InspireMD seeks FDA approval for carotid stent system - Investing.com
InspireMD submitted a PMA application to the FDA for its CGuard Prime carotid stent system, based on the C-GUARDIANS trial's low major adverse event rate. The company prepares for a potential U.S. launch in H1 2025, aiming to establish CGuard Prime as the industry standard. InspireMD reported a 5.4% revenue increase in Q2 2024 but also a net loss of $7.9 million, highlighting financial challenges. Investors monitor the company's financial health and market performance, noting its expanding market presence and potential growth opportunities.
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InspireMD submitted a PMA application to the FDA for its CGuard Prime carotid stent system, based on the C-GUARDIANS trial's low major adverse event rate. The company prepares for a potential U.S. launch in H1 2025, aiming to establish CGuard Prime as the industry standard. InspireMD reported a 5.4% revenue increase in Q2 2024 but also a net loss of $7.9 million, highlighting financial challenges. Investors monitor the company's financial health and market performance, noting its expanding market presence and potential growth opportunities.