InspireMD(US:NSPR) Globenewswireยท2025-05-09 11:00Core Insights - InspireMD, Inc. reported a total revenue increase of $18,000, or 1.2%, for Q1 2025, reaching $1,529,000 compared to $1,511,000 in Q1 2024, driven by the adoption of CGuard technology despite foreign exchange impacts and inventory management by distributors [4][6] - The company is optimistic about receiving FDA approval for the CGuard Prime carotid stent system in Q3 2025, which is expected to drive future growth [3][11] - Total operating expenses rose by $4,046,000, or 52.5%, to $11,752,000 in Q1 2025, primarily due to increased salaries and preparations for the CGuard Prime launch [6][7] Financial Performance - Gross profit for Q1 2025 remained unchanged at $292,000 compared to Q1 2024 [5] - Net loss for Q1 2025 was $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 of 2024 [7][17] - Cash and cash equivalents and marketable securities decreased to $26,086,000 as of March 31, 2025, down from $34,637,000 as of December 31, 2024 [8] Operational Highlights - The company has established a world-class commercial team in preparation for the anticipated U.S. launch of CGuard Prime [3][11] - Continued enrollment in the CGUARDIANS II pivotal study for the CGuard Prime system is progressing at an excellent pace [11] - InspireMD is actively engaging with the FDA regarding the PMA application for CGuard Prime, with a focus on operational readiness for the U.S. market [11]