Full Press Release Details
InspireMD Announces Reimbursement
Coverage for MGuard Coronary
Embolic Protection Stent (EPS) from Brazil's Largest Private Insurer
- More than 18 Million Brazilians have
Reimbursable Access to MGuard EPS -
BOSTON and TEL AVIV, MAY 16 -
InspireMD, Inc. ("InspireMD" or the "Company") (NYSE MKT: NSPR), a leader in embolic protection stents,
today announced that it received reimbursement approval for the MGuard Coronary Embolic Protection Stent (EPS) from UNIMED,
Brazil's largest private health care insurer.
Alan Milinazzo, InspireMD's President
and CEO said, "Reimbursement in Brazil is a significant achievement that should enable us to expand our presence globally
and further penetrate this important market of over 195 million citizens. We are pleased that UNIMED is recognizing MGuard's clinical
value in preventing unstable plaque and clots from breaking away and causing further trauma in acute heart attack patients. "
According to the Brazilian Society of Interventional
Cardiology (SBHCI), of the approximately 30,000 Brazilians treated for acute heart attacks each year, roughly one-third experience
ST-segment elevation on ECG (STEMI) and require Primary PCI.
"This is the first step in a process
that is expected to eventually enable doctors to treat patients with acute coronary syndromes, particularly those with acute myocardial
infarction who may be at a high risk of distal embolization, with this innovative EPS system that has shown improved procedural
outcomes" said Prof. Dr. Alexandre A. Abizaid, Director of Interventional Cardiology at Institute Dante Pazzanese in S o
UNIMED is the largest cooperative medical
system both in Brazil and globally, providing private health insurance to more than 18 million Brazilians. With 38% of the Brazilian
health plan market, UNIMED has more than 109,000 physicians and 3,097 hospitals in its network, according to Brazil's National
Health Insurance Agency (ANS).
About Stenting and MGuard EPS
Standard stents were not engineered for
heart attack patients. They were designed for treating stable angina patients whose occlusion is different from that of an occlusion
in a heart attack patient.
In acute heart attack patients, the plaque
or thrombus is unstable and often breaks up as the stent is implanted, causing downstream blockages (some of which can be fatal)
in a significant portion of heart attack patients.
The MGuard EPS is integrated with a precisely
engineered micro net mesh to prevent the unstable arterial plaque and thrombus (clots) that caused the heart attack blockage from
While offering superior performance relative
to standard stents in STEMI patients with regard to ST segment resolution, the MGuard EPS requires no change in current physician
practice - an important factor in promoting acceptance and general use in time-critical emergency settings.
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary
MGuard technology to make its products the industry standard for embolic protection stents 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
InspireMD intends to pursue applications
of this technology in coronary, carotid and peripheral artery procedures. InspireMD's common stock is quoted on the NYSE
MKT under the ticker symbol NSPR.
MGuard EPS is CE Mark approved. It is not
approved for sale in the U.S. by the U.S. Food and Drug Administration (FDA) 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, multi-national 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-K/T 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.
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