InspireMD(US:NSPR)2025-05-09 13:30Financial Data and Key Metrics Changes - CGuard revenue for Q1 2025 reached $1,530,000, reflecting a 1.2% year-over-year growth [5][21] - Gross profit for Q1 2025 was $292,000, flat compared to Q1 2024, with a gross margin of 19.1% [21] - Total operating expenses increased by $4,000,000 or 52.5% to $11,752,000 in Q1 2025 compared to Q1 2024 [21] - Net loss for Q1 2025 totaled $11,166,000 or $0.22 per share, compared to a net loss of $7,032,000 or $0.21 per share in the same period in 2024 [21] Business Line Data and Key Metrics Changes - CGuard stent sales totaled 2,611 units in Q1 2025, contributing to a total of approximately 64,000 implants sold to date [5][6] - Anticipated U.S. approval and launch of CGuard Prime is expected in Q3 2025, with preparations underway for a significant demand [6][7] Market Data and Key Metrics Changes - The U.S. market for carotid artery disease treatments is shifting towards endovascular procedures, with a significant conversion from surgery to stenting expected [8][12] - The introduction of CGuard Prime is anticipated to catalyze this shift, with potential revenue generation of approximately $12,000,000 based on current sales benchmarks [8][12] Company Strategy and Development Direction - The company is focused on expanding its commercial and clinical foundation throughout 2025, aiming for robust growth driven by the launch of CGuard Prime and the Switchgard neuroprotection system [9][19] - A state-of-the-art facility in Miami, Florida, is being established to support U.S. operations and meet market demand efficiently [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving FDA approval for CGuard Prime and highlighted the importance of building a strong commercial team to support the launch [6][30] - The company remains engaged with the FDA and is optimistic about the approval timeline, despite some delays due to agency processes [30][40] Other Important Information - The company has received FDA approval for the investigational device exemption for the CGuardians two pivotal study, with strong enrollment progress [16][33] - The company is also advancing its TCAR strategy with plans for a fully integrated TCAR solution, anticipating FDA clearance in late 2026 [17][36] Q&A Session Summary Question: Update on CGuard Prime FDA approval timeline - Management explained that the timeline was adjusted due to the scheduling of the facility site audit and subsequent feedback from the FDA, but they remain confident in achieving approval [30][40] Question: Enrollment progress in CGuardians two study - Enrollment is progressing well with eight active sites, and feedback from vascular surgeons has been positive regarding the use of CGuard Prime [33] Question: Update on Switchgard and FDA engagement - The company has resubmitted its IDE to the FDA, with a revised timeline for clearance expected in late 2026 [36] Question: Impact of FDA changes on review team and timelines - Management confirmed that the review team remains intact and interactions with the FDA are positive, despite some delays [40] Question: Commercial organization hiring strategy - The company plans to moderate hiring until FDA approval, ensuring a strong foundation is in place for the product launch [44] Question: Expectations for CREST two trial results - Management indicated that the results will depend on the severity of the enrolled patients, with expectations that it may not change current practices significantly [52]