Application — Intracortical
Axoft FINESSE first-in-human soft neural probe study (NCT06673264)
Lab or organization
Axoft FINESSE first-in-human study (NCT06673264)
The registered first-in-human study of Axoft’s Fleuron ultrasoft neural probe, a sub-acute feasibility study in patients already scheduled for brain tumor or epileptic-tissue resection. Registry facts are from ClinicalTrials.gov (verified October 27, 2026); result claims are company-reported or from a preprint that has not been peer reviewed, and are labeled as such.
Study facts
| Field | Value and source scope |
|---|---|
| Registry | NCT06673264; interventional, single-group, device feasibility, no masking [1] |
| Official title | FINESSE: First-In-Human Trial Using a NovEl Soft Neural Probe: an IDEAL StagE 1 Study [1] |
| Sponsor and site | Axoft, Inc.; Centro de Vacunación e Investigación SA (CEVAXIN) - The Panama Clinic, Panama City, Panama [1] |
| Status | Completed: actual start March 14, 2025, actual completion August 21, 2025 (primary completion the same date) [1] |
| Enrollment | 5 (actual) [1]; company-reported: first four cases completed in March and April 2025 [2] |
| Procedure | Sub-acute insertion of the soft neural probe into the section of brain tissue due to be removed, during the scheduled resection; 30-day follow-up visit [1] |
| Primary outcome | Feasibility assessed by adverse events from surgery to the 30-day follow-up [1] |
| Secondary outcomes | Feasibility assessed by use (average Net Promoter Score, first 20 minutes); local tissue-effect biocompatibility by histopathology of the insertion track (H&E stained area of affected tissue, within 3 months of resection) [1] |
| Company-reported results | Probes implanted and explanted at about 1 cm depth in cortical and subcortical tissue using standard functional-neurosurgery tools; about 20 minutes of recording per case across cortical layers and subcortical regions; single-neuron signals and field potentials recorded without drift correction, stable over the implantation period; a biomarker of consciousness detected under a sensory stimulus task [2] |
| Material claims | Fleuron described as 10,000 times softer than the polyimide used in existing implantable BCIs (company claim) [2]; up to 1,024 recording sites in a single minimally-invasive depth probe (preprint claim) [3] |
| Publication status | medRxiv preprint posted April 25, 2025; PubMed notes it has not been peer reviewed by a journal [3] |
Primary sources
- ClinicalTrials.gov, NCT06673264. Verified October 27, 2026.
- Axoft completes first four FINESSE cases, Business Wire, April 22, 2025. Company press release.
- Le Floch, Ye et al., Clinical translation of ultrasoft Fleuron probes for stable, high-density, and bidirectional brain interfaces, medRxiv 2025.04.24.25326126. Preprint, not peer reviewed.