MC10 and AbbVie are working together to launch clinical trials exploring the use of BioStamp nPoint, a system of wearable sensors that collects health data from multiple sclerosis (MS) patients, to determine if the information may serve as meaningful measures for clinical studies.
MC10’s BioStamp nPoint is a class II, FDA 510(k)-cleared wearable device that can be used at home or in clinical settings for the continuous collection of physiological data in patients; it is intended for both clinical trials and research studies A 510(k) clearance means the device was considered at least as safe and effective as a legally marketed device not subject to pre-market approval.
BioStamp nPoint consists of flexible, body-conforming, rechargeable and reusable sensor patches, which can be placed anywhere in the body, and are able to record data for 24 hours. Several sensors can be worn at a time, to measure different body parts, and provide more comprehensive data.
The system can be configured to do 44 standard measurements, including vital signs (e.g., heart and respiration rates), activity (e.g., step count, time spent active), posture, muscle electrical activity and sleep (e.g., wakefulness), all with clinically validated accuracy, according to MC10.
The devices are wireless, and all collected data are processed and stored in a cloud (server) that can be synchronized with other systems. The BioStamp nPoint in-home kit also comes with an app that guides patients through sensor application, study activities, and allows them to communicate with the research team.
According to MC10, many pharmaceutical companies, as well as academic research teams, already are employing this system to gather health data of patients across several therapeutic areas.
“We are excited to work with a world leader in CNS [central nervous system] therapies and look forward to exploring novel data and metrics that help to advance clinical development” Arthur Combs, MD, chief medical officer of MC10, said in a press release.
The clinical trials planned by MC10 and AbbVie will investigate the use of BioStamp nPoint system for collecting a wide range of data and metrics from MS patients, and address its usefulness as outcome measures, or endpoints, in future clinical trials targeting the disease.
“We are excited to explore the BioStamp nPoint System’s ability to unobtrusively collect clinically relevant data continuously from subjects in more natural settings. This technology has the potential to improve the quality of data we collect and at the same time reduce the burden on study participants,” said Michael Gold, MD, AbbVie’s vice president for development neurosciences.