InspireMD Enrolls and Treats First Patients at Ballad Health System in U.S. Registration C-Guardian Clinical Trial of CGuard EPS
23 July 2021 - 10:30PM
InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic
Prevention Stent System (EPS) device for the treatment of Carotid
Artery Disease (CAD) and stroke prevention, today announces the
initiation of enrollment and successful completion of the first
cases of the Company’s U.S. registration C-Guardian trial of CGuard
EPS.
The first patients, who were under the care of principal
investigator, Chris Metzger, M.D., system chair of clinical
research at Ballad Health System in Eastern Tennessee, were
successfully implanted with the CGuard EPS stent device. These are
the first of 315 patients who are expected to be enrolled in the
trial and treated with CGuard EPS in the treatment of carotid
artery stenosis in symptomatic and asymptomatic patients undergoing
carotid artery stenting.
“I believe that the initiation of this trial marks an important
milestone for the potential approval of CGuard EPS and the
potential of CGuard EPS in advancing the treatment of CAD and
stroke prevention,” commented Dr. Metzger. “The wealth of clinical
evidence and real-world experience outside the U.S. in the approved
served markets with CGuard, demonstrating positive outcomes for
patients was very compelling, which drew us to lead this trial to
advance the CGuard EPS in the U.S. We are thrilled to participate
in such an important effort to bring next generation devices to the
growing therapeutic effort of treating CAD.”
InspireMD CEO, Marvin Slosman, added, “This milestone marks the
beginning of what we consider to be the next step in our journey of
establishing CGuard EPS as the leading stent device for treatment
of CAD and the transition from surgical intervention to
endovascular therapy. The U.S. market has been a priority for our
company and we believe that the C-Guardian trial will potentially
pave the way to CGuard becoming available to physicians and their
patients to realize the ongoing results from our current 33 served
global markets. We are grateful to Dr. Metzger and the Ballad
Health System for leading this effort and their commitment to
advancing our collective goals to improve patient outcomes and
stroke prevention.”
InspireMD Director, and renowned Cardiologist and Carotid
expert, Dr. Gary Roubin, shared, “I am thrilled to contribute to
the realization of this important milestone for InspireMD and
encouraged to see the many years of advancing the treatment of
Carotid Artery Disease take another step with the potential of
having CGuard available to the medical community in the U.S.”
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet® technology
to make its products the industry standard for carotid stenting by
providing outstanding acute results and durable, stroke-free,
long-term outcomes.
Forward-looking Statements
This press release contains “forward-looking
statements.” Such statements may be preceded by the words
“intends,” “may,” “will,” “plans,” “expects,” “anticipates,”
“projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,”
“potential” or similar words. For example, the Company is using
forward-looking statements when it discusses the number of expected
patients to be enrolled in the trial, that the initiation of the
trial marks an important milestone for the potential approval of
the CGuard EPS and towards advancing the treatment of CAD and
stroke prevention, and that the initiation of the trial marks the
beginning of the next step in the Company’s journey towards CGuard
EPS being utilized in the U.S. Forward-looking statements are not
guarantees of future performance, are based on certain assumptions
and are subject to various known and unknown risks and
uncertainties, many of which are beyond the Company’s control, and
cannot be predicted or quantified and consequently, actual results
may differ materially from those expressed or implied by such
forward-looking statements. Such risks and uncertainties include,
without limitation, risks and uncertainties associated with (i)
market acceptance of our existing and new products, (ii) negative
clinical trial results or lengthy product delays in key markets,
(iii) an inability to secure regulatory approvals for the sale of
our products, (iv) intense competition in the medical device
industry from much larger, multinational companies, (v) product
liability claims, (vi) product malfunctions, (vii) our limited
manufacturing capabilities and reliance on subcontractors for
assistance, (viii) insufficient or inadequate reimbursement by
governmental and other third party payers for our products, (ix)
our efforts to successfully obtain and maintain intellectual
property protection covering our products, which may not be
successful, (x) legislative or regulatory reform of the healthcare
system in both the U.S. and foreign jurisdictions, (xi) our
reliance on single suppliers for certain product components, (xii)
the fact that we will need to raise additional capital to meet our
business requirements in the future and that such capital raising
may be costly, dilutive or difficult to obtain and (xiii) the fact
that we conduct business in multiple foreign jurisdictions,
exposing us to foreign currency exchange rate fluctuations,
logistical and communications challenges, burdens and costs of
compliance with foreign laws and political and economic instability
in each jurisdiction. More detailed information about the Company
and the risk factors that may affect the realization of
forward-looking statements is set forth in the Company’s filings
with the Securities and Exchange Commission (SEC), including the
Company’s Annual Report on Form 10-K and its Quarterly Reports on
Form 10-Q. Investors and security holders are urged to read these
documents free of charge on the SEC’s web site at
http://www.sec.gov. The Company assumes no obligation to publicly
update or revise its forward-looking statements as a result of new
information, future events or otherwise.
Investor Contacts:
Craig ShoreChief Financial OfficerInspireMD,
Inc.888-776-6804craigs@inspiremd.com
CORE IRinvestor-relations@inspiremd.com
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