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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 reported strong revenue growth driven by its CGuard™ EPS, achieving an 87.5% increase in Q4 2021 over Q4 2020, totaling $1,291,000, and a 55.9% year-over-year growth for the full year with $4,495,000. The company established reimbursement approval for CGuard from the French National Authority and its inclusion in a major clinical trial. However, it reported a net loss of $4,097,000 for Q4 2021, widening from the previous year's loss. Despite expenses rising 27% due to clinical trials and expansion efforts, cash reserves stood strong at $34.0 million.
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.
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