Periodic Reporting for period 2 - EPINOSTICS (Artificial Intelligence powered epilepsy diagnostics)
Reporting period: 2021-09-01 to 2022-08-31
Epilepsy is one of the most prevalent chronic neurologic conditions and an important cause of disability and mortality. More than 65 million people worldwide suffer from epilepsy. In Europe, more than 6 million people are affected by epilepsy, leading to a total cost of €13.8 billion annually. 47% of the costs is caused by direct healthcare costs, 53% by other costs (i.e. productivity losses).
Neuro Event Labs is a team of medical and technological experts with a mission to help people with epilepsy live better lives. We are developing the revolutionary epilepsy diagnostics tool so that neurologists are able to select an efficient treatment plan for each patient.
The objective of the EPINOSTICS project has been to make Neuro Event Labs the global leader in epilepsy diagnostics. In order to reach the objective, we have developed new version of our product to address needs of full epilepsy population (65 million) including faster and more accurate diagnosing, safety in acute epilepsy care and management of individual epilepsy. Developed version of the product has been then clinically validated, results peer reviewed and approved by regulatory authorities (CE, FDA).
Neuro Event Labs is a team of medical and technological experts with a mission to help people with epilepsy live better lives. We are developing the revolutionary epilepsy diagnostics tool so that neurologists are able to select an efficient treatment plan for each patient.
The objective of the EPINOSTICS project has been to make Neuro Event Labs the global leader in epilepsy diagnostics. In order to reach the objective, we have developed new version of our product to address needs of full epilepsy population (65 million) including faster and more accurate diagnosing, safety in acute epilepsy care and management of individual epilepsy. Developed version of the product has been then clinically validated, results peer reviewed and approved by regulatory authorities (CE, FDA).
Regarding software analytics platform we have the 3D model ready for human pose detection and software ready for all seizures detection.
In regard to hardware development and design we have developed and installed the HW prototype for real time seizure detection. Also, the validation in clinical trial has been completed.
Also, we have performed 3 iterations of BOM optimizations; and developed and piloted the self-installation version of the device to reach re-visited BOM target with additional functionalities and achieved 600€ BOM.
We have completed clinical trials related to new technology developed during EPINOSTICS and completed validation as part of the trials. Also we have updated CE indication and intended use to match EPINOSTICS outcomes. FDA 510(k) application is under final review and expect to have FDA clearance during October 2022 or early November.
We have presented our results in respective epilepsy conferences during last 12 months (Copenhagen Epilepsy Conference October 2021, AES Chicago December 2021 and Epilepsy conference in Genova July) and planning to further present comprehensive outcome of EPINOSTICS in AES conference Nashville, December 2022. Also marketing materials, aligned with regulatory claims have been updated according to new capabilities.
In regard to hardware development and design we have developed and installed the HW prototype for real time seizure detection. Also, the validation in clinical trial has been completed.
Also, we have performed 3 iterations of BOM optimizations; and developed and piloted the self-installation version of the device to reach re-visited BOM target with additional functionalities and achieved 600€ BOM.
We have completed clinical trials related to new technology developed during EPINOSTICS and completed validation as part of the trials. Also we have updated CE indication and intended use to match EPINOSTICS outcomes. FDA 510(k) application is under final review and expect to have FDA clearance during October 2022 or early November.
We have presented our results in respective epilepsy conferences during last 12 months (Copenhagen Epilepsy Conference October 2021, AES Chicago December 2021 and Epilepsy conference in Genova July) and planning to further present comprehensive outcome of EPINOSTICS in AES conference Nashville, December 2022. Also marketing materials, aligned with regulatory claims have been updated according to new capabilities.
Target of the EPINOSTICS project is to leverage existing version of the product from convulsive seizures detection during night-time to include all motor seizure type that are happening during day or night. During the project, progress has been great, and we have been able to demonstrate that we can meet those targets and provide objective diagnostics for healthcare professionals to improve and speed up diagnosis and patient case, but also for patients to receive better, accurate and personalised care and safety. We have validated usage of developed version of the product and algorithm with all variety of patients from age, race, size and form of epilepsy point of view. We are well on track in commercialising our innovation to meet big unmet meet in epilepsy where diagnosis takes years, misdiagnosis is 30% and 1/3 of patients suffer uncontrolled seizures.
These listed impacts are going to be measured alongside with commercial usage as post market and clinical utility studies based on real world evidence and usage.
These listed impacts are going to be measured alongside with commercial usage as post market and clinical utility studies based on real world evidence and usage.