OXFORD, England & PASADENA, Calif.– Rockley Photonics Holdings Limited (NYSE: RKLY) (“Rockley”), a global leader in photonics-based health monitoring and communications solutions, today announced the Bioptx™ platform of biomarker sensing products and solutions for the medical and healthcare market. The Bioptx healthcare sensing platform is expected to provide medical institutions, such as hospitals, research clinics, pharmaceutical companies, medical device manufacturers, and other healthcare providers, with the ability to monitor the general wellness of individuals.
The Bioptx sensing platform will integrate various sensing capabilities, including Rockley’s patented silicon-photonics-based laser technology. Rockley’s technology has the potential to significantly enhance the range of biomarkers that can be detected and measured by current sensors. The expanded range of biomarkers will include core body temperature, blood pressure, body hydration, alcohol, lactate, and glucose trends, among others. These new measurement capabilities have the potential to transform healthcare by providing real-time insights into a variety of health conditions and by enabling early detection of multiple disease states.
The cloud analytics and AI capabilities of the Bioptx sensing platform will allow medical institutions to analyze biomarker information, monitor general health conditions, and track population health metrics. These insights have the potential to support and improve a variety of healthcare treatments, including remote patient monitoring, medical therapies, management of chronic conditions, and drug development.
The Bioptx sensing platform will include a range of hardware and software solutions that enable non-invasive, continuous, and real-time monitoring of multiple biomarkers, from a wearable biosensing wristband to cloud analytics and artificial intelligence (AI). Rockley also plans to offer additional cloud-based subscription services that enhance the capabilities of the biosensing platform.
The Bioptx line of sensing products, which will address specific needs of the professional healthcare market, is the second product line to leverage Rockley’s silicon-photonics-based biosensing platform. The company’s VitalSpex™ product line will address the consumer wearable market. Both product lines incorporate Rockley’s highly disruptive silicon photonics technology and clinic-on-the-wrist™ miniaturizing technology.
Rockley had previously projected that it would introduce commercial products into the professional healthcare market in 2024. The announcement of the Bioptx product line and shipping of engineering samples come two years earlier than projected to meet the demand from our customers and partners. The company shipped the first of its engineering samples to multiple customers in January of 2022. The first commercial products in the Bioptx line are expected to be available as early as the second half of 2022.
“Launching the Bioptx product line two years earlier than planned represents a significant step forward in the deployment and commercialization of our biomarker sensing platform and will allow us to develop and refine our algorithms and analytics for the healthcare market more quickly,” said Dr. Andrew Rickman, chairman and chief executive officer of Rockley. “People are interested in taking a more proactive role in managing their health, and professional healthcare providers are looking for a holistic approach to outcome-based programs. I believe our Bioptx biosensing platform has the potential to significantly advance this new approach by providing non-invasive, continuous remote patient monitoring that’s much more accurate and tracks a broader range of health conditions.”
“With the potential for additional revenue that could begin as early as 2023, the new Bioptx platform also gives Rockley the opportunity to offer new software and cloud services in addition to the wristband,” added Mahesh Karanth, Rockley’s chief financial officer. “These new opportunities build on our already strong customer base of two of the world’s top ten medical equipment and device manufacturers and twelve leading global consumer electronics companies, potentially increasing Rockley’s market opportunity by as much as $15 billion.”
Rockley intends to use the data and learnings gathered from the Bioptx line to further refine the sensing algorithms, cloud analytics, and AI of its sensing platform. The launch of a healthcare-specific biosensing product line is expected to accelerate Rockley’s access to data and the refinement and expansion of its platform functionality. Rockley expects that these refinements will allow it to expand the intended uses of the Bioptx product line and move forward with plans to seek certification from the U.S. Food and Drug Administration (FDA) that products in the Bioptx line meet the FDA’s definition of a medical device, per Section 201(h) of the Food, Drug, and Cosmetic Act.
Rockley expects that customers will initially use its Bioptx platform to monitor the general wellness of individuals under care or in studies. After products in the Bioptx line receive approval from the FDA or other regulatory agencies, Rockley anticipates that customers will expand product use into preventive and diagnostic care, such as remote patient monitoring and diagnosis.
