InspireMD Resumes MGuard Prime Sales and Prioritizes DES and Carotid - New Product Programs

BOSTON, InspireMD, Inc. ("InspireMD" or the "Company"), 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 registration trial.

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."

Source: InspireMD, Inc.