Periodic Reporting for period 2 - BFORE (Breakthrough Brain Stimulation Device for Epilepsy)
Okres sprawozdawczy: 2024-03-01 do 2025-02-28
With 180 million patients in Europe alone, brain disorders are a major burden, accounting for approx. 45% of the total European healthcare budget. Epilepsy is the 4th most common brain disorder in Europe with 6 million patients in total, 400,000 new cases every year and annual healthcare costs of 20 bn Euros.
The project BFORE is about a novel innovative method for the therapy of focal cortical epilepsy, especially, when medications are not effective, also referred to as drug refractory epilepsy. The method is provided by the EASEE system (Epicranial Application of Stimulation Electrodes for Epilepsy). The EASEE system was developed by Precisis GmbH, and clinical prototypes are currently at TRL6-7. The project aims to further develop the EASEE system towards TRL9 in order to realize a series product optimized for market entry.
The main objectives of the project are to further secure the business case, improve IPR operability and reduce risks (WP1); expand the market and commercialization activities (WP2); further improve the technical solution in terms of safety, reliability and operability (WP3); and develop a process in order to establish the transfer from prototype to series production in term of technology scale-up (WP4). With this project, a novel therapy will become available for an unmet medical need. It has a high impact on individual patient’s life as well as on health and economic scale.
The project BFORE is about a novel innovative method for the therapy of focal cortical epilepsy, especially, when medications are not effective, also referred to as drug refractory epilepsy. The method is provided by the EASEE system (Epicranial Application of Stimulation Electrodes for Epilepsy). The EASEE system was developed by Precisis GmbH, and clinical prototypes are currently at TRL6-7. The project aims to further develop the EASEE system towards TRL9 in order to realize a series product optimized for market entry.
The main objectives of the project are to further secure the business case, improve IPR operability and reduce risks (WP1); expand the market and commercialization activities (WP2); further improve the technical solution in terms of safety, reliability and operability (WP3); and develop a process in order to establish the transfer from prototype to series production in term of technology scale-up (WP4). With this project, a novel therapy will become available for an unmet medical need. It has a high impact on individual patient’s life as well as on health and economic scale.
The main technical achievements are the following: The design of the clinical prototype has been analyzed in detail and significantly optimized in order to support a higher reliability, safety and availability (lifetime) as it was available in the original design of the clinical prototypes. Here also a major PCBA redesign was needed on the one hand and on the other hand the HW/SW codesign was modified to have much less power consumption of the implanted system. Improvements for the stability and cybersecurity safe RF communication have been developed and evaluated. All design activities have been aligned to be compatible with the new regulations relevant for compliance according to the medical device regulation (MDR). Methods for automated unit-testing during engineering as well as integration, verification and validation have been developed. On process level, technology scale up development was performed in order to transfer the manual prototype level manufacturing steps towards better controlled, scalable and partly automated manufacturing. Finally, an end-of-line test system for the series device was developed.
WP1: Further development of IPR operability. Submission of further applications at the Luxemburg patent office. European unity patent granted for the EASEE system electrode design.
WP2: New communication channels established, PR activities focused to reach patients and professionals. Relevant reimbursement schemes have been secured for various European countries and first sales and marketing have been developed. Training and certification for field clinical engineers and staff set up for activities in regulated health environments. Focus was shed on stakeholders’ management activities on federal and European/global level.
WP3: Substantial design activities performed on hardware, software level and integration testing initiated, Cybersecurity conception released, and Design of new UI and Ux Elements developed. All development efforts ensure a higher safety, reliability, and availability of the medical product.
WP4: Ongoing supervision of progress with support of external consultants. Regular workshops or follow-up meetings, partially on-site at main supplier. Polarion documentation and regulatory item management is unrolled, and training is planned for Q2 2024. The configuration of the ERP system for more functions and business processes is modelled and allows control and automation of order, billing and manufacturing steps. This additional control instrument provides a basis for further evaluations on a cost-benefit approach. Additional optimization efforts in development of automated test methods and guided assembly tools will help to increase the yield and to be prepared during the scale up phase.
WP2: New communication channels established, PR activities focused to reach patients and professionals. Relevant reimbursement schemes have been secured for various European countries and first sales and marketing have been developed. Training and certification for field clinical engineers and staff set up for activities in regulated health environments. Focus was shed on stakeholders’ management activities on federal and European/global level.
WP3: Substantial design activities performed on hardware, software level and integration testing initiated, Cybersecurity conception released, and Design of new UI and Ux Elements developed. All development efforts ensure a higher safety, reliability, and availability of the medical product.
WP4: Ongoing supervision of progress with support of external consultants. Regular workshops or follow-up meetings, partially on-site at main supplier. Polarion documentation and regulatory item management is unrolled, and training is planned for Q2 2024. The configuration of the ERP system for more functions and business processes is modelled and allows control and automation of order, billing and manufacturing steps. This additional control instrument provides a basis for further evaluations on a cost-benefit approach. Additional optimization efforts in development of automated test methods and guided assembly tools will help to increase the yield and to be prepared during the scale up phase.