News | March 25, 2024

Innodem Neurosciences' ETNA™-MS Obtains Health Canada's Approval

Montreal, QC /CNW/ - 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."

About Innodem Neurosciences
Innodem Neurosciences is a leading digital biomarker and AI company specializing in the development of a proprietary, mobile, non-invasive eye-tracking technology called ETNA™ (Eye Tracking Neurological Assessment). ETNA™-MS is software as a medical device (SaMD, Class II) that can be used in clinic or remotely through patient self-testing. ETNA™-MS captures patient responses to brief oculomotor tests displayed on the screen of an iPad Pro within 10 minutes. These tasks are designed to assess several key neurological functions known to be affected by multiple sclerosis, and to capture several hundred eye movement parameters in response to visually presented stimuli during specifically designed eye-tracking tests. The eye movement data is then analyzed by powerful machine learning algorithms to provide an EDSS score (between 1 and 4.5) that is correlated to the EDSS score obtained by a specialized MS clinician, potentially improving efficiencies and access to care. The ETNA™ technology is also being further validated in ongoing observational trials with participants diagnosed with other neurodegenerative and mental disorders, such as Parkinson's disease, Alzheimer's disease, Friedreich's ataxia, and cancer-related cognitive disorders ("chemo brain"). Innodem's core team, led by cognitive neurologist and CEO Dr. Étienne de Villers-Sidani, is made up of an intersectional group of neuroscientists, software engineers, data scientists, healthcare professionals and serial entrepreneurs. The company's mission is to become the leading digital biomarker and AI company to better serve the needs of the global health system.

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Source: Innodem Neurosciences

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