Carotid artery stenting combined with medical therapy demonstrated a significantly lower stroke risk compared to intensive medical therapy alone in patients with severe asymptomatic carotid stenosisMIAMI, Nov. 24, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, welcomes the recent presentation and publication of CREST-2 data which demonstrated positive clinical outcomes for carotid arter ...

Core Insights - InspireMD, Inc. successfully launched its CGuard Prime carotid stent system in the U.S., contributing to record quarterly revenue growth [1][2] - The company reported a 39% increase in total revenue for Q3 2025, reaching $2.5 million compared to $1.8 million in Q3 2024 [3] - Despite revenue growth, the company experienced a net loss of $12.7 million for Q3 2025, compared to a net loss of $7.9 million in the same period last year [7] Business Highlights - The U.S. commercial launch of the CGuard Prime system has shown strong demand, with over 100 procedures completed across leading hospitals [9] - The company raised $58 million in gross proceeds, enhancing its ability to expand its commercial team and operations [2] Financial Performance - U.S. revenue for Q3 2025 was $497,000, while international revenue was $2.0 million, driven by the CGuard Prime launch and increased market penetration [3] - Gross profit for Q3 2025 was $864,000, an increase from $414,000 in Q3 2024, attributed to higher margin revenue from the U.S. launch [4] - Total operating expenses rose by 57% to $13.9 million in Q3 2025, primarily due to increased headcount and infrastructure costs [5] Financial Metrics - Financial income for Q3 2025 decreased by 40% to $343,000 compared to $572,000 in Q3 2024 [6] - Cash and cash equivalents as of September 30, 2025, were $63.4 million, up from $34.6 million at the end of 2024 [7] - The weighted average number of ordinary shares used in computing net loss per share was 73,466,501 for Q3 2025 [14]

Core Insights - InspireMD, Inc. has achieved significant milestones, including FDA approval for its CGuard Prime carotid stent system and the commencement of its commercial rollout in the U.S. [3][10] - The company raised $58 million in gross proceeds, indicating strong investor confidence in its growth potential [3][10] Financial Results for Q2 2025 - Total revenue for Q2 2025 increased by $39,000, or 2.3%, to $1,778,000 compared to $1,739,000 in Q2 2024, driven by the adoption of CGuard technology [4] - Gross profit decreased by $18,000, or 5.4%, to $313,000 from $331,000 in Q2 2024 [5] - Total operating expenses rose by $4,741,000, or 55.2%, to $13,332,000 compared to $8,591,000 in Q2 2024, primarily due to increased salaries and costs associated with the U.S. sales force expansion [6] - Net loss for Q2 2025 was $13,151,000, or $0.26 per share, compared to a net loss of $7,909,000, or $0.22 per share, in Q2 2024 [8] Financial Results for the First Half of 2025 - Revenue for the first half of 2025 increased by $57,000, or 1.8%, to $3,307,000 from $3,250,000 in the same period of 2024 [11] - Gross profit for the first half decreased by $18,000, or 2.8%, to $605,000 compared to $623,000 in the first half of 2024 [12] - Total operating expenses for the first half increased by $8,787,000, or 53.9%, to $25,084,000 compared to $16,297,000 in the same period of 2024 [13] - Net loss for the first half totaled $24,317,000, or $0.48 per share, compared to a net loss of $14,941,000, or $0.43 per share, for the same period in 2024 [15] Business Developments - The company received PMA approval from the FDA for the CGuard Prime carotid stent system and commenced its commercial launch in the U.S. [10] - InspireMD also received CE Mark approval for CGuard Prime EPS under the European Medical Device Regulation, with plans for a launch in Q3 [10] - The leadership team was strengthened with the appointment of Mike Lawless as CFO and the addition of Raymond W. Cohen to the Board of Directors [10]

Company Overview - InspireMD, Inc. is a developer of the CGuard Prime carotid stent system aimed at preventing strokes [1] - The company utilizes proprietary MicroNet™ mesh technology to enhance the effectiveness of its carotid stenting products [2] Financial Results Announcement - InspireMD will release its second quarter 2025 financial results on August 5, 2025 [1] - A conference call and webcast will be held at 8:30 a.m. Eastern Time to discuss the financial results and recent highlights [1] Access to Earnings Call - Interested parties can access the live earnings call via telephone or through a webcast on InspireMD's website [2] - A replay of the webinar will be available shortly after the call and archived on the company's website [2]

Core 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]