Positive Results of InspireMD’s MASTER Trial to be Published on November 6 in Journal of American College of Cardiology
TEL AVIV, Israel, November 5, 2012 /PRNewswire/ –
InspireMD, Inc. (“InspireMD” or the “Company”) (OTC: NSPR) announced today that the
randomized 432-patient MASTER trial of its embolic protective MGuard stent will be
published in the November 6, 2012 print edition of the peer-reviewed Journal of American
College of Cardiology, Vol. 60, No. 19.
The online version of the paper, authored by Gregg W. Stone, MD and others, appeared a
week ago Wednesday (October 24) at:
http://content.onlinejacc.org/article.aspx?articleid=1377008, coinciding with Dr.
Stone’s presentation of the findings at the Late Breaking Clinical Trials session of the
24th Annual Transcathater Cardiovascular Therapeutics (TCT) scientific meeting in Miami,
October 22-26.
The findings showed the novel MGuard EPS provided a statistically and clinically
significant acute advantage and, as a result, may hold the potential to lower the
incidence of adverse sequela and prolong survival of heart attack victims.
MGuard EPS is CE Mark approved. It is not approved for sale in the U.S. by the Food
and Drug Administration (FDA) at this time. The Company plans to initiate a FDA approval
study in 1Q 2013.
The study met its primary endpoint (proportion of patients with ST segment resolution
of greater than or equal to 70%, measured at 60 to 90 minutes post procedure), showing the
MGuard EPS was significantly superior to the control arm of bare metal and drug eluting
stents in the treatment of heart attack patients.
— Significantly more patients treated with the MGuard EPS achieved complete ST
resolution (a measure of blood flow restoration to the heart muscle) compared to the
control arm (57.8% vs. 44.7%, P=0.008), a relative improvement of 29 percent.
— The MGuard EPS showed a significant improvement in coronary artery blood flow
compared with the control, including: (1) superior rates of restoring normal blood flow
(TIMI-3 flow) (91.7% vs. 82.9%, P=0.006, a relative improvement of 10.6%); and (2)
significantly less incomplete blood flow (TIMI-0/1 flow) post PCI (1.8% vs. 5.6%, P=0.01,
a relative improvement of 67.9%).
Although the study’s secondary endpoints were not powered for statistical
significance, they showed positive trends.
— The trial showed a trend toward lower mortality (0% vs. 1.9%, P=0.06) at 30 days
and smaller infarct size as measured by post procedure cardiac MRI (17.1gr vs. 22.3gr,
p=0.27) in the MGuard EPS arm versus control.
— There was no difference between the groups in the secondary endpoint of myocardial
blush grade, which is an angiographic measure of blood flow to the cardiac muscle (MBG2/3
83.9% vs. 84.7%, P=0.81).
The MASTER (MGuard for Acute ST Elevation Reperfusion) trial randomized 432 patients
to MGuard EPS (217) and 216 to either bare metal stents (60%) or drug eluting stents
(40%). Fifty centers in nine countries participated in the trial. Patients are being
followed for one year.
Dr. Stone, the study’s chairman, is the Director of the Cardiovascular Research and
Education Center for Interventional Vascular Therapy at New York-Presbyterian
Hospital/Columbia University Medical Center.
About Stenting and MGuard EPS
Standard stents weren’t 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 that prevents
the unstable arterial plaque and thrombus (clots) that caused the heart attack blockage
from breaking off.
While offering superior performance relative to standard stents in STEMI patients, 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 is a medical device company focusing on the development and
commercialization of its proprietary stent system technology, MGuard(TM). InspireMD
intends to pursue applications of this technology in coronary, carotid and peripheral
artery procedures. InspireMD’s common stock is quoted on the OTC under the ticker symbol
NSPR.
About MGuard(TM) Embolic Protection Coronary Stent
MGuard(TM) EPS combines a coronary stent merged with an embolic protection
specifically designed for acute MI patients. The embolic protection is comprised of an
ultra-thin polymer micron net that is integrated with the stent. The MGuard EPS is
designed to provide outstanding and lifelong embolic protection, without affecting
deliverability. MGuard EPS is CE Mark approved. MGuard(TM) is 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, 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
From 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.
For additional information:
InspireMD Desk
Redington, Inc.
+1-212-926-1733
+1-203-222-7399
inspiremd@redingtoninc.com
SOURCE InspireMD, Inc
