Rockley Photonics Announces Bioptx™ Biomarker Sensing Platform for Professional Healthcare, Including First-of-its-Kind Non-Invasive, Continuous Biosensing Wristband

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.

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Sample Use of Rockley Bioptx Biosensing Wristband (Photo: Business Wire)

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.

More information about Rockley’s digital health monitoring solution is available here: https://rockleyphotonics.com/healthcare-sensing.

About Rockley Photonics

A global leader in photonics-based health monitoring and communications solutions, Rockley Photonics is developing a comprehensive range of photonic integrated circuits and associated modules, sensors, and full-stack solutions. From next-generation sensing platforms specifically designed for mobile health monitoring and machine vision to high-speed, high-volume solutions for data communications, Rockley is laying the foundation for a new generation of applications across multiple industries. Rockley believes that photonics will eventually become as pervasive as micro-electronics, and it has developed a platform with the power and flexibility needed to address both mass markets and a wide variety of vertical applications.

Formed in 2013, Rockley is uniquely positioned to support hyper-scale manufacturing and address a multitude of high-volume markets. Rockley has partnered with numerous tier-1 customers across a diverse range of industries to deliver the complex optical systems required to bring transformational products to market.

To learn more about Rockley, visit rockleyphotonics.com.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release that are not historical facts constitute “forward-looking statements” for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding Rockley’s future expectations, beliefs, plans, objectives, and assumptions regarding future events or performance. The words “accelerate,” “advance,” “allow,” “anticipate,” “believe,” “can,” “capability,” “continue,” “could,” “develop,” “enable,” “estimate,” “eventual,” “expand, “expect,” “focus,” “forward,” “future,” “goal,” “intend,” “may,” “might,” “opportunity,” “outlook,” “plan,” “possible,” “position,” “potential,” “predict,” “project,” “revolutionize,” “seem,” “should,” “trend,” “vision,” “will,” “would” or other terms that predict or indicate future events, trends, or expectations, and similar expressions or the negative of such expressions may identify forward-looking statements, but the absence of these words or terms does not mean that a statement is not forward-looking. Forward-looking statements in this press release include, but are not limited to, statements regarding the following: (a) the anticipated and potential features, scope, goals, and benefits of the Company’s platform, products, and technology, including its first-of-its-kind biosensing wristband, cloud analytics and AI; (b) Rockley’s continued focus on the commercialization of its platform in the health monitoring space and timing for the development thereof; (c) Rockley’s strategy for monetizing the data collected from its biomarking sensing products; (d) the potential for continuous measurement of key biomarkers to transform healthcare by providing real-time insights into a variety of health conditions and enable early detection of multiple disease states; (e) the potential to leverage data collected from Rockley’s biomarking sensing products to improve a variety of healthcare treatments, including remote patient monitoring, medical therapies, management of chronic conditions, and drug development; (f) the timing for the commercial availability of Rockley’s products; (g) the potential effectiveness of the wearable sensing platform for determining key biomarkers; (h) the expectation that the cloud-based analytics and AI capabilities of Rockley’s platform can help develop a more holistic assessment of a person’s health and well-being; (i) Rockley’s belief that its cloud and AI infrastructure can enable additional capabilities for the fast-growing digital health domain and help individuals make more informed decisions about their health and well-being; and (j) .

Forward-looking statements are subject to several risks and uncertainties (many of which are beyond Rockley’s control) or other assumptions that may cause actual results or performance to differ materially from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the following: (i) Rockley’s ability to achieve customer acceptance and commercial production of its products and technology, including in a timely and cost-effective manner; (ii) Rockley’s ability to achieve customer design wins and convert memoranda of understanding and development contracts into production contracts; (iii) risks related to purchase orders, including the lack of long-term purchase commitments, the cancellation, reduction, delay, or other changes in customer purchase orders, and if and to the extent customers seek to enter into licensing arrangements in lieu of purchases; (iv) Rockley’s history of losses and need for additional capital and its ability to access additional financing to support its operations and execute on its business plan, as well as the risks associated therewith; (v) legal and regulatory risks; (vi) risks associated with its fabless manufacturing model and dependency on third-party suppliers; (vii) Rockley’s reliance on a few significant customers for a majority of its revenue and its ability to expand and diversify its customer base; (viii) Rockley’s financial performance; (ix) the impacts of COVID-19 on Rockley, its customers and suppliers, its target markets, and the global economy; (x) Rockley’s ability to successfully manage growth and its operations as a public company; (xi) fluctuations in Rockley’s stock price and Rockley’s ability to maintain the listing of its ordinary shares on the NYSE; (xii) Rockley’s ability to anticipate and respond to industry trends and customer requirements; (xiii) changes in the current and future markets in which Rockley is or may be engaged; (xiv) risks related to competition and intellectual property; (xv) market opportunity and demand for Rockley’s products and technology, as well as the customer products into which Rockley’s products and technology are incorporated; (xvi) risks related to international operations; (xvii) risks related to cybersecurity, privacy, and infrastructure; (xviii) risks related to financial and accounting matters; (xix) general economic, financial, political, and business conditions, both domestic and foreign; (xx) Rockley’s ability to realize the anticipated benefits of its recently completed business combination with SC Health Corporation; and (xxi) Rockley’s ability to realize the anticipated benefits of strategic partnerships, as well as other factors described under the heading “Risk Factors” in Rockley’s quarterly report on Form 10-Q for the quarter ended September 30, 2021, and in other documents Rockley files with the Securities and Exchange Commission in the future.

The forward-looking statements contained in this press release are based on various assumptions, whether or not identified in this press release, and on Rockley’s current expectations, beliefs, and assumptions and are not predictions of actual performance. If any of these risks or uncertainties materialize, or should any of these assumptions prove incorrect, actual results may differ materially from those discussed in or implied by these forward-looking statements. There can be no assurance that future developments affecting Rockley will be those that have been anticipated. These forward-looking statements speak only as of the date hereof and Rockley does not intend to update or revise any forward-looking statements, whether because of new information, future events, or otherwise, except as required by law.

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