Movano Inc. (NASDAQ:MOVE), a health technology company designing devices that inspire and empower you to live a healthier, happier life, today announced the completion of an Institutional Review Board (IRB)-approved glucose pilot study, which was conducted on 10 participants with type 1 diabetes of varying gender, age, ethnicity, and weight in conjunction with an independent FDA-compliant clinical lab.
During each four-hour session, participants wore Movano’s wrist-worn wearable prototype, which uses the Company’s proprietary Radio Frequency-enabled ICs and allows Movano to calculate glucose, blood pressure, heart rate, and respiration rate estimates. The study will compare the Movano data to results captured with an FDA-cleared finger stick glucose tester, a subject’s existing CGM device, and/or a vital sign monitoring device. The study will ultimately allow Movano to further refine the algorithms it uses to calculate glucose values and vital sign measurements and will also help guide the Company as to what specific follow-on studies will be done in support of future FDA clearances.
“The goal for our technology is to create devices that are stylish and affordable for you to wear every day and are also cleared by the FDA to help you better monitor and manage the effects of chronic conditions, like diabetes and hypertension,” said Dr. John Mastrototaro, CEO of Movano Inc. “To do so, we have an aggressive roadmap to test our radio frequency-enabled technology and pursue accuracy studies to eventually gain FDA clearances for heart rate, SpO2, respiratory rate as well as non-invasive glucose and cuffless blood pressure monitoring. The glucose pilot we just completed is extremely valuable as it allows us to gather the data needed to improve the accuracy of our algorithms and hone in on our future clinical study plans.”