InspireMD(US:NSPR)2025-11-10 21:06Revenue Growth - For the three months ended September 30, 2025, revenue increased by $713,000, or 39.4%, to $2,523,000, compared to $1,810,000 for the same period in 2024, driven by the commercial launch of CGuard Prime in the U.S.[105] - The revenue increase included a $490,000 rise in North America due to the official commercial launch of CGuard Prime following FDA approval in June 2025, and a $223,000 increase in international markets due to continued adoption of CGuard technology[105] - For the nine months ended September 30, 2025, revenue increased by $770,000, or 15.2%, to $5,830,000, attributed to the commercial launch of CGuard Prime in the U.S.[113] Market Potential - The addressable market for the CGuard Carotid Stent System and SwitchGuard NPS is estimated to be approximately $1.3 billion, with a total available market of approximately $9.3 billion assuming full penetration of treatment for high-grade carotid artery stenosis[94] - In October 2023, the Centers for Medicare and Medicaid Services expanded coverage for carotid artery stenting to include asymptomatic and standard risk patients, significantly increasing the U.S. CAS addressable market[92] Product Approvals and Launches - The CGuard Carotid Stent System received PMA approval from the FDA on June 23, 2025, and CE Mark approval under the EU's MDR on June 12, 2025[96][98] - The CGuard EPS was launched in over 30 countries, with a distribution agreement executed in February 2021 to expand presence in Asian markets[87] - The Company is developing a new transcarotid artery revascularization system, SwitchGuard NPS, to enhance its product offerings in the vascular treatment space[93] Financial Performance - For the three months ended September 30, 2025, gross profit increased by $450,000, or 108.7%, to $864,000, with a gross margin of 34.2% compared to 22.9% in the same period of 2024[107] - The net loss for the nine months ended September 30, 2025, increased by $14,194,000, or 62.2%, to $37,025,000, primarily due to a $13,826,000 increase in operating expenses[120] Expenses - Research and development expenses decreased by $280,000, or 7.2%, to $3,635,000, primarily due to the completion of the C-GUARDIANS clinical study[108] - Selling and marketing expenses increased by $2,920,000, or 198.4%, to $4,392,000, driven by higher staffing levels for the commercial launch of CGuard Prime in the U.S.[109] - General and administrative expenses rose by $2,399,000, or 68.8%, to $5,888,000, mainly due to increased compensation and professional services related to U.S. operations[110] Cash Flow and Financial Position - Cash and cash equivalents as of September 30, 2025, were $63,403,000, compared to $18,916,000 as of December 31, 2024[128] - Net cash used in operating activities increased by $10,640,000, or 70.4%, to $25,758,000 for the nine months ended September 30, 2025[129] - Cash provided by financing activities for the nine months ended September 30, 2025, was $55,569,000, significantly higher than $16,889,000 in the same period of 2024[131] - The company has an accumulated deficit of $291 million as of September 30, 2025, raising substantial doubt about its ability to continue as a going concern[121] Clinical Trials - The C-GUARDIANS trial enrolled 316 patients across 24 trial sites, with a 30-day DSMI rate of 0.95% and a one-year follow-up rate of 1.95%[90][91] Financing Activities - The Company raised approximately $16.9 million from the exercise of Series I Warrants following the PMA approval of CGuard Prime[99] - The Company completed a private placement offering that generated approximately $40.1 million in gross proceeds, with a placement fee of about $2.4 million[101]