| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | April 10, 2025 4:30 P.M. |
| Form: | S-3 | ||||||
| |||||||
| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | April 10, 2025 4:30 P.M. |
| Form: | S-3 | ||||||
| |||||||
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4 - InspireMD, Inc. (0001433607) (Issuer)
MIAMI, June 24, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (the "Company") (NASDAQ:NSPR), developer of the CGuard Prime Carotid Stent System for the prevention of stroke, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket application (PMA) approval of the CGuard Prime Carotid Stent System in the United States. The PMA approval is backed by best-in-class evidence from the Company's C-GUARDIANS pivotal trial, first presented at the Leipzig Interventional Course (LINC) in May 2024. The study, which enrolled 316 patients across 24 sites in the United States and Europe, evaluated the safety and efficacy of CGuard Prime for treating carotid artery stenosis. C
MIAMI, June 13, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (NASDAQ:NSPR), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced the company has received CE Mark approval under the European Medical Device Regulation (MDR) for the CGuard® Prime EPS. CGuard® Prime was developed incorporating extensive user feedback and optimizes deliverability and deployment of the proven CGuard stent. With its proprietary MicroNet™ mesh, CGuard is designed to reduce both early and late embolic events by trapping debris against the vessel wall, preventing plaque prolapse and embolization that can cause stroke. "Securing CE Mark certification under the EU MDR is a ma
MIAMI, June 03, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (NASDAQ:NSPR), developer of the CGuard™ Prime carotid stent system for the treatment of carotid artery disease and prevention of stroke, today announced the appointment of Michael Lawless, an industry veteran, as Chief Financial Officer, effective on or prior to June 30, 2025 (the "Effective Date"). On the Effective Date, Mr. Lawless will succeed Craig Shore, who has served as Chief Financial Officer of InspireMD for nearly 15 years. Mr. Lawless is an experienced public company CFO with decades of financial leadership throughout the healthcare space. For the past three years, he has served as CFO of Lifeward (formerly ReWalk Robotic
8-K - InspireMD, Inc. (0001433607) (Filer)
8-K - InspireMD, Inc. (0001433607) (Filer)
8-K - InspireMD, Inc. (0001433607) (Filer)
4 - InspireMD, Inc. (0001433607) (Issuer)
4 - InspireMD, Inc. (0001433607) (Issuer)
4 - InspireMD, Inc. (0001433607) (Issuer)