A digital biomarker for ALS - pison neural biosensor - amyotrophic lateral sclerosis (ALS) is a lethal degenerative neurological disease with progressive loss of all motor function and no known cure

Pison Technology, Inc. received a $459,097 Project Grant award from the National Institute of Neurological Disorders and Stroke (NINDS) under the Extramural Research Programs in the Neurosciences and Neurological Disorders (CFDA 93.853) program, with an award date of June 12, 2025 and completion date of May 31, 2026. This Fast-Track Phase I/Phase II award supports the development and validation of a digital biomarker for amyotrophic lateral sclerosis (ALS) using Pison's wrist-worn neural biosensor device. The biosensor utilizes surface electromyography (sEMG) technology to continuously generate real-time, high-fidelity neurologic signals that are processed through cloud-based algorithms to characterize disease progression in ALS patients.

The primary deliverable is a scalable, remotely deployable digital biomarker platform that enables remote monitoring of ALS disease progression from patients' homes. By translating physiologic sEMG data into clinically meaningful biomarkers, this technology is designed to facilitate early disease identification, enable real-time patient monitoring, inform clinical decision-making regarding treatment effectiveness, and support more prompt clinical responses to disease changes. The project builds upon Pison's previous work with both ALS patients and healthy populations, de-risking the development of a diagnostic and monitoring tool that addresses a critical need in ALS management, particularly as new disease-modifying therapies become available.

Disease management is largely palliative. The landscape of ALS management is changing with the arrival of newly approved therapies and with other disease-modifying drugs on the horizon. This change prioritizes the need for early identification and monitoring of disease before the inexorable loss of motor neuron function. Pison has previously created a mobile wrist-worn device that uses surface electromyography (semg) to generate data in real time, continuously, and remotely, generating high-fidelity neurologic signals. This physiologic data is then cleaned, characterized, and labeled instantaneously by cloud-based algorithms and immediately available for use. The work to date has used this physiologic data to enable gesture control of third-party devices. The purpose of this fast-track phase i / phase II proposal is to assess the pison neural biosensor as a scalable source of a digital biomarker for the characterization of disease progression in ALS. This previous work done both in patients with ALS and in healthy populations partially DE-risks the project, providing confidence in pison's ability to deliver a data-driven digital biomarker for this disease obtained from an easily deployable device that serves the needs of this specific population. The data obtained will have the fidelity and reliability to inform the creation of a disease biomarker measurable remotely, in the home of persons with ALS (pals), and will provide a significant advancement in the diagnosis and monitoring of this patient population. This will aid in the rapid understanding of the patient's condition and the effect of treatment and allow for more prompt responses to clinical changes. Such a biomarker will be highly innovative in this disease state, as well as in other neurodegenerative diseases in the future. IT is pison's goal in phase i of this grant to create a version of our neural sensor that can be used by pals in a clinical setting, with the assistance of clinical personnel. If this goal can be accomplished, as defined by specific usability and data quality metrics, phase II will focus on developing a digital biomarker that will allow identification and tracking of pals in a scalable and remotely deployable system that can be used without clinical assistance in the patients' home.