Rockley Photonics announced the initial results from two important IRB-approved human studies using a first-generation Alpha prototype of their non-invasive and laser-based cuffless blood pressure monitor. This innovative, wearable device is currently in advanced development. The first study successfully demonstrated intra-subject tracking of blood pressure compared to measurements using an intra-arterial pressure transducer, or an A-line, which is the gold-standard method to continuously monitor blood pressure during surgery and in the ICU.

Thirty (30) subjects participated in the study, where blood pressure changes were induced using a repeated leg press exercise. Utilizing only the Rockley laser-based signal and a single-point blood pressure calibration, blood pressure changes from -10 mmHg to +25 mmHg were within target accuracy according to both FDA recognized consensus standards ISO 81060-2 and IEEE 1708. Future studies will focus on expanded blood pressure ranges.

A second longitudinal study followed subjects with repeat visits up to 34 days post calibration. Here, Rockley device predictions were compared to dual-observer auscultation measurements (cuff-based with split stethoscope). Subjects included both healthy and hypertensive adult volunteers between ages 18 and 71 years.

Despite real-world variability in device placement, the use of multiple devices per subject, and higher reference error, the longitudinal study results were comparable to the A-line study over the same BP range, and within sight of meeting the ISO 81060-2 and IEEE 1708 accuracy targets. Notably, the error did not increase over the time period from initial calibration. Potential use cases for the device focus on management of hypertension in various patient populations, where frequent insight may be leveraged in challenging-to-monitor scenarios, such as those that experience white coat hypertension or undergo regular treatments for kidney disease or heart failure.

Rockley plans to engage with FDA via the Q-sub process in the coming months to obtain feedback on future clinical study design and data analysis.