Results of InspireMD’s MASTER Stent Trial Scheduled for Late Breaking Trials Session at TCT in Miami, FL Oct. 24
TEL AVIV, Israel, September 27, 2012 /PRNewswire/ –
Trial Studied Performance Of MGuard(TM) Embolic Protection Stent (EPS) In
433 Patients Undergoing Emergency Treatment For Heart Attacks
InspireMD, Inc. (OTCBB: NSPR) (the “Company” or “InspireMD”), a medical device company
focusing on the development and commercialization of its proprietary MGuard(TM) embolic
protection stent platform technology for use in patients with Acute Myocardial Infraction
announced today that Gregg W. Stone, MD will present initial results of the 433-patient
randomized MASTER trial on October 24, 2012 at the 24th Annual Transcatheter
Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular
Research Foundation, in Miami, Florida (October 22-26).
InspireMD previously announced (on August 20) that the MASTER (MGuard forAcute ST
Elevation Reperfusion) trial demonstrated a positive outcome in patients suffering heart
attacks when compared to commercially-approved bare metal or drug-eluting stents.
Presentation of detailed findings by Dr. Stone, the study’s Chairman, is scheduled for
the Late Breaking Trials session in the main arena on Wednesday October 24 at 11:40 AM
under the title “A Prospective, Randomized Trial of PET Micronet Mesh-Covered Stent vs.
Standard Stents in Patients with ST-Segment Elevation Myocardial Infarction.”
“The TCT conference is one of the world’s premier events for new data and developments
in interventional cardiology”, said Robert Ratini, InspireMD’s vice president of sales and
marketing. “We are honored that the committee found the MASTER trial important enough for
inclusion in the prestigious Late Breaking Clinical Trials session. We are hopeful this
will broaden clinical awareness and adoption of our MGuard Embolic Protection Stent for
the benefit of our customer physicians and their patients”
MASTER is the first Company-sponsored randomized clinical study comparing the
MGuard(TM) Embolic Protection Stent to commercially-approved bare metal or drug-eluting
stents in heart attack patients undergoing primary percutaneous coronary intervention
Eleven earlier single arm studies and one 40-patient physician-sponsored randomized
trial showed the MGuard(TM) embolic protection stent to be effective in restoring blood
The MGuard(TM) Embolic Protection Stent is a coronary stent integrated with a
proprietary Micronet technology. The Micronet is designed to hold plaque and thrombus in
place against the wall of the blocked artery, preventing debris from falling in to the
bloodstream and causing a potentially fatal downstream blockage.
Approximately 850,000 heart attack patients worldwide are expected to receive stents
this year, accounting for $1.7 billion of stent sales, or nearly 30 percent of the $6.0
billion global stent market.
Plans for a U.S. FDA registration trial of the MGuard(TM) embolic protection stent are
underway, with patient enrollment expected to begin during the first quarter of 2013.
Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of
the Cardiovascular Research Foundation. TCT gathers leading medical researchers and
clinicians from around the world to present and discuss the latest developments in the
The Cardiovascular Research Foundation (CRF) is an independent, academically focused
nonprofit organization dedicated to improving the survival and quality of life for people
with cardiovascular disease through research and education. Since its inception in 1991,
CRF has played a major role in realizing dramatic improvements in the lives of countless
numbers of patients by establishing the safe use of new technologies, drugs and therapies
in interventional cardiovascular medicine.
For more information about CRF, visit http://www.crf.org.
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 listed on the OTC BB under the ticker
About MGuard(TM) Embolic Protection Coronary Stent
MGuard(TM) 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(TM) is designed to
provide outstanding and lifelong embolic protection, without affecting deliverability.
MGuard(TM) is CE Mark approved.
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, including the Company’s Annual Report on Form 10-K,
its 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.
For additional information: InspireMD Desk at: Redington, Inc. +1-212-926-1733 +1-203-222-7399 firstname.lastname@example.org
SOURCE InspireMD, Inc.