PR96270

MONTREAL, May 31, 2022 /PRNewswire=KYODO JBN/ --

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(TM) 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.

About INNODEM NEUROSCIENCES

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. Eìtienne 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

About MCRA

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

SOURCE INNODEM NEUROSCIENCES