Alio’s SmartPatch Technology Under Review in New Study

Alio Inc. has launched a multi-center and international investigational study to expand its U.S. Food and Drug Administration (FDA)-cleared technology beyond the dialysis space.

The 300-participant CAVA study will assess Alio’s SmartPatch technology for non-invasive monitoring of critical health metrics from the calf, including hemoglobin, hematocrit, potassium levels, SpO₂ level, blood volume, and heart rate. A preliminary study earlier this year showed a high correlation between the data acquired on the calf as compared to Alio’s previous FDA validations studies, and as compared to gold standard. This advancement would extend the use of Alio’s platform to patients who may not have vascular access sites.
 
“We are excited to embark on this important study building on the initial promise of the Alio Platform for kidney patients,” Alio CEO David Kuraguntla said. “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 non-invasive, longitudinal and patient-friendly solution is ideally suited to address the insufficient and resource intensive nature of managing such patients and elevate the standard of care at the same time.”
 
The CAVA study builds on Alio’s previous clinical research, which demonstrated the accuracy and reliability of its technology when used on arm-based vascular access sites. Those results proved Alio to be superior to current technologies and were the foundation of Alio’s two prior FDA clearances: skin temperature, auscultation sound data and heart rate in 2022, and hematocrit, hemoglobin and potassium in 2023, becoming the world’s first non-invasive potassium monitor.
 
“Purpose-built technology designed with holistic intentions and the patient in mind has the potential to transform chronic disease management by enabling critical decision making,” Alio Chief Technology Officer Samit Gupta stated. “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.”
 
Alio Inc. is a medical technology company focused on delivering AI-driven health insights through non-invasive, wireless monitoring for people with chronic conditions. The Alio Platform, powered by the SmartPatch, hub, and portal, is FDA-cleared to monitor hematocrit, hemoglobin, potassium, auscultation, heart rate and skin temperature—all without the need for blood draws, finger pricks or microneedles. Alio uses artificial intelligence to analyze data and create actionable insights. These insights enable targeted interventions with the potential for improved health outcomes and reduced hospitalizations. Currently indicated for hemodialysis patients, the Alio Platform will soon be available for all patients with chronic conditions, with additional metrics under development. Alio has built a team of seasoned leaders with diverse backgrounds spanning across industries and segments such as medical devices, wearable technology, government relations, commercialization, and reimbursement.