After publishing encouraging preliminary results of its brain-computer interface (BCI) technology in first-in-human trials, Axoft today announced plans to sell its BCI-enabling materials to researchers and private organizations for R&D uses.
Paul Le Floch, co-founder and CEO of Cambridge, MA-based neurotechnology company Axoft, told Medtech Insight that Axoft’s Fleuron material can be used for a wide range of applications amid its unique properties. Fleuron is 10,000 times softer than the polyimide used in existing BCIs, and Le Floch believes, will enable the development of a new class of BCI that is safer, more conformal and longer-lasting in the brain. But the materials can also be used beyond BCI applications.
“We have customers who are using this in making their own electrodes for all types of measurements in the body, we have customers that are using it in microfluidics or in organ-on-a-chip [and neural interfaces],” Le Floch explained. He added that in addition to selling Fleuron directly, Axoft plans to also work with partners to help them integrate Fleuron into their systems or build their own products, including BCIs.
Key Takeaways
- Axoft is now selling its Fleuron material, which it claims is 10,000 times softer than existing BCI substrates, for use in R&D.
- Preliminary human trial results in Panama show Fleuron-enabled probes can be safely implanted and detect neural biomarkers related to consciousness.
- Axoft plans to develop its own soft-BCI to help coma patients with covert consciousness.
Besides generating revenue, he said, “this helps us generate some rapid iteration and feedback on the material to keep improving it and keep developing better materials for BCI, because it doesn’t stop at the first version of Fleuron. The more we commercialize, the more we learn about what customers need, we can keep developing materials that are really adapted to interface with the body in general.”
Axoft is developing a soft-BCI device to help coma patients with covert consciousness – or patients that appear unconscious and unresponsive but show signs of awareness through detectable brain activity – communicate.
Last month, the company announced preliminary results of its first-in-human study where neurosurgeons at the Panama Clinic in Panama implanted Axoft’s device in four patients undergoing brain tumor resection.
The study showed that Axoft’s Fleuron probes could be safely implanted and explanted from the cortical and subcortical tissues at less than 1 centimeter of depth and reliably record 20 minutes of brain activity.
In addition, the study showed that the Fleuron probes were also able to detect a biomarker of consciousness under a sensory stimulus task using a standard auditory task to elicit brain responses characteristic of conscious states. The results showed that the BCI can accurately distinguish between awake and anesthetized patients based on neural activity, Le Floch said.
Axoft’s BCI received breakthrough device designation from the US Food and Drug Administration in 2022. Le Floch will now work with the agency on an investigational device exemption to evaluate the device in patients with disorders of consciousness. He estimates that Axoft may be able to start a feasibility study in 2027.
Axoft also announced on 14 May that it has secured an exclusive licensing agreement with Stanford University to commercialize the implant for R&D applications. Axoft co-founder and scientific advisor Jia Liu started developing Fleuron during his postdoctoral studies at Stanford University before joining Le Floch at Harvard University to scale the technology for a wide range of bioelectronics applications. Both universities are using Fleuron for their own research and Le Floch believes that the broader research and industry stand to benefit from Fleuron as it has the potential to become a new standard in biomedical engineering.
Other companies that have already tested or implanted their devices in humans include Elon Musk’s Neuralink, Synchron, Inbrain and Blackrock Neurotech. Synchron, which received FDA breakthrough device designation in 2020, became the first company to receive an investigational device exemption from the FDA to conduct trials of a permanently implantable BCI in patients. The company also made headlines yesterday with the announcement that it will be the first BCI company to achieve native integration with a new BCI Human Interface Device (BCI HID) profile with its partner Apple. This will eventually enable people to control their Apple devices with neural signals captured by BCIs.
Le Floch, however, believes that Axoft’s technology platform will usher in a new era for BCI development because of its focus on biocompatibility, soft materials and a minimally invasive implant location.
While both Synchron and Neuralink developed BCIs for people who are paralyzed due to neurological diseases, their approaches differ. Synchron’s Stentrode is inserted into a blood vessel and positioned near the motor cortex, while Neuralink’s BCI penetrates the brain and requires robotic craniotomy.
“If Axoft succeeds at developing the next generation of materials for BCI, a lot of companies will have to move to new materials to make their BCI,” Le Floch predicts.