ETNA(TM) Device from the Leading Digital Health & AI Company Innodem Neurosciences Receives FDA "Breakthrough" Designation for Multiple Sclerosis
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
本プレスリリースは発表元が入力した原稿をそのまま掲載しております。また、プレスリリースへのお問い合わせは発表元に直接お願いいたします。
このプレスリリースには、報道機関向けの情報があります。
プレス会員登録を行うと、広報担当者の連絡先や、イベント・記者会見の情報など、報道機関だけに公開する情報が閲覧できるようになります。