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Company description

Celestra Health Systems develops a cloud-based gait analysis platform designed to monitor neurological conditions such as Multiple Sclerosis (MS) and Parkinson's Disease. The platform has been designated by the FDA as a Class II medical device and uses machine learning algorithms to quantitatively measure patient mobility in natural, free-living environments. Celestra Health serves global pharmaceutical firms, research institutions, and healthcare providers, and has conducted nine clinical trials across four countries — the United States, United Kingdom, Germany, and Canada — in collaboration with neurologists and patient advisors.

The platform is built on the clinical observation that gait quality correlates strongly with neurological disease progression, and that walking is consistently ranked by patients as the primary factor affecting quality of life. By continuously monitoring subtle changes in walking patterns, the platform aims to detect disease progression earlier than conventional clinical assessments and to enable intervention before irreversible neurological damage occurs.

Core Platform and Technology

• The platform is described as a "Gait Lab in a Shoe," providing accuracy comparable to a multi-million-dollar gait laboratory, according to Celestra Health's clinical trial results.
• Data is collected via wearable smart insoles equipped with gyroscopes, accelerometers, and pressure sensors, supplemented by data from smartphones and smartwatches.
• The smart insoles measure pressure exerted by different areas of the foot, as well as acceleration and rotational movement in three dimensions.
• Proprietary AI algorithms measure over 400 aspects of a patient's gait at a rate of up to 200 times per second, constructing a detailed walking signature and tracking changes over time.
• Each walking session is assigned a quality score between 0 and 100, with 100 representing perfect walking, based on 15-minute sessions recorded in the patient's natural environment.
• Algorithms have been trained on what Celestra Health describes as the world's largest database of walking samples collected under free-living conditions from patients with neurological conditions.

Clinical Performance and Detection Capabilities

• Clinical trial results indicate the platform can detect changes in disease condition with greater sensitivity than existing clinical measures; for example, changes detectable within three months that only appear in standard clinical assessments after twelve months.
• In one documented MS patient case, the platform detected a decrease in walking quality within the first two months of monitoring, while the patient's Expanded Disability Status Scale (EDSS) score remained unchanged at 6.0 after twelve months, and the Timed 25-Foot Walking Test showed only a 16% worsening — below the 20% threshold for meaningful clinical change.
• Continuous monitoring enables the formation of an accurate picture of disease impact over time, supporting both clinical assessment and pharmaceutical drug efficacy evaluation.
• The platform is designed to help pharmaceutical firms assess drug therapy effectiveness more quickly than previously possible.

Device Design and Usability

• The platform was designed in consultation with a global team of patients and clinicians, with a focus on ease of use for both groups.
• A patient usability rating of 85% was measured over twelve months of continuous use.
• Smart insoles are positioned as more reliable and easier to use than strap-based sensors, which do not measure pressure and may not be attached in a consistent position from day to day.
• Unlike strap-based systems that require attaching four or more sensors to specific body locations such as wrists, ankles, sternum, lumbar, and feet, the smart insole approach reduces the burden on patients.
• While the platform incorporates movement data from smartwatches and smartphones to improve accuracy, it is designed to go beyond what wrist- or pocket-based devices can measure for neurological conditions.

Regulatory Status and Clinical Reach

• The gait analysis software has received FDA designation as a Class II medical device.
• Celestra Health is currently involved in nine clinical trials across four countries, with data from these trials used to continually refine gait measurement algorithms.
• Customers include global pharmaceutical companies, research institutions, and healthcare providers.

Celestra Health positions its platform as a tool for earlier detection of neurological disease progression, more sensitive monitoring of patient mobility over time, and faster assessment of therapeutic interventions in clinical and pharmaceutical research settings.

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