Though Rockley Photonics got off to a rocky start this year by filing for Chapter 11 bankruptcy in January, the proceedings ultimately lasted less than six months from start to finish—and the company is already back to work on the development of its wearable biosensors.
That includes fine-tuning its blood-pressure-monitoring sensor, a laser-based system that could be embedded in a wrist-worn device to collect blood pressure measurements without the standard mechanism of an inflating cuff.
Rockley unveiled preliminary results from a pair of studies of the monitor this week. The promising—if not entirely successful—outcomes build on an initial pilot study the company wrapped up last year which proved that its lasers could accurately and continuously measure blood pressure through the skin.
According to a Wednesday release from Rockley, the first study recruited 30 participants and compared its sensor’s readings of their blood pressure to readings collected by the “gold standard” for continuous blood pressure monitoring, an intra-arterial pressure transducer, commonly known as an A-line. Rockley’s device was calibrated using only one data point.
Throughout the test period, participants performed leg press exercises to spark changes in blood pressure, shifting between 10 mmHg lower and 25 mmHg higher than normal levels. Rockley’s device tracked those changes with an accuracy level well within the bounds of two FDA-recognized standards, the company reported.
The second study was less of a home run: It compared the Rockley sensor’s readings to those of the A-line over the course of 34 days after the sensor’s initial single-point calibration. Its accuracy levels weren’t quite as high this time around, with Rockley saying in the release that it was “within sight of meeting” the same standards as before.
However, the company also noted that its device’s results “were comparable to the A-line study over the same BP range” and that the higher reference error stayed constant throughout the study period, rather than pushing the sensor’s readings further from the A-line’s over time.
Next up, Rockley said it plans to work with the FDA to shape its next clinical studies of the technology and its analysis of the resulting data, all toward an aim of eventually securing the agency’s clearance for the cuffless blood pressure monitoring system—a feat already accomplished by fellow wearables makers Biobeat Medical and LiveMetric.
“There’s an art to taking a reliable blood pressure measurement using a traditional cuff. However, blood pressure measurements using wearables have long been a challenge,” Zahi Fayad, Ph.D., a member of Rockley’s scientific advisory board and a professor at Mount Sinai’s Icahn School of Medicine, said in the release. “It is very exciting to see this cuffless technology becoming available, as it enables frequent measurements and can provide a seamless and easy practitioner and patient experience.”
The study results come about two months after Rockley emerged from Chapter 11 bankruptcy. In early June, the company announced that it had wrapped up the financial restructuring plan proposed as part of the bankruptcy proceedings.
According to Rockley, it emerged from the bankruptcy protections with all of its material customer contracts still in place, with its tech development programs all on track to keep moving forward and with $35 million in new funding from its stakeholders to boot.
Along the way, Andrew Rickman, Ph.D., retook his place at the helm; he’d originally been replaced as CEO last December by then-Chief Financial Officer Richard Meier, but, when Rockley emerged from bankruptcy, it did so with Rickman back in the driver’s seat.