Axoft, a neurotechnology company, has announced the approval of its first-in-human clinical study, set to begin in early 2025 at The Panama Clinic. The study will explore the usability of Axoft’s innovative soft materials, which mimic the mechanical properties of brain tissue and are designed to enhance the stability of the tissue-electronics interface in implantable Brain-Computer Interfaces (iBCIs). This groundbreaking study at The Panama Clinic marks the first time a bio-inspired material of this kind has been authorized for use in humans.
Axoft, a neurotechnology company, is set to begin its first-in-human clinical study in early 2025 at The Panama Clinic, marking a significant milestone in the development of implantable Brain-Computer Interfaces (iBCIs). The study will demonstrate the usability of Axoft’s innovative soft materials, designed to mimic the mechanical properties of brain tissue, ensuring a more stable and seamless interface between the brain and electronics. This bio-inspired material is the first of its kind to be authorized for human use, offering a promising solution for patients with chronic neurological disorders.
Dr. Paul Le Floch, co-founder and CEO of Axoft, emphasized the company’s mission to address unmet medical needs through iBCIs. “We believe that by making iBCIs safer and more effective, while also ensuring they’re user-friendly and not overengineered, they can become a scalable solution to help millions of patients suffering from chronic neurological conditions, including paralysis and neuropsychiatric disorders,” said Dr. Le Floch. Existing iBCIs often struggle with long-term functionality due to their rigidity and limited biocompatibility, which hinder their ability to maintain a stable and high-resolution interface with soft biological tissues. Axoft’s brain-like polymer materials, however, are designed to reduce these challenges by offering a more natural integration with brain tissue.
Axoft’s technology is unique in that it allows for a high-resolution neural interface using minimally-invasive surgical techniques. The company’s patent-pending materials and devices stand out for their remarkable properties, including:
- Unmatched Biocompatibility: Axoft’s materials are over 10,000 times softer than the plastic materials used by most iBCI companies and 1 million times softer than silicon. This softness reduces the formation of scar tissue and implant drift within the brain, which is common with traditional materials.
- Long-Term Signal Stability: In animal models, Axoft’s iBCI has already demonstrated the ability to track the electrical activity of single neurons for over a year, showing its potential for long-term use.
- High Bandwidth Interface: The iBCI’s dense array of sensors and stimulators maximizes the amount of information exchanged between the brain and electronics, improving the accuracy and efficiency of communication.
Dr. Ricardo Bermúdez, a neurosurgeon at The Panama Clinic, expressed enthusiasm about Axoft’s approach. “The technology’s minimally-invasive surgical method and ability to be inserted anywhere in the brain allow us to address a wide range of clinical needs,” he said.
The study at The Panama Clinic will include up to five patients who are undergoing brain resection surgery. Participants will be awake during the procedure, allowing for real-time testing of Axoft’s iBCI and the decoding of voluntary brain activity.
Axoft has partnered with bioaccess®, a leading Medtech contract research organization, to facilitate this clinical study. The company grew out of research from Dr. Jia Liu’s Lab of Bioelectronics at Harvard University, and has secured a licensing contract with the institution. Axoft has raised over $18 million in funding to date, including a recent oversubscribed $10.1 million pre-Series A round. The company continues to make significant strides in clinical research, with publications in Nature Nanotechnology and Nature Neuroscience.
About Axoft:
Founded in 2021 and based in Cambridge, Massachusetts, Axoft is pioneering the development of implantable Brain-Computer Interfaces (iBCIs) using bio-inspired materials. The company is focused on creating a seamless interface between the brain and electronics, enabling high-resolution measurement and stimulation across all brain regions. Axoft’s mission is to provide transformative treatments for neurological disorders by addressing critical unmet needs in the field of neurotechnology.
