Shockwave Medical Announces That CMS Has Created New Codes for Intravascular Lithotripsy
June 08 2020 - 4:30PM
Shockwave Medical, Inc. (Nasdaq: SWAV), a pioneer in the
development and commercialization of Intravascular Lithotripsy
(IVL) to treat complex calcified cardiovascular disease, announced
today that the Centers for Medicare & Medicaid Services (CMS)
has issued new codes for IVL procedures performed in peripheral
arteries in both the hospital outpatient and inpatient settings.
The new Healthcare Common Procedure Coding System (HCPCS)
outpatient and International Classification of Diseases, Tenth
Revision, Procedure Coding System (ICD-10-PCS) inpatient codes will
go into effect on July 1 and October 1, 2020, respectively.
Under these new codes, Medicare payment rates for IVL procedures
performed in the hospital outpatient and inpatient settings,
respectively, are consistent with current payment levels for other
similar peripheral artery interventional procedures.
“The decision by CMS to assign codes for peripheral IVL
procedures in both outpatient and inpatient settings is an
important validation of Shockwave’s technology as a unique and
distinct therapy for treating complex calcified disease in the
peripheral arteries,” said Doug Godshall, President and Chief
Executive Officer of Shockwave Medical. “We look forward to
continued engagement with CMS as these new codes will now enable
the collection of cost data specific to IVL procedures, which is
the information the agency utilizes when making future adjustments
to procedure payment levels. The appreciation for IVL’s
unique ability to safely and effectively treat these challenging
patients is growing globally and we are grateful that CMS has taken
this important first step on the path towards establishing a
reimbursement level that appropriately reflects the clinical value
delivered by IVL.”
For more information and a complete listing of codes, please go
to https://shockwavemedical.com/reimbursement/.
Conference CallShockwave Medical will host a
conference call at 2:30 p.m. Pacific Time / 5:30 p.m. Eastern Time
today, Monday, June 8, 2020, to provide further detail. The call
may be accessed through an operator by dialing 866-795-9106 for
domestic callers or (470) 495-9173 for international callers, using
conference ID: 3267348. A live and archived webcast of the event
will be available at https://ir.shockwavemedical.com.
About Shockwave Medical, Inc. Shockwave Medical
is focused on developing and commercializing products intended to
transform the way calcified cardiovascular disease is treated. The
company aims to establish a new standard of care for medical device
treatment of atherosclerotic cardiovascular disease through their
differentiated and proprietary local delivery of sonic pressure
waves for the treatment of calcified plaque, which they refer to as
Intravascular Lithotripsy (IVL). IVL is a minimally invasive,
easy-to-use and safe way to significantly improve patient outcomes.
To view an animation of the IVL procedure and for more information,
visit www.shockwavemedical.com.
Forward-Looking Statements This press release
contains statements relating to Shockwave’s expectations,
projections, beliefs, and prospects (including statements regarding
Shockwave’s product development outlook), which are
“forward-looking statements” within the meaning of the federal
securities laws and by their nature are uncertain. Words such as
“believe,” “may,” “will,” “estimate,” “continue,” “anticipate,”
“intend,” “expect,” “plans,” and similar expressions are intended
to identify forward-looking statements. Such forward-looking
statements are not guarantees of future performance, and you are
cautioned not to place undue reliance on these forward-looking
statements.
Forward-looking statements include, but are not limited to
statements about: the impact of the COVID-19 pandemic on our
operations, financial results, and liquidity and capital resources,
including on our sales, expenses, supply chain, manufacturing,
research and development activities, clinical trials and employees;
our ability to design, develop, manufacture and market innovative
products to treat patients with challenging medical conditions,
particularly in peripheral artery disease, coronary artery disease
and aortic stenosis; our expected future growth, including growth
in international sales; the size and growth potential of the
markets for our products, and our ability to serve those markets;
the rate and degree of market acceptance of our products; coverage
and reimbursement for procedures performed using our products; the
performance of third parties in connection with the development of
our products, including third-party suppliers; regulatory
developments in the United States and foreign countries; our
ability to obtain and maintain regulatory approval or clearance of
our products on expected timelines; our plans to research, develop
and commercialize our products and any other approved or cleared
product; our ability to scale our organizational culture of
cooperative product development and commercial execution; the
development, regulatory approval, efficacy and commercialization of
competing products; the loss of key scientific or management
personnel; our expectations regarding the period during which we
qualify as an emerging growth company under the JOBS Act; our
ability to develop and maintain our corporate infrastructure,
including our internal controls; our financial performance and
capital requirements; and our expectations regarding our ability to
obtain and maintain intellectual property protection for our
products, as well as our ability to operate our business without
infringing the intellectual property rights of others.
These forward-looking statements are only predictions based on
our current expectations and projections about future events. There
are important factors that could cause our actual results, level of
activity, performance or achievements to differ materially from the
results, level of activity, performance or achievements expressed
or implied by the forward-looking statements. These factors, as
well as others, are discussed in greater detail in our filings with
the Securities and Exchange Commission (SEC), including in Part I,
Item IA - Risk Factors in our most recent Annual Report on Form
10-K filed with the SEC, and in our other periodic and other
reports filed with the SEC. There may be additional risks of
which we are not presently aware or that we currently believe are
immaterial which could have an adverse impact on our business. Any
forward-looking statements are based on our current expectations,
estimates and assumptions regarding future events and are
applicable only as of the dates of such statements. We make no
commitment to revise or update any forward-looking statements in
order to reflect events or circumstances that may change.
Media Contact: Scott Shadiow
+1.317.432.9210sshadiow@shockwavemedical.com
Investor Contact:Debbie Kaster, Gilmartin
Groupinvestors@shockwavemedical.com
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