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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 (Nasdaq: NSPR) announced it will report Q1 2023 financial results on May 9, 2023, before market opening. A conference call will take place at 8:30 a.m. EDT the same day to discuss the results and provide a corporate update. The company focuses on developing the CGuard™ Embolic Prevention Stent System aimed at treating Carotid Artery Disease to prevent strokes. InspireMD seeks to position its technology as the industry standard for carotid stenting.
Forward-looking statements caution that actual results may differ from expectations due to a variety of risks including market acceptance, regulatory challenges, and competition. Investors can access detailed risk factors in InspireMD's SEC filings.
InspireMD reported a 25.7% decrease in total revenue for Q4 2022, totaling $1.03 million, with CGuard EPS sales down 20.6% to $1.03 million due to lapses in CE Mark certification. However, full-year revenue rose 15% to $5.17 million, driven by an 18.9% increase in CGuard sales. The net loss for Q4 2022 was $4.85 million, or $0.60 per share, up from a loss of $4.10 million in Q4 2021. Operating expenses increased by 21.5% to $5.13 million, influenced by FDA study-related costs. InspireMD has resumed CGuard shipments in CE Mark territories and is on track to complete U.S. trial enrollment by Q2 2023, with anticipated CE Mark re-certification in coming weeks.
InspireMD, Inc. has promoted Andrea Tommasoli to Chief Operating Officer, effective March 20, 2023. Tommasoli, who previously served as Senior Vice President of Global Sales & Marketing since 2020, has a strong background in the medical device industry, having held leadership positions at Integra LifeSciences and St. Jude Medical. His promotion comes at a pivotal time as the company enhances its operational capacity to support the commercial growth of its CGuard™ Embolic Prevention Stent System. CEO Marvin Slosman emphasized Tommasoli's significant contributions to expanding the CGuard EPS's market presence and his readiness to lead during this critical phase.
TEL AVIV, Israel, March 2, 2023 - InspireMD, Inc. (Nasdaq: NSPR) announced that it will release its fourth quarter and full-year 2022 financial results on March 30, 2023, before market open. The management will host a conference call at 8:30 a.m. EDT to discuss the results and provide a corporate update. This event is aimed at engaging the investment community and highlighting developments regarding its CGuard™ Embolic Prevention Stent System designed to treat Carotid Artery Disease and prevent strokes.
InspireMD, Inc. (NSPR) has appointed Shane Gleason as General Manager of North America and Vice President of Global Marketing. Gleason brings extensive experience in vascular interventions and successful product launches, essential for the company's growth. As InspireMD nears the completion of its C-Guardian U.S. IDE clinical trial, Gleason's expertise is expected to aid in transitioning to U.S. market readiness. He aims to leverage InspireMD's CGuard EPS and new products like the SwitchGuard TCAR system for a successful market entry. The company focuses on making its proprietary MicroNet technology the industry standard for carotid stenting.
InspireMD has launched a video series titled "12 Days of Carotid Stenting," featuring top vascular specialists discussing the carotid treatment market's trends. Available from November 28, 2022, the series aims to highlight the advantages of the CGuard™ Embolic Prevention Stent System for stroke prevention. CEO Marvin Slosman emphasized the series' role in showcasing technology differentiation and the shift towards stenting practices over surgical interventions. The initiative supports InspireMD's goal of establishing CGuard™ as the global standard for treating carotid artery disease.
InspireMD (NSPR) announced its participation in the 2022 VEITH Symposium from November 15 to 19 in New York City. CEO Marvin Slosman highlighted the significance of the event for promoting the CGuard™ Embolic Prevention System (EPS), emphasizing its growing clinical data advantages over competitors. Multiple presentations will showcase clinical results and long-term outcomes of CGuard, particularly in carotid artery stenting. This exposure aims to enhance awareness of the technology amongst vascular medicine specialists.
InspireMD announced its third-quarter 2022 results, showcasing a 38.8% year-over-year growth in CGuard™ revenue, reaching $1.43 million. The company sold 2,624 stents, up from 1,709 in 2021. Operating expenses increased 20.7% to $4.98 million, leading to a net loss of $4.53 million or $0.58 per share. A strategic partnership with NAMSA aims to enhance device development. The company continues to progress with its U.S. IDE trial, currently enrolling at 24 sites, and anticipates completion by end of Q1 2023.
InspireMD (Nasdaq: NSPR) will report its Q3 2022 financial results on November 8, 2022, before the markets open. A conference call and webcast will be held at 8:30 a.m. EDT to discuss the results and provide updates on corporate developments. Investors are encouraged to access the webcast 15 minutes prior. The company aims to set industry standards for carotid stenting through its proprietary MicroNet® technology, enhancing patient outcomes and preventing strokes.
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