InspireMD Announces the European Society of Cardiology 2020 “Best Poster Award” for Updated Data from the PARADIGM-EXTEND...
September 03 2020 - 6:30AM
InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™
Embolic Prevention System (EPS) for the prevention of stroke caused
by carotid artery disease (CAD), today announces the award for Best
ESC Congress Poster for the presentation of updated data from the
large, long-term PARADIGM-EXTEND study of the CGuard™ Embolic
Prevention System (EPS), as part of the European Society of
Cardiology 2020 Carotid Update e-presentation at the European
Society of Cardiology (ESC) Congress 2020. PARADIGM/EXTEND is an
investigator-driven on-going study performed with CGuard Carotid
stent for primary and secondary stroke prevention in a large,
consecutive all-comers population, with 5 years (60 months)
follow-up.
PARADIGM-EXTEND current results for 480 patients of the expected
total of 550 that completed the 30-day follow-up were
presented. There were no peri-procedural major strokes or
death. The total death/stroke /myocardial incidence at 30 days was
1.04% (5/480) due to two minor strokes, one myocardial infarction
and two stent-unrelated deaths. In the study, 354/480 patients
completed the 12-month follow-up with only 1 patient experiencing
in-stent restenosis, 0.28% (1/354). At the 12-month follow-up
there were no other device-related adverse clinical events.
Finally, 46/480 patients completed the 60-month follow-up period
with one more case of in-stent restenosis and no additional cases
of device-related stroke.
The lead investigator of the study and ESC Congress presenter
was Prof Piotr Musialek, Jagiellonian University Department of
Cardiac & Vascular Diseases John Paul II Hospital, Kraków,
Poland. Prof Musialek stated, “In consecutive all-comer patients,
CGuard EPS stent nearly abolished, in an unprecedented magnitude,
stroke risk in relation to carotid restenosis. Based on the
PARADIGM-EXTEND and other accumulated clinical data on CGuard’s
safety and efficacy, in our ESC 2020 Carotid Update Lecture we
indicated that increasing the use of the MicroNet-covered stent
demonstrates a fundamental change in the carotid revascularization
paradigm, with significantly larger proportions of patients now
able to benefit from this technology and a percutaneous procedure
rather than surgery.”
“The results from this investigator-driven initiative and
resulting recognition of best poster, continue to demonstrate that
CGuard provides extended safety and stroke prevention efficacy when
added to optimized medical therapy. We continue to prioritize
patient care by focusing on measuring evidence that confirms
the superiority of CGuard EPS in preventing neurovascular
events. Recognition of this data through acknowledgement of this
sort builds confidence and awareness within the physician
community. Our global expansion strategy and intention to
bring CGuard to the United States builds on the foundation of
real-world experience and results. We believe the novel
MicroNet technology, which is at the heart of the CGuard system,
provides a clear differentiator in terms of prevention of
additional ischemic events and restenosis,” said Marvin Slosman,
InspireMD’s CEO. “We are grateful to Professor Musialek and
Jagiellonian for their work on the PARADIGM-EXTEND study, and we
look forward to sharing further results of this study and other key
milestones as we continue to follow patients’ outcomes.”
The ESC Congress 2020 is being held digitally from August
29-September 2, 2020 and can be accessed via
https://www.escardio.org/Congresses-&-Events/ESC-Congress.
About the PARADIGM-EXTEND StudyThe
PARADIGM-EXTEND study was designed to evaluate long-term clinical
efficacy and safety of the CGuard system’s use in 550 consecutive
carotid revascularization patients. The study is an
all-comer, all-referrals-tracked study with no exclusion criteria
other than a lack of Neurovascular Team-determined indication.
Clinically asymptomatic patients were to receive revascularization
only in case of increased-stroke-risk characteristics.
Adverse events are independently adjudicated. To date,
480 patients (39-87 years, 60% symptomatic, 142 women) with 514
arteries crossed the first follow-up window of 30 days.
About The CGuard® EPS The CGuard® Embolic
Protection System is an advanced platform solution designed to
deliver the flexibility of the traditional open-cell stent with
advanced protection from peri-procedural and post-procedural
embolic events caused by plaque prolapse through the stent strut
that can lead to stroke. CGuard’s unique MicroNet® technology
mitigates the prolapse and associated embolization and has shown
superior clinical outcomes for patients against alternative carotid
stent types, conventional or next-generation double-layer stents,
as well as invasive procedures such as endarterectomy, a major
surgical procedure. InspireMD’s CGuard™ has created a new
dimension in the protected treatment of carotid artery disease with
the potential to truly establish a new standard of care for the
management of carotid artery disease and stroke prevention.
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.
InspireMD’s common stock is quoted on the NYSE American under
the ticker symbol NSPR, and certain warrants are quoted on the NYSE
American under the ticker symbol NSPR.WS and NSPR.WSB.
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. 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) the
impact of the COVID-19 pandemic on our manufacturing, sales,
business plan and the global economy; (v) intense competition in
the medical device industry from much larger, multinational
companies, (vi) product liability claims, (vii) product
malfunctions, (viii) our limited manufacturing capabilities and
reliance on subcontractors for assistance, (ix) insufficient or
inadequate reimbursement by governmental and other third party
payers for our products, (x) our efforts to successfully obtain and
maintain intellectual property protection covering our products,
which may not be successful, (xi) legislative or regulatory reform
of the healthcare system in both the U.S. and foreign
jurisdictions, (xii) our reliance on single suppliers for certain
product components, (xiii) 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 (xiv) 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
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