MIAMI, Nov. 19, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced plans to participate in a fireside discussion at the upcoming Piper Sandler 37th Annual Healthcare Conference on Wednesday, December 3rd at 12:30 pm Eastern Time (ET). A live audio webcast and replay of the discussion may be accessed on the “Investor Calendar” section of the company’s website at: https://event.webcasts.com/starthere.jsp?ei ...

Revenue 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]

Financial Performance - Total revenue for Q3 2025 increased by 39% to $2.5 million compared to $1.8 million in Q3 2024[3] - Gross profit for Q3 2025 was $864,000, up from $414,000 in Q3 2024, reflecting a favorable sales mix[4] - Net loss for Q3 2025 was $12.7 million, or $0.17 per share, compared to a net loss of $7.9 million, or $0.16 per share, in Q3 2024[9] - Cash and cash equivalents as of September 30, 2025, were $63.4 million, up from $34.6 million as of December 31, 2024[9] Revenue Breakdown - 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] Operating Expenses - Total operating expenses for Q3 2025 rose by 57% to $13.9 million, primarily due to increased headcount and infrastructure costs[7] Strategic Initiatives - The company raised $58 million in gross proceeds to support its commercial rollout and talent acquisition[2] - InspireMD aims to transform the carotid intervention market with a stent-first approach, indicating a strategic focus on innovation and market expansion[2] Operational Highlights - The company completed over 100 U.S. carotid procedures using the CGuard Prime system during the quarter[5] - InspireMD strengthened its leadership team by appointing Peter A. Soukas, M.D., as Chief Medical Officer[5]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 reached $2.5 million, representing a year-over-year growth of 39% and a sequential growth of over 40% [4][14] - Gross profit increased by $450,000 or over 100% to $864,000 compared to $414,000 for Q3 2024 [15] - Gross margin improved to 34.2% of revenue during Q3 2025, up from 22.9% in Q3 2024 [16] - Net loss for Q3 2025 was $12.7 million, or $0.17 per share, compared to a net loss of $7.9 million or $0.16 per share for the same period in 2024 [17] Business Line Data and Key Metrics Changes - U.S. revenue for Q3 2025 was $497,000, marking the first quarter of recorded U.S. commercial revenue following FDA approval [14] - International revenue for Q3 2025 was $2.0 million, an increase of 12% compared to $1.8 million in Q3 2024 [14] Market Data and Key Metrics Changes - The company has completed over 100 cases in the U.S. since the launch of CGuard Prime, with many procedures performed in large Integrated Delivery Networks (IDNs) [6][28] - Globally, the company has sold nearly 70,000 stents to date, reflecting a shift in the carotid interventional market towards a stent-first approach [6] Company Strategy and Development Direction - The company aims to drive sustainable penetration and growth in the market for CGuard Prime, focusing on building traction methodically [5] - The clinical pipeline includes multiple programs and studies to expand the reach of the technology, with expected FDA approvals for new products in the coming years [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, citing strong early momentum in the U.S. and continued demand for the CGuard stent platform internationally [4][19] - The company anticipates revenue of approximately $2.5-$3.0 million in Q4 2025, with expectations for continued growth in U.S. sales and stable international demand [19] Other Important Information - The company raised gross proceeds of $40.1 million through a PIPE offering and $17.9 million from the exercise of milestone-based financing tranches [18] - The new Chief Medical Officer, Dr. Peter Sukas, will oversee clinical and medical topics to advance awareness of the technology [9] Q&A Session Summary Question: Initial physician feedback on CGuard Prime - Management reported strong enthusiasm from physicians, with a solid foundation of clinical data and real-world experience leading to positive anticipation for the U.S. launch [21] Question: Metrics on U.S. launch, including device ASP and account onboarding - The company is positioning CGuard Prime as a workhorse product with a modest premium pricing strategy, aiming for broad adoption [26][28] Question: Breakdown of revenue guidance for Q4 - The guidance consists of stable international sales with expectations for growth in the U.S. market [35] Question: Ordering patterns from initial users - Initial orders are being placed with a focus on utilization, with representatives present during cases to ensure proper training and familiarity with the product [38]

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 appointed Dr. Peter A. Soukas as Chief Medical Officer to enhance its clinical and medical strategy during a critical phase for the company [1][2] Company Overview - InspireMD is focused on developing the CGuard® Prime carotid stent system aimed at preventing strokes, utilizing proprietary MicroNet™ mesh technology to achieve superior acute results and long-term outcomes [5] Leadership Appointment - Dr. Soukas brings extensive experience in vascular intervention, serving as Director of Vascular Medicine at The Miriam Hospital and Associate Professor at Brown University, where he founded the Vascular and Endovascular Medicine Fellowship Program [2][3] - His background includes being a principal investigator in over 24 carotid stenting trials and more than 150 endovascular trials, along with delivering over 300 invited lectures and publishing numerous peer-reviewed papers [3] Strategic Vision - Dr. Soukas expressed his commitment to guiding InspireMD in clinical and medical topics, aiming to enhance awareness of the CGuard Prime stent platform and improve patient care through collaboration with clinical partners [4]

Core Insights - InspireMD, Inc. will release its third quarter 2025 financial results on November 4, 2025, and will host a conference call and webcast at 8:30 a.m. Eastern Time to discuss these results and recent highlights [1]. Company Overview - InspireMD, Inc. is focused on developing the CGuard® Prime carotid stent system aimed at preventing strokes [1]. - The company utilizes its proprietary MicroNet™ mesh technology to establish its products as the industry standard for carotid stenting, emphasizing outstanding acute results and durable, stroke-free long-term outcomes [2]. Investor Information - Interested parties can access the live earnings call via telephone or through a live webinar on InspireMD's website, with a replay available shortly after the call [2]. - The company's common stock is traded on Nasdaq under the ticker symbol NSPR [2].

Company Overview - InspireMD, Inc. (NASDAQ:NSPR) is a Florida-based medical device company focused on developing and commercializing treatments for carotid artery and other vascular diseases [4] - The company offers systems such as the CGuard carotid embolic prevention system and the SwitchGuard neuroprotection system [4] Investment Activity - Parkman Healthcare Partners LLC has increased its position in InspireMD, Inc. by 37.1% during the first quarter, acquiring 316,700 shares, resulting in a total ownership of 1,171,416 shares, which is approximately 3.82% of the company [1] Strategic Positioning - InspireMD employs a procedure-agnostic strategy, being the first to invest in a comprehensive toolkit for carotid procedures, enhancing both carotid artery stenting (CAS) and transcarotid artery revascularization (TCAR) [2] - The company has initiated hiring plans to bolster its sales and clinical support teams, which has positively impacted its market engagement and position [3] Leadership Changes - The appointment of Mike Lawless as the new CFO is a significant development, bringing extensive financial experience and a strong commitment to the company's mission [3]

Company Overview - InspireMD, Inc. is a developer of the CGuard® Prime carotid stent system aimed at preventing strokes [1] - The company is publicly traded on Nasdaq under the ticker symbol NSPR [5] Leadership Appointment - Dan Dearen has been appointed to the Board of Directors, bringing nearly 40 years of experience in the medical device and life sciences sectors [1][2] - His previous roles include President, co-Founder, and Chief Financial Officer of Axonics, Inc., which was acquired by Boston Scientific for $3.7 billion in November 2024 [2][3] Strategic Importance - The appointment of Mr. Dearen is seen as timely as InspireMD continues its U.S. commercial launch of the CGuard Prime stent system [2] - The company aims to lead the carotid intervention market and execute its long-term value-creation strategy [2] Market Potential - Mr. Dearen expressed optimism about InspireMD's potential to change the standard of care in vascular medicine and improve patient outcomes [2] - The company utilizes proprietary MicroNet™ mesh technology to enhance the effectiveness of its carotid stenting products [5]

Summary of InspireMD Conference Call Company Overview - **Company**: InspireMD - **Technology**: Proprietary MicroNet® technology for stroke prevention - **Market Position**: Revolutionizing the carotid intervention market after 20 years of stagnation due to stenting technology and reimbursement issues [2][3] Key Points Market Dynamics - **Reimbursement Changes**: CMS reimbursement approval in October 2023 has significantly impacted the market, allowing InspireMD to address the full 160,000 annual procedures in the U.S. [3][6] - **Market Size**: The U.S. carotid intervention market is approximately $1 billion, with a global market much larger [7] - **Procedure Statistics**: There are about 155,000 procedures in the U.S. annually, with nearly 3 million people globally diagnosed with untreated high-grade carotid stenosis [7] Product and Technology - **Device Approval**: FDA approval for CGuard™ Prime received nine weeks prior to the call, marking a significant milestone for the company [5][18] - **Clinical Outcomes**: Achieved sub-1% complication rates after 30 days, the best ever in carotid intervention [6][11] - **Mechanism of Action**: The device features a 20-micron PET mesh sock to prevent plaque from prolapsing through stent struts, reducing the risk of post-procedural strokes [4][9] Competitive Landscape - **Competitors**: Competing with large strategic companies, particularly following the acquisition of Silk Road Medical by Boston Scientific [26] - **Market Opportunity**: Despite competition, InspireMD believes it has the best product in the market and is well-positioned due to a lack of innovation in carotid stenting over the past 20 years [26][27] Commercial Strategy - **Sales Team**: Focused on hiring experienced sales professionals from the vascular market to drive early commercial traction [15][16] - **Demand Creation**: High demand for the product, with physicians actively seeking the technology [16][17] - **Go-to-Market Strategy**: Targeting specific customers using a claims database to streamline sales efforts [16] Financials and Capital Structure - **Recent Funding**: Raised $113 million in May 2023 and an additional $40 million through PIPE structures, indicating strong investor support [19][20] - **Investment Focus**: Emphasis on capitalizing on market opportunities post-approval, with a focus on growth and establishing a leadership position in the carotid space [18][19] Future Outlook - **Growth Potential**: Anticipated shift from open surgery to stenting, with projections of stenting procedures increasing to 80-85% in the coming years [8] - **Pipeline Development**: Plans for additional products, including a TCAR device called SwitchGuard, expected to be approved by mid-2026 [13][14] Additional Insights - **Patient Impact**: The difference in stroke rates (5% vs. <1%) highlights the significance of the technology for patient outcomes [25] - **Operational Challenges**: The company is focused on maturing its operations to meet high demand while ensuring product quality and physician comfort with the new technology [24] This summary encapsulates the key points discussed during the InspireMD conference call, highlighting the company's strategic position, product innovations, market dynamics, and future growth potential.