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 blood pressure clinical study, which was conducted on 110 consented participants at the Movano Clinical Lab over a six week period in the fourth quarter of 2021.
“The completion of our third IRB-approved blood pressure study is a critical step forward on our multi-year journey to bring simple, smart and personalized medical devices to the market. It gives us data from a diverse group of people that we’ll use to improve our algorithms, and it’ll help us evaluate what studies we need to conduct in the future,” said Dr. John Mastrototaro, CEO of Movano Inc.
During the study, participants wore Movano’s adjustable full finger ring prototype and its wrist-worn wearable prototype along with a hospital-grade FDA-cleared vital signs monitor as the control. Movano’s devices collected pulse pressure waveform data, which will be compared to data from the control device in order to further its signal processing and algorithms. Movano’s proprietary integrated circuits in the wrist-worn prototype, which are supported by a radio-frequency technology platform, app and cloud infrastructure, allow Movano to calculate blood pressure, glucose, heart rate, and respiration rate estimates. The ring prototype also has an optical sensor to estimate SpO2 measurements and an accelerometer to measure steps and calories.
“We recently unveiled our first product, the Movano Ring, that aims to help women affordably monitor vital health information. While the initial Movano Ring may not have FDA clearances at launch, we plan to pursue Class II designations for our future products, to add medical data, including heart rate, respiration rate, SpO2, cuffless blood pressure and non-invasive glucose monitoring, in a step-by-step fashion over time,” continued Dr. Mastrototaro.
Movano also plans to execute its second glucose study with an independent FDA-compliant clinical lab during the first quarter of 2022. Similar to the initial glucose clinical study in December 2020, all subjects are expected to be persons with Type 1 diabetes with varying gender, age, ethnicity and BMI.