Neurotechnology company Axoft has announced promising preliminary results from its first-in-human clinical study of an ultrasoft, high-density brain-computer interface. The FINESSE study, which began just two and a half years after the company's seed funding round, successfully demonstrated that Axoft's implantable brain-computer interfaces (iBCIs) can safely decode brain signals in human patients.
The breakthrough technology utilizes Axoft's novel Fleuron™ material, which is 10,000 times softer than the polyimide used in existing iBCIs. This revolutionary material offers superior biocompatibility and significantly reduces tissue scarring and lead migration over time—addressing key limitations of conventional rigid neural implants.
Clinical Study Results Show Promising Outcomes
In March and April 2025, neurosurgeons at The Panama Clinic implanted Axoft's iBCIs into four patients undergoing brain tumor resection. The devices successfully recorded 20 minutes of brain activity through different cortical layers and subcortical regions. The patients' tumors were localized in brain regions involved in various cognitive processes, including motor planning and visual processing, requiring either anesthetized or awake surgery.
Dr. Ricardo Bermúdez, Brain and Spine Senior Neurosurgeon at The Panama Clinic and Principal Investigator on the FINESSE study, expressed enthusiasm about the technology's potential: "Axoft's device has the potential to revolutionize how we collect neural data. I was impressed by the minimal disruption caused to the brain tissues and the quality of data that was captured. It is a leapfrog technology compared to existing rigid electrodes that we use in monitoring and functional neurosurgery."
Key findings from the study include:
-
Fleuron probes can be safely implanted and explanted from cortical and subcortical tissues at approximately 1 cm depth, with sensors capable of measuring single neuron signals from cortical layers and grey matter tracks using standard tools for functional neurosurgery.
-
The probes can immediately record high-density single neuron information and field potentials across different depths from the brain, without requiring drift correction.
-
Neural data measured by Fleuron probes remained stable throughout the 20-minute implantation period, with no signal drift at the single neuron resolution—a benefit attributed to the softness of the implant.
-
The Axoft Fleuron probes successfully detected a biomarker of consciousness during a sensory stimulus task.
Technical Advantages Over Conventional Neural Interfaces
Dr. Charles P. Couturier, Neurosurgeon at the Montreal Neurological Institute and Assistant Professor at McGill University, highlighted how Axoft's technology challenges long-standing assumptions in the field: "For decades, researchers believed implants needed to be extremely thin—due to their rigidity—to reliably record signals from individual brain cells. This study challenges that long-standing assumption."
He added, "Axoft's Fleuron material is soft and flexible, allowing it to move with the brain's natural pulsations. That unique property leads to more stable recordings, improved access to deeper brain regions, and significantly enhanced bandwidth. It's the first time I've seen an implant that truly matches the brain's softness and its movement, and we can observe that stability in the electrophysiological recordings."
Research Demonstrates Broader Applications
Alongside the clinical study results, Axoft announced a new research article titled "Clinical translation of ultrasoft neural probes for stable, high-density and tissue-wide bidirectional brain interfaces." The April 2025 preprint outlines several important capabilities of the Fleuron technology:
- The bandwidth of Axoft iBCIs can be scaled up to 1,024 sensors on a single lead.
- Fleuron creates less scar tissue than polyimide at 3, 6, and 9 months after implantation in animal brains.
- Repeatable, stable, high-density, single-neuron interfaces can be achieved with Fleuron probes that have 128 channels and cover 8 times more brain tissue compared to conventional probes.
- The technology can be successfully deployed in large animal models and human studies.
Potential Impact on Neurological Disorders
Dr. Paul Le Floch, co-founder and CEO of Axoft, emphasized the company's unique approach: "Axoft is the only iBCI company to invent its own bio-inspired material to improve implant safety and efficacy, which is a testament to our commitment to addressing existing bottlenecks and accelerating the impact of iBCIs for both patients and physicians."
The technology shows particular promise for disorders of consciousness, with Dr. Le Floch noting that their research offers "promising results on the ability of our Fleuron probes to create stable and high-density interfaces with various brain regions, and how we might revolutionize the standard of care for prognosis and communication in disorders of consciousness."
Future Directions
Founded in 2021 and headquartered in Cambridge, Massachusetts, Axoft is building implantable Brain-Computer Interfaces leveraging bio-inspired materials to enable a seamless interface between the brain and electronics. The company aims to allow for measurement and stimulation at high resolution in any brain region.
In addition to the recent preprint, Axoft and its Fleuron material have been featured in research published in Nature Nanotechnology and IEEE Xplore. In the coming months, Axoft will continue its collaboration with The Panama Clinic to conclude its first-in-human study and prepare for a second study with a more advanced version of its iBCI.
The company's mission focuses on unlocking new treatments for patients suffering from neurological disorders by producing iBCIs that address critical unmet needs in the field of neurotechnology.
