Rockley Photonics Announces Results of Preliminary Human Study Measuring Hydration and Introduces a Novel Hydration Index

- Confirms performance of Rockley’s non-invasive biomarker sensing platform in measuring hydration levels

- Correctly predicts dehydration 99% of the time

- Introduces the Rockley Hydration Index™, a powerful new measurement scale designed to provide a simple way to understand personal hydration levels

Rockley Photonics Holdings Limited (NYSE: RKLY) (“Rockley”), a global leader in photonics-based health monitoring and communications solutions, today announced that the company has successfully completed its preliminary human study measuring hydration levels using Rockley’s non-invasive biomarker sensing platform. Rockley has also created a new hydration index for reporting relative hydration levels with the potential to simplify the complex process of measuring personal hydration.

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Rockley Hydration Index™ (Graphic: Business Wire)

Preliminary results of Rockley’s human study examining active hydration levels before, during, and after exercise show that the miniaturized photonics-based sensor in the Rockley biosensing platform can monitor water absorption and is sensitive to water concentration changes in different layers of the dermis. The study shows that a Rockley wearable device was able to correctly predict dehydration in human subjects 99% of the time and detect the normal state of body water content (euhydration) 82% of the time. The ability to monitor changes in body water levels on a routine basis through a Rockley-powered device has the potential to help people and healthcare professionals make better-informed choices about their personal and patient hydration needs, respectively, including the amount and timing of fluid consumption.

Until now, there has been no single “gold standard” method for measuring hydration. Using current methodologies, properly measuring a person’s hydration level involves a combination of costly and time-consuming laboratory tests to assess the osmolality and electrolyte concentrations in physiological fluids, such as urine and blood.

To fill the need for a monitoring solution that assesses hydration levels and doesn’t impinge on a person’s lifestyle, Rockley has developed a photonics-based technique with the potential to monitor hydration levels on a more routine basis and simplify the reporting of relative hydration levels. The Rockley Hydration Index™ will examine laboratory and field-appropriate hydration assessment techniques and correlate their output to the spectral data generated by the Rockley biomarker sensor. By expressing hydration as a number, the Rockley Hydration Index has the potential to make it easy for people to check if they are over- or under-hydrated and deliver insights or recommendations tailored to each person’s individual hydration needs.

“The need to maintain hydration is important for overall wellness. However, maintaining healthy hydration habits can be challenging, and most people are not aware of if or when their bodies may experience a dehydration-related problem,” said Dr. Stavros Kavouras, professor of nutrition and director of the Hydration Science Lab at Arizona State University. “By routinely monitoring hydration using a wearable device and simplifying how hydration levels are reported, Rockley has provided a simple yet powerful method for people to understand their hydration levels and take action based on those insights.”

“The results of our hydration study are promising and show how our wearable sensing platform can measure hydration levels,” said Dr. Andrew Rickman, chairman and chief executive officer of Rockley. “Our consumer healthtech and medtech customers recognize that measuring hydration levels non-invasively on a regular basis has far-reaching use cases and potential.”

As a solitary biomarker, assessing hydration can provide important insights about certain health conditions. By integrating the non-invasive, real-time monitoring of a broad range of multiple biomarkers — including core body temperature, blood pressure, heart rate, blood oxygen, lactate, ethanol, urea, glucose, and more — the Rockley biosensing platform will analyze the data from all these biomarkers holistically, leveraging Rockley’s cloud-based analytics and AI capabilities. This combined analysis has the potential to provide valuable new insights about an individual’s overall health.

Rockley’s in-house hydration study represents the third in a series of studies designed to evaluate and refine the performance of Rockley’s biomarker sensing platform. The hydration study was conducted at a dedicated Rockley research laboratory, overseen by full-time research staff with extensive experience and credibility in the fields of clinical research and study management. The study included men and women over the age of 18 and people of varied races and skin tones. The hydration study has been approved by the WIRB – Copernicus Group Institutional Review Board.

Further details about Rockley’s hydration studies have been published in a new whitepaper: The Quest for Hydration Management, available for download on Rockley’s website.

More information about Rockley’s digital health monitoring solution is available here: https://rockleyphotonics.com/biomarker-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 by enabling the detection of core body temperature from a wearable device; (b) the importance of the ability to monitor key biomarkers like core body temperature on a continuous basis; (c) the potential impact of the ability to miniaturize the monitoring of key biomarkers into a tiny form factor; (d) the ability of the PIC sensors in Rockley’s sensing platform to detect detail beyond today’s LED-based sensor technology, discern varying signatures of water absorption, and determine core body temperature; (e) the potential effectiveness of the wearable sensing platform for determining core body temperature; (f) the timing and potential results of Rockley’s ongoing human studies and the ability of such studies to help optimize algorithms and refine performance across a broad range of biomarkers; (g) 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; (h) 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; (i) the anticipated and potential features, scope, goals, and benefits of the Company’s platform, products, and technology; (j) its development of a range of photonic integrated circuits and associated modules, sensors, and full-stack solutions; (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; (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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