InspireMD Inc. (NASDAQ: NSPR) dropped 6.68% after the company announced the commencement of enrollment and completed the first cases of its US registration C-Guardian study of CGuard EPS.
C-Guardian trial to enroll 315 patients
Under the care of lead investigator Chris Metzger, the first patients were implanted successfully with a CGuard EPS stent device. The patients were the first out of 315 patients the trial expected to enroll treated with CGuard EPS in carotid artery stenosis treatment in asymptomatic and symptomatic individuals going through carotid artery stenting.
Metzger said, “I believe that the initiation of this trial marks an important milestone for the potential approval of CGuard EPS and the potential of CGuard EPS in advancing the treatment of CAD and stroke prevention. The wealth of clinical evidence and real-world experience outside the U.S. in the approved served markets with CGuard, demonstrating positive outcomes for patients was very compelling, which drew us to lead this trial to advance the CGuard EPS in the U.S. We are thrilled to participate in such an important effort to bring next generation devices to the growing therapeutic effort of treating CAD.”
InspireMD to avail CGuard EPS for CAD treatment
CEO Marvin Slosman said that this is a significant milestone marking the start of the journey of making CGuard EPS a leading stent device for CAD treatment. As a result, this will help transition to endovascular therapy from surgical intervention. He said that the US market is a priority for InspireMD, and they hope the C-Guardian trail will open the way for the availability of CGuard to patients and physicians.
InspireMD Director Gary Roubin stated, “I am thrilled to contribute to the realization of this important milestone for InspireMD and encouraged to see the many years of advancing the treatment of Carotid Artery Disease take another step with the potential of having CGuard available to the medical community in the U.S.”