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InspireMD, Inc. (NASDAQ: NSPR), located at 800 Boylston Street, Suite 16041, Boston, Massachusetts, is a pioneering medical device company. It specializes in the development and commercialization of its proprietary MicroNet stent platform technology, which addresses complex vascular and coronary diseases. The company's flagship products include the CGuard Carotid Embolic Prevention System (CGuard EPS) and the MGuard Prime Embolic Protection System (MGuard Prime EPS).
The CGuard EPS, which integrates MicroNet technology with a self-expandable nitinol stent, is primarily used for carotid artery applications and is a significant revenue driver for the company. InspireMD operates globally, with key markets in Italy, Germany, Russia, among others.
In a recent move, InspireMD has focused on expanding its intellectual property portfolio to support its strategic direction. October 2023 saw the Centers for Medicare and Medicaid Services (CMS) expand coverage for carotid artery stenting, including asymptomatic and standard-risk patients. This development is expected to enhance the adoption of InspireMD's products.
Additionally, in the third quarter of 2023, InspireMD reported its financial results and ongoing projects. They are currently enrolling patients in a study to investigate the safety and feasibility of using CGuard EPS for treating acute ischemic stroke patients with tandem lesions. This study is expected to enroll 15 patients across three U.S. sites.
CEO Marvin Slosman emphasized the importance of this study in addressing carotid lesions in acute stroke settings, marking a crucial step in their long-term growth strategy. The company also continues its work on the Premarket Approval Application (PMA) for the C-GUARDIANS U.S. IDE trial, anticipating key milestones in 2024 and 2025.
InspireMD's common stock is listed on the Nasdaq under the ticker symbol NSPR. For more information, visit their website at www.inspiremd.com.
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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