Periodic Reporting for period 1 - EGNITE (Engineering Graphene for developing Neural Interfaces to revolutionize how we treat neurological diseases)
Reporting period: 2023-05-01 to 2024-04-30
Neurological disorders impact over a billion individuals worldwide, with 25-35% of patients unresponsive to traditional pharmacological treatments, leaving them with limited options. Neuroelectronic therapies have emerged as a promising alternative, focusing on decoding & modulating neural activity to restore function. However, current neuroelectronic implants, typically made of metals like platinum & iridium, have significant limitations, including poor resolution, low specificity & high invasiveness.
INBRAIN (www.inbrain-neuroelectronics.com) is advancing graphene semiconductor technology to develop implantable precision brain-computer interface (BCI) neurotherapies at scale. Graphene offers unmatched signal resolution & micrometric precision, enabling the detection of patient-specific biomarkers & triggering adaptive responses for improved outcomes in personalized neurological therapies.
INBRAIN is developing a platform from 2 iterative products:
1. High Resolution Acute Cortical Interface: This product is designed for brain decoding and mapping in resection procedures & BCI applications. It aims to safely map & decode functional & non-functional signals, guiding precise resection procedures while preserving vital areas related to language & cognition amongst others.
2. BCI Therapeutics Platform: This platform is intended for applications such as Parkinson’s disease, epilepsy, & translating thought to speech in severely impaired patients.
INBRAIN (www.inbrain-neuroelectronics.com) is advancing graphene semiconductor technology to develop implantable precision brain-computer interface (BCI) neurotherapies at scale. Graphene offers unmatched signal resolution & micrometric precision, enabling the detection of patient-specific biomarkers & triggering adaptive responses for improved outcomes in personalized neurological therapies.
INBRAIN is developing a platform from 2 iterative products:
1. High Resolution Acute Cortical Interface: This product is designed for brain decoding and mapping in resection procedures & BCI applications. It aims to safely map & decode functional & non-functional signals, guiding precise resection procedures while preserving vital areas related to language & cognition amongst others.
2. BCI Therapeutics Platform: This platform is intended for applications such as Parkinson’s disease, epilepsy, & translating thought to speech in severely impaired patients.
The High Resolution Acute Cortical Interface, part of EGNITE project, has undergone extensive pre-clinical testing following EU & US regulatory standards. A key study, conducted under Good Laboratory Practice, confirmed the safety of this graphene interface under conditions similar to those anticipated for first-in-human (FIH) applications. Additionally, comprehensive biological evaluations in compliance with ISO 10993-1: 2018 has been performed in collaboration with NAMSA, a reputable testing laboratory.
With positive results from these tests, MHRA has granted regulatory approval for a FIH study in Manchester. Insights from this study are being integrated into design iterations aimed at producing a high-density interface superior to metal-based alternatives with a focus on usability, reliability, cost-effectiveness & scalable manufacturing. The goal is to secure commercial use approval in US via the 510k pathway.
With positive results from these tests, MHRA has granted regulatory approval for a FIH study in Manchester. Insights from this study are being integrated into design iterations aimed at producing a high-density interface superior to metal-based alternatives with a focus on usability, reliability, cost-effectiveness & scalable manufacturing. The goal is to secure commercial use approval in US via the 510k pathway.
To further assess BCI capabilities, INBRAIN collaborates with clinical & academic partners to utilize this graphene-based cortical interface in its approved configuration. The aim is to evaluate the decoding of central brain functions, such as movement & speech production. Integrating this technology into our implantable BCI therapeutics platform paves the way for a new treatment paradigm, enabling real-time, precision therapeutics for both central & peripheral nerve applications.