Full Press Release Details
Announces Positive Long-Term Safety and Efficacy Data from Ongoing CGuard
EPS Registries at the Recent 45th Annual Symposium
on Vascular and Endovascular Issues,
Horizons (VEITHsymposium)
Aviv, Israel- November 29, 2018 - InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard Embolic
Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today announced details
from several presentations of updated CGuard EPS data at the recent VEITHsymposium in New York. The results of three separate
registries confirm the long-term benefits of CGuard EPS in preventing late embolic events.
his presentation, Piotr Musialek, MD, DPhil, Jagiellonian University Professor of Cardiovascular Medicine, Jagiellonian University
Dept. of Cardiac & Vascular Diseases, John Paul II Hospital, Krakow, Poland, presented an update of his ongoing PARADIGM-Extend
clinical trial of "all comers" with high-risk carotid stenosis in 251 patients treated with CGuard EPS.
Musialek noted, "CGuard EPS delivers excellent safety and efficacy both during the procedure and at long-term 36-month
follow-up. This is especially encouraging as this is an "all comers" registry which includes patients with high-risk
carotid lesions such as aneurysms, dissections or highly calcified lesions. I am not aware of any other device that has demonstrated
such sustained long-term benefits."
during the VEITHsymposium, Professor Christian Wissgott, Director at Westk stenklinikum Heide, Heide, Germany, presented
positive six-month follow-up data on 70 consecutive patients treated with CGuard EPS, which mirror Professor Musialek's
results. Among the findings, CGuard EPS demonstrated a 100% technical success rate. Additionally, there were no pre-interventional
complications observed, and no peri- or post-interventional strokes observed. At six months, no intrastent restenosis was observed,
and DWI-MRI data from 29 of the 70 patients detected no new ipsilateral lesions in the brain after thirty days and six months.
on the results, Professor Wissgott stated, "The novel CGuard EPS with the combination of an open-cell nitinol stent
and a micro-mesh cover leads to the prevention of post-procedural embolic events. The CGuard is easy and safe to implant
due to its very smooth wall adaption to the vessel wall and lack of foreshortening."
Laura Capoccia, MD, PhD, Assistant Professor of Vascular Surgery University, Vascular Surgeon, Vascular and Endovascular Surgery
Division, Department of Surgery, Rome, Italy and Francesco Speziale, MD, Vascular and Endovascular Surgery Division, Department
of Surgery, University of Rome, presented an update on the ongoing IRONGUARD 2 Multicenter Prospective Registry Study of 342 patients
with severe carotid stenosis. Again, the presentation, which included data from 15 centers, showed no major stroke, no permanent
neurologic symptoms, no restenosis and no neurologic deaths in 51 of the 342 patients who completed one-year follow-up.
Jim Barry, Chief Executive Officer of InspireMD, commented, "The findings from these ongoing studies in Poland, Germany
and Italy further highlight the long-term clinical benefits of CGuard EPS in preventing embolic events in patients undergoing
minimally-invasive procedures for stroke treatment. These are three separate clinical studies across geographies and clinical
specialties with highly positive and consistent long term results. This clearly differentiates CGuard EPS from other technologies
on the market and, we believe, represents a significant advancement in treatment of carotid artery disease."
of the presentations can be found at www.inspiremd.com.
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 Event features presentations from world renowned vascular specialists with emphasis on the latest advances, changing concepts
in diagnosis and management, pressing controversies and new techniques.
seeks to utilize its proprietary MicroNet technology to make its products the industry standard for treatment of carotid
artery disease by providing outstanding acute results and durable stroke free long-term outcomes.
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.
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) 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.