InspireMD Announces Important Clinical Data from MASTER and CARENET Trials

• MASTER I and MASTER II Pooled Data Show Statistically Significant Mortality Benefit 
• CARENET 30 Day DW-MRI Data Demonstrates Significant Reduction in New Ischemic Ipsilateral Lesions

BOSTON, InspireMD, Inc., 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-segmentElevated 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 CGuardTM 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."

Source: InspireMD, Inc.