Periodic Reporting for period 1 - GphT-BCI (Graphene Transistors for High-Density Brain-Computer Interfaces)
Periodo di rendicontazione: 2023-12-01 al 2024-11-30
Brain-computer interfaces (BCIs) are moving from research to commercial use, with significant excitement and a projected market size of €5.25B by 2030. However, a comprehensive technology platform for accurate and scalable BCIs is missing. Current methods using passive metal electrodes are invasive and limited in resolution and bandwidth. Our novel graphene-based transistors (GphT) overcome these issues, offering high resolution, multiplexing, and wide frequency sensitivity with minimal invasiveness. Developed under the FET-Graphene Flagship and BrainCom projects, this technology has shown exceptional performance in animal tests. The GphT-BCI project aims to scale up production, develop compliant electronics, and create a functional prototype for clinical trials.
After the EIC Transition project, we'll apply for the EIC Accelerator (2026-2028) to bridge the market gap and prepare for commercial scale-up. Objectives include developing compliant microfabrication processes, designing and validating medical electronics, integrating technology into a functional prototype, creating data management software, validating safety and functionality in large animals, preparing a clinical investigation plan, updating the business model, and protecting IP.
In terms of expected impact, the GphT-BCI project aims to advance brain signal decoding, improve neurosurgical precision, and enable innovative neuromodulation therapies. It seeks to transform the BCI market, reduce healthcare costs, and drive comercialization and job creation. The project will enhance patient quality of life, make advanced medical technology more accessible, and support disabled individuals.
After the EIC Transition project, we'll apply for the EIC Accelerator (2026-2028) to bridge the market gap and prepare for commercial scale-up. Objectives include developing compliant microfabrication processes, designing and validating medical electronics, integrating technology into a functional prototype, creating data management software, validating safety and functionality in large animals, preparing a clinical investigation plan, updating the business model, and protecting IP.
In terms of expected impact, the GphT-BCI project aims to advance brain signal decoding, improve neurosurgical precision, and enable innovative neuromodulation therapies. It seeks to transform the BCI market, reduce healthcare costs, and drive comercialization and job creation. The project will enhance patient quality of life, make advanced medical technology more accessible, and support disabled individuals.
During Period 1, significant progress was made in advancing the technology to industry standards. Rigorous quality control measures were established, ensuring process reliability, and achieving a high device yield of approximately 95% on 100 mm wafers. The upscaling to 150 mm wafers was accomplished with positive initial results in standardization. The read-out electronics requirements were defined, and a high-level system architecture design was constructed, identifying main system elements and initiating interface definitions. The ASICv1 tapeout is scheduled for March 24th, capable of driving 16 columns and reading out 8 rows, with modular design allowing parallel operation. General system requirements were successfully defined, and system and interface specifications were drafted. Preliminary considerations for integrating preclinical/clinical prototypes within the INBRAIN ecosystem were made. Test applications for data transmission and demodulation were developed and validated, with plans to integrate components into an OpenEphys plug-in for real-time data visualization. A comprehensive risk assessment was completed and submitted, establishing agreements with CROs for biological and sterilization safety. Clinical and pre-clinical requirements were collected and drafted, a thorough design for an acute study was defined, and initial considerations for chronic studies were made, leveraging insights from the acute study.
The project aims to revolutionize BCIs with graphene-based transistors (gSGFETs), offering high-resolution brain signal decoding, full bandwidth recording, and local signal amplification. These advancements will enhance neurosurgical precision, reduce post-surgery side effects, and improve patient outcomes. The project targets the BCI market, with applications in epilepsy, Parkinson's disease (PD), and stroke. The economic burden of brain disorders in Europe is $800B annually, highlighting the project's potential for significant societal and healthcare impact.
To ensure the project's future success, it is crucial to start pending tasks on active sensing leads, refine the ASIC design for frequency domain multiplexing, and integrate graphene-based thin-film sensors into clinical prototypes. Additionally, implementing test environment components into an OpenEphys plug-in, ensuring system sterilization compatibility, and conducting biocompatibility risk assessments are essential. Drafting the clinical investigation plan for FIH and completing interim and final business plans outlining the product development roadmap and commercialization strategy are also key priorities.
To ensure the project's future success, it is crucial to start pending tasks on active sensing leads, refine the ASIC design for frequency domain multiplexing, and integrate graphene-based thin-film sensors into clinical prototypes. Additionally, implementing test environment components into an OpenEphys plug-in, ensuring system sterilization compatibility, and conducting biocompatibility risk assessments are essential. Drafting the clinical investigation plan for FIH and completing interim and final business plans outlining the product development roadmap and commercialization strategy are also key priorities.