Axoft spun out from Harvard University in 2021. Image credit: Dragon Claws via Getty.

Axoft has received approval from the Ministry of Health of Panama and the Panama Clinic’s Ethics Committee to conduct a first-in-human study of its novel soft materials that mimic the mechanical properties of brain tissue and are tailored to improve the stability of the tissue-electronics interface for implantable brain-computer interfaces (iBCIs).

According to the neurotechnology company, the trial (NCT06673264) is to demonstrate the viability of the soft materials used in its iBCI. It also marks the first time in which bio-inspired material of the sort it has developed has been authorised for use in humans.

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The overall goal of the interventional study is to assess whether Axoft’s iBCI can be used in human brain tissue, with the main determinates being to gauge if there are any problems when inserting the soft neural probe into brain tissue, and whether it can record electrical signals from the brain tissue – as per the trial’s study plan.

Taking place at The Panama Clinic hospital in Panama City in early 2025, the trial has enrolled five patients who are already scheduled for brain tumour or epileptic tissue removal surgery. During these procedures, patients will remain awake during the testing of Axoft’s iBCI as it is inserted into the section of patients’ brain tissue that is due to be removed, to enable the decoding of volitional brain activity.

In developing the soft material, Axoft said its overall mission is to answer unmet medical needs with iBCIs. By making them safer and more effective while ensuring they remain user-friendly, it hopes they may become a scalable solution in providing relief to millions of people suffering from chronic neurological disorders, including conditions that cause paralysis, and for emerging indications in neuropsychiatry.

Axoft co-founder and CEO Dr Paul Le Floch commented: “Due to their rigidity and limited biocompatibility, many existing iBCIs fail to achieve a stable and high-resolution interface with soft biological tissues over the long term when implanted in the brain.

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“Axoft’s brain-like polymer materials enable a seamless and stable interface with deep brain tissues. With this early feasibility study, we will generate initial safety data and demonstrate that Axoft’s iBCI can be used to decode neural signals in humans while minimising disruption to the brain and integrating with existing surgical workflows.”

Massachusetts, US-based Axoft was founded in 2021, spinning out of research from Dr Jia Liu’s Lab of Bioelectronics at Harvard University. In the same year, Dr Le Floch received the Forbes 30 under 30 distinction for science. To date, the company has raised around $18m in funding.

Editor’s note: This article was updated December 20 to correct the approving authority from the US Food & Drug Administration, to the Ministry of Health of Panama.