Multiple sclerosis is usually assessed by a test that measures how far and how well the patient walks. Called the Expanded Disability Status Scale, or EDSS, it is scored according to clinician observations along with patient-reported information. This decades-old test has become the gold standard for tracking MS progression, but it still has limitations, according to Charis Leachman, chief medical officer of the startup BeCare Link.
The EDSS takes about 90 minutes and can only be performed in MS centers, which may be far for some patients. Even for those close to a center, the test is usually only done once a year. The problem is that MS is characterized by flare-ups and relapses, while symptoms come and go.
“Once a year is not going to capture the nature of the disease,” said Leachman, a neurologist.
BeCare has developed software that allows MS patients to take the EDSS on a personal mobile device. The tests and assignments take about 15 minutes to complete, and all grading is done by the app’s machine learning algorithms. The software is currently available for MS patients, and the company is working to expand the technology to other neurological indications.
BeCare was one of the companies that participated in the recent Pitch Perfect competition MedCity INVEST PharmaTech Conference. The Rumson, New Jersey-based startup was announced as the winner. Chris De Luca, digital partner at Sanofi Ventures, who was one of the competition judges, said BeCare’s approach to “rethinking the MS healthcare experience from the ground up – while making an engaging product – with a focus on clinical validation is fundamental to improve outcomes and quality of life for patients living with this chronic disease.
Leachman co-founded BeCare from the clinician’s perspective. Her experience includes 30 years in private practice as well as a faculty appointment at Yale School of Medicine. She also spent time testing experimental drugs while working for a contract research organization (CRO). Leachman said she and other clinicians were hampered by the inadequacy of the neurological exam. Human scoring is subjective and one physician or researcher’s interpretation of the results may differ from another.
Leachman said BeCare focuses on MS first because the disease involves all parts of the neurological system. The app requires patients to complete 12 tasks that assess motor function, finger function, cognitive ability, memory and walking. Some of these tasks are gamified to make them more engaging for users. Patients are also asked to answer questions about diet, sleep and exercise.
The software captures patient responses along with other measures. As an example, Leachman cites a patient who was asked to touch his nose. For a personal test, the clinician will write “yes” or “no” regarding the patient’s ability to perform this task. But BeCare’s app measures speed and coordination, as well as how far off target the patient is.
“It’s no longer a yes or no, it’s a more precise answer and it can be tracked over time,” Leachman said.
Leachman argues that BeCare’s technology is superior to an assessment performed by two different clinicians, or even by the same clinician at two different points in time. The company has conducted two clinical trials comparing the software to traditional EDSS. The results show that the results are very similar. But Leachman said the advantage of BeCare is that it provides objective, not subjective, data. Also, the patient’s doctor or anyone else consulting on the case can view this data securely by logging into a portal.
BeCare’s MS app has been cleared by the FDA and is available for free download by anyone. Leachman said the revenue would come from insurance reimbursement for the technology as part of remote monitoring. The company also aims to make money from pharmaceutical companies and CROs that sign deals to use the technology. Biogen is currently using the MS application in a postmarketing study to further evaluate one of its drugs, Leachman said.
Work is currently underway to expand the platform to other neurological diseases. The next step is the development of a general neurological examination that can be administered by primary care physicians. This test will help diagnose neurological problems earlier, allowing patients to be referred to a specialist sooner, Leachman said.
BeCare’s neurological review is expected to be ready by the end of September. Also in development are applications for the neuromuscular diseases amyotrophic lateral sclerosis and myasthenia gravis. In the longer term, the company aims to offer an application for Alzheimer’s disease. Some of the indications BeCare is pursuing, along with the goal of bringing the technology to pharmaceutical companies for use in monitoring clinical trials, would put the company in competition with Modality.AI, a San Francisco-based startup commercializing its own neurological assessment software for mobile devices.
BeCare has raised about $7 million from investors to date, Leachman said. The company is seeking to raise an additional $7 million to support a longitudinal clinical trial for the MS application and to clinically test the technology in other neurological indications.
“The pandemic has driven the need to provide better remote treatment,” Leachman said. “But the need will continue and grow both because people will want to keep much of their care remotely, but also because we need to improve health care by improving neurological screening.”
Photo by BeCare Link