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.