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InspireMD Inc. (NSPR) is a medical device company pioneering MicroNet stent technology for stroke prevention through advanced carotid artery treatments. This page serves as the definitive source for verified corporate announcements, clinical developments, and strategic updates.
Investors and medical professionals will discover timely updates including FDA regulatory progress, international clinical trial results, product launch details, and partnership announcements. All content undergoes rigorous verification to ensure accuracy and relevance to stakeholder decision-making.
The resource features critical developments in vascular intervention technology, including innovations in embolic protection systems and expansion into new global markets. Users can track the company's progress through major clinical study publications and regulatory milestone achievements.
Bookmark this page for structured access to InspireMD's latest verified news. Check regularly for updates on carotid stenting advancements, financial disclosures, and evidence-based medical device innovations shaping stroke prevention care.
InspireMD (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System for carotid artery disease and stroke prevention, has announced it will report second quarter 2024 financial results on Tuesday, August 6th, before market open. The company will host a conference call and webcast at 8:30 am EDT to discuss financial results and provide a corporate update.
Investors can access the call via toll-free number 1-800-445-7795 or international number 1-785-424-1699, using Conference ID: IMD2Q24. A live webcast will be available on the company's website, with replay access after the call. This event offers an opportunity for stakeholders to gain insights into InspireMD's financial performance and business developments.
InspireMD announced the full exercise of 12.9 million Series H warrants, raising $17.9 million in gross proceeds and $16.9 million after fees. This follows positive one-year outcomes from the C-GUARDIANS pivotal trial of the CGuard Carotid Stent System. The warrant holders include notable healthcare investors like Marshall Wace and OrbiMed. This funding is part of a larger $113.6 million private placement announced in May 2023. CEO Marvin Slosman highlighted that the capital will be used to advance the CGuard Prime Carotid Stent System towards FDA approval and its U.S. launch in 2024, aiming to cater to a broad range of physicians and patient needs.
InspireMD announced positive one-year follow-up results from the C-GUARDIANS clinical trial of the CGuard™ Carotid Stent System, showing the lowest reported primary endpoint event rate of 1.95% for any carotid stent or embolic protection device pivotal trial. These results will support a Premarket Approval (PMA) application to the FDA in H2 2024, with a potential U.S. commercial launch in H1 2025, if approved. The trial enrolled 316 patients across 24 sites in the U.S. and EU, focusing on those with carotid artery stenosis at high risk for carotid endarterectomy. The study's primary endpoint is a composite of major adverse events, including death, stroke, or myocardial infarction within 30 days post-procedure, or ipsilateral stroke from day 31 to day 365 post-procedure.
InspireMD reported its Q1 2024 financial results, highlighting a 22% increase in CGuard EPS revenue to $1.51 million compared to Q1 2023.
The company sold 2,553 CGuard stent systems, up 25.6% year-over-year.
Gross profit decreased by 21.6% to $292,000 due to higher training costs, with gross margins falling to 19.4% from 30.1%.
Total operating expenses rose 62.1% to $7.7 million, driven by higher share-based compensation.
Net loss widened to $7.03 million, or $0.21 per share, from $4.26 million, or $0.53 per share, in Q1 2023.
Cash reserves stood at $34 million as of March 31, 2024, down from $39 million at year-end 2023.
The company also highlighted the acceptance of one-year outcomes from the C-GUARDIANS IDE trial for presentation at LINC 2024 and leadership appointments for CGUARDIANS II clinical trial.
InspireMD, Inc. (Nasdaq: NSPR) will report first quarter 2024 financial results on May 14th before the markets open. The company will host a conference call and webcast to review financial results and provide corporate updates at 8:30 a.m. EDT on the same day.
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