Full Press Release Details
Reports on Expanded 2 Year Follow-up Results
the PARADIGM Clinical Study Using CGuard EPS
Presented at EuroPCR 2018
Sustained Safety and Cerebral Embolic Prevention out to 24 months
Aviv, Israel- May 24, 2018 - InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS), thrombus
management technologies and neurovascular devices, today announced that Professor Piotr Musia ek, from the Department of
Cardiac and Vascular Diseases, John Paul II Hospital, Krako w, Poland, presented the expanded 24 month follow-up results
from the PARADIGM-Extend Clinical Study utilizing CGuard EPS at EuroPCR 2018, in Paris on May 24, 2018.
is the continuation of PARADIGM, an investigator-led clinical study evaluating the use of CGuard EPS in patients with symptomatic
or asymptomatic carotid artery stenosis with increased stroke risk. The latest results include 251 patients, which is more than
double the patient population of 101, which was previously reported in December 2017. Overall cumulative data showed no major
strokes in the peri-procedural or post-procedural period up to 30 days (0%). There was one minor peri-procedural stroke (0.4%),
and only one death (non-device related) at 30 days (0.4%). These results are consistent with earlier reported data in the first
patient cohort. Importantly, there were no stroke or stroke-related deaths between 12 and 24 months.
Musialek, commented, "The 24-month clinical and duplex ultrasound evidence is consistent with the unprecedented, sustained
safety and cerebral embolism prevention efficacy of CGuard EPS in both symptomatic and asymptomatic patients with carotid
feel privileged to have had Professor Musialek, one of the leading interventional cardiologists in Europe, present his expanded
results of the PARADIGM study at EuroPCR 2018," said James Barry, PhD, Chief Executive Officer of InspireMD. "Professor
Musialek's PARADIGM-Extend trial continues to demonstrate consistent and strong clinical evidence of durable protection
against potential stroke that can result from post procedural embolization. In addition, the duplex ultrasound data confirms normal
vessel healing with the CGuardTM EPS device and with no indication of any long term in-stent restenosis. These results
include a significant proportion of challenging patients that would have otherwise been sent to surgery (carotid endarterectomy).
Furthermore, these results are consistent with other CGuard EPS clinical trials including: CARENET, IRON-GUARD, WISSGOTT
Study and CASANA Study. This excellent data continues to build on the extensive body of evidence supporting the clinical advantages
of CGuard EPS in preventing stroke that can result from high grade carotid stenosis."
is the official annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and the world-leading
course in interventional cardiovascular medicine. Bringing together over 12,000 clinicians and industry executives each year,
EuroPCR is the global forum for sharing within and between all interventional communities. EuroPCR 2018 took place in Paris from
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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