Movano Health announced the results of its Institutional Review Board (IRB)-approved blood pressure clinical study. Movano Health's prototype, which incorporated its SoC, demonstrated a level of accuracy within the standards recognized by the FDA for blood pressure monitoring devices. The Company's algorithm for blood pressure monitoring utilized data from its prototype system combined with the subject's demographic information and a recent blood pressure reading.

The prototype achieved an overall mean absolute difference (MAD) of 5.9 mmHg, which is below the 7 mmHg MAD required per a standard for wearable, cuffless blood pressure measuring devices (IEEE1708a-2019). The Company is also evaluating AI-based individual calibration methods to further enhance the future performance of the device. The 44-participant study, conducted at the Movano Health Clinical Lab, assessed the accuracy of its wrist-worn wearable prototype compared to a hospital-grade FDA-cleared blood pressure monitor.

The study measured the blood pressure of each participant multiple times, including while under stress, which resulted in an average participant systolic blood pressure range of 25 mmHg and a total study range of 85 - 171 mmHg. The Company's 4 x 6.7 mm SoC combines multiple antennas and a variety of frequencies in the smallest ever RF-enabled integrated circuit designed specifically for blood pressure and glucose monitoring. After shrinking its multi-chip architecture from four chips into one in mid-2022, Movano Health began using the patented SoC in clinical studies this year, which has materially improved the accuracy of its blood pressure measurements as seen by the results of this most recent study.

In its current form factor, Movano Health's wearable prototype represents one of the smallest and most accessible ways to measure blood pressure. Hypertension has reached epidemic proportions in the United States and is often labeled the silent killer as many don't know they are affected. According to the American Heart Association, high blood pressure affects half of Americans ages 20 years and older ?

or more than 122 million people ? and 59 million Americans have prehypertension. Movano Health's cutting-edge RF technology has the potential to empower individuals and their clinicians to better monitor and manage their high blood pressure on a daily basis.

Movano Health is planning to execute a multi-week study to determine whether periodic calibration is required and refine its AI models on an individual patient basis beginning in the fourth quarter of 2023. Following the completion of this longitudinal study, the Company intends to conduct a clinical trial for its 510(k) submission to the FDA.