04:28 PM EDT, 06/24/2025 (MT Newswires) -- InspireMD ( NSPR ) said Tuesday the Food and Drug Administration has granted premarket application approval of the CGuard Prime Carotid Stent System in the US.

The approval is backed by a trial that enrolled 316 people across 24 sites in the US and Europe and assessed the safety and efficacy of CGuard Prime to treat carotid artery stenosis.

The FDA's approval of the CGuard Prime system triggers the second of four milestone-driven warrant tranches under the private placement deal of up to $113.6 million announced in May 2023, the company said, adding gross proceeds from the warrant tranche are expected to be $17.9 million, if exercised in full.

The company's shares were rising past 9% in recent after-hours trading.