Alio Launches CAVA Study to Expand Wearable Platform for Chronic Condition Monitoring

Key Insights

• Alio, Inc. has initiated the CAVA study to broaden the application of its AI-powered wearable technology beyond dialysis patients to those with various chronic conditions.
• The CAVA study will enroll 300 participants to assess the SmartPatch's ability to non-invasively monitor key health metrics from the calf, such as hemoglobin and potassium levels.
• The aim is to validate additional body placement locations, potentially extending the platform's reach to patients without vascular access sites and improving chronic disease management.

Alio, Inc., a company specializing in AI-driven clinical-grade wearables, has announced the commencement of its Calibration and Validation (CAVA) study. This multi-center, international investigational study aims to expand the capabilities of the Alio Platform beyond its current use in dialysis, to serve a broader population of individuals living with chronic conditions.

The CAVA study will evaluate Alio’s SmartPatch technology for the non-invasive monitoring of critical health metrics via calf placement. These metrics include hemoglobin, hematocrit, potassium levels, SpO2, blood volume, and heart rate. The study plans to enroll up to 300 participants. Preliminary data has demonstrated a strong correlation between calf-acquired data and data from Alio’s previous FDA validation studies, as well as comparisons to gold standard measurements. This advancement would allow the Alio platform to be used on patients without vascular access sites.

Expanding Access and Improving Chronic Care

"We are excited to embark on this important study building on the initial promise of the Alio Platform for kidney patients," stated David Kuraguntla, CEO of Alio. "By validating additional placement locations on the body with CAVA, we aim to expand on our prior regulatory clearances and serve a wider range of patients with critical health insights, including those with chronic kidney disease, heart failure, and other chronic conditions."

Alio's technology has already received two FDA clearances: one in 2022 for skin temperature, auscultation sound data, and heart rate, and another in 2023 for hematocrit, hemoglobin, and potassium. The latter made Alio the first non-invasive potassium monitor in the world. These clearances were based on clinical research demonstrating the accuracy and reliability of the technology when used on arm-based vascular access sites.

Future Applications and Technology

Samit Gupta, CTO of Alio, emphasized the potential of patient-centric technology to transform chronic disease management. "With additional metrics including clinical markers, blood pressure and electrolytes nearing FDA validation studies, Alio’s technology could help clinicians intervene earlier, potentially reducing complications and improving outcomes for patients."

The Alio Platform, which includes the SmartPatch, hub, and portal, utilizes AI to analyze data and generate actionable insights. The company envisions its technology enabling targeted interventions, leading to improved health outcomes and reduced hospitalizations for individuals with chronic conditions.