The pipeline.
One platform, three regulatory tracks, one indication today, energy-agnostic by design.
The device presented is under preclinical/clinical investigation. It is not FDA approved nor CE labelled.
| Asset | Indication | Pre-clinical | FIM / IDE | Regulatory | Commercial |
|---|---|---|---|---|---|
| Clinical AI Engine M1 / M2 / M3 / M4 |
Cardiac ablation guidance (RF + PFA) | Complete | FIM published | FDA pre-submission programme active | Post-clearance |
| PS-OCR dual-energy Catheter | Atrial fibrillation, paroxysmal & persistent | Complete | FIM complete • IDE in development | PMA path | Dates under NDA |
| Guidance Layer OEM Licence | Third-party RF and PFA ablation platforms | Validated | Partner-led pilots planned post-AI-clearance | Partner pathways | Begins post AI Engine clearance |
| Future indications | Ventricular tachycardia, atypical flutter, scar mapping | Exploratory | — | — | — |
First-in-human published
100% specificity for durable PFA at three-month follow-up in the FIM cohort. Peer-reviewed in Europace, February 2025. No hemolysis, no neurovascular complications.
FDA pre-submission programme
Clinical AI Engine under active FDA pre-submission, with a Predetermined Change Control Plan drafted against FDA 2024 final guidance. Submission and clearance dates depend on regulator feedback.
IDE → PMA
Pivotal study supports the integrated catheter system. PMA pathway. Dated milestones are shared with qualified partners under NDA.
Timelines reflect current management expectations and are subject to clinical, regulatory, and operational risks. Full milestone detail and gating dependencies available under NDA. See /investors.