ETNA was granted Breakthrough Device designation by the Food & Drug Administration (FDA) last year and this patented, mobile, software technology is embodied in an application that is used in an ongoing observational trial that began in 2021 in collaboration with Novartis
Innodem Neurosciences, a leading digital health and AI company, announced today that it has signed a multimillion, multi-year Commercial Framework Agreement with Novartis Pharmaceuticals Canada Inc. (Novartis) to support its continued efforts towards its innovative ETNA technology (Eye Tracking Neurological Assessment).
ETNA was granted Breakthrough Device designation by the Food & Drug Administration (FDA) last year and this patented, mobile, software technology is embodied in an application that is used in an ongoing observational trial that began in 2021 in collaboration with Novartis. During the trial, ETNA turns a home tablet into a device capable of capturing in minutes and analyzing through powerful machine learning algorithms several hundreds of functional Eye Movement Biomarkers (EMBs) and Gaze Mapping Biomarkers (GMBs) that can be used to support clinical management.
This commercial agreement follows the favorable results of the observational trial involving people living with multiple sclerosis (MS). The peer reviewed performance data, which are the subject of a publication in Frontiers in Neurology, can be accessed here: https://www.frontiersin.org/articles/10.3389/fneur.2023.1243594/abstract.
The promising data indicates that EMBs and GMBs may have the potential to assist healthcare professionals in detecting subtle signs of clinically significant disease progression including cognition that may not show up using conventional imaging or currently approved blood biomarkers.
“In the past year, the non-invasive, mobile ETNA technology was used by people living with MS during an observational trial where they were able to self-test at home because of the powerful processing capabilities of today’s off-the-shelf tablets. With the test results and using AI models, we were able to replicate similar findings of past published academic research papers demonstrating how eye tracking can be used to monitor MS disease status and progression. Novartis has recognized Innodem’s scalable technology and pending its regulatory clearance, intends to help us bring it to the mainstream with this collaboration,” said Marc Reeves, Co-Founder and Chief Business Officer, Innodem Neurosciences. “We believe that remote self-testing could improve the efficiencies of the healthcare system and extend this capability to people living with MS residing in rural areas who cannot easily access a specialist,” he added.
“Pending regulatory clearance, the new agreement will include a pan-Canadian pilot project in up to -15 sites leading towards a jointly developed commercial plan to make ETNA readily available to the Canadian MS community,” said Dr. Étienne de Villers-Sidani, cognitive neurologist, main founder and Chief Executive Officer, Innodem Neurosciences.
“This commercial framework agreement with Innodem Neurosciences is an important example of our ongoing commitment to reimagining medicine and improving access to innovation that Canadians deserve,” said Andrea Marazzi, Country President, Novartis Pharmaceuticals Canada Inc. “By paving the way for a more proactive approach to care in multiple sclerosis, we aim to accelerate the path to much needed solutions that could help improve outcomes for people living with this debilitating disease.”
Source: Company Press Release