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 [6][22] - Gross profit for Q1 2025 was $292,000, flat compared to Q1 2024, with a gross margin of 19.1% [22] - Total operating expenses increased by $4,000,000 or 52.5% to $11,752,000 compared to Q1 2024 [22] - 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 [24] 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 [6][7] - Anticipated U.S. approval and launch of CGuard Prime is expected in Q3 2025, with preparations underway for a significant demand [7][10] Market Data and Key Metrics Changes - The market for carotid artery procedures is shifting from surgery to stenting, with endovascular procedures expected to represent the majority by next year [9] - The introduction of CGuard Prime is anticipated to catalyze this shift, with potential revenue generation of approximately $12,000,000 based on current sales volume [9] 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 [10][13] - A state-of-the-art facility in Miami, Florida, is expected to enhance domestic production and meet market demand efficiently [13] - The company is building a differentiated comprehensive solution for carotid revascularization, aiming to reshape the market and drive long-term growth [19] 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 [31][32] - The company remains optimistic about the clinical pipeline, with strong enrollment in the CGuardians two pivotal study and a focus on advancing the TCAR strategy [16][20] 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 [19] - Receipt of premarket approval from the FDA would trigger additional financing tranches, supporting the company's growth strategy [20][21] 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][31] Question: Enrollment progress in CGuardians two study - Enrollment is progressing well with eight active sites, and feedback from vascular surgeons has been positive [34] 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 [37] 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 [42][43] 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 [46][48] 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 [54]