InspireMD FY Conference Summary Company Overview - **Company**: InspireMD (NasdaqCM:NSPR) - **Event**: 2025 Piper Sandler Healthcare Conference - **Date**: December 03, 2025 Key Industry Insights - **Industry**: Carotid artery disease treatment and intervention - **Recent Trial**: CREST-2 trial results were favorable for intervention, specifically TFCAS, showing statistically significant benefits over medical management [4][11][12] Core Points and Arguments 1. **Market Transition**: The transition from open surgery to endovascular procedures is accelerating, supported by the favorable CREST-2 trial results and prior CMS approval for stenting-first approaches [8][14] 2. **Interventionalist Perspective**: The CREST-2 trial results encourage interventionalists to treat more patients with stenting, expanding the patient base for carotid disease treatment [12][20] 3. **Surgical Interventionalist Perspective**: Surgical interventionalists are likely to shift towards TCAR (Transcarotid Artery Revascularization) as a preferred method due to the positive outcomes of stenting in the CREST-2 trial [13][14] 4. **Patient Demographics**: CREST-2 included 70% asymptomatic patients, indicating a potential increase in early treatment for carotid artery disease [19][20] 5. **Market Size**: Approximately two-thirds of diagnosed patients in the U.S. with carotid artery disease are currently treated with medical management alone, indicating a significant opportunity for intervention [21][22] 6. **Stent Technology**: The stents used in CREST-2 were older generation, while InspireMD's CGuard stent is a newer, closed-cell design that has shown better outcomes in previous studies [24][28] 7. **Commercial Launch**: InspireMD's commercial launch in the U.S. began in Q3 2025, with a focus on controlled growth and physician training [38][39] 8. **Revenue Guidance**: For Q4 2025, InspireMD provided a revenue guidance of $2.5-$3 million, based on strong international performance and early U.S. launch results [46][48][50] Additional Important Insights 1. **Referral Pathway Changes**: The CREST-2 results are expected to influence referral patterns, with more vascular surgeons considering TCAR and interventionalists seeing increased patient referrals [33][34] 2. **Pipeline Products**: InspireMD is working on integrating the CGuard stent with Boston Scientific's Enroute neuroprotection device, with FDA submission expected in the first half of 2026 [53][54] 3. **Tandem Lesions Study**: An early feasibility study is underway to demonstrate the protective value of CGuard in acute stroke settings, with over 50% enrollment achieved [75][79] 4. **Market Dynamics**: The carotid intervention market is expected to grow not by increasing the number of operators but by enabling existing operators to treat more patients effectively [35][36] This summary encapsulates the key points discussed during the InspireMD FY Conference, highlighting the company's strategic direction, market opportunities, and ongoing clinical developments.

Core Insights - The CREST-2 study demonstrated that carotid artery stenting combined with intensive medical therapy significantly reduces the risk of stroke compared to intensive medical therapy alone in patients with severe asymptomatic carotid stenosis [1][2][4] - The study results were presented at major medical conferences and published in the New England Journal of Medicine, marking a pivotal moment for the treatment of carotid disease [1][4] Study Details - CREST-2 was a NIH-sponsored clinical trial involving 155 centers globally, comparing outcomes of carotid artery stenting plus intensive medical management against intensive medical management alone [4] - The primary outcome measured was a composite of any stroke or death, assessed from randomization to 44 days, or ipsilateral ischemic stroke during the follow-up period of up to 4 years [4] - A total of 1245 patients were randomized in the stenting trial, while 1240 patients were randomized in the endarterectomy trial [4] Company Positioning - InspireMD's CGuard Prime carotid stent system is positioned as a leading option for carotid stenting, supported by the positive CREST-2 results and over 65,000 global implants [3][5] - The company emphasizes the effectiveness of its MicroNet™ mesh technology in achieving low adverse event rates, with a reported 1.93% major adverse event rate through 12 months in high surgical risk patients [3]

Core Viewpoint - InspireMD, Inc. is set to participate in a fireside discussion at the Piper Sandler 37th Annual Healthcare Conference on December 3rd, 2025, highlighting its focus on carotid stenting technology aimed at stroke prevention [1]. Company Overview - InspireMD, Inc. develops the CGuard® Prime carotid stent system, utilizing proprietary MicroNet™ mesh technology to establish its products as the industry standard for carotid stenting [2]. - The company aims to deliver exceptional acute results and long-term outcomes that are stroke-free, emphasizing its commitment to innovation in the healthcare sector [2]. - InspireMD's common stock is traded on Nasdaq under the ticker symbol NSPR, and the company actively shares important investor information on its website [2].

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]