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InspireMD (NSPR) investor relations material
InspireMD Piper Sandler 37th Annual Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Key market and clinical trends
CREST-2 trial data showed statistically significant benefit for stenting over medical management, accelerating the shift from open surgery to endovascular approaches for carotid disease.
CMS approval of the NCD in October 2023 opened the market for a stenting-first approach, further driving adoption.
Interventionalists and vascular surgeons are increasingly favoring stenting, with more patients expected to be treated earlier in their disease course.
Closed-cell and second-generation stents, such as CGuard, demonstrated superior outcomes compared to older open-cell stents.
CREST-2 data is expected to increase the number of patients eligible for intervention and expand the overall market.
Commercial launch and financial outlook
U.S. commercial launch began in Q3 2023 with a trained sales force, now doubled to about 30 reps, and over 100 patients treated in the initial phase.
The company is focused on controlled, high-quality adoption, prioritizing physician experience and product stickiness.
Q4 2023 global revenue guidance is $2.5–$3 million, with expectations to reach the higher end of the range based on strong trends.
Q3 2023 revenue was $2.5 million, with $2 million international and $500,000 U.S. sales.
Growth strategy centers on increasing case volume per existing operator rather than expanding the operator base.
Pipeline and clinical development
C-GUARDIANS-2 trial, integrating CGuard with Silk's Enroute device, targets FDA submission in the first half of 2026; enrollment is progressing well.
SwitchGuard neuroprotection system (C-GUARDIANS-3) aims for 510(k) clearance in the first half of 2027, with a 30-day safety endpoint and 25 sites participating.
SwitchGuard will maintain familiar functionality for vascular surgeons, with added features for safety and ease of use; pricing will seek a premium for new features.
Early feasibility study for tandem lesions is over 50% enrolled, aiming to demonstrate the value of CGuard in acute stroke settings and expand access among neuro interventionalists.
Success metrics for acute stroke interventions differ from elective cases, influencing future development and labeling decisions.
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