RS-Neuromarkers Updates
From June 2025 to May 2027
📅 Project kick-off (done)
Kick-off to review our project RS Neuromarkers (June,2, 2025).
📅 Study initiation package (done)
We are organizing a clinical trial to collect real-world data, which will enable us to refine our algorithms and develop our biomarkers. We finalized our dossier (protocol, consent form, insurance, organization with the hospital, etc).
📅 ISO 13485 certification obtained (done)
Resolve Stroke's Quality Management System was certified ISO 13485:2016 in September 2025, an important milestone on our path toward CE marking and FDA clearance.
📅 First peer-reviewed publication (done)
The results of our ESRIR feasibility study were published in the peer-reviewed journal Critical Care (May 2026): "Bedside three-dimensional acoustic angiography and perfusion monitoring in aneurysmal subarachnoid hemorrhage", open access. This work lays the scientific foundation for RS-USP and RS-LVO.
📅 SCULPT clinical trial launch (done)
We launched our clinical trial at CHU Montpellier in October 2025. The objective is to compare bedside perfusion measurements from our SYLVER ultrasound system with CT perfusion (RapidAI) in neuro‑ICU patients, to validate SYLVER’s perfusion metrics and build the clinical dataset that will power future RS‑USP and RS‑LVO biomarkers.
📅 System performance upgrade (done)
We upgraded our SYLVER ultrasound system: two new units are now built and fully operational, one at CHU Montpellier supporting the SCULPT clinical trial, the other in our R&D lab. Image quality was significantly improved, with signal quality gains that exceeded our internal target for this phase of the project.
📅 RS-USP and RS-LVO: first working prototypes (done)
Our two biomarkers now exist as working lab prototypes. RS-USP (perfusion) and RS-LVO (large-vessel occlusion detection) both run end-to-end on real ultrasound data, and met their bench-testing targets. The next step, already under way, is their validation on clinical data from the SCULPT trial.
📅 SCULPT trial: acquisitions milestone (ongoing)
Recruitment at CHU Montpellier continues, and the trial has already gathered more paired ultrasound/CT scans than we had targeted for this stage of the project. Because neuro-ICU recruitment is naturally non-linear, the ethics committee (CPP Ouest VI) approved an extension of the trial timeline in April 2026 to make sure we reach our full clinical cohort.
📅 Validating RS-USP and RS-LVO on clinical data (ongoing)
With both biomarkers now working as lab prototypes, we have moved into their validation phase: benchmarking RS-USP and RS-LVO against controlled laboratory tests, and comparing their outputs to clinical reference imaging (CT perfusion and CT angiography) using data collected in the SCULPT trial. This is a key step toward integrating both biomarkers into SYLVER.
📅 Sharing our science at conferences (ongoing)
Over the past year our team presented RS-Neuromarkers at a dozen scientific and medical conferences across Europe and the US, including EuroNeuro, SFAR, the Neurocritical Care Society meeting, ESICM and ECR. Highlights included a dedicated evening workshop for about 50 clinicians at Station F (Paris), and a Best Poster award at the ESICM Intensive Care Innovation Forum.
📅 Growing our patent portfolio (ongoing)
Our patent portfolio now covers six patent families protecting our core ultrasound and biomarker technologies. We also completed an updated Freedom-to-Operate analysis in June 2026, confirming no blocking issues as we prepare for commercialization.
📅 Contributing to open ultrasound research (ongoing)
We are preparing a curated, de-identified data contribution to OpenH-RF, an open-science initiative led by Stanford University, TU Eindhoven and NVIDIA to build a large-scale open dataset of ultrasound data. Our contribution will help the broader research community while keeping our proprietary biomarker algorithms protected.