InspireMD Announces Reimbursement Coverage for MGuard(TM) 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, Israel, May 16, 2013 /PRNewswire/ –
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(TM) 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 Sao Paulo, Brazil.
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(TM) 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
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 events.
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.
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
[http://us.lrd.yahoo.com/SIG=117ej2487/EXP=1327079007/**http%3A/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.
For additional information: InspireMD Desk Redington Inc., +1-212-926-1733 +1-203-222-7399 email@example.com
SOURCE InspireMD, Inc.