• First contract research organization (CRO) to explore use of Rockley’s Bioptx™ biomarker sensing platform for non-invasive monitoring of multiple biomarkers during clinical trials
  • Rockley Bioptx™ wearable devices set to transform clinical research by enabling decentralized trials, generating crucial insights into the health and well-being of participants

Rockley Photonics Holdings Limited (NYSE: RKLY) (“Rockley”), a global leader in photonics-based health monitoring and communications solutions, today announced a new partnership with a top ten, global contract research organization (CRO) that provides full-service clinical development services to biopharmaceutical customers. Under the agreement, the CRO and Rockley will collaborate on strategic programs to integrate Rockley’s health monitoring solutions into clinical research studies, including its Bioptx™ biosensing wristband, cloud services, and other elements of its biomarker sensing platform for continuous, near real-time, non-invasive measurement of multiple biomarkers. The addition of Rockley’s wearable devices and artificial intelligence (AI) capabilities to clinical research has the potential to enable decentralized trials, increase the frequency and accuracy of vital sign monitoring, and expand the range of biomarker information collected from research participants, whether at a clinic or in a remote location.

In this collaboration, the CRO is expected to use Rockley-powered remote monitoring wearables as a tool for researchers to better understand various factors affecting the health and well-being of trial participants. The Rockley Bioptx wristbands will potentially allow the CRO to collect in-depth data about an expanded range of biomarkers, including core body temperature, blood pressure, heart rate, blood oxygen, and body hydration, among others. By gathering and analyzing data on key biomarkers, this new partnership has the potential to enhance the opportunity for the Rockley platform to provide pharmaceutical companies and healthcare professionals with a more thorough understanding of how specific treatments and interventions affect a patient’s overall health.

Traditional approaches in clinical trials have relied primarily on intermittent assessments of biological data, usually gathered by on-premises tests performed at a designated trial site or clinic. By leveraging Rockley’s remote biosensing capabilities, CROs could expand the boundaries of clinical trials beyond the confines of a clinic by monitoring participants as they go about their daily lives. This greater flexibility could allow CROs to broaden the types of trials conducted — e.g., in-clinic, virtual, hybrid, and decentralized — thereby extending data assessments into situations closer to real-world conditions. The integration of Rockley’s cloud analytics and AI capabilities could allow CROs to develop a deeper understanding of trial results and the interactions of various biomarkers and health conditions.

Rockley expects that the comprehensive data produced by its biosensing wristbands could have a significant impact on study design, patient selection, and go/no-go decisions. Rockley-powered devices have the potential to improve patient recruitment and compliance, as patients would need to make fewer office visits. Additionally, adhering more closely to the trial protocol requirements would be simplified, reducing protocol deviations. The anticipated decrease in site visits would also reduce site and resource burden, leading to cost savings.

Dr. Andrew Rickman, chairman and chief executive officer of Rockley, said, “Partnering with CROs expands our reach in medtech and creates exciting opportunities for clinicians and researchers to conduct decentralized clinical trials and gain crucial insights into the health and well-being of patients throughout the trial, regardless of their location. With the extended range of biomarker detection and the ability to monitor those biomarkers on a routine basis, Rockley-powered wearables are poised to add a new dimension to clinical research and bring us one step closer to realizing our goal of improving health outcomes for everyone.”

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,” “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 potential of Rockley’s sensing platform to provide real-time insights about a variety of health conditions and enable the early detection of disease states through continuous, near real-time, non-invasive measurement of a wide range of biomarkers; (b) the ability of Rockley’s wearable devices and artificial intelligence (AI) capabilities to enable decentralized trials, increase the frequency and accuracy of vital sign monitoring, and expand the range of biomarker information collected from research participants; (c) the ability of Rockley’s platform to transform clinical research by enabling decentralized trials, generating crucial insights into the health and well-being of participants; (d) the ability of Rockley’s platform to provide pharmaceutical companies and healthcare professionals with a more thorough understanding of how specific treatments and interventions affect a patient’s overall health; (e) the ability to expand the boundaries of clinical trials beyond the confines of a clinic by monitoring participants as they go about their daily lives; (f) the ability of CROs to broaden the types of trials conducted and extend data assessments into situations closer to real-world conditions; (g) the ability of Rockley’s cloud analytics and AI capabilities to allow CROs to develop a deeper understanding of trial results and the interactions of various biomarkers and health conditions; (h) the impact the data produced by Rockley’s biosensing wristbands will have on study design, patient selection, and go/no-go decisions; (i) the potential to reduce costs and improve patient recruitment and compliance through the use of Rockley’s devices; (j) the ability to Rockley’s devices to add a new dimension to clinical research and bring us one step closer to realizing our goal of improving health outcomes for everyone; (k) Rockley’s belief that photonics will eventually become as pervasive as micro-electronics; and (l) Rockley’s potential to support hyper-scale manufacturing, address a multitude of high-volume markets, and deliver the complex optical systems required to bring transformational products to market.

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; and (xx) 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 annual report on Form 10-K, 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.

Media Debra Raine Rainemakers Telephone: +1 415-349-7432 Email: rockleyphotonics@rainemakers.com

Investors Gwyn Lauber Rockley Photonics Telephone: +1 626-995-0001 Email: investors@rockleyphotonics.com

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