ETNA™ DEVICE FROM THE LEADING DIGITAL HEALTH & AI COMPANY INNODEM NEUROSCIENCES RECEIVES FDA "BREAKTHROUGH" DESIGNATION FOR MULTIPLE SCLEROSIS

MONTREAL, May 31, 2022 /PRNewswire/ -- Innodem Neurosciences, a leading provider of innovation and technology for the convergence of neurosciences, digital health, pharmaceutical and artificial intelligence, is proud to announce that its novel mobile eye tracking technology for people living with multiple sclerosis has been granted "Breakthrough Device" designation by the U.S. Food & Drug Administration.

The proposed indication of use includes: "The Eye-Tracking Neurological Assessment for Multiple Sclerosis (ETNA™ for MS) is intended to record eye movements for use in estimating disease severity in Multiple Sclerosis (MS) patients, which will aid clinicians to track disease progression. The intended patient population are all individuals having already received a diagnosis of MS, irrespective of MS subtype (relapsing-remitting (RRMS), secondary- progressive (SPMS), primary-progressive (PPMS), and progressive-relapsing (PRMS)), who present with oculomotor symptoms or signs."

Innodem's patented mobile software technology is embodied in an intuitive application that turns an off-the-shelf electronic tablet into a polyvalent and precise device that captures Eye Movement Biomarkers (EMBs) and Gaze Mapping Biomarkers (GMBs) in minutes remotely informing clinicians about MS disease status and progression to adjust treatment and improve patient outcomes.

"Eye tracking technology has been around for decades, and the literature demonstrates that eye movements can serve as powerful markers of brain health, particularly in MS. However, this technology was complex to use, expensive, and the data collected did not allow clinicians to benefit from it for their patients. EMBs/GMBs can detect subtle changes in motor and cognitive function found in MS progression but difficult or impossible to quantify during routine neurological exams or with conventional brain imaging (MRI). Up until now, with current standard of care in MS, several years are usually required before clinicians confidently establish the presence of disease progression. With regular, more frequent quantitative monitoring of MS disease status expressed as indices of motor and cognitive function, including patient estimates on the well-established clinical scale EDSS, clinicians can adjust or initiate appropriate therapy to preserve the brain of their patients" said Dr. Étienne de Villers-Sidani, cognitive neurologist, main founder, and CEO of Innodem.

"The interesting thing with the convergence of neurosciences, digital health, pharmaceutical and artificial intelligence device applications is that the more data we obtain, the more accurate Software-as-a Medical Device algorithms become at detecting and tracking the presence and progression of these various devastating neurological conditions," added Tim Marjenin, Vice President, Head of Neurology Regulatory Affairs at MCRA.

"I would like to outline the importance of our partnership with MCRA who contribute regularly as our GoTo regulatory consultants – we could not have done this without them" added Innodem's co-founder & Chief Business Officer, Marc Reeves.

In preparation for a future deNovo submission, Innodem is conducting a clinical trial involving patients living with MS and where weekly self-testing data will assist healthcare professionals in detecting subtle sign of clinically significant disease progression that may not show up using magnetic resonance imaging (MRI) or blood tests such as serum neurofilament light chain (sNfL). Innodem management is hopeful that the multi-year trial will demonstrate that novel digital EMBs & GMBs can measure these changes accurately and cost-effectively while improving quality of care and quality of life of individuals living with MS. "A clinician whose patient is transitioning to the progressive form of MS may recommend a better adapted treatment which could, if detected early, prevent this individual from developing severe neurological impairments. No practical tools currently exist to detect such a transition to progressive MS and I believe EMBs & GMBs can fill that important gap," added Dr. Etienne de Villers-Sidani.

Founded in 2016 as a spin-off from the Montreal NEURO (McGill University), Innodem Neurosciences has developed patented mobile digital biomarking technology of neurodegenerative diseases such as Multiple Sclerosis, Alzheimer's disease, Parkinson's disease and related disorders, Frontotemporal Dementia and related disorders and Cancer-Related Cognitive Impairment ("chemo brain"). This novel eye-tracking and cognition testing technology is embodied in a HIPAA compliant system consisting of an intuitive tablet application connected to a cloud-based AI infrastructure. The app is made up of a series of tasks that are completed in minutes, where a user's eye movements are recorded in data sets called Eye Movement Biomarkers (EMBs) and Gaze Mapping Biomarkers (GMBs). Innodem's core team, led by cognitive neurologist & CEO Dr. Étienne de Villers-Sidani, is composed of an intersectional group of neuroscientists, software engineers, data scientists, healthcare professionals and serial entrepreneurs. The company's mission is to provide easier ways to do remote testing for all stages of neurodegenerative diseases and cancer-related cognitive impairment to improve quality of care and patient outcomes, at unseen levels of user-friendliness and cost-effectiveness for the global health system. www.innodemneurosciences.com

MCRA is the leading privately held independent medical device and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its clients industry experience at integrating its six business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, and distribution logistics to provide a dynamic, market-leading effort from innovation conception to commercialization. MCRA's integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, and Tokyo, Japan and served nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices and medical device cybersecurity. www.mcra.com

For Innodem: Valérie Gonzalo, AGO Communications, 514-626-6976, valerie@agocom.ca; For MCRA: Alyssa Howard, Senior Director, Business Development, Phone: 215.870.3952, ahoward@mcra.com