American Medical Association Issues New CPT Code for Neovasc Reducer Procedure
January 29 2021 - 8:00AM
via NewMediaWire -- Neovasc, Inc. ("Neovasc" or the "Company")
(NASDAQ, TSX: NVCN) announced today that the American Medical
Association (AMA) has issued a new Current Procedural Terminology
(CPT®) Category III Code for transcatheter implantation of a
coronary sinus reduction device. The code is effective July 1,
2021.
The AMA is responsible for managing the CPT coding system that
the Centers for Medicare and Medicaid Services (CMS) use to track
procedures. Obtaining a dedicated CPT code describing the Neovasc
Reducer™ (Reducer) implant procedure is an important step towards
securing adequate reimbursement in the United States.
“We are pleased that the AMA has included the
Reducer procedure as a Category III code,” commented Fred Colen,
President and CEO of Neovasc. “Obtaining adequate reimbursement for
Reducer is a critical component of our long-term growth strategy
that will enable broad-based adoption of the technology upon FDA
approval. While we are still evaluating our options for bringing
the device to the U.S. market and through an FDA approval process,
the new CPT code is an important step in the follow-on
reimbursement process.”
Designated a “Breakthrough Medical Device” by the
U.S. Food and Drug Administration (FDA), the Reducer is eligible
for coverage under the Medicare Coverage of Innovative Technologies
(MCIT) Executive Order upon FDA approval. According to CMS, the
MCIT rule will provide national Medicare coverage as early as the
same day as FDA market authorization for breakthrough devices and
coverage would last for four years. This new coverage pathway will
offer beneficiaries nation-wide predictable access to new,
breakthrough devices to help improve their health outcomes.
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.
CPT is a registered trademark of the American
Medical Association.
Investors
Mike Cavanaugh
Westwicke/ICR
Phone: +1.646.877.9641
Mike.Cavanaugh@westwicke.com
Media
Sean Leous
Westwicke/ICR
Phone: +1.646.677.1839
Sean.Leous@icrinc.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
impact that the CPT coding system will have on securing adequate
reimbursement for the reducer in the United States, execution of
the Company’s long-term growth strategy, the broad-based adoption
of the Reducer technology upon FDA approval 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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