The company received approval to conduct the first-in-human studies at the end of 2024. It launched the FINESSE study just two and a half years after its seed funding round, according to a news release.
Cambridge, Massachusetts–based Axoft designed the study to show that its iBCIs, using its novel Fleuron material, can safely decode brain signals. Fleuron, which is 10,000 times softer than the polyimide material used in existing iBCIs, the company says, offering superior biocompatibility while reducing tissue scarring and lead migration over time.
Axoft designed its technology to enable a high-resolution depth neural interface using minimally invasive surgery techniques. The material also exhibits long-term signal stability, as it has been used to track the electrical activity of single neurons for over a year in animal models. Additionally, Axoft touts a high density of sensors and stimulators, maximizing the information exchanged between the brain and electronics.
In addition to the study results, Axoft also announced new research demonstrating the benefits of the Fleuron material. Findings show how it can improve iBCI bandwidth, stability, and access to deep brain regions in clinical settings, according to the company.
“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.”
More about the Axoft study findings
Axoft said that, in March and April, neurosurgeons at The Panama Clinic implanted its iBCIs into four patients. These patients, undergoing brain tumor resection, had 20 minutes of brain activity recorded through different cortical layers and subcortical regions. The tumors were located in brain regions involved in various cognitive processes. Those include motor planning and visual processing, which required either anesthetized or awake surgery.
According to the company, the study found that Fleuron probes can be safely implanted and explanted from cortical and subcortical tissues at approximately 1 cm depth. This includes working with sensors to measure single-neuron signals from cortical layers and gray matter tracts. It also involves using standard tools for functional neurosurgery.
Fleuron probes demonstrated the ability to immediately record high-density single-neuron information and field potentials across various depths, according to Axoft. They also demonstrated this without needing drift correction.
Axoft reported stable neural data over the 20-minute duration of implantation. The signal doesn’t drift at the single-neuron resolution due to the softness of the implant. Probes can also detect sensory neural signals responding to the oddball paradigm, the company says. In this experiment, a deviant stimuli interrupts a sequence of repeated stimuli. Additionally, Fleuron probes proved successful in detecting a biomarker of consciousness under a sensory stimulus task.
Additional research paper findings
Separately, the research paper highlighted the ability to integrate Fleuron into an iBCI. Axoft says its iBCI bandwidth can scale up to 1,024 sensors on a single lead. Fleuron created less scar tissue than polyimide at three, six and nine months after implantations in animal brains, the company said.
Axoft says Fleuron probes can deliver repeatable, stable, high-density, single-neuron interfaces at 128ch while covering eight times more brain tissue compared to conventional probes. Fleuron proved capable of deployment in large anical models and in-human studies.
Next, Axoft plans to continue working with The Panama Clinic to conclude the first-in-human study. Then, it aims to prepare for a second study with a more advanced version of its iBCI.
“Axoft is the only iBCI company that is also an inventor of a bio-inspired material, 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 a stable and high-density interface with various brain regions, and how we might revolutionize the standard of care for prognosis and communication in disorders of consciousness.”
