Full Press Release Details
First Patient Enrolled Into New CGuardTM CARENET (CARotid Embolic protection study using microNET)
Protection System Expands to Treat Carotid Artery Disease
19, 2014 - InspireMD, Inc. ("InspireMD" or the "Company") (NYSE MKT: NSPR), a leader in
embolic protection systems, today announced that it has successfully enrolled the first patient into the CARENET (CARotid
Embolic protection study using microNET) multi-center European clinical trial for the new CGuardTM carotid
embolic protection system.
The CARENET clinical study is a multi-specialty
trial that is designed to provide data and evidence of the CGuard carotid embolic protection system to better understand the complexities
and challenges of patients that experience carotid artery disease. The objective of the CARENET study is to evaluate the safety
and efficacy of the CGuard system in the treatment of carotid lesions in consecutive patients suitable for carotid artery stenting
The proprietary CGuard carotid embolic
protection system uses the same MicroNet technology featured on the MGuard and MGuard Prime coronary embolic
protection systems. The MicroNet technology is a single fiber knitted mesh wrapped on an open cell stent platform designed to trap
debris that can travel downstream after a patient is treated with traditional stenting methods. This technology seeks to protect
patients from plaque debris and blood clots breaking off and traveling distally in the arteries which can lead to life threatening
strokes. The size, or aperture, of the MicroNet pore' is only 150-180 microns in order to maximize protection against
the potentially dangerous plaque and thrombus which is liberated during the procedure.
"Initiating the CARENET trial
ahead of schedule is important for the Company and is indicative of the tremendous clinical interest about the potential benefits
of the MicroNet technology in this complex setting," stated Alan Milinazzo, Chief Executive Officer of InspireMD. "The
excitement from physicians around the CGuard design and its potential clinical benefit is viewed as a potential breakthrough for
carotid stenting therapy. The CARENET study is the first step towards that clinical validation."
"I have treated many patients
with carotid artery disease over the years, and I am excited to participate in the CARENET clinical trial using the unique CGuard
embolic protection system," stated Professor Joachim Schofer, MD, from the Hamburg University Cardiovascular Center, in Hamburg,
Germany. "The small pore size of the MicroNet technology allows excellent blood flow while trapping potentially harmful
plaque debris and thrombus. The CGuard technology provides an elegantly simple solution for embolic protection that has not been
available in the past. I look forward to using this device with other sites throughout Europe in the CARENET trial to help treat
my patients with carotid disease."
For more information about InspireMD
and its offerings, visit www.inspire-md.com.
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) and peripheral artery procedures. InspireMD's common stock
is quoted on the NYSE MKT under the ticker symbol NSPR.
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)
our limited manufacturing capabilities and reliance on subcontractors for assistance, (vii) insufficient or inadequate reimbursement
by governmental and other third party payers for our products, (viii) our efforts to successfully obtain and maintain intellectual
property protection covering our products, which may not be successful, (ix) legislative or regulatory reform of the healthcare
system in both the U.S. and foreign jurisdictions, (x) our reliance on single suppliers for certain product components, (xi) 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 (xii) 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 Transition Report on Form 10-KT 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.
Todd Fromer / Garth Russell
KCSA Strategic Communications
Phone: 212-896-1215 / 212-896-1250
Email: tfromer@kcsa.com / grussell@kcsa.com
Samantha Wolf / Taylor McGrann
KCSA Strategic Communications
212-896-1220 / 212-896-1253