InspireMD (OTC:NSPR) said today that it’s halting enrollment in a clinical trial of its flagship MGuard stent to focus on developing new drug-eluted stents with an unnamed strategic partner, abandoning plans to bring the MGuard device to the U.S. market.
The news sent NSPR shares down 5.0% to $1.90 apiece as of about 11:30 a.m. today.
InspireMD in June began re-introducing the MGuard Prime EPS in Europe after pulling it last April and suspending the Master II trial due over the risk of the stent being dislodged during implantation. Today the Boston-based company said it believes that all MGuard Prime inventory has been "successfully modified" and that it was back to "full commercial activities" in Europe as of Oct. 10.
That news was overshadowed by the announcement that InspireMD is closing enrollment in the Master II trial and will follow the 310 patients already participating in the study for a year.
"This decision will allow the company to direct more resources to the [drug-eluting stent] 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," according to a press release.
"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 1st DES candidate via partnership and expect to have a DES platform for CE submission in the back half of 2015," CEO Alan Milinazzo said in prepared remarks. "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."