Axoft Successfully Completes First Four Cases of First-in-Human Clinical Study of its Ultrasoft, High-Density Brain-Computer Interface

Axoft, a neurotechnology company, today announced preliminary results from its first-in-human clinical study, FINESSE, which began just two and a half years after the company’s seed funding round and was designed to show that Axoft’s implantable brain computer interfaces (iBCIs) can safely decode brain signals. The iBCIs in the study are made using Axoft’s novel Fleuron™ material, which is 10,000x softer than the polyimide used in existing iBCIs, offers superior biocompatibility, and significantly reduces tissue scarring and lead migration over time. In addition to the study results, Axoft announced a new research article that demonstrates how Fleuron can improve iBCI bandwidth, stability and access to deep brain regions in clinical settings.

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<>Clinical Applications and Results
“Axoft’s device has the potential to revolutionize how we collect neural data,” said Dr. Ricardo Bermúdez, Brain and Spine Senior Neurosurgeon at The Panama Clinic and Principal Investigator on the FINESSE study. “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.”

In March and April, neurosurgeons at The Panama Clinic implanted Axoft’s iBCIs into four patients undergoing brain tumor resection and reliably 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, which required either anesthetized or awake surgery. Result highlights from the study include:

• Fleuron probes can be safely implanted and explanted from cortical and subcortical tissues at ~1 cm depth, with sensors to measure single neuron signals from cortical layers and grey matter tracks, and using standard tools for functional neurosurgery.
• Fleuron probes can immediately record high-density single neuron information and field potentials across different depths from the brain, without the need for drift correction.
• The neural data measured by Fleuron probes is stable over the duration of implantation (20 minutes), and the signal does not drift at the single neuron resolution, due to the softness of the implant.
• Axoft Fleuron probes were able to detect a biomarker of consciousness under a sensory stimulus task.

“Axoft is redefining what’s possible with implantable brain-computer interfaces,” said Charles P. Couturier, MD, PhD, Neurosurgeon at the Montreal Neurological Institute and Assistant Professor at McGill University. “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. 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. This technology has the potential to transform how we study the brain and how we diagnose and treat neurological disease.”

<>Pre-Print Research Paper Highlights
Titled “Clinical translation of ultrasoft neural probes for stable, high-density and tissue-wide bidirectional brain interfaces,” Axoft’s April 2025 preprint research article outlines how:

• Fleuron can be integrated in an iBCI.
• 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 128ch and cover 8x more brain tissue compared to conventional probes.
• Fleuron can be deployed in large animal models and in-human studies.

“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,” said Dr. Paul Le Floch, co-founder and CEO of Axoft. “Our first-in-human study and related research article offer 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.”

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.

About Axoft
Founded in 2021 and headquartered in Cambridge, Massachusetts, Axoft is building implantable Brain-Computer Interfaces (iBCIs) leveraging bio-inspired materials to enable a seamless interface between the brain and electronics, and allow for measurement and stimulation at high-resolution in any brain region. Axoft is on a mission to unlock new treatments for patients suffering from neurological disorders by producing iBCIs that answer critical unmet needs. For more information, visit www.axoft.us or follow us on LinkedIn.

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