InspireMD, Inc. has announced the submission of a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its CGuard Prime carotid stent system. This system is designed to prevent stroke by treating carotid artery stenosis, a condition where the carotid arteries become narrowed, restricting blood flow to the brain.
The PMA application is supported by data from the C-GUARDIANS clinical trial, which involved 316 patients across 24 sites in the U.S. and Europe. The trial demonstrated a primary endpoint major adverse event rate of 1.95% at one year post-procedure. According to InspireMD, this is the lowest rate recorded for any carotid stent or embolic protection device pivotal trial to date. The findings were initially presented at the Leipzig Interventional Course (LINC) 2024.
Clinical Trial Outcomes
The C-GUARDIANS trial assessed the safety and efficacy of the CGuard Prime system in patients with carotid artery stenosis. The 1.95% major adverse event rate at one year included stroke, death, and myocardial infarction related to the procedure or device. These results suggest a potentially improved safety profile compared to existing carotid stenting options.
Commercialization Plans
Marvin Slosman, CEO of InspireMD, expressed optimism regarding the FDA review process and the company's readiness for a potential U.S. commercial launch in the first half of 2025, contingent upon approval. InspireMD is actively establishing commercial and operational infrastructure in the U.S. to support the introduction of CGuard Prime.
Technology and Mechanism
The CGuard Prime system incorporates InspireMD's proprietary MicroNet technology. This technology is designed to provide superior acute results and long-term outcomes in carotid stenting, aiming to establish the product as the industry standard.
Financial Considerations
In the second quarter of 2024, InspireMD reported a 5.4% revenue increase, with earnings of $1.74 million. However, the company also experienced a 32.6% decrease in gross profit and a 48% rise in operating expenses, resulting in a net loss of $7.9 million for the quarter. Despite these financial dynamics, InspireMD is moving forward with preparations for the C-GUARDIANS II and C-GUARDIANS III trials, anticipating increased operating expenses in the coming year.
Market and Future Prospects
InspireMD is also involved in the CREST-2 clinical trial and is investing in CAS and TCAR products and programs. The company's strategic focus on clinical trials and product development, along with engagement with the medical community, indicates potential growth opportunities in the coming years, particularly with the anticipated approval and launch of CGuard in the U.S. market.
