant coronary blockages, almost half may have evidence of
microvascular impairment. Microvascular angina can occur when the
small blood vessels in the heart have increased resistance to blood
flow and prevent sufficient oxygenated blood from reaching portions
of the heart muscle. Patients with microvascular angina may require
frequent hospitalizations, often undergo repeat invasive
procedures, have an impaired quality of life and a poor
prognosis.
Fred Colen, President and Chief Executive Officer of Neovasc,
commented, “Microvascular angina is a burden for patients,
physicians and healthcare systems worldwide. Neovasc is committed
to continuing to generate evidence supporting the safety and
efficacy of the Reducer therapy, which is the only device of its
kind on the market today. We are pleased to support the
consequential COSIMA study, and we wish to thank the investigators
for their efforts to commence the trial.”
Patients that meet all the inclusion criteria for the trial,
including objective evidence of ischemia documented by non-invasive
testing such as a cardiac stress test, that are not good candidates
for traditional stenting or bypass surgery, and that have evidence
of an elevated Index of Microvascular Resistance, are eligible for
inclusion in the clinical trial.
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 within the myocardium of the heart and 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.
While the Reducer is not approved for commercial use in the
United States, the FDA granted Breakthrough Device designation to
the Reducer in October 2018. This designation is granted by the FDA
in order to expedite the development and review of a device that
demonstrates compelling potential to provide a more effective
treatment or diagnosis of life-threatening or irreversibly
debilitating diseases. In addition, there must be no FDA approved
treatments presently available, or the technology must offer
significant advantages over existing approved
alternatives.
Refractory angina, resulting in continued symptoms despite
maximal medical therapy and without revascularization options, is
estimated to affect 600,000 to 1.8 million Americans, with 50,000
to 100,000 new cases per year.
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 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 Tiara™ for the transcatheter treatment of
mitral valve disease, which is currently under clinical
investigation in the United States, Canada, Israel and Europe. For
more information, visit: www.neovasc.com.
InvestorsMike CavanaughWestwicke/ICRPhone:
+1.646.877.9641Mike.Cavanaugh@westwicke.com
MediaSean LeousWestwicke/ICRPhone:
+1.646.866.4012Sean.Leous@westwicke.com
Forward-Looking Statement Disclaimer
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. When used herein,
the words "expect", "anticipate", "estimate", "may", "will",
"should", "intend," "believe", and similar expressions, are
intended to identify forward-looking statements.
Forward-looking statements may involve, but are not limited
to, the number of patients expected to be enrolled in the COSIMA
trial, the preliminary case reports suggesting the Reducer may be a
beneficial treatment for microvascular angina, the Company’s
intention to continue to generate evidence supporting the safety
and efficacy of the Reducer and the 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 doubt about the Company’s
ability to continue as a going concern; risks related to the recent
COVID-19 coronavirus outbreak or other health epidemics, which
could significantly impact the Company’s operations, sales or
ability to raise capital or enroll patients in clinical trials and
complete certain Tiara development milestones on the Company’s
expected schedule; 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 sale of a
significant number of Common Shares; risks relating to the
possibility that the Company’s common shares (the “Common Shares”)
may be delisted from the Nasdaq or the TSX, which could affect
their market price and liquidity; risks relating to the Company’s
conclusion that it did have effective internal control over
financial reporting as of December 31, 2020 but not at December 31,
2019 and 2018; risks relating to the Common Share price being
volatile; risks relating to the possibility that the Common Shares
may be delisted from the Nasdaq or the TSX, which could affect
their market price and liquidity; risks relating to the Company’s
significant indebtedness, and its effect on the Company’s financial
condition; 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; risks relating
to claims by third-parties alleging infringement of their
intellectual property rights; risks relating to 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
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; risks relating to 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 relating to the extensive regulation of the
Company’s products and trials by governmental authorities, as well
as the cost and time delays associated therewith; risks relating to
post-market regulation of the Company’s products; risks relating to
health and safety concerns associated with the Company’s products
and industry; risks relating to 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; risks relating to the
possibility 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 the possibility that the Company could be treated
as a "passive foreign investment company"; risks relating to
breaches of anti-bribery laws by the Company’s employees or agents;
risks relating to 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;
risks relating to 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 relating to 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
conflicts of interests among the Company's officers and directors
as a result of their involvement with other issuers; and risks
relating to 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.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 Management's Discussion and Analysis
for the three months ended March 31, 2021 (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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