What You Should Know:
– Valencell, the company whose optical heart rate technology enabled the ability of wearables to accurately measure cardiovascular vitals during exercise, today announced plans to launch its own branded product line in the digital health sector as it concentrates efforts to bring solutions to market to manage chronic diseases.
– The company’s first product candidate being showcased at CES is focused on helping people monitor and manage hypertension by combining an intuitive app with an innovative over-the-counter device to accurately measure blood pressure (BP) from the finger without a cuff or calibration.
Pioneers of biometric technology enter the digital health space, developing own-branded solutions for chronic disease management
Founded in 2006 with a vision to help people live longer, healthier lives, Valencell’s proven inventions, sensor technology, and algorithms can be found in tens of millions of wearable and hearable devices, in over 90 products, for companies such as Samsung, Suunto, Bose, Jabra, Huawei, and Sony. While Valencell was established as a technology provider in consumer sports and fitness wearables, its foundational technology has the potential to realize the dream of seamless chronic disease management through easy-to-use, high-compliance digital health solutions.
Pending FDA Clearance, the launch of the Valencell fingertip device will further the company’s vision of bringing life-changing digital health solutions to consumers and is a strategic evolution for the company. Having developed solutions for some of the world’s leading wearable companies, Valencell is now driven to bring its own portfolio of digital therapeutics to market. Powered by its patented biometric sensor technology, over 150 patents, proprietary AI models, and analytics that have been clinically validated using thousands of datasets over many years, it begins with a focus on hypertension.
“Having spent sixteen years perfecting the ability to capture health data from multiple areas of the body and developing solutions for third parties, I am excited for Valencell to embark on a new chapter. In reviewing our company strategy, we concluded developing our own solutions was the most effective way to get to market faster since the lion’s share of the regulatory and research development already falls upon Valencell,” said Dr. Steven LeBoeuf, President, and co-founder of Valencell. “Beginning with the number one silent killer, hypertension, Valencell is developing digital health solutions that take out all the friction and barriers to capturing and acting on health data to help make it easier for people to take control over their health, live longer, healthier, and more productive lives.”
Meeting Demands Under Pressure
Valencell’s first chronic disease management solution aims to help those with hypertension better and more regularly measure blood pressure and maintain treatment compliance. The device is being designed to measure blood pressure in less than a minute using a small probe on the middle finger without the need for bulky or painful cuffs.
Photoplethysmography (PPG) sensors within the device use reflected light to measure blood flow patterns. Proprietary AI algorithms, developed from PPG datasets comprising more than 7,000 patients, will be used to process this information with physical characteristics (age, weight, gender, height) to calculate a blood pressure measurement. Diastolic and systolic results are then displayed on the device’s built-in screen and transmitted via Bluetooth to the app. Unlike other technologies, the Valencell BP technology will not need to be calibrated to a BP cuff, a capability that has so far eluded the industry.
Valencell’s solution is expected to be the world’s first cuffless, calibration-free blood pressure monitor in a fingertip form factor, with the company targeting FDA Clearance in late 2023. Altogether, this has the potential to enable the world’s first over-the-counter cuffless BP monitoring solution. Although the device has been designed as a stand-alone blood pressure monitor, it has the potential to become a powerful tool to help manage hypertension when paired with its accompanying app. The easy-to-use mobile app has been designed to track and store readings and allow users to set reminders to take their blood pressure.
Users will also have the ability to view trends over time, track the frequency of their measurements, and download and share data. Valencell will soon expand the app’s capabilities to enable seamless hypertension management. After providing users with a baseline of their current blood pressure profile, the app will help coach users, through targeted diet and exercise plans, towards improved cardiovascular health, followed by ongoing health maintenance.
A further upgrade will enable integration within digital healthcare platforms used by healthcare providers to improve physician-directed care. While designed for individual use, the Valencell solution is expected to be CPT Eligible, meaning health professionals and practices using it for Chronic Care Management and/or Remote Patient Monitoring will qualify for reimbursement.
Globally, more than a billion people suffer from hypertension, and it accounts for approx. ten million deaths per year, yet often hypertension has little or no symptoms and is difficult to manage on an ongoing basis. According to the CDC, hypertension affects nearly one-third of Americans, or 75 million people, aged 18 or older. Additionally, for approximately one-half of adults with hypertension (nearly 35 million people), it is uncontrolled, costing $131 billion a year in healthcare costs in the US alone.
Critical to managing hypertension and saving lives are regular and reliable BP measurements, yet in a nationwide survey, 62% of Americans with hypertension only measure their BP a few times a month or less, far below expert recommendations of twice daily. However, in a study of consumers that monitored BP at home, 80% of respondents stated they would increase the frequency of measurements using a fingertip device. “The ability to accurately measure blood pressure is essential in ensuring those with cardiovascular conditions adhere to treatments and lifestyle changes their physicians recommend. Anything that makes this easier for people to do can save lives, dollars, and time,” commented Dr. Bill Kraus, Professor of Medicine, Duke University of Medicine. “The rise of digital health solutions and coaching apps are a welcomed trend but are only as good as the data that goes into them. Using the Valencell device that is as simple and painless as pulse oximeters could improve treatment adherence and outcomes and would be a welcomed solution to a largely unmet clinical need.”
The Future of Digital Therapeutics
With new algorithms, form factors, and clinical data, blood flow patterns have the potential to measure health statistics ranging from respiratory rates, oxygen levels, cardiac efficiency, and blood pressure. The ability to place these capabilities into ubiquitous, everyday objects that are so intuitive they make it easy for consumers to manage their own health brings the promise of genuinely personal, preventative medicine close to reality.
In the future, Valencell plans to extend its hypertension management offering towards passive blood pressure monitoring in popular wearable form-factors, leveraging its technology. Additionally, the company is investigating how its foundational technology can be applied within these form-factors towards managing diabetes, kidney disease, and coronary artery disease.