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InspireMD Announces Important Clincial Data from MASTER, CARENET Trials: Pooled Data Showed Statistically Significant Mortality Benefit

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InspireMD, Inc. (NYSE: NSPR)
("InspireMD" or the "Company"), a leader in embolic protection systems
("EPS"), today announced results from two important clinical trials. 30 day
results from the MASTER II trial which enrolled 310 of a planned 1114 patients
was presented at a major cardiology congress in Israel earlier today. The
trial was suspended in October 2014 as a result of a corporate shift in
strategy to a next generation MGuard drug eluting stent (DES) platform. The
Company also announced ipsilateral DW-MRI results from the CARENET Trial for
the CGuard system which successfully completed enrollment in July.

MASTER II was a global clinical trial conducted under a U.S. Food and Drug
Agency (FDA) Investigational Device Exemption (IDE) and was intended for U.S.
registration of the MGuard Prime coronary EPS for use in patients presenting
with STEMI (ST-segment Elevated Myocardial Infarction). The MASTER II trial
was designed to show superiority of ST segment resolution 60-90 minutes post
procedure as well non-inferiority in all-cause death or recurrent target
vessel myocardial infarction. While the trial was halted well short of the
planned enrollment, the Company elected to unblind the data and present the
results on behalf of the study investigators.

Today at the International Conference for Innovations in Cardiovascular
Systems meeting in Tel Aviv Israel, Dr. Gregg Stone, Professor of Medicine at
Columbia University and principal investigator of the trial, presented 30 day
results on the 310 patients enrolled in MASTER II as well as pooled data from
MASTER II and the 433 patient MASTER I trial completed and published in 2012.
While in MASTER I, the primary endpoint of superiority in ST-segment
resolution was achieved (57.8% vs. 44.7%, p=0.008), MASTER II did not show a
difference in ST-segment resolution between MGuard and control stents
(FDA-approved bare metal or drug eluting stents) 56.9% vs. 59.3% (p=0.68).
Pooled data between MASTER I and MASTER II for ST resolution continued to
favor MGuard 57.5% vs. 50.7% for control (p=0.07).

Impressively, 30 day mortality results for the MGuard in the MASTER II trial
remained low (0.6% vs. 1.9%, p=0.62), consistent with all previous MGuard
trials and registries and overall MACE (Major Adverse Cardiac Events) was
favorable for MGuard (2.6% vs. 4.5% p=0.36). Pooled mortality data for MASTER
I and II showed a statistically significant reduction in mortality with MGuard
(0.3% vs. 1.9%, p=0.04). Infarct size, another important indicator of
mortality, showed a positive trend for MGuard in MASTER II (mean 22.60% vs.
27.48%, p=0.16), as well as in the pooled analysis (mean 18.80% vs. 22.24%,
p=0.26).

"The data from MASTER II supports further clinical evaluation of the MGuard
Prime EPS," stated Dr. Stone. "While the number of patients enrolled in MASTER
II were not powered for any endpoints, it was encouraging to see the
significant difference in mortality with the pooled data, with other
indicators of improved reperfusion success with the MGuard technology. We
look forward to the development of a DES version of MGuard in the near future
to continue a pivotal clinical evaluation of the MicroNet embolic protection
system."

CARENET data was also presented today at the ICI in Tel Aviv by Prof. Piotr
Musiałek, Co-Principal Investigator for the CARENET study, from Jagiellonian
University Medical College at John Paul II Hospital, in Krakow, Poland. He
reported new positive clinical data from the CGuard^TM CARENET (CARotid
Embolic protection study using microNET) Trial. The CARENET trial recruited a
total of 30 patients and showed exceptional safety and efficacy with 0% MACCE
(meaning no death, stroke or myocardial infarction) at 30 days, substantially
lower than in other carotid stenting trials. Additionally, the incidence of
new ischemic ipsilateral lesions as assessed by Diffusion Weighted Magnetic
Resonance Imaging (DW-MRI) after carotid artery stenting was 37.0%, a
reduction of approximately 50% when compared to published historical control
groups of non-mesh covered carotid stents.The CARENET trial also reported an
average lesion volume per patient that was 10 times smaller than historical
control groups. The reduction in both the incidence and volume of new ischemic
lesions indicates therapeutic benefits of the MicroNet technology and that the
benefits of using this device may extend beyond the acute procedural period.

Alan Milinazzo, CEO of InspireMD commented, "We are very encouraged to see the
trend in mortality improvement with MGuard in MASTER II and very excited to
show a statistically significant benefit in mortality when our two MASTER
randomized trials are pooled together. These data further support our
strategy in partnering with a drug eluting stent manufacturer to re-enter the
clinic to conduct a pivotal trial that will not only enroll more quickly but
may ultimately show the definitive benefit of the MicroNet embolic protection
in patients presenting with STEMI." Milinazzo added, "Our CGuard product
continues to excite physicians during our limited market release (LMR) and
today's positive CARENET data should generate even more interest in using this
breakthrough technology."

Posted-In: News FDA Press Releases

 

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