Neovasc Announces 2021 Renewal of German Reimbursement NUB Status 1 Designation for Neovasc Reducer for Treatment of Refracto...
February 02 2021 - 8:30AM
via NewMediaWire -- Neovasc, Inc. ("Neovasc" or the
"Company") (NASDAQ, TSX: NVCN) today announced that
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 once again for 2021.
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.
InEK renewed the status of the Neovasc Reducer as
Status 1 – the highest priority designation available. The NUB
decision is valid for one year and can be renewed
annually. For 2021, 241 German hospitals applied for the
Reducer NUB, and they can now negotiate full reimbursement coverage
for the Neovasc Reducer therapy. For 2020, a total of 182 hospitals
had applied – the increase suggests continued interest in Reducer
therapy in Germany.
Fred Colen, Chief Executive Officer of Neovasc,
commented, “We are pleased that the German reimbursement
authorities have once again granted the Reducer NUB Status 1. Our
team has been focused on securing broad reimbursement coverage for
Reducer so that more patients can benefit from the therapy.
Obtaining NUB Status 1 for 2021 is an important component of our
overall strategy.”
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(TM) 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.
Investors
Mike Cavanaugh
Westwicke/ICR
Phone: +1.646.877.9641
Mike.Cavanaugh@westwicke.com
Media
Sean Leous
Westwicke/ICR
Phone: +1.646.866.4012
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, our ability to
commercialize Reducer or otherwise expand its use or access to
Reducer therapy, the Company’s ability to successfully navigate the
complex reimbursement process in Germany, the Company’s ability to
build on progress and optimize the value of its devices, the
expansion of its product range, growth opportunities in Germany or
otherwise in Europe, continued interest in Reducer therapy in
Germany or elsewhere, prospects for regulatory approvals and the
growing cardiovascular marketplace. 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, 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 Report on Form 20-F and in the Management’s
Discussion and Analysis for the three and nine months ended
September 30, 2020 (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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