Inspiremd Stock Price, News & Analysis

InspireMD (Nasdaq: NSPR) has submitted a Premarket Approval (PMA) application to the FDA for its CGuard Prime carotid stent system. The application is based on positive one-year data from the C-GUARDIANS pivotal clinical trial, which showed a primary endpoint major adverse event rate of 1.95% through twelve months post-procedure - the lowest reported for any carotid stent or embolic protection device pivotal trial to date. The study enrolled 316 patients across 24 trial sites in the U.S. and Europe. InspireMD anticipates a U.S. commercial launch in H1 2025, if approved, and is building commercial and operational infrastructure for market entry.

InspireMD (Nasdaq: NSPR) reported its Q2 2024 financial results and provided a business update. Key highlights include:

1. Positive outcomes from the C-GUARDIANS IDE clinical trial of CGuard™ Prime carotid stent system, with a 1.95% one-year primary endpoint event rate.
2. Plans to submit a Premarket Approval (PMA) application to the FDA this quarter.
3. Raised $17.9 million in gross proceeds from Series H warrants exercise.
4. Q2 2024 CGuard EPS revenue increased by 5.4% to $1.74 million.
5. Net loss for Q2 2024 was $7.909 million, or $0.22 per share.
6. Cash, cash equivalents, and marketable securities stood at $47.2 million as of June 30, 2024.

InspireMD (Nasdaq: NSPR) congratulates investigators on completing enrollment in the CREST-2 clinical trials, which evaluate carotid revascularization for stroke prevention. The company's CGuard™ Embolic Prevention Stent System was the only investigational carotid stent approved by FDA for inclusion in the trials, with 23 cases implanted. This approval followed InspireMD's successful IDE supplement application in February 2022.

The CREST-2 trials compare carotid revascularization and intensive medical management to medical management alone in patients with asymptomatic high-grade carotid stenosis. The study aims to determine the optimal treatment for these patients and ensure the use of state-of-the-art innovation for the best possible outcomes.

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.