ANALYSIS: WEARABLE TECHNOLOGY
Analysis and Opinion section sponsored by
From bankruptcy to blood pressure trials: Rockley Photonics’ rise to success
Nicholas Witts reports on Rockley Photonics’ ongoing development of a wearable, laser- based blood pressure monitor
S
ince emerging from bankruptcy in June 2023 with $35 million in fresh
funding from stakeholders, health tech company Rockley Photonics has made advances in its development of a wearable, laser-based blood pressure monitor with the completion of two new trials. The monitor, named the Bioptx Biosensing Band, is a first-of-its-kind infrared biosensing wristband that is now moving another step closer to commercialisation.
How does the novel, laser- based technology work? The Bioptx Biosensing Band can detect and measure multiple biomarkers by combining infrared laser sensing technology, visible photoplethysmogram sensors, and software-configurable proprietary algorithms. Through this approach, the Bioptx could be used to manage hypertension in patients and provide frequent insights for challenging-to-monitor scenarios, such as for people who need regular treatments for kidney disease or heart failure. Rockley Photonics CEO
Andrew Rickman says: “One of the single largest public health actions that anyone could do, certainly here in the US and in many other countries, is to go after hypertension. A way to do this is by essentially providing the population with the ability to be able to have their blood pressure recurrently measured in the background. For many people, it’s treatable, either by lifestyle changes or, in many cases, medication.” The information collected by
the Bioptx Biosensing Band is processed into a form that a healthcare professional can
8 Electro Optics October 2023
put into their platform. It can then be used as part of the patient’s records, later reviewed and becoming a key source of information. Rickman adds: “We wanted to create something that basically plugged into the patient to get the broad range of biomarkers, and then to allow that data to be utilised through secure channels, and according to the cybersecurity rules. All of this comes down to providing that data in the cloud to the healthcare provider.”
What were the study results and why do they matter? To ensure that this technology can demonstrate reliable support for such healthcare challenges, it was subjected to trialling with two IRB (Institutional Review Board)-approved human studies. The first of the two IRB-
approved studies demonstrated intra-subject tracking of blood pressure compared to measurements using an intra- arterial pressure transducer, or an A-line. This testing continuously monitors blood pressure during surgery and in ICU settings. The study, involving 30 subjects, demonstrated how the laser-based signal and a single-point blood pressure calibration were able to monitor blood pressure changes from -10 mmHg to +25 mmHg within target accuracy, according to both FDA-recognised consensus standards ISO 81060-2 and IEEE 1708. The second trial, a longitudinal study that followed subjects with repeat visits up to 34 days post-calibration, compared device predictions with cuff-based/split stethoscope measurements. The longitudinal study
results were comparable to the A-line study over the same
The Bioptx Biosensing Band
blood- pressure range, and within sight of meeting the ISO 81060-2 and IEEE 1708 accuracy targets. There was real-world variability in device placement, the use of multiple devices per subject, and higher reference error; however, errors did not increase over the time period from initial calibration, Rockley Photonics says. Dr Richard Kuntz, Scientific Advisor to Rockley Photonics, says: “Rockley’s device shows
“Rockley’s device shows promise that it will perform with the accuracy expected from traditional medical devices”
promise that it will perform with the accuracy expected from traditional medical devices, which can vastly improve patient compliance and overall case management.” By completing the two IRB-approved human studies, Rockley Photonics has been able to expand its findings beyond the initial proof-of- concept study from 2022.
What’s next for the Bioptx Biosensing Band? In the coming months, Rockley Photonics plans to engage with the FDA to obtain feedback on future clinical-study design and data analysis, helping
it to identify and implement improvements that can be made to the upcoming alpha iteration of the new device. Alongside this, Rockley Photonics has also launched a first-generation API Developer Platform, which it says will capture rich sensor data from subjects in free-living conditions and enable rapid integration of sensor data and cloud-computed biomarkers by the developer community. The platform will be key in
gathering information from the Bioptx Biosensing Band, beyond blood pressure alone. It will include information on heart rate, heart-rate variability, respiratory rate, blood-oxygen saturation, body temperature, and hydration status. In doing so, it will provide data access to those engaged in commercial activities and research with Rockley Photonics. Dr Zahi Fayad, Director of
the Biomedical Engineering and Imaging Institute at the Icahn School of Medicine at Mt. Sinai and member of Rockley’s Scientific Advisory Board says: “Until now, data has been locked away in a kind of black box that we could only get batched data from and didn’t have the ability to get what we needed when we needed it. This [API Developer Platform launching] is a significant development.” EO
www.electrooptics.com
Rockley Photonics
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50
