InspireMD reports Q2 EPS (24c) vs. (59c) last year

Reports Q2 revenue $1.65M vs. $1.53M last year. Marvin Slosman, CEO of InspireMD, commented: “Our second quarter was marked by several transformational milestones for our business, including the financing of up to $113.6 million that we announced in May. This capital allows us to advance our business towards multiple value-creating milestones, including obtaining potential regulatory approval of and launching our CGuard stent system in the U.S., initiating regulatory pathways for new advanced indications for CGuard, and developing new products, while at the same time continuing to grow our business in approved markets outside of the United States. We also announced completion of enrollment in our C-Guardians IDE trial, which includes the first ever cases performed with our CGuard Prime CAS stent delivery platform that we also plan to include in our regulatory submissions. Importantly, enrollment was completed efficiently in under 24 months and gives us line of sight to results and, if successful, a PMA submission in the second half of next year. In parallel, we continue to advance critical pre-commercial activities in the U.S. with the goal of launching CGuard Prime in the first half of 2025, if approved. The ongoing shift toward an endovascular standard of care with both CAS and TCAR, highlighted by the current CMS proposed decision memo to expand reimbursement for CAS, further validates our strategic direction. We are striving to serve all physician specialties that treat carotid disease, both CAS and TCAR, with our best-in-class CGuard EPS implant. We believe we are optimally positioned to make the CGuard EPS stent system the standard of care, not only in the U.S. but globally,” Mr. Slosman concluded.