Full Press Release Details
Announces Preliminary 2 Year Follow-up Results from the
PARADIGM Clinical Study Using CGuard EPS
procedure or device related adverse events at 24 months
presented at the 2017 VEITHsymposium in New York
ICI Meeting 2017 in Tel Aviv
Aviv, Israel- December 5, 2017 - InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus
management technologies and neurovascular devices, today announced the preliminary 24 month follow-up results in the PARADIGM
101 Clinical Study utilizing CGuard EPS. Dr. Piotr Musia ek, Department of Cardiac and Vascular Diseases, John Paul
II Hospital, Krako w, Poland, presented the long-term follow-up at the 2017 VEITH Symposium in New York on November 16th,
2017 and the ICI Meeting 2017 in Tel Aviv on December 4, 2017.
is an investigator-led clinical study evaluating the use of CGuard EPS in 101 consecutive all-comer patients with symptomatic
or high-risk asymptomatic carotid artery stenosis. The data presented illustrate that no periprocedural or postprocedural intervention
related death, major stroke, or myocardial infarction had occurred in the study patients at 24-month follow-up.
excellent results in PARADIGM-101 are consistent with the other CGuard EPS Trials, including CARENET, IRON-GUARD, WISSGOTT
Study and CASANA Study. The PARADIGM study long-term preliminary results further confirm the sustained benefits of CGuard
out to two years and make it a potential permanent therapeutic protection option for all-comer patients with carotid artery disease.
Barry, PhD, Chief Executive Officer of InspireMD, commented, "We are excited to see Prof. Musialek's report out on
the long-term follow-up data from the PARADIGM study, which represents the longest known clinical follow-up with any such carotid
devices to date. This is just antoher piece of data that continues to reinforce the potential benefits of CGuard EPS. The 24 month
follow-up data from this trial simply confirms the sustained long term benefit CGuard could provide to pateints with carotid artery
VEITHsymposium provides vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists
with a unique and exciting format to learn the most current information about what is new and important in the treatment of vascular
disease. The 5-day event features rapid-fire presentations from world renowned vascular specialists with emphasis on the latest
advances, changing concepts in diagnosis and management, pressing controversies and new techniques.
ICI Meeting 2017 is the premier international conference for innovations in cardiovascular systems (heart, brain and peripheral
vessels) and high-tech life science companies.
seeks to utilize its proprietary MicroNet technology to make its products the industry standard for embolic protection
and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization,
no reflow and major adverse cardiac events.
intends to pursue applications of this MicroNet technology in coronary, carotid (CGuard ), neurovascular, and peripheral
artery procedures. 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.
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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
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