A wearable patch, a bedside hub and a cloud that turn continuous body signals into clinical-grade data for kidney care teams.
Alio, the Broomfield, Colorado medical-technology company that legally still trades as Graftworx, has spent more than a decade on a single, stubborn idea: that the routine blood work keeping chronic-disease patients alive should not require a needle, a lab trip, or a wait. Its answer is the SmartPatch, a wearable sensor that measures blood chemistry through the skin.
The patch is worn directly over a patient's arteriovenous fistula or an upper-extremity artery - the same access point used during dialysis. From there it captures a stream of metrics and relays raw data to a bedside hub, which uploads it to the Alio Medical Cloud. Proprietary algorithms turn the raw signal into readings a clinician can act on, presented in a care-team portal.
Alio's first area of focus is end-stage kidney disease. For a dialysis patient, the standard cadence of lab work is roughly one blood draw a month. The SmartPatch takes readings every few hours, painlessly. That change in cadence is the whole point: the company cites that about 65% of dialysis-related hospitalizations are considered preventable, and continuous data is designed to catch the warning signs before they become emergencies.
In 2023 the SmartPatch became the world's first non-invasive potassium monitor. Potassium is a quiet danger in kidney patients - a spike can be fatal - and until now there was no way to watch it between visits without a blood test. That milestone, alongside FDA clearance and a Series C round, marked Alio's shift from a long research project into a commercializing product.
This is such a pivotal moment for our organization, one which is the culmination of years of hard work.
Worn over the vascular access site, it non-invasively senses vital blood and body metrics.
Collects raw data from the patch and securely uploads it to the cloud.
Proprietary algorithms process raw signal into clinically actionable readings.
Care teams review metrics and alerts, and intervene early - remotely.
Leads Alio's strategy and its regulatory and commercial push, from first FDA clearance through the Series C round and the expansion beyond kidney care.
Drives the sensing, signal-processing and algorithm work that lets a wearable measure clinical-grade metrics through the skin.
Alio deploys its FDA-cleared platform to dialysis providers, hospitals and health systems, pairing device hardware with recurring cloud and remote-monitoring services.
Care teams and their end-stage kidney disease patients, reached through providers and health systems. Early deployments include an Intermountain Healthcare pilot.
David Kuraguntla and Samit Gupta start the company that becomes Alio, pursuing non-invasive monitoring of vascular access.
Alio completes its first pilot study of the SmartPatch in a partnership with Intermountain Healthcare.
FDA 510(k) clearance for skin temperature, auscultation sound and heart rate from arm-based vascular access sites.
First close led by the Widjaja Family Investment Office pushes total funding past $61M.
The platform adds FDA-cleared potassium, hemoglobin and hematocrit monitoring.
A calibration and validation study aims to expand clearance beyond the vascular access site to a broader range of patients.
Alio sits at the intersection of medical devices and digital health, in the fast-growing category of remote patient monitoring. Its most direct competition is not another patch so much as the incumbent workflow itself: central-lab blood testing and point-of-care draws that give clinicians periodic snapshots rather than a continuous signal.
In the kidney-care neighborhood, Alio operates alongside dialysis and device companies such as Outset Medical, Diality and Quanta, and works with the broader ecosystem of global kidney-care providers. Its wedge is specificity - a non-invasive potassium reading is something the standard toolkit simply cannot produce continuously - and a strategy of starting narrow in end-stage kidney disease before broadening, as the 2024 CAVA study signals, toward a wider patient population and conditions like heart failure.
Alio makes the SmartPatch, a non-invasive wearable that continuously tracks metrics like potassium, hemoglobin, hematocrit, heart rate and skin temperature, plus the hub, cloud and clinician portal that deliver the data to care teams.
It is the world's first non-invasive potassium monitor and reads clinical-grade blood chemistry through the skin over the vascular access site - no needles - taking readings every few hours instead of the traditional roughly monthly blood draw.
Its first focus is patients with end-stage kidney disease and those on dialysis, and its customers are dialysis providers, hospitals and health systems whose care teams monitor those patients.
Yes. Alio received FDA 510(k) clearance in 2022 for skin temperature, auscultation sound and heart rate, and expanded cleared metrics in 2023 to include hematocrit, hemoglobin and potassium.
More than $61 million in total, including an $18 million first close of its Series C round in December 2022 led by the Widjaja Family Investment Office.