InspireMD, Inc. (Nasdaq: NSPR) is a medical device company specializing in the development and commercialization of advanced stent systems aimed at treating carotid artery disease and preventing strokes. The company manufactures and markets its products globally, with a focus on its proprietary stent platform. InspireMD's operations include manufacturing, packaging, and distributing its products, primarily from its facility in Israel, with plans to expand manufacturing capabilities in the U.S..
- CGuard™ Prime Carotid Stent System - Treats carotid artery disease and prevents strokes, designed with advanced technology to improve patient outcomes. Currently under FDA review for Premarket Approval (PMA) and anticipated for U.S. commercial launch in the second half of 2025.
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- Given the slight timeline extension for CGuard Prime FDA approval, what specific contingency plans do you have in place to mitigate the potential regulatory delays, and how might these delays impact your broader commercialization strategy?
- With active engagement from the FDA and the recent final facility site audit, can you provide more detailed insights on the remaining outstanding issues from the audit and how they might influence your expected Q3 approval timeline?
- In light of the projected late 2026 clearance for the SwitchGuard device and its resubmitted IDE, what key enrollment or study milestones could potentially accelerate or further delay this timeline, and how are you preparing for either scenario?
- Considering the 52.5% increase in Q1 operating expenses largely due to ramping up the U.S. sales force and infrastructure ahead of FDA approval, how sustainable is this spending approach if FDA approval timelines extend further than anticipated?
- Regarding the enrollment progress in the CGuardians II trial, with only 8 active sites currently, what measures are being taken to ensure adequate enrollment pace and robust clinical outcomes, and how might slower-than-expected enrollment affect your overall clinical roadmap?
Research analysts who have asked questions during InspireMD earnings calls.
Competitors mentioned in the company's latest 10K filing.
| Company | Description |
|---|---|
The company is identified as a manufacturer of products used in connection with carotid artery stenting (CAS) procedures, competing in the market for carotid embolic prevention systems. | |
This competitor is noted as a large company involved in the production of products for CAS procedures, with significant resources and established market presence. | |
The company is highlighted as a major competitor in the CAS market, leveraging its extensive financial, technological, and marketing resources. | |
Cordis Corporation | This competitor is mentioned as one of the manufacturers of CAS-related products, competing in the same market segment. |
Terumo Medical Corporation | The company is listed as a competitor in the CAS market, producing products that compete with the company's offerings. |
C.R. Bard, Inc. | This competitor is noted for its involvement in the stent market and its history of patent litigation, which underscores its competitive stance in the industry. |
W.L. Gore & Associates | The company is identified as a competitor in the stent market, with a history of patent litigation reflecting its active role in the competitive landscape. |
Recent press releases and 8-K filings for NSPR.
- InspireMD, Inc. (NSPR) has raised approximately $58 million in combined gross proceeds.
- This financing includes an equity private placement (PIPE) that generated $40.1 million and the exercise of warrants that generated $17.9 million.
- The warrant exercise was triggered by the U.S. Food and Drug Administration (FDA) premarket application approval (PMA) of the CGuard Prime carotid stent system.
- The company intends to use the net proceeds to fund operations, including sales and marketing and research and development, to support the U.S. launch of CGuard Prime.
- InspireMD, Inc. (NSPR) announced the official commercial launch of its CGuard Prime carotid stent system in the U.S. on July 9, 2025, following FDA premarket application (PMA) approval.
- The CGuard Prime is a novel mesh-covered carotid stent designed to improve patient safety by minimizing early and late embolism risk for stroke prevention, utilizing a dual layer design with MicroNet™ and SmartFit™ technology.
- This U.S. launch represents a pivotal milestone for InspireMD, which has already secured double-digit market share for the CGuard Prime in over 30 countries globally.
- InspireMD is focused on the impending FDA approval and commercialization of its next-generation CGuard carotid stent, with final details being submitted to the FDA.
- The U.S. market for carotid revascularization is estimated at just under $1 billion, significantly expanded by CMS coverage in October 2023 to include all standard risk patients for stenting procedures.
- The CGuard stent features a unique MicroNet mesh platform and has demonstrated strong clinical results, including a 30-day composite endpoint of death, stroke, and MI at 0.95% in a 316-patient pivotal trial.
- The company raised a $113 million funding round in May 2023 to support its commercial launch plan.
- InspireMD reported total revenue of $1,529,000 for the first quarter ended March 31, 2025, an increase of 1.2% compared to the same period in 2024, and a net loss of $11,166,000, or $0.22 per basic and diluted share.
- As of March 31, 2025, the company's cash and cash equivalents and marketable securities totaled $26,086,000, a decrease from $34,637,000 as of December 31, 2024.
- InspireMD is optimistic for anticipated FDA approval of its CGuard Prime carotid stent system in the third quarter of 2025.
- The company has advanced its commercial infrastructure and operational readiness in preparation for the anticipated U.S. launch of the CGuard Prime carotid stent system.