Successful Completion of Rekovar’s Adult Hypoxia Study

Rekovar has successfully ran three adult clinical trials with the collaboration with Vital Signs Research Group, a hypoxia lab solely dedicated to running hypoxia studies throughout October to December 2023. The goal of the study was to validate Rekovar’s NeoMonki Wearable’s (Rekovar’s next-generation health monitoring wearable) pulse oximeter for precision accuracy.

A hypoxia study for pulse oximeter, a sensor for monitoring a person's blood oxygen saturation, calibration is a controlled experiment designed to evaluate and calibrate the accuracy of pulse oximeters. Pulse oximeters are non-invasive medical devices that measure the saturation of oxygen in the bloodstream, typically referred to as SpO2. For these devices to provide accurate readings, they must be calibrated using data from individuals at varying blood oxygen saturation levels. In a hypoxia study, participants are typically exposed to reduced oxygen levels in a controlled environment to simulate conditions of reduced oxygen saturation. During this exposure, blood samples may be drawn and analyzed using a blood gas analyzer, which provides a direct measurement of blood oxygen saturation. The readings from the pulse oximeter are then compared with the blood gas analyzer measurements to determine the accuracy and reliability of the pulse oximeter under different conditions.

For this study, two devices were attached to the patient. One Neomonki device was placed on the patient’s wrist and one on the patient’s ankle. The goal of the study was to collect data and validate our design changes on the pulse oximeter sensor to improve the signal quality. Each patient would undergo a hypoxia protocol that would bring their SpO2 levels to various levels, and plateaus at predetermined levels for blood samples to be collected and analyzed for blood oxygen level. After collecting data from the clinical trial, the data is used to develop calibration coefficients from the calibration regression line to be used for the upcoming multicenter study clinical trial.