Stent technology maker InspireMD (OTC:NSPR) gained a few points on Wall Street today on news that the FDA gave the company a conditional green light to proceed with a clinical trial of its MGuard Embolic Protection Stent.
The FDA concurred with the overall study design, InspireMD said, and minor details are still being hashed out while the company begins initial enrollment in the investigational device exemption study.
The news sent NSPR shares up more than 6% as of 12:30 p.m. when they were trading at $2.09 apiece just a day after InspireMD announced that it raised nearly $23 million from a public stock offering.
"Receiving this approval to commence our FDA trial is a significant milestone," president & CEO Alan Milinazzo said in prepared remarks. "This trial will provide an excellent opportunity to validate the safety and effectiveness of MGuard EPS in another large multi-center, randomized trial, comparing both bare metal and drug eluting stents, the current therapy for STEMI patients."
InspireMD’s MASTER II IDE trial will enroll 1,114 patients at 35 U.S. sites and another 35 sites in Europe, according to a press release. The study is the 2nd in a string of clinical trials evaluating the effectiveness of the MGuard EPS platform in support of various worldwide regulatory submissions.
The company last month announced that it had won CE Mark approval in the European Union for the MGuard blood clot stent.
The study will enroll patients with ST Elevation Myocardial Infarction, evaluating complete ST resolution as well as death and target vessel myocardial infarction. The trial includes a 356-patient substudy evaluating the effect of the MGuard EPS on MRI-measure vessel infarct size, according to the company.