Axoft, a neurotechnology company, today announced the approval of its first-in-human clinical study, which will take place in early 2025 at The Panama Clinic. The study will demonstrate the usability of Axoft’s 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). Axoft’s study with The Panama Clinic marks the first time this type of bio-inspired material is authorized for human use.
“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.”
Axoft’s technology enables a high-resolution depth neural interface using minimally-invasive surgery techniques. The company’s novel, patent-pending material and device are differentiated by:
- Unmatched Biocompatibility: >10,000x softer than plastic materials used by most iBCI companies (e.g. Polyimide, Parylene C) and >1,000,000x softer than silicon, Axoft’s materials reduce scar tissue and implant drift within the brain over time.
- Long-Term Signal Stability: Axoft has already shown that its iBCI can track the electrical activity of single neurons for over a year in animal models.
- High Bandwidth Interface: With a high density of sensors/stimulators, Axoft’s iBCIs maximize the information that can be exchanged between the brain and electronics.
“It’s exciting to work with a company like Axoft that thought about the properties of the human brain when they designed their implant,” said Dr. Ricardo Bermúdez, a neurosurgeon and investigator at The Panama Clinic. “The technology’s minimally-invasive surgical approach and ability to be inserted anywhere in the brain enables physicians like me to address a wide range of unmet clinical needs.”
With the first patient planned for early 2025, 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.
To enable this study, Axoft partnered with bioaccess, the leading Medtech contract research organization (CRO) that specializes in facilitating medical device clinical research in Latin America.
