Multiple sclerosis is usually assessed with tests that measure how far a patient can walk and how well they can walk. Called the Expanded Disability Status Scale or EDSS, it is scored based on clinician observations as well as patient-reported information. Charisse Litchman, chief medical officer at startup BeCare Link, said the decades-old test has become the gold standard for tracking MS progression, but it still has limitations.
EDSS takes about 90 minutes and can only be done in MS centers, which can be far away for some patients. Even for those close to the center, testing is usually done only once a year. The problem is that MS is characterized by flare-ups and relapses as symptoms come and go.
“Once a year doesn’t capture the essence of the disease,” says neuroscientist Litchman.
BeCare has developed software to enable MS patients to use EDSS on their personal mobile devices. It takes about 15 minutes to execute the tests and tasks, and all scoring is done by the app’s machine learning algorithm. The software is currently available for MS patients, and the company is working to expand the technology to other neurological indications.
BeCare is one of the companies that recently entered the Pitch Perfect competition MedCity INVEST PharmaTech Conference. The Ramson, NJ-based startup was named a winner. Cris De Luca, digital partner at Sanofi Ventures and one of the judges for the competition, said BeCare’s approach was “to reimagine the MS wellness experience from the ground up while making a compelling product. , with a focus on clinical validation, is critical to improving outcomes and quality of life for patients with this chronic disease.”
Litchman co-founded BeCare with a clinician’s perspective. Her experience includes 30 years in private practice, as well as faculty appointments at Yale University School of Medicine. She also spends time testing experimental drugs while working for a contract research organization (CRO). Litchman said she and other clinicians were held back by inadequate neurological examinations. Human scoring is subjective, and one physician or researcher may interpret the results differently than another.
Litchman said BeCare first focused on MS because the disease covers all parts of the nervous system. The app asks patients to perform 12 tasks that assess motor function, finger function, cognition, memory, and walking. Some of these tasks are gamified to make them more attractive to users. Patients were also asked to answer questions about diet, sleep, and exercise.
The software captures the patient’s response along with other measures. As an example, Litchman cites a patient being asked to touch his or her nose. For field tests, clinicians will write “yes” or “no” to the patient’s ability to perform the task. But BeCare’s app measures speed and coordination, as well as how far a patient is from the norm.
“It’s no longer ‘yes’ or ‘no’, it’s a more accurate answer and it’s traceable over time,” Litchman said.
Litchman believes that BeCare’s technology is superior to assessments performed by two different clinicians, or even the same clinician, at two different time points. The company has already conducted two clinical trials comparing the software to traditional EDSS. The results showed that the results were very similar. But Litchman said the strength of BeCare is that the data it produces is objective, not subjective. In addition, the patient’s doctor or anyone else consulting on the case can view this data securely through the login portal.
BeCare’s MS app is FDA-approved and free for anyone to download. Revenue will come from insurance reimbursements for technology used as part of remote monitoring, Litchman said. The company also aims to make money from pharmaceutical companies and CROs who have signed agreements to use the technology. Biogen is currently using the MS app in a post-marketing study to further evaluate one of its drugs, Litchman said.
Efforts are underway to expand the platform to other neurological disorders. The next step is to develop a general neurological exam that can be performed by primary care physicians. The test will help diagnose neurological problems earlier, allowing patients to be referred to specialists sooner, Litchman said.
The BeCare neurological exam is expected to be ready by the end of September. Applications for the neuromuscular diseases amyotrophic lateral sclerosis and myasthenia gravis are also in development. In the long run, the company aims to provide applications for Alzheimer’s disease. Some of the signs that BeCare is pursuing, and the goal of making the technology available to pharmaceutical companies for clinical trial monitoring, will bring the company together with Modality.AI, a San Francisco-based startup, has commercialized its own neuro-assessment software for mobile devices.
To date, BeCare has raised about $7 million from investors, Leachman said. The company is seeking to raise an additional $7 million to support longitudinal clinical trials for MS applications as well as clinical trials of the technology in other neurological indications.
“The pandemic has driven the need to provide better teletherapy,” Leachman said. “But demand will continue and grow, both because people want to keep most of their care remotely, and because we need to improve healthcare through improved neurological examinations.”
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