Welcome to our dedicated page for Inspiremd news (Ticker: NSPR), a resource for investors and traders seeking the latest updates and insights on Inspiremd stock.
InspireMD, Inc. (NSPR) is a medical device company whose news flow centers on its CGuard® Prime carotid stent system and proprietary MicroNet™ mesh technology for stroke prevention. Company press releases and SEC filings describe InspireMD as the developer of CGuard® Prime for the treatment of carotid artery stenosis, with a focus on making its products a standard approach in carotid stenting.
News about InspireMD often covers clinical milestones and peer-reviewed publications. For example, the company announced that results from its C-GUARDIANS pivotal trial of the CGuard® Prime carotid stent system were published in the Journal of the American College of Cardiology, with data showing low rates of disabling stroke or myocardial infarction through 30 days and low ipsilateral stroke rates through one year. InspireMD has also highlighted external clinical evidence such as the CREST-2 study in the New England Journal of Medicine, which it views as supportive of carotid artery stenting combined with medical therapy.
Investors following NSPR can also expect updates on regulatory and commercial developments. Recent filings report FDA PMA approval for the CGuard Prime Carotid Stent System in the United States and subsequent announcements of a U.S. commercial launch. Quarterly earnings releases describe the impact of CGuard Prime on revenue and provide commentary on procedure volumes and expansion of the company’s commercial team.
Additional news items include capital-raising transactions, such as private placements and warrant exercises, as well as changes in board composition and senior medical leadership. Together, these updates give readers insight into InspireMD’s clinical progress, regulatory status, commercialization efforts, and corporate governance. This page aggregates such NSPR news so readers can review the company’s key announcements in one place.
InspireMD, Inc. (NYSE American: NSPR) announced the appointment of Patrick Jamnik as Vice President of Business Development and Strategic Initiatives. Mr. Jamnik will focus on advancing the company’s goals, particularly in the U.S. market. He brings over 15 years of experience from roles at large medical technology firms. InspireMD granted Mr. Jamnik 162,920 shares of restricted stock and options for 54,307 shares as inducement awards. Both the restricted stock and options will vest in equal installments over three years, contingent on his employment status.
InspireMD (NYSE American: NSPR) announced the appointment of Dr. Christina Brennan as a strategic advisor to facilitate the CARENET-III pivotal study for the CGuard™ Carotid Stent System, aimed at preventing strokes due to carotid artery disease. The FDA has approved the company to proceed with this crucial study. Dr. Brennan brings over 20 years of clinical research experience, particularly in vascular studies. InspireMD's CGuard EPS employs unique MicroNet® technology to enhance safety and efficacy in carotid artery treatments, potentially establishing a new standard of care.
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.
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