Axoft announced today that it received approval to conduct a first-in-human study for its novel soft materials for brain-computer interfaces (BCIs).
Cambridge, Massachusetts–based Axoft develops soft materials that mimic the mechanical properties of brain tissue. It tailors them to improve the stability of the tissue-electronics interface for implantable BCIs (iBCIs). BCIs remain a hot space, with analysts recently suggesting the market opportunity could reach $400 billion in the coming years. Axoft has raised $18 million itself to date to support its patent-pending material.
The company plans to evaluate its technology at The Panama Clinic in early 2025. It says this marks the first human use of this type of bio-inspired material.
With the first patient planned for early February, Axoft’s study at The Panama Clinic will include up to five patients undergoing existing brain resection surgery. Study participants will be awake during the testing of Axoft’s iBCI, allowing for the decoding of volitional brain activity.
More about the Axoft technology
Axoft designed its technology to enable a high-resolution depth neural interface using minimally invasive surgery techniques. It has significant biocompatibility and softness to reduce scar tissue and implant drift within the brain over time. The material has long-term signal stability, too, tracking 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.
“Our mission is to answer unmet medical needs with iBCIs. We believe that by making iBCIs safer and more effective, while also ensuring they’re user-friendly and not-overengineered, they will become a scalable solution to help millions of patients suffering from chronic neurological disorders. This includes conditions causing paralysis and for emerging indications in neuropsychiatry,” said Dr. Paul Le Floch, co-founder and CEO of Axoft. “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. 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 minimizing disruption to the brain and integrating with existing surgical workflows.”
