Innodem Neurosciences' ETNA™-MS obtains Health Canada's Approval
Innodem Neurosciences, a leading digital health and AI company, announced today that its ETNA™-MS has been cleared for commercial use by Health Canada. The Eye Tracking Neurological Assessment for Multiple Sclerosis (ETNA™-MS) is a software as a medical device (SaMD, Class II) intended to administer a non-invasive test and provide an Expanded Disability Status Scale (EDSS) score in the range between 1.0 and 4.5 for use in tracking disease progression in MS patients.
ETNA™-MS turns an iPad Pro into a medical device that can be used in a clinic or at home through patient self-testing. The test lasts less than 10 minutes and includes short videos that were designed to highlight eye movement abnormalities as the patient performs several simple eye movement tasks. During this process, hundreds of eye movement parameters are extracted, combined, and processed by machine learning algorithms. Ultimately, ETNA™-MS provides quickly and automatically an EDSS score (between 1.0 to 4.5) with the potential to improve reproducibility, accuracy, efficiency, access to care and overall convenience.
"As far as we know, this is a world first that we hope the Canadian MS community will embrace for optimal management of people living with MS," said Marc Reeves, Chief Business Officer, Innodem Neurosciences.
ETNA™-MS has 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.
"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," said Dr. Étienne de Villers-Sidani, cognitive neurologist, main founder and Chief Executive Officer, Innodem Neurosciences.
Innodem Neurosciences and Novartis Pharmaceuticals Canada Inc. share a commitment to advancing innovation in MS and making a difference for people living with this debilitating disease in Canada, and globally.
"The approval of ETNA™-MS is a key milestone in our ongoing commercial framework agreement with Innodem Neurosciences, bringing us one step further in closing the gap in care for people living with MS," said Erin Keith, Vice President, Neuroscience at Novartis Pharmaceuticals Canada Inc. "Through our commitment to reimagine medicine and cross-sector collaboration, we are taking innovation in MS beyond therapeutics, paving a path to much needed solutions that Canadians deserve."