Achieves positive results in pilot human study assessing blood pressure measurement capabilities from a Rockley-powered wrist-worn device, setting the stage for larger study
Demonstrates signal quality and measurement technique capable of potentially providing a new continuous measurement technique for cardiovascular health
Advances readiness of Rockley sensing platform’s broad biomarker detection capabilities for Rockley’s customer base of 17 leading global consumer electronics and medical device companies
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 the first stage of its human studies examining the measurement of blood pressure using Rockley’s biomarker sensing platform.
In this pilot study, Rockley researchers have demonstrated that a photonics-based sensor worn on the wrist can measure blood pressure non-invasively. Instead of applying a blood pressure cuff, which can be awkward or inconvenient and cause discomfort for some, Rockley’s wearable wrist-worn solution has the potential to provide hassle-free, clinical-grade data about key cardiovascular indicators.
The Rockley blood pressure sensing device used in the study features a unique laser-based approach and advanced algorithms employing Rockley’s cloud and AI capabilities. The signals produced by the Rockley sensor were compared directly with signals produced at the same time and location by an off-the-shelf photoplethysmography (PPG) module, which employs green light-emitting diodes (LED) and is the technology employed by most wearables on the market today, often with the aid of a blood pressure cuff for calibration. The signals from the Rockley sensor were shown to provide stronger correlation with the control blood pressure readings from a cuff than standard green-LED PPG signals.
In addition to demonstrating blood pressure measurement, the study showed that Rockley’s wrist-based sensing platform produces a strong correlation of heart rate (HR) and heart rate variability (HRV) measurement with results from commonly used electrocardiogram (ECG) equipment.
Rockley’s in-house blood pressure studies are part of a continuing slate of human studies designed to evaluate and refine the performance of Rockley’s biomarker sensing platform in measuring a wide range of biomarkers, including core body temperature, blood pressure, body hydration, alcohol, lactate, and glucose trends. The blood pressure study, which was conducted under IRB approval by the WIRB-Copernicus Group Institutional Review Board (WCG IRB), involved multiple measurements from 40 human subjects resulting in over 480 total readings.
“Following the recent success of our core body temperature studies, the results of our pilot blood pressure study using wrist-based measurement are extremely encouraging,” said Dr. Hooman Abediasl, senior vice president of product engineering at Rockley. “These positive results represent a huge step forward in validating our sensing solution and its ability to deliver powerful multi-biomarker functionality in a highly manufacturable wearable form factor.”
Rockley announced its biomarker sensing platform in the summer of 2021. Since the announcement, the Rockley sensing platform has continued to gain significant traction in both the consumer and medtech markets. To date, Rockley has contracted with seventeen leading global manufacturers: twelve global consumer electronics customers, including six of the top-ten players in the wearables market, and five medical device companies, including two of the top-ten players in the medical equipment space.
“Demonstrating the ability to measure blood pressure from a wrist-worn device is essential in the development of our biosensing platform, for us and for our growing customer base,” added Dr. Andrew Rickman, chief executive officer and founder of Rockley. “This study represents a critical step towards achieving our goal of measuring multiple biomarkers. Even more exciting is that the results from this study have demonstrated a quality of both signal and measurement techniques that have the potential to enable a new class of cardiovascular health monitoring. Whether in consumer wearables or medtech, our customers understand that the ability to measure blood pressure from a wristband or smartwatch could have an enormous impact on personal healthcare.”
Rockley believes that the combination of its sensing technology and its cloud and artificial intelligence (AI) infrastructure can provide better information for healthcare providers and greater peace of mind for patients, athletes, and people anywhere who’d like meaningful insights into their health and well-being.
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,” “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,” “realize,” “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 and clinical grade data about a variety of health conditions, including cardiovascular health, and monitor blood pressure, heart rate and heart rate variability from a wearable device; (b) the importance of the ability to monitor key biomarkers like blood pressure 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 potential to leverage data collected from Rockley’s biomarking sensing products to enable additional capability for the fast-growing digital health domain; (e) the potential effectiveness of the wearable sensing platform for determining key biomarkers, including blood pressure, heart rate and heart rate variability; (f) 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; (g) Rockley’s belief that its cloud and AI infrastructure can provide better information for healthcare providers and greater peace of mind for people who’d like meaningful insights into their health and well-being; and (h) the anticipated and potential features, scope, goals, and benefits of the Company’s platform, products, and technology.
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.