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. (NSPR) announced that its CGuard™ Carotid Stent has been approved for use in the CREST-2 Trial, a pivotal study sponsored by NINDS to assess treatment efficacy for carotid artery disease. This trial will involve approximately 2,480 participants over four years, focusing on preventing strokes in asymptomatic patients with significant carotid stenosis. CGuard, utilizing advanced MicroNet technology, enhances the stenting procedure. This inclusion in a major clinical trial marks a significant milestone, potentially validating InspireMD's technology and expanding market opportunities.
InspireMD, Inc. (NSPR) has announced it will report fourth quarter and full year 2021 financial results on March 8, 2022, prior to market opening. A conference call is scheduled for the same day at 8:30 a.m. ET to review these results and provide updates on corporate developments. The company focuses on its CGuard™ Embolic Prevention Stent System for carotid artery disease and stroke prevention. InspireMD aims to set industry standards with its proprietary MicroNet® technology, enhancing both acute and long-term patient outcomes.
InspireMD has appointed Dr. Adnan Siddiqui to its Scientific Advisory Board, enhancing its expertise in the management of vascular diseases. A neurovascular surgeon with extensive experience, Dr. Siddiqui's role aims to advance the CGuard™ Embolic Prevention Stent System and support the development of new indications. InspireMD emphasizes the CGuard's superior patient outcomes compared to traditional methods, emphasizing the potential for improved stroke prevention. The company aims to establish its MicroNet® technology as the standard in carotid stenting.
InspireMD, Inc. (Nasdaq: NSPR) will participate in the 16th Biennial Scientific Meeting of the International Andreas Gruentzig Society (IAGS) from January 31 - February 3, 2022, in Punta Cana, Dominican Republic. CEO Marvin Slosman is set to present on February 1 at 11:30 am EST. The meeting aims to tackle challenges in cardiovascular disease treatment and enhance collaboration among researchers and clinicians. InspireMD focuses on stroke prevention technology, particularly its CGuard™ Embolic Prevention Stent System.
InspireMD, Inc. (Nasdaq: NSPR) announced a live case demonstration of its CGuard™ Embolic Prevention Stent System at the ISET 2022 Conference on January 18, 2022. The presentation, led by Dr. Chris Metzger, aims to showcase the advantages of CGuard in preventing strokes caused by Carotid Artery Disease. With 40 patient enrollments in the C-Guardians IDE trial, the company received global recognition for CGuard’s safety and efficacy. InspireMD continues to strive to establish its technology as the industry standard for carotid stenting.
InspireMD reported a 23.8% increase in CGuard EPS revenue for Q3 2021, totaling $1,031,000, driven by a resurgence in procedural activity post-COVID. The company received a positive reimbursement opinion from the French National Authority for Health, bolstering its market presence in France. Despite a substantial cash position of $37.1 million, net losses widened to $4.1 million, or $0.53 per share, compared to a loss of $2.2 million in Q3 2020. Gross margin fell sharply to 8.6% from 30.4% due to rising costs, while operating expenses surged 65.4%.
InspireMD (Nasdaq: NSPR) announced results from the SIBERIA randomized clinical trial demonstrating the effectiveness of its CGuard MicroNet-covered stent in reducing silent brain infarcts compared to the conventional Acculink stent. The study showed a 57% reduction in lesions and a 4.5-fold reduction in total infarct volume. The findings, published in the JACC, provide level 1 evidence favoring CGuard in preventing cerebral embolization. InspireMD’s CEO expressed optimism about the technology potentially changing standard care for carotid artery disease.
InspireMD (Nasdaq: NSPR) will announce its third quarter 2021 financial results on November 9, 2021, before market opening. The company, known for its CGuard™ Embolic Prevention Stent System, will host a conference call at 8:30 a.m. ET on the same day to discuss results and corporate updates. Interested parties can participate via toll-free and international numbers or access a live webcast on the company’s website.
InspireMD (NSPR) announced that its CGuard EPS stent system has received a positive reimbursement opinion from the French National Authority for Health (HAS), effective October 25, 2021. This milestone marks a crucial step towards the commercial launch of CGuard EPS, previously approved by CNEDIMTS for use in treating carotid artery disease. The stent aims to enhance treatment options, moving away from surgical methods. InspireMD's unique MicroNet technology is designed to improve patient outcomes.
InspireMD, developer of the CGuard™ Embolic Prevention System, reported a revenue increase of 231.6% in Q2 2021, totaling $1,038,000 compared to $313,000 in Q2 2020, driven by a recovery in procedural volumes. The gross profit rose to $262,000, with a gross margin of 25.2%. However, operating expenses increased by 59.2% to $3,702,000. The net loss for the quarter was $3,507,000 or $0.46 per share. The company initiated the “C-Guardians” IDE clinical trial, transferring its stock listing to Nasdaq to enhance investor access.