Indivi

Indivi is a Swiss MedTech company specializing in the development of software-based digital biomarker platforms that transform consumer smartphones into clinically validated tools for neurological disease monitoring and research. Headquartered in Basel, Indivi operates at the intersection of neuroscience, software-as-a-medical-device (SaMD), and machine learning. Its mission is to make clinical-grade assessments accessible outside traditional healthcare settings by leveraging everyday mobile devices to passively and actively capture real-world health data.

The company has gained prominence through its flagship solution, dreaMS, a CE-marked app designed to monitor multiple sclerosis symptoms by tracking a range of motor and cognitive functions via smartphone sensors. dreaMS enables patients to perform guided tests from home that evaluate gait, balance, dexterity, speech, and cognition, producing continuous and objective data that complement traditional clinical scales. The platform eliminates the need for frequent hospital visits and delivers a higher resolution of patient behavior over time.

Indivi's core innovation lies in its ability to extract digital biomarkers from raw sensor data, using a combination of signal processing and machine learning algorithms. These biomarkers are designed to capture subtle changes in patient conditions and enhance sensitivity in clinical trials. Data is collected through various modalities including accelerometers, gyroscopes, touchscreen interactions, front-facing cameras, and voice recordings. All information is processed and anonymized in compliance with GDPR and managed through ISO 13485-certified infrastructure, ensuring the platform is suitable for deployment in regulated healthcare environments.

Beyond multiple sclerosis, Indivi’s technology is being adapted for broader neurological applications. Its second major product, Konectom™, is a smartphone-based assessment platform originally developed by Biogen and now licensed by Indivi. It extends Indivi’s technology stack to Parkinson’s disease and other neurodegenerative conditions. In 2024, the company formalized a multi-year collaboration with Biogen to unify both platforms and jointly develop new digital endpoints for use in global clinical trials.

The company's research pipeline includes collaborations with academic and industry partners such as the University of Basel, Boston University, and Politecnico di Torino. These partnerships are focused on validating algorithms, testing trial readiness, and exploring applications in neurodevelopmental and neurodegenerative disorders. Indivi’s modular platform architecture also allows it to support custom study designs, making it attractive to pharmaceutical companies looking to incorporate decentralized monitoring solutions into their R&D workflows.

Indivi's business model is based on long-term software licensing and platform deployment contracts with pharmaceutical companies, clinical research organizations, and academic partners. The company provides technical integration, regulatory support, and analytic capabilities as part of its offering. Its bring-your-own-device (BYOD) strategy lowers logistical barriers for deployment in large-scale studies, while maintaining high-quality data capture across heterogeneous hardware environments.

By combining clinical-grade precision with digital scalability, Indivi addresses critical bottlenecks in neurological drug development, including recruitment, patient engagement, and endpoint sensitivity. The ability to generate dense, real-world datasets over long periods helps improve statistical power in trials and accelerates time-to-insight for researchers and sponsors.

Keywords: digital biomarkers, software as a medical device, SaMD, multiple sclerosis, Parkinson’s, neurodegenerative disease, smartphone sensors, machine learning, artificial intelligence, clinical trials, gait analysis, cognitive testing, CE-certified, ISO 13485, decentralized trials, BYOD, neurological monitoring, drug development, precision medicine.