Ultrasoft 128-channel depth probe from Axoft, tested for about 20 minutes in tissue due for resection in a first-in-human study in 2025. Preprint and company claims; not a chronic implant.
Independent, source-linked catalog sheet. Not a manufacturer-issued datasheet, regulatory decision or instructions for clinical use. Human evidence does not establish approval. Source-specific restrictions, conflicts and missing specifications are retained below.
Axoft Fleuron ultrasoft neural probe
Axoft’s Fleuron probe is an ultrasoft depth electrode that recorded single-neuron activity for about 20 minutes in four patients having tumor tissue removed in Panama. This sheet uses the company release, the ClinicalTrials.gov record and the preprint, so results are company-reported and unreviewed. Dimensions and impedance are Unreported.
Identity
Field
Value and source scope
Device
Axoft Fleuron ultrasoft depth probe (128-channel version used in the first-in-human study) [1][2]
Manufacturer
Axoft, Inc. [1][3]
Interface class
Penetrating depth probe for single-neuron recording and stimulation [1][2]
Origin
Company device; Fleuron is described as a family of ultrasoft, ultra-low-k dielectric materials compatible with thin-film microfabrication [2]
First demonstrated
First-in-human cases in March and April 2025 at The Panama Clinic [1][3]
First human implant
Unreported
Species studied
Human (acute, intraoperative); rodent models up to 18 months per the preprint [1][2]
Regulatory status
Investigational; first-in-human feasibility study (FINESSE, IDEAL Stage 1) [1][3]
Function
Record single neuron signals and field potentials across depths; the preprint also describes bidirectional interfaces [1][2]
Target tissue
Cortical and subcortical tissue scheduled for resection, about 1 cm depth [1]
Geometry and architecture
Field
Value and source scope
Interface type
Depth electrode of ultrasoft thin-film Fleuron material [2]
Array layout
Unreported
Electrode count
128 channels in the first-in-human probes; the preprint reports up to 1,024 sites integrated in a single depth electrode in preclinical work [1][2]
Pitch
Unreported
Electrode lengths
Unreported
Shank width and thickness
Unreported
Tip and exposed site geometry
Unreported
Contact coating
Unreported
Insulation
Unreported
Insertion method
Unreported
Anchoring and fixation
Unreported
Electrode and channel physics
Field
Value and source scope
Exposed site area
Unreported
Electrode material
Unreported
Impedance (with measurement frequency)
Unreported
Noise floor or SNR
Unreported
Recording modality
Unreported
Sampling rate
Unreported
Stimulation capability
Unreported
Charge injection limit
Unreported
Reference and ground
Unreported
Tissue interface and bioresponse
Field
Value and source scope
Target tissue
Unreported
Insertion trauma and BBB disruption
Unreported
Vascular disruption risk
Unreported
Micromotion sensitivity
Unreported
Gliosis and encapsulation
Unreported
Neuron loss near sites
Unreported
Foreign-body response mitigation
Unreported
Typical failure modes
Unreported
System architecture
Field
Value and source scope
Onboard electronics
Unreported
Data path
Unreported
Telemetry bandwidth
Unreported
Sampling rate
Unreported
Power
Unreported
Thermal management
Unreported
Packaging and hermeticity
Unreported
MRI compatibility
Unreported
Surgical complexity
Unreported
Output connectors
Unreported
Performance envelope
Field
Value and source scope
Acute yield
Unreported
Chronic yield
Unreported
Stability over time
Unreported
Longevity
Unreported
Revision and explant experience
Unreported
Adverse events
Unreported
Notable demonstrations
Unreported
Clinical and preclinical evidence
Field
Value and source scope
Human subjects
Four patients undergoing tumor resection per the April 2025 release; ClinicalTrials.gov lists 5 actual enrollment [1][3]
Preclinical cohort
Unreported
Follow-up duration
About 20 minutes of intraoperative recording per patient; the registry status is COMPLETED, start 2025-03-14 [1][3]
Indications
Unreported
Trials and registries
NCT06673264, FINESSE: First-In-Human Trial Using a NovEl Soft Neural Probe, single site (Panama City) [3]
Primary outcomes
Company-reported: safe insertion and explantation at about 1 cm depth, immediate single-neuron recordings without drift correction over the 20-minute window, and detection of a consciousness biomarker under a sensory task. Not peer reviewed (preprint) [1][2]
Key limitations
Acute resection-tissue study only; not a chronic implant in humans. Company and preprint claims; probe dimensions, impedance and material properties were not extracted [1][2]
Engineering tradeoffs
Field
Value and source scope
Strengths
Unreported
Limitations
Unreported
Scaling constraints
Unreported
Version boundary
The 128-channel probe from the first-in-human release. The 1,024-site figure is a preclinical result in the preprint, not the human device.