Full Press Release Details
MGuard Prime Sales and Prioritizes DES and Carotid - New Product Programs
commercial re-launch complete in direct markets
Stent (DES) program advances in development with partners
to suspend enrollment to support DES and Carotid Opportunities
call this morning at 8:30 a.m. ET
BOSTON, MA - October
14, 2014 - InspireMD, Inc. ("InspireMD" or the "Company") (NYSE MKT: NSPR), a leader
in stent Embolic Protection Systems (EPS), today provided commercial, development and clinical updates on the MGuard Prime coronary
EPS product line and positioned the Company to address more efficiently its emerging MGuard and CGuard commercial opportunities.
The Company indicated that it believes
all MGuard Prime inventory has been successfully modified and that it is back to full commercial activities in direct markets in
Western Europe as of October 10th. Further, all returned distributor inventory has been modified and the majority of its distributor
partners have begun shipping product back into hospital accounts. The Company expects direct and distributor based selling to ramp
up throughout the fourth quarter of 2014 and to be enhanced by the launch of the CGuard Carotid product.
Positive CGuard first in man (FIM)
data was reported last month in the CARENET trial presented at the Transcatheter Therapeutics Meeting (TCT) in Washington DC. CGuard
demonstrated 100% procedural success, 0% MACE at 30 days and a significant improvement in reducing new ischemic lesions as measured
by diffusion weighted magnetic resonance imaging (dwMRI), as compared to historical controls.
The Company reported today that it
has successfully entered the second phase of development work with the first Drug Eluting Stent (DES) candidate via strategic partnership.
As previously communicated, the Company expects to bring two viable (CE approved) DES products into an animal testing phase (II)
which, if successful, is expected to lead to submission for CE registration of a DES MicoNet platform in the second half of 2015.
The initial technical feasibility testing phase (I) of DES candidates had a 100% success rate, enabling the program to progress
on schedule with no additional work required prior to commencing the next phase of testing.
In light of current market conditions
moving toward continued DES adoption and the delay in enrollment due to the FDA review process, the Company has decided to revise
its MGuard strategy for the U.S. This includes the decision not to resume enrollment in the MASTER II trial for the primary endpoints
of ST segment resolution and death and target vessel re MI. This decision will allow the Company to direct more resources to the
DES program and commercial activities for the MGuard and CGuard. As a result of this change, MASTER II will no longer be an FDA
The Company successfully enrolled 310
patients in MASTER II trial prior to suspending enrollment in April due to product manufacturing process changes. The initial clinical
analysis of these 310 patients at 30 day follow up showed encouraging clinical results in the MGuard group vs the control group.
The Company will continue to follow these 310 MASTER II patients for one year from time of enrollment, and expects to report 30
day data at a major medical meeting in the first quarter of 2015.
Alan Milinazzo, CEO of InspireMD, stated,
"On the commercial front, we are now back to full activities in our direct markets outside the US, and we are seeing usage
return to pre-Voluntary Field Action (VFA) levels within our existing direct customer base. We will begin shipping product to new
customers in our direct markets during this current quarter. Our final post-VFA MGuard Prime commercial milestone will be to return
to full commercial activities in all of our distributor markets, which represent the majority of our current customer base. The
simultaneous re launch of MGuard Prime with our new CGuard commercial activities should provide our sales channel with positive
momentum going into 2015."
Milinazzo continued, "During
the past month we have made significant progress on our DES development program. Most importantly, we are ready to begin animal
testing of our first DES candidate via partnership and expect to have a DES platform for CE submission in the back half of 2015.
Finally, our decision to suspend enrollment in MASTER II and evaluate our interim data will guide our evolving clinical strategy
in order to insure that we maximize our clinical investments to help drive adoption of our MGuard and CGuard technology."
Investor Conference Call
The Company will host a conference
call at 8:30 a.m. ET on Tuesday, October 14th to review these updates on its MGuard Prime coronary EPS and business outlook. Participants
should call (877) 407-0784 (United States) or (201) 689-8560 (International) and request the InspireMD call or provide confirmation
code: 13593465. A live webcast of the call will also be available on the Investor Relations section of the Company's website
at www.inspire-md.com/site_en/for-investors. Please allow 10 minutes prior to the call to visit this site to download and
install any necessary audio software.
An archive of the webcast will be available
approximately one hour after completion of the live event and will be accessible on the Investor Relations section of the Company's
website at www.inspire-md.com/site_en/for-investors for a limited time. A dial-in replay of the call will also be available
to those interested until October 21st. To access the replay, dial (877) 870-5176 (United States) or (858) 384-5517 (International)
and enter code: 13593465.
For more information about InspireMD
and its offerings, visit www.inspire-md.com.
About Stenting and MGuard Prime 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
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 Prime EPS is integrated with a precisely engineered micro net mesh that is designed to prevent 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 with regard to ST segment resolution, the MGuard
Prime 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 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) and peripheral artery procedures. InspireMD's common stock
is quoted on the NYSE MKT under the ticker symbol NSPR.
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, (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 and (xiv) the escalation of hostilities
in Israel, which could impair our ability to manufacture our products. 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