Axoft Gains Panamanian Approval to Study its Soft Neural Implants

Panama’s Ministry of Health and the Panama Clinic’s Ethics Committee has approved Axoft’s first-in-human clinical 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). 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,” Axoft Co-Founder/CEO Dr. Paul Le Floch said. “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:

• Biocompatibility: More than 10,000 times softer than plastic materials used by most iBCI companies (e.g. Polyimide, Parylene C) and more than 1 million times 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 more than 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.”

Axoft’s study at The Panama Clinic will include up to five patients undergoing existing brain resection surgery. Study participants will be awake during Axoft’s iBCI testing, allowing for volitional brain activity decoding.

Axoft partnered with medtech contract research organization bioaccess to execute the study. bioaccess specializes in facilitating Latin American medical device clinical research.

Axoft resulted from research conducted by Dr. Jia Liu’s Lab of Bioelectronics at Harvard University, and the company has secured a licensing contract with the institution. Last year, Axoft published papers outlining the capabilities of its novel brain implant technology in Nature Nanotechnology and Nature Neuroscience, and in 2021 Dr. Le Floch received the Forbes 30 under 30 distinction for Science. The company’s continued momentum and clinical translation has led to an oversubscribed $10.1 million pre-Series A round from both new and existing investors. To date, Axoft has raised more than $18 million in funding.

Founded in 2021 and headquartered in Cambridge, Mass., Axoft is building implantable iBCIs that leverage bio-inspired materials to enable a seamless interface between the brain and electronics, and allow for measurement and stimulation at high-resolution in any brain region. Axoft aims to unlock new treatments for patients suffering from neurological disorders by producing iBCIs that answer critical unmet needs.