Axoft’s CEO Sees Potential For Soft Neural Implant To Help Coma Patients With Signs Of Brain Activity Communicate

Brain computer interfaces (BCI) that allow people who can’t easily move or speak to communicate are increasingly becoming a reality.

Paul Le Floch, co-founder and CEO of Cambridge, MA-based start-up Axoft, has high hopes that its brain-computer interface (BCI) in development will eventually be used to help patients in a coma with signs of brain activity communicate and regain their health. But it’s still early days.

In the coming months, Axoft plans first-in-human studies in up to five patients at the Panama Clinic in Panama, who are undergoing brain tumor resection surgery, evaluate the safety of its device. The study also seeks to demonstrate that the device can be used to decode neural signals while minimizing disruption to the brain, Le Floch told Medtech Insight.

He believes that Axoft’s BCI stands apart from other BCIs in that it’s made of soft materials that mimic the mechanical properties of brain tissue, therefore reducing inflammation and ensuring long-term signal stability while maintaining high resolution and high bandwidth.

If all goes as planned, Axoft will use the data from the Panama Clinic trial to pursue a clinical study at a major hospital in Boston to evaluate the device’s potential for interpreting brain signals in comatose patients with covert consciousness, a state of awareness following severe brain injury or neurological disorder that evades routine beside exams.

Covert Consciousness

Studies have shown that as many as 25% of patients who appear to be in a coma or other unresponsive state show inner signs of awareness when evaluated with advanced brain-imaging methods or monitoring of electrical activity, according to a multinational study assessing disorders of consciousness whose findings were published in August 2024 in the New England Journal of Medicine.

In 2017, covert consciousness was detected in seemingly unaware patients who had just been admitted to the intensive care unit of Massachusetts General Hospital with severe brain injuries, indicating that the covert phenomenon can occur in people who just recently suffered a serious brain injury as well as in patients who have been in a coma for months, according to an article in Scientific American.

“It’s a very recent field, very nascent,” Le Floch said. “It’s only been in the last 10 years that there’s been a lot more research and articles talking about covert consciousness in patients who are in a prolonged coma.”

“It’s a very recent field, very nascent. It’s only been in the last 10 years that there’s been a lot more research and articles talking about covert consciousness in patients who are in a prolonged coma.”

Paul Le Floch, CEO Axoft

To diagnose whether patients are in an “hidden consciousness state” as Le Floch describes the covert phenomenon, doctors record brain reactions with a task-based electroencephalography (EEG) or a functional MRI (fMRI), but both techniques have limitations.

fMRIs require a specialized imaging room and moving an unstable patient. They also only offer a glimpse of patient’s level of consciousness, because the tests evaluate brain activity in response to auditory questions and don’t allow for continuous monitoring. An EEG test can be done more easily at the bedside, but its readings may be altered by resolution, electrical artifacts and changes to the placement of electrodes from one session to another, which is also problematic.

“We realized that there is a great need for BCI in that space, because there is absolutely no treatment, and we don’t really know what to do with the patients that are in a coma for a very long time,” Le Floch said. “One of the goals of the product [in development] will be to interpret essentially what their brain is trying to say or communicate, and to be able to provide a better diagnosis than currently done with functional MRI and eventually guide rehab.”

Le Floch hopes that the company’s BCI technology will eventually be a much more versatile solution than task-based fMRI testing. Provided the US Food and Drug Administration gives Axoft the green light to conduct an early-feasibility study to further evaluate Axoft’s technology in patients with brain injury who are unresponsive but show signs of consciousness, their technology will likely be compared to existing stereo-EEG technology used in epilepsy monitoring, Le Floch said.

Axoft is currently pursuing breakthrough device designation from the FDA. Le Floch anticipates that it will take another two years before the technology may make its way into a pilot study.

Other BCI makers have already tested or implanted their devices in humans.

The forerunner in BCI development, Elon Musk’s Neuralink, claimed just this week that a third person has been implanted with its device; the first patient was paralyzed from a spinal cord injury, the second reportedly also has a spinal cord injury and a third person reportedly has a special device connected to their brain.

Synchron received an FDA breakthrough device designation in 2020 and became the first company to receive an investigational device exemption from the FDA to conduct trials of a permanently implantable BCI in patients. Other companies in this space include Blackrock Neurotech and Inbrain.

“Sometimes the bar for improving quality of life can be very high for BCI devices, because they need to perform better than any other assistive technology that’s available, while for patients in a prolonged coma there is absolutely no solution,” Le Floch explained. “If we can just understand if the patient can say yes or no, it’s a massive difference in the way we can treat a patient and potentially improve their state – the bar is lower, but the stakes are very high.”

Founded in 2021, Axoft was spun out of Jia Liu’s Lab of Electronics at Harvard University. Liu was Le Floch’s advisor while he was pursuing a doctorate in mechanical engineering and material sciences at Harvard. Le Floch received the Forbes 30 under 30 distinction for science in 2022. To date, Axoft has raised around $18m in funding, he said.

He explained that the brain regions that show signs of consciousness are not always the same in patients who suffered from a traumatic brain injury. These regions are not necessarily on the surface of the brain, so it’s important to design the BCI in a way that allows its depth to vary so it can interface with these regions. The Axoft implant is soft and can package a large number of sensors located along the length of the implant, which allows for capturing relevant signals in the context of detecting covert consciousness, he said.

“Sometimes one patient’s [BCI] might be very superficial for communication, sometimes it’s a bit deeper – we can test various behavioral paradigms of consciousness by being able to probe deeper brain regions,” he said.

The implantation requires a minimally invasive surgery and involves drilling a small opening into the skull to access the target brain area. Then tiny electrodes are threaded into the target area. The implant is then connected to an external recording device to analyze the brain data. Ultimately, Le Floch believes that its technology may not only have applications to help “unlock access” to parts of the brain that are still healthy and functional in patients with covert phenomenon and help them communicate, but also for rehabilitation.

“The idea of neuropsychologists and neurologists is that by having this neurofeedback available with the device, we can also use that in the future to guide rehabilitation training and help them recover toward being conscious again,” Le Floch said. “First we want to use the device for continuous and precise diagnostics and establish communication with patients that have covert consciousness.”