InspireMD(US:NSPR)2025-05-09 13:32Financial Data and Key Metrics Changes - CGuard revenue reached $1,530,000, reflecting a 1.2% growth year over year [5] - 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 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 [23] Business Line Data and Key Metrics Changes - CGuard stents sold 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 expected in Q3 2025, with preparations underway for significant demand [6][9] Market Data and Key Metrics Changes - The market for carotid artery procedures is shifting from surgery to stenting, with endovascular procedures expected to dominate in the near future [8] - The introduction of CGuard Prime is expected to catalyze this shift, with potential revenue generation of approximately $12,000,000 based on current sales benchmarks [8] Company Strategy and Development Direction - The company is focused on expanding its commercial and clinical foundation throughout 2025, with a commitment to scaling U.S. operations [9][12] - A state-of-the-art facility in Miami, Florida is being established to support domestic production and meet market demand efficiently [12] 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 in additional time for the approval process [30] - The company remains optimistic about the clinical pipeline, with strong enrollment in the CGuardians two pivotal study and plans for further studies [15][33] Other Important Information - The company has successfully enrolled the first four patients in a tandem lesion early feasibility study, reflecting its commitment to the neurovascular community [18] - Receipt of premarket approval from the FDA would trigger additional financing tranches, supporting the company's growth strategy [19][20] 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 the need for additional feedback from the FDA [30] Question: Enrollment progress in CGuardians two study - Enrollment is progressing well with eight active sites, and feedback from vascular surgeons has been positive [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 interactions with the FDA remain consistent, despite some disruptions, and they are confident in their submission [41] Question: Commercial organization hiring strategy - The company plans to moderate hiring until FDA approval but remains confident in the current team's foundation [44][46] Question: Expectations for the 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 [51]