Neovasc Comments on New ICD-10-CM Diagnosis Codes for Refractory Angina
15 Setembro 2022 - 10:05AM
via NewMediaWire – Neovasc Inc. (“Neovasc” or the “Company”)
(NASDAQ, TSX: NVCN) today commented on the Centers for Medicare and
Medicaid Services (“CMS”) development of new codes for the
diagnosis and tracking of refractory angina. The new codes will be
utilized in the current, 10th revision of the International
Statistical Classification of Diseases and Related Health Problems
Clinical Modification (“ICD-10-CM”). The latest update was
published in the ICD-10-CM Tabular List of Diseases and Injuries
2023 Addenda and will be effective October 1, 2022.
“The creation of new ICD-10-CM codes for refractory angina is an
important step for patients and clinicians. Historically, there has
been no way to differentiate patients with this most difficult and
burdensome form of chronic stable chest pain,” said Tim Henry,
M.D., Medical Director, The Carl and Edyth Lindner Center for
Research and Education, Christ Hospital, Cincinnati, and immediate
past president of the Society for Cardiovascular Angiography &
Interventions. “Moving forward, we now have a mechanism to define
and measure the treatment costs and resulting outcomes of these
patients.” Dr. Henry serves as National Co-Principal Investigator
in COSIRA-II, the company’s pivotal clinical trial in the United
States for the Neovasc Reducer (“Reducer”).
In total, nine new refractory angina codes were created. The
primary new code, I20.2 Refractory Angina Pectoris, was
supplemented with eight additional new codes describing refractory
angina in combination with various conditions pertaining to
atherosclerosis, or hardening of the heart’s arteries. The new
ICD-10-CM codes will help clinicians identify and accurately
diagnose patients with refractory angina, a painful and
debilitating condition that occurs when the heart muscle does not
get enough oxygen. Patients with refractory angina have a high
incidence of hospitalization and resource use1.
“Today’s announcement is another important step forward
for patients with refractory angina and for the Neovasc Reducer as
an option for treating this disease,” added Bill Little, Neovasc
Chief Operating Officer. “The creation of the new ICD-10-CM codes
will help to ensure appropriate measurement of the costs and
clinical outcomes in patients who suffer from the burden of
refractory angina.”
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
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 2011, 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.
1 J Am Heart Assoc. 2015 Jan 30;4(2):e001287. doi:
10.1161/JAHA.114.001287
Contacts
InvestorsMike CavanaughICR WestwickeEmail:
Mike.Cavanaugh@westwicke.com
MediaSean LeousICR WestwickeEmail:
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 contained in
the news release may involve, but are not limited to, statements
regarding the announcement being an important step forward for
patients with refractory angina and for the Reducer, the creation
of the new ICD-10-CM codes helping to ensure appropriate
measurement of the costs and clinical outcomes in patients that
suffer from the refractory angina 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, 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 for the
year ended December 31, 2021 and in the Management’s Discussion and
Analysis for the three and six months ended June 30, 2022 (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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