Neovasc Announces German Reimbursement Renewal and Commercial Progress
February 08 2022 - 8:05AM
via NewMediaWire -- Neovasc, Inc. (Neovasc or the Company)
(NASDAQ, TSX: NVCN) today announced the German Institute
for the Hospital Remuneration System ("InEK") has awarded the
Neovasc Reducer™ ("Reducer"), a CE-Marked medical device for the
treatment of refractory angina, NUB Status 1 designation yet again
for 2022. Additionally, the Company announced the 500th
patient has been treated in Germany.
New examination and treatment methods (NUBs) are comprised of
novel and innovative medicines, medical products and procedures
that can be utilized by hospitals before reaching full
reimbursement eligibility. The NUB process opens the path for
negotiations between hospitals and health insurers for the
reimbursement of new medical treatments in the German healthcare
system. InEK is responsible for prioritizing new therapies
in Germany through the NUB process.
Reducer has been granted Status 1 – the
highest priority designation available. The NUB decision is
valid for one year and can be renewed annually. For 2022, 256
German hospitals applied for the Reducer NUB, and they can now
negotiate full reimbursement coverage for the Reducer therapy.
“Our team has been focused on securing broad
reimbursement coverage for Reducer so more patients can benefit
from the therapy,” commented Fred Colen, Chief Executive Officer of
Neovasc. “Obtaining NUB Status 1 for 2022 from the German
reimbursement authorities is a vital component of our overall
strategy. In the past several quarters, we have had significant
reimbursement wins in Germany, France, the U.K., and the United
States. These reimbursement expansions are a testament to the
profound impact that the Reducer can have on patients.”
500th patient treated with the Reducer in
Germany
The Cardiology team at Helios-Kliniken, Schwerin,
Germany recently completed the 500th implant of the Reducer in
Germany. The procedure marks another meaningful step as the Company
continues to expand adoption of the procedure. Prof. Alexander
Staudt, Director of Cardiology, and Dr. Philipp Hammer performed
the procedure.
“We are extremely grateful to be able to offer
this treatment for our patients with chronic refractory angina,”
commented Prof. Staudt. “Prior to the availability of the Reducer,
we struggled to treat these patients. Now, we have a reliable
treatment option that offers them hope.”
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. Reducer is
investigational in the United States in the COSIRA-II clinical
trial. Refractory angina, resulting in continued symptoms
despite maximal medical therapy and without revascularization
options, affects millions of patients worldwide, who typically lead
severely restricted lives because of their disabling symptoms. The
Reducer is designed to alter blood flow within the myocardium of
the heart and increase the perfusion of oxygenated blood to
ischemic areas of the heart muscle, which may provide relief of
angina symptoms.
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 under clinical
investigation 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.
Contacts
Investors:
Mike Cavanaugh
ICR Westwicke
Phone: +1.617.877.9641
Email: Mike.Cavanaugh@westwicke.com
Media:
Sean Leous
ICR Westwicke
Phone: +1.646.866.4012
Email: Sean.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 Company’s focus
on securing broad reimbursement coverage for Reducer, the impact
that the Reducer can have on patients, the growing incidence of
refractory angina and the growing cardiovascular marketplace.
Forward-looking statements are based on estimates and assumptions
made by the Company considering its experience and its perception
of historical trends, current conditions and expected future
developments, market, and other conditions as well as other factors
that the Company believes are appropriate in the circumstances.
Many factors could cause the Company's actual results, performance,
or achievements to differ materially from those expressed or
implied by the forward-looking statements, including those
described in the "Risk Factors" section of the Company's Annual
Information Form and in the Management's Discussion and Analysis
for the three and nine months ended September 30, 2021 (copies of
which 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.
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