InspireMD, Inc. - NSPR STOCK NEWS

InspireMD announced FDA approval for the pivotal CARENET-III study of the CGuard™ Carotid Stent System, targeting stroke prevention in carotid artery disease (CAD) patients. This marks a significant step for InspireMD as it aims to expand into the U.S. market. The clinical trial will involve 315 subjects across 40 institutions, emphasizing the potential of CGuard EPS, which offers advanced embolic protection. CAD is responsible for over 6.2 million deaths globally, with U.S. healthcare costs surpassing $34 billion. InspireMD aims to set a new standard in carotid artery management.

InspireMD, Inc. (NYSE American: NSPR) has been awarded the Best ESC Congress Poster for the PARADIGM-EXTEND study, highlighting the CGuard™ Embolic Prevention System's effectiveness in preventing strokes due to carotid artery disease. Initial data from 480 patients indicate a 30-day death/stroke/myocardial incidence of 1.04%, with minimal adverse events and low restenosis rates. The study underscores CGuard’s potential to enhance patient outcomes and transform carotid revascularization practices. InspireMD aims to expand globally and bring CGuard to the U.S., building on demonstrated clinical efficacy.

InspireMD, Inc. (NYSE American: NSPR) announced a virtual corporate presentation by CEO Marvin Slosman at the LD Micro 500 on September 3, 2020, at 4:20 PM EST. The presentation will include a live Q&A session with investors. Additionally, Slosman will be available for one-on-one meetings from September 1-4, 2020. InspireMD develops the CGuard™ Embolic Prevention System aimed at preventing strokes related to carotid artery disease. For further details, visit the webcast link.

InspireMD, Inc. (NYSE American: NSPR) announced on August 10, 2020, that it has regained compliance with NYSE American's listing standards as of August 7, 2020. This follows a Deficiency Letter received on August 14, 2019, regarding insufficient stockholders' equity, reported at less than $6 million. The company resolved this issue through a recent funding transaction that raised approximately $10.7 million. InspireMD focuses on the CGuard™ Embolic Prevention System, aiming to set a standard in carotid stenting with its innovative MicroNet® technology.

InspireMD reported significant developments in Q2 2020, including FDA conditional approval for its Investigational Device Exemption, allowing a pivotal study for its CGuard™ Embolic Prevention System. The company received permission to market the CGuard™ MicroNet stent in Brazil and secured $11.5 million through a follow-on public offering. However, revenue fell 76.9% year-over-year to $313,000, driven by a decrease in sales volume due to COVID-19. Operating expenses decreased by 11.4%, but the net loss widened to $2.48 million, or $0.20 per share.

InspireMD, Inc. (NYSE American: NSPR) will announce its fiscal Q2 2020 financial results on August 5, 2020, at 8:00 AM ET. A conference call will follow at 8:30 AM ET, where management will discuss the results and provide updates on corporate developments. Participants need to pre-register for the call. The company is focused on its CGuard™ Embolic Prevention System to prevent strokes associated with carotid artery disease. Forward-looking statements caution investors regarding various risks that could impact future performance.

InspireMD, Inc. (NSPR) announced promising early results from the SIBERIA trial, presented during EuroPCR on June 25, 2020. This study compares the CGuard™ Embolic Prevention System to the Acculink™ stent for carotid artery revascularization in high-risk patients. Key findings include a 78% reduction in cerebral lesion volume with CGuard™ and zero new cerebral lesions at 30 days, contrasting with six lesions in the Acculink™ group (p=0.03). The trial highlights CGuard™'s potential to redefine standards in carotid stenting, aiming for safer, less invasive options.

InspireMD (NYSE American: NSPR) has priced a public offering of 22,222,200 units at $0.45 each, aiming to raise approximately $10.0 million. Each unit includes one share of common stock and one Series F warrant for $0.495 per share. The underwriter has a 45-day option to purchase an additional 3,333,333 units for up to $1.5 million. Funds will support research, development, marketing, and general corporate purposes. The offering is expected to close on June 5, 2020, pending customary conditions.

InspireMD reported a substantial revenue increase of 149.2% for Q1 2020, totaling $1,034,000, driven mainly by strong sales of the CGuard™ Embolic Prevention System (EPS), which rose 158.2% to $971,000. The company also noted a recovery from third-party sterilizer failures that impacted previous sales. Gross profit improved to $295,000 compared to a gross loss last year, with a gross margin of 28.5%. Despite a net loss of $1,978,000, cash reserves were reported at $3,141,000. InspireMD aims to expand its product offerings and market reach.