Multiple sclerosis is typically assessed by a test that that measures how far and how well a patient walks. Called the expanded disability status scale, or EDSS, it’s scored according to a clinician’s 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 Charisse Litchman, chief medical officer of startup BeCare Link.
The EDSS takes about 90 minutes and can only be conducted at MS centers, which might be far away for some patients. Even for those close to a center, the test is typically done just once a year. The problem is that MS is characterized by flareups and relapses as symptoms come and go.
“Once a year is not going to capture the nature of the disease,” said Litchman, a neurologist.
BeCare has developed software that enables MS patients to take the EDSS on a personal mobile device. Performing the tests and tasks takes about 15 minutes, and all of the scoring is done by the app’s machine-learning algorithms. The software is currently available to 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 Pitch Perfect contest at the recent MedCity INVEST PharmaTech Conference. The Rumson, New Jersey-based startup was named the winner. Cris De Luca, partner, digital, at Sanofi Ventures, who was one of the judges for the contest, said that the BeCare’s approach to “reimagining the MS health experience from the ground up—while making an engaging product—with a focus on clinical validation, is fundamental to improving outcomes and quality of life for patients living with this chronic illness.”
Litchman co-founded BeCare with a clinician’s perspective. Her experience includes 30 years in private practice, as well as a faculty appointment at the Yale School of Medicine. She also spent time testing experimental drugs while working for a contract research organization (CRO). Litchman said that she and other clinicians were stymied by the inadequacy of the neurologic exam. Human-conducted scoring is subjective, and the interpretation of the results by one physician or investigator may be different than that of another.
Litchman said BeCare focused on MS first because the disease encompasses all parts of the neurologic 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 in order to make them more engaging for users. Patients are also asked to respond to questions about diet, sleep, and exercise.
The software captures patient responses along with other measures. As an example, Litchman cited a patient being asked to touch his or her nose. For an in-person test, a clinician would write “yes” or “no” regarding the patient’s ability to perform that task. But BeCare’s app measures speed and coordination, as well as how far off the mark a patient is.
“No longer is it ‘yes’ or ‘no,’ it’s a more accurate answer and it’s trackable over time,” Litchman said.
Litchman contends that BeCare’s technology is better than having assessments done by two different clinicians, or even the same clinician at two different points in time. The company has conducted two clinical trials that compared the software to the traditional EDSS. Results showed that the results were very similar. But Litchman said the advantage of BeCare is that it yields objective rather than subjective data. Also, the patient’s physician, or anyone else consulting on the case, can view those data securely by logging on to a portal.
BeCare’s MS app has received FDA clearance and it is available for anyone to download for free. Litchman said revenue will come from insurance reimbursement of the technology as a 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 app in a post-marketing study to further assess one of its drugs, Litchman said.
Work is underway to expand the platform to other neurological disorders. The next step is developing a general neurologic exam that can be administered by primary care physicians. This test will help diagnose neurologic problems earlier, enabling patients to be referred to a specialist sooner, Litchman said.
The BeCare neurological exam is expected to be ready by the end of September. Also in development are apps for the neuromuscular disorders amyotrophic lateral sclerosis and myasthenia gravis. Longer term, the company aims to offer an app for Alzheimer’s disease. Some of the indications that BeCare is pursuing, along with goal to place the technology with pharma companies for use in clinical trial monitoring, would put the company in competition with Modality.AI, a San Francisco-based startup that has commercialized its own neurological assessment software for mobile devices.
BeCare has raised about $7 million from investors to date, Litchman said. The company is looking to raise another $7 million to support a longitudinal clinical trial for the MS app and for clinical testing of the technology in other neurological indications.
“The pandemic drove home the need for delivering better remote treatment,” Litchman said. “But the need will continue and grow, both because people will want to keep much of their care remote but also because we need to improve healthcare by improving the neurologic exam.”
Photo by BeCare Link