InspireMD Announces Submission of Premarket Approval Application to FDA Seeking U.S. Regulatory Approval of the CGuard™ Prime Carotid Stent System
InspireMD Inc. (NSPR)
NASDAQ:AMEX Investor Relations:
inspiremd.com/en/investors/investor-relations
Company Research
Source: GlobeNewswire
PMA based on overwhelmingly positive results from the pivotal C-GUARDIANS clinical study that were first presented at LINC 2024 in May U.S. commercial launch anticipated in H1 2025, if approved TEL AVIV, Israel and MIAMI, Sept. 16, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that it has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) seeking marketing approval for the CGuard Prime carotid stent system in the U.S. The PMA application is based on the overwhelmingly positive one-year data from the Company’s C-GUARDIANS pivotal clinical trial that were presented at the Leipzig Interventional Course (LINC) 2024 in May. The C-GUARDIANS clinical trial evaluated the safety and efficacy of CGuard for the treatment of carotid artery stenosis. The study enrolled 316 patients across 24 trial sites in the U.S. and Europ
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News
- InspireMD, Inc. (NYSE: NSPR) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- InspireMD Third Quarter 2024 Earnings: US$0.16 loss per share (vs US$0.15 loss in 3Q 2023) [Yahoo! Finance]Yahoo! Finance
- InspireMD Inc (NSPR) Q3 2024 Earnings Call Highlights: Revenue Growth Amid Rising Costs and ... [Yahoo! Finance]Yahoo! Finance
- InspireMD Reports Third Quarter 2024 Financial Results and Provides Business UpdateGlobeNewswire
- What To Expect From InspireMD Inc (NSPR) Q3 2024 Earnings [Yahoo! Finance]Yahoo! Finance
NSPR
Earnings
- 11/12/24 - Beat
NSPR
Sec Filings
- 11/14/24 - Form SC
- 11/14/24 - Form SCHEDULE
- 11/12/24 - Form 10-Q
- NSPR's page on the SEC website