Inspire Medical granted premarket application approval for CGuard Prime

Inspire Medical announced that the FDA has granted premarket application approval of the CGuard Prime Carotid Stent System in the United States. The company’s announcement of FDA approval of the CGuard Prime Carotid Stent System triggers the second of four milestone-driven warrant tranches pursuant to the private placement financing of up to $113.6M announced in May 2023. Gross proceeds from this warrant tranche are expected to be $17.9M if exercised in full. Proceeds, if any, will be used to support the imminent commercial launch of the CGuard Prime Carotid Stent System in the United States, initiating new regulatory pathways for advanced applications of our CGuard stent platform, and developing new products, while at the same time continuing to develop business outside of the United States.