Alio's New Study Aims for Broader FDA Clearance for Patients

Author: Olivia Taylor Updated: 09-14-2024 06:36 AM

Alio Launches Innovative CAVA Study for Broader Patient Care

Alio, Inc., a leader in AI-powered clinical-grade wearables, has announced the launch of its groundbreaking study, known as the CAVA study, focusing on multi-center and international research. This study seeks to significantly expand the FDA clearance of the Alio Platform, which has previously specialized in vascular access for dialysis patients.

Expanding Capabilities Beyond Dialysis

The primary goal of the CAVA study is to explore the capabilities of Alio's innovative SmartPatch technology, which enables non-invasive monitoring of vital health metrics. This includes critical parameters like hemoglobin, hematocrit, potassium levels, blood oxygen saturation, blood volume, and heart rate, all measured from the calf.

The Study's Scope and Objectives

With an expected enrollment of up to 300 participants, the CAVA study builds upon previous research that highlighted a strong correlation between data collected in the calf and data gathered in earlier FDA validation studies. This could bring new opportunities for patients who currently lack vascular access, ultimately extending the platform's applicability.

Leadership's Vision

David Kuraguntla, CEO of Alio, expressed his excitement about the study, emphasizing the potential of the Alio Platform to provide significant health insights for patients with chronic conditions. He believes that expanding the placement locations validated by CAVA will enhance Alio’s regulatory clearances, allowing their technology to benefit a wider demographic, including those with chronic kidney disease and heart failure.

Building on Proven Success

The new study comes on the heels of Alio's previous clinical research, which validated their technology’s accuracy and reliability using traditional arm-based vascular access sites. The results were impressive, establishing Alio as a leader in the field and laying the groundwork for their prior FDA clearances in 2022 and 2023, which were centered on monitoring hematocrit, hemoglobin, potassium levels, and more.

Emphasis on Patient-Centric Innovation

Samit Gupta, CTO of Alio, echoed the sentiment that the technology developed by Alio was purpose-built to target chronic disease management challenges. He noted that incorporating additional metrics, including blood pressure and electrolytes, may soon transition into FDA validation studies, allowing healthcare providers to deliver timely interventions that could potentially reduce complications.

About Alio

Alio, Inc. stands at the forefront of medical technology with a mission to deliver transformative health insights powered by AI and non-invasive monitoring techniques. Currently, the Alio Platform is specifically indicated for hemodialysis patients, but with ongoing developments, it aims to support a broader category of patients managing chronic health conditions.

Utilizing the SmartPatch, hub, and portal, Alio’s offerings are FDA-cleared for a range of monitoring applications, eliminating the need for uncomfortable procedures like blood draws or finger pricking. By leveraging artificial intelligence, Alio processes health data to generate actionable insights that can lead to improved patient outcomes and reduce reliance on hospital care.

Frequently Asked Questions

What is the focus of the CAVA study by Alio?

The CAVA study aims to expand the FDA clearance of Alio's technology to provide broader health monitoring solutions for patients with chronic conditions, beyond just dialysis.

How many participants are expected to enroll in the CAVA study?

Up to 300 participants are expected to enroll in the CAVA study to evaluate the capabilities of Alio's SmartPatch technology.

What health metrics will be monitored in the CAVA study?

The study will monitor crucial health metrics such as hemoglobin, hematocrit, potassium levels, SpO₂, blood volume, and heart rate from the calf.

What has been the previous success of Alio's technology?

Alio's earlier clinical research established the accuracy and reliability of its monitoring systems, which led to FDA clearances for devices that measure hematocrit, hemoglobin, potassium, and more.

What is the main benefit of Alio's technology for patients?

Alio's technology offers non-invasive monitoring solutions that can improve health outcomes, facilitate timely interventions, and reduce hospitalizations for those with chronic conditions.

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