Full Press Release Details
Receives EU Regulatory Approval for Additional Supplier of CGuardTM Delivery Catheters
BOSTON, MA - December 2, 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 receipt of a DEKRA medical device certification
for the manufacture and commercialization of its CGuardTM delivery catheter, which now incorporates some design enhancements
and a lower cost manufacturing structure to support the scale-up of operations. The certification also allows the Company to add-on
facilities for seamless manufacturing work flow. DEKRA is a notified body for global certification of products, combining CE Marking
with ISO 13485 Quality Management Systems in the testing of medical devices for sale in the European Union (EU). The delivery
catheter is commercialized in conjunction with the Company's CGuard Embolic Prevention System (EPS).
Alan Milinazzo, CEO of InspireMD commented,
"We are pleased to receive DEKRA certification for our enhanced CGuardTM delivery catheter, used when delivering
the CGuardTM EPS into the carotid anatomy, supporting a more profitable and fluid scaling of our manufacturing operations.
Our CGuardTM system continues to be well received during our initial product launch in key markets around Europe and
our recent positive 12 month CARENET data should bolster our commercial efforts going forward."
Twelve month CGuardTM CARENET
(CARotid Embolic protection Study using microNET) trial results demonstrated zero strokes or stroke-related
deaths. 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. In
addition, the all-comer single center PARADIGM trial continue to show favorable angiographic and clinical outcomes in using
the CGuardTM system in treating patients with carotid artery disease. PARADIGM 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.
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary
MGuardTM 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 CGuardTM Embolic
Prevention System (EPS) uses the same MicroNetTM technology featured on the MGuardTM and MGuard PrimeTM
coronary Embolic Protection Systems. The CGuardTM 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
MicroNetTM is a bio-stable mesh woven from a single
strand of 20 micron Polyethylene Terephthalate. CGuardTM 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