Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the
development and commercialization of Intravascular Lithotripsy
(IVL) to treat severely calcified cardiovascular disease, announced
today that the pivotal results from the DISRUPT CAD III study
have been accepted for presentation in a late-breaking clinical
science session at TCT Connect. The Investigational Device
Exemption (IDE) study is the first study powered to evaluate the
safety and effectiveness of coronary IVL in the treatment of
severely calcified coronary arteries.
“We are delighted that the CAD III data will be featured as part
of a late-breaking session at TCT Connect,” said Keith D. Dawkins,
M.D., Chief Medical Officer of Shockwave Medical. “On behalf of the
entire Shockwave team, I want to thank all of the investigators,
research coordinators and patients who have supported this study
from the start and whose enthusiasm and perseverance, even amid
COVID, got us to this point today. Completing the CAD III study
represents a significant milestone for Shockwave and we look
forward to the results being shared by the investigators at TCT
Connect.”
In addition to the primary endpoint analysis, TCT Connect
accepted and will post data from a prospective optical coherence
tomography (OCT) sub-analysis of 100 patients within the CAD III
cohort authored by Dr. Richard Shlofmitz, M.D., FACC, Chairman of
Cardiology at St. Francis Hospital, The Heart Center.
The details of the late-breaking session are as follows:
Presentation Title: |
Disrupt CAD III: Safety and Effectiveness of Intravascular
Lithotripsy for Treatment of Severe Coronary
Calcification |
|
|
Time: |
October 15, 2020 at 12:30 pm
Eastern Time |
|
|
Presenter: |
Dr. Dean Kereiakes, M.D., FACC,
FSCAI, Medical Director of The Christ Hospital Heart and Vascular
Center and the Christ Hospital Research Institute; Professor of
Clinical Medicine, The Ohio State University; Co-Principal
Investigator of DISRUPT CAD III |
Shockwave will be hosting an event for analysts and
institutional investors at 4:30 p.m. eastern time on Thursday
October 15, 2020, after the late-breaking session. The webcast
event will include remarks from Dr. Dean Kereiakes as well an
interactive question and answer session with a panel of experts.
Interested parties may access a live audio webcast of the
presentation by visiting the “Investors” section of Shockwave’s
website at https://ir.shockwavemedical.com. A replay of the webcast
will be available following the presentation.
Shockwave C2 Coronary IVL catheters are commercially available
for the treatment of de novo coronary artery disease in Europe and
select other geographies; they are limited to investigational use
in the United States.
About DISRUPT CAD III
DISRUPT CAD III is a prospective, multicenter, single-arm,
global IDE study designed to demonstrate the safety and
effectiveness of the Shockwave Coronary IVL System with the
Shockwave C2 Coronary IVL Catheter in de novo, calcified, stenotic,
coronary arteries prior to stenting. The study enrolled 384
patients, exceeding the minimum requirement of 372 patients, per
the a priori statistical plan agreed by the FDA. Patients were
enrolled at 47 sites in the United States, France, Germany, and the
United Kingdom. Patients will be followed for two years.
The study is assessing freedom from major adverse cardiac events
(MACE) within 30 days of the index procedure as the primary safety
endpoint. The primary effectiveness endpoint is procedural success
defined as stent delivery with a residual stenosis less than 50
percent and without in-hospital MACE.
The co-principal investigators of the study were Dean Kereiakes
and Jonathan Hill, M.D., Consultant Cardiologist at Royal Brompton
Hospital in London.
About Shockwave Medical, Inc.
Shockwave is focused on developing and commercializing products
intended to transform the way calcified cardiovascular disease is
treated. Shockwave aims to establish a new standard of care for the
interventional treatment of atherosclerotic cardiovascular disease
through differentiated and proprietary local delivery of sonic
pressure waves for the treatment of calcified plaque, which the
company refers 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. Our business and operations are
subject to a variety of risks and uncertainties and, consequently,
actual results may differ materially from those projected by any
forward-looking statements. Factors that could cause actual results
to differ from those projected include, but are not limited to: the
impact of the COVID-19 pandemic on our operations,
financial results, and liquidity and capital resources, including
on 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 risks
and uncertainties, 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 Kasterdkaster@shockwavemedical.com
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