Innodem Neurosciences has signed a multi-year agreement with Novartis Canada to continue developing Innodem's digital biomarker eye-tracking technology, a noninvasive method to monitor disease progression in multiple sclerosis (MS). The multimillion-dollar commercial agreement comes on the heels of promising data from an observational trial, sponsored by the two companies, that tested the technology — dubbed Eye Tracking Neurological Assessment, or ETNA — in people with MS. The application, which runs on regular home tablets and is powered by artificial intelligence (AI), confirmed the links between eye movement and MS clinical assessments. It also showed that eye-tracking technology can measure disease severity and cognitive status in MS participants. "In the past year, the non-invasive, mobile ETNA technology was used by people living with MS during an observational trial where they were able to self-test at home because of the powerful processing capabilities of today's off-the-shelf tablets," Marc Reeves, co-founder and chief business officer of Innodem, said in a company press release. "With the test results and using AI models, we were able to replicate similar findings of past published academic research papers demonstrating how eye tracking can be used to monitor MS disease status and progression." MS is marked by an inflammatory attack on healthy nerve cells in the brain and spinal cord, which damages the myelin sheath, a fatty protective coating around nerve fibers. Damage to myelin interferes with nerve signaling, leading to MS symptoms. Such damage also can affect nerves that supply the eyes, resulting in subtle changes in eye movement that cannot be detected with MRI scans. Capturing these changes could lead to earlier assessments of disease progression and cognitive status and earlier switches to more effective treatments. Capturing eye movement biomarkers on a tablet. ETNA, which has yet to be approved for use by regulatory authorities, turns a home tablet into a device capable of capturing eye movement biomarkers (EMBs) that reflect brain health. It also captures gaze-mapping biomarkers (GMBs) that assess cognitive functioning. EMB and GMB data are collected when a person performs a series of simple visual tasks that can be completed in minutes. The application tracks patients' eye movements and gaze patterns, which are extracted and recorded. By requiring a tablet only, patients can be assessed in a clinic’s waiting room before a neurologist visit. Remote self-testing on a home tablet also can help assess disease progression at home in those with limited access to a neurologist. "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," Reeves said. "Novartis has recognized Innodem's scalable technology and pending its regulatory clearance, intends to help us bring it to the mainstream with this collaboration." Under the terms of the agreement, the companies intend to launch a pilot project at up to 15 clinical sites across Canada in advance of ETNA commercialization. "Pending regulatory clearance, the new agreement will include a pan-Canadian pilot project in up to 15 sites leading towards a jointly developed commercial plan to make ETNA readily available to the Canadian MS community," said Étienne de Villers-Sidani, MD, cognitive neurologist and Innodem's main founder and CEO. ETNA was granted breakthrough device designation by the U.S. Food and Drug Administration last year, a status given to medical equipment that provides advantages over currently available options. It is intended to speed the development, review, and approval of devices and comes with benefits to the manufacturer. "This commercial framework agreement with Innodem Neurosciences is an important example of our ongoing commitment to reimagining medicine and improving access to innovation that Canadians deserve," said Andrea Marazzi, country president at Novartis Canada. "By paving the way for a more proactive approach to care in multiple sclerosis, we aim to accelerate the path to much needed solutions that could help improve outcomes for people living with this debilitating disease."