Product 1 that is part of EGNITE's project targets the development of graphene-based cortical brain interfaces. This acute application is the safest and quickest way to bring graphene to market for the first time ever and consolidate graphene as the Neurotechnology material of the future. During the de-risking phase, the cortical interface was developed at first for use in pre-clinical large animal studies and subsequently, in a first-in-human setting. Three large animal studies have been executed so far. The first study evaluated the ability to record brain signals with micro graphene electrodes in a human relevant model. This was achieved using a Gen I of the cortical interface. Later the design was updated, and the fabrication performed according to the new industrial processes developed at INBRAIN. The novel design aimed for use in humans has been further tested and de-risked using the same intraoperative animal model. These two latest studies confirmed the superiority of graphene vs current metal electrodes in signal quality and high-density resolution to map brain signals. The latest study was a Good Laboratory Practice (GLP) safety study that demonstrated the safe recording and stimulation of brain signals using the developed interface according to its intended use and to the first in human study. In the meantime, we have also been advancing with the industrialization of our technology exploring different encapsulation strategies and transferring from the 4-inch to the 6-inch wafers.
The current cortical interface allows interconnection to existing CE Marked medical grade electrophysiology equipment, is proven to be biocompatible, sterile, and safe to be used in human surgeries. Activities have been carried out to achieve the MHRA regulatory approval to conduct the first-in human (FIH) study.
After the FIH study, the learnings will be incorporated into the design iteration and will deliver an interface for commercial use. This interface will be validated with further preclinical evaluations, and afterwards submitted to the FDA for commercialization into the US market. A 510k route (predicate use, no need for clinical studies) has been discussed already with the FDA. This design iteration will focus on usability, reliability, cost of goods and setting up the manufacturing of the product for commercial numbers.
