CAMBRIDGE, Mass. — Neurotechnology company Axoft has successfully completed the first four procedures in its first-in-human clinical trial, marking a key milestone for its innovative brain-computer interface (BCI) technology. The early results from the FINESSE study highlight the safety and functionality of Axoft’s implantable BCI, made with its proprietary Fleuron™ material, which is designed to improve biocompatibility and signal stability in brain implants.
The trial, which began just two and a half years after Axoft’s seed funding round, is evaluating the company’s new approach to decoding brain signals. Unlike traditional rigid electrodes, Axoft’s Fleuron material is approximately 10,000 times softer than polyimide, allowing for better integration with brain tissue and reducing long-term complications such as scarring and lead migration.
In March and April, neurosurgeons at The Panama Clinic implanted Axoft’s BCI devices into four patients undergoing brain tumor surgeries. The implants, placed in regions associated with motor planning and visual processing, recorded 20 minutes of brain activity across various cortical layers and subcortical regions. The surgeries required both anesthetized and awake patients, depending on the tumor’s location.
The results demonstrated that the Fleuron probes could be safely implanted and removed from brain tissue at depths of approximately one centimeter. These probes successfully captured high-density signals from individual neurons and field potentials without the need for signal drift correction. Notably, Axoft’s technology detected biomarkers of consciousness during sensory stimulation tasks, showcasing its potential for future neurological applications.
Dr. Ricardo Bermúdez, senior neurosurgeon at The Panama Clinic and principal investigator of the trial, praised the minimal disruption caused by the implants and the high quality of the neural data collected. “Axoft’s device represents a leap forward compared to the rigid electrodes we currently use,” he said.
The trial’s outcomes are supported by new research published by Axoft, which details how the Fleuron material enhances bandwidth, stability, and access to deeper brain regions. The preprint article, titled “Clinical translation of ultrasoft neural probes for stable, high-density and tissue-wide bidirectional brain interfaces,” outlines the device’s ability to scale up to 1,024 sensors on a single lead and reduce scar tissue formation in animal studies. The research further demonstrated that the probes could achieve stable, high-density single-neuron recordings over larger areas of brain tissue compared to conventional electrodes.
Dr. Charles P. Couturier, neurosurgeon at the Montreal Neurological Institute and assistant professor at McGill University, noted the significance of these findings. “For decades, we believed implants needed to be rigid and thin to record from individual brain cells,” he said. “Axoft’s soft, flexible Fleuron material moves with the brain’s natural pulsations, providing unprecedented stability and access to deep brain regions.”
Axoft’s CEO and co-founder, Dr. Paul Le Floch, emphasized the importance of the company’s proprietary material in advancing BCI technology. “We’re the only BCI company to invent its own bio-inspired material to improve implant safety and performance,” he said. “Our first-in-human study and supporting research show the potential of Fleuron probes to create stable, high-density interfaces with multiple brain regions, which could transform care for patients with neurological disorders.”
The company plans to continue its collaboration with The Panama Clinic to complete the current trial and prepare for a second study featuring an enhanced version of its BCI system. Axoft’s technology and research have also been highlighted in publications such as Nature Nanotechnology and IEEE Xplore, reflecting the growing interest in its novel approach to brain-computer interfaces.
