Full Press Release Details
Announces Positive Twelve Month Follow-Up CARENET
Trial Data at VEITH Symposium 2015
BOSTON, MA - November 20, 2015
- InspireMD, Inc. (NYSE MKT: NSPR) ("InspireMD" or the "Company"), a leader in embolic prevention
systems (EPS), neurovascular devices and thrombus management technologies, announced today positive 12 month follow up data from
its CGuardTM CARENET (CARotid Embolic protection Study using microNET) trial at the 42nd
Annual Symposium on Vascular and Endovascular Issues (VEITH) in New York. Prof. Piotr Musia ek, Co-Principal Investigator
for the CARENET study, from Jagiellonian University Medical College at John Paul II Hospital, Krakow, Poland, presented the 12
month follow up data, an industry first on a mesh covered carotid stent technology.
At the New Techniques, Technologies and Concepts
session, Prof. Musialek presented the new data on the InspireMD CGuardTM Mesh Covered Carotid Stent Program. His lecture,
entitled "MicroNet Covered Embolic Prevention Carotid Stent System: From CARENET And PARADIGM Studies To Routine Clinical
Practice," focused on the CARENET 12 month results, which demonstrated zero strokes or stroke-related deaths at 12 months.
Further, duplex ultrasound analysis confirmed no changes in the in-stent velocities between 6 and 12 months. This indicates no
sign of vessel narrowing and is consistent with the durability of carotid artery treatment seen using CGuardTM. According
to Prof. Musialek, previously demonstrated reduction in both the incidence and the volume of new ischemic lesions, together with
the 12 month data that show minimal restenosis concern, suggests that the therapeutic benefits of the CGuardTM technology
may extend well beyond the acute procedural period.
Prof. Piotr Musialek commented, "It is
very exciting to present the 12 month follow up data from the CGuardTM CARENET study, which continues to validate the
use of the MicroNetTM covered CGuardTM, with zero strokes at 12 months. In addition, the 12 month data showed
no change in peak systolic velocity between 6 months and 12 months, suggesting no restenosis concerns. These findings, combined
with the results from our recent all-comer single center PARADIGM trial, continue to show the increased therapeutic benefits of
the CGuardTM technology in treating patients with carotid artery disease. This technology is a game-changer in today's
practice of carotid revascularization and my colleagues and I look forward to continued use of this unique technology in routine
Alan Milinazzo, CEO of InspireMD commented,
"Twelve month CARENET results further validate that the CGuardTM represents a superior next generation stenting
technology, supporting broader application in carotid artery disease treatment, with physicians steadily impressed with its superior
clinical data. We plan to leverage compelling CARENET and PARADIGM clinical evidence to expand upon our ongoing, active CGuardTM
commercial activities."
PARADIGM, led by principal investigator
Prof. Musialek, is an investigator-initiated Prospective evaluation of All-comer peRcutaneous cArotiD
revascularization In symptomatic and increased-risk asymptomatic carotid artery stenosis, using CGuard Mesh-covered
embolic prevention stent system, indicated that the CGuard system is appropriate for use in an all-comer carotid revascularization
population and is associated with an extremely favorable angiographic and clinical outcome.
VEITH Symposium 2015 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.
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary
MGuard with MicroNetTM 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.
InspireMD intends to pursue applications of
this MicroNet technology in coronary, carotid (CGuardTM), neurovascular, and peripheral artery procedures. InspireMD's
common stock is quoted on the NYSE MKT under the ticker symbol NSPR.
The proprietary CGuard Embolic Prevention
System (EPS) uses the same MicroNet technology featured on the MGuard and MGuard Prime coronary Embolic Protection
Systems. The CGuard EPS is designed to prevent peri-procedural and late embolization by trapping potential emboli against
the arterial wall while maintaining excellent perfusion to the external carotid artery and branch vessels.
MicroNet is a bio-stable mesh woven
from a single strand of 20 micron Polyethylene Terephthalate.
CGuard EPS is CE Marked and not approved
for sale in the U.S. by the U.S. Food and Drug Administration at this time.
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)
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.
Chief Financial Officer
Phone: 1-888-776-6804 FREE
Email: craigs@inspiremd.com
Phone: (212) 554-5482