Valencell is an innovator of intuitive, accurate, and easy-to-incorporate digital health solutions with a focus on addressing unmet needs in the prevention and management of chronic diseases. Pulse 2.0 interviewed Valencell founder and president Dr. Steven LeBoeuf to learn more.
Dr. LeBoeuf’s Background
Dr. LeBoeuf is an inventor of more than 100 granted patents in the field of wearable biomedical sensing. And Dr. LeBoeuf said:
“I have been widely referenced as one of the foundational innovators in wearable PPG sensors that are now embedded in millions of wearables on the market today.”
“Before founding Valencell in 2006, I pioneered innovations in solid-state materials, multiwavelength optoelectronic devices, high-power electronics, nanostructured materials and devices, and biochemical sensor systems while serving as a Senior Scientist and Biosensor Project Lead for General Electric. I have developed dozens of strategic partnerships with industry-leading consumer technology brands, medical professionals, research institutions, medical device manufacturers, health and fitness companies, and start-ups.”
“One of the most broadly quoted scientists and entrepreneurs in the field of wearable PPG sensing, I have served as a speaker at 50+ events around the world and am routinely interviewed by journalists, industry analysts, venture capitalists, and academic researchers.”
“As a founding pioneer in modern wearables, I have managed Valencell’s foundational patent portfolio, which has been licensed to dozens of companies around the world and implemented in 40+ wearable devices, ranging from earbuds, hearing aids, wristbands, leg bands, smartwatches, virtual reality systems, headbands and more. I hold a Ph.D. in Electrical Engineering from North Carolina State University, where I have been inducted into the Electrical and Computer Engineering (ECE) Hall of Fame, and a B.S. degree in Electrical Engineering and Mathematics at Louisiana Tech University.”
Formation Of Valencell
How did the idea for Valencell come together? Dr. LeBoeuf shared:
“Valencell’s foundational vision was quite radical at the time. In September of 2006, there were no iPhones, no Fitbit, no consumer fitness market (to speak of), and all consumer heart rate monitors useful for exercise were relegated to ECG chest straps. Valencell’s vision was to empower people to live longer, healthier lives through validated physiological insights, and it was clear that this required seamless, personalized physiological monitoring through devices that people already wear on a regular basis.”
“Namely, we could not count on changing consumer behavior to monitor what’s important – we needed to be seamless with how people live their lives.”
“Since the technology for physiological monitoring in earbuds, wrist devices, and rings (devices people already wear) simply didn’t exist, we knew we had to develop this from scratch. This foundational thinking is what earned us one of the most valuable wearable PPG patent portfolios in the marketplace.”
“Because the sports and fitness market was characterized by a lower barrier-to-entry than FDA-regulated healthcare markets, and because there was a serious unmet need for a technology that would enable accurate heart rate monitoring during exercise that didn’t require a chest strap, Valencell jumped right into the sports and fitness market headfirst in 2009.”
“This allowed Valencell to generate customers and revenue to help fund R&D next-generation biomedical wearable technology. Over the years, as the market has matured and as the market for consumer medical wearables has now emerged, Valencell has directed its efforts towards solving big problems in healthcare by improving health outcomes and preventing chronic disease via innovative, consumer-friendly digital health solutions.”
Favorite Memory
What has been your favorite memory working for Valencell so far? Dr. LeBoeuf reflected:
“My favorite memories have a common theme – watching our multidisciplinary team work together to solve big problems. My happiest moments are sittin’ back and watchin’ the team channel controlled chaos into something really special and unique.”
Challenges Faced
What challenges did Dr. LeBoeuf face in building Valencell and has the current macroeconomic climate affected your company? Dr. LeBoeuf acknowledged:
“Valencell’s original strategy was to build its own product portfolio of medical wearables. However, we quickly estimated that this strategy would require raising tens of millions of dollars, and we simply didn’t have access to that type of funding. Fortunately, since consumer-friendly biometric wearable tech didn’t really exist at the time, we had the opportunity to enter the market with new technology in a ‘white space’ that could be licensed to the big guys. In this approach, our strategy changed from ‘do it all yourself’ to “let’s rise on the shoulders of giants.”
“The challenge with this approach is that it is difficult for an ambitious company to control its destiny as a technology provider to the consumer marketplace. Firstly, protecting one’s inventions is extremely difficult in the current oligarchic U.S. patent system, which rewards high-dollar tech oligarch infringers at the expense of entrepreneurial innovators.”
“At some point, you can begin investing more in patent protection and litigation than in R&D for next-generation solutions, which begins to run against the company’s foundational vision. Secondly, over the years, our attempts to seed the market with next-gen technology and compelling tech-powered user experiences felt more and more like the proverbial ‘tail waggin’ the dog.’ Namely, we had storyboards of killer use cases and user experiences leveraging new innovative monitoring solutions, but pushing this from the bottom-up through big consumer brands was becoming toilsome and unrewarding. It became clear to us that controlling our destiny would require us to build our own consumer solutions. We chose medical wearables as we have strong differentiation in this area, a high barrier to entry from competitors, and the right vision for the complete user experience.”
“However, it should be noted that this emerging market of medical wearables has posed a whole new set of challenges, which we have previously published here. In short, there’s a trade-off between controlling one’s destiny and facing a diverse set of challenges head-on.”
Core Products
(Not FDA Cleared. Not for sale in the US.)
What are Valencell’s core products and features? Dr. LeBoeuf explained:
“Valencell is an acclaimed innovator in digital health solutions with a focus on chronic disease management. We develop and deliver medical-grade digital health solutions that are intuitive, accurate, and easy to incorporate into everyday health routines. Recent innovations have propelled Valencell from the sports/fitness marketplace into the consumer medical sector, where we have now built upon our legacy technology to enable our own branded solutions, targeting over-the-counter use.”
“The Valencell team is centered around the vision of empowering people to live longer, healthier lives through validated physiological insights. Valencell’s claim to fame is the development and commercialization of the world’s first optical-based heart rate monitoring technology that can accurately track heart rate during exercise. With our medical focus, we have turned our attention toward blood pressure monitoring and other medical metrics.”
Evolution Of Valencell’s Technology
How has Valencell’s technology evolved since launching? Dr. LeBoeuf noted:
“Powered by advanced analytics built upon tens of thousands of raw datasets collected from thousands of human subjects, Valencell has been breathing life into wearable photoplethysmography (PPG) sensors for over 15 years. If you’ve seen the green blinking lights on the back of a smartwatch or fitness band, that’s probably utilizing at least one of Valencell’s inventions.”
“Those lights are shining light into the body, and the sensor is capturing blood flow patterns within the scattered light. The challenge is that these patterns cannot be extracted in a simple, linear fashion. To address this limitation, Valencell has developed a “Deep-PPG” neural network that is capable of analyzing these patterns to determine biometrics such as blood pressure, heart rate, heart rate variability, blood oxygenation, respiration rate, and more.”
“Valencell is introducing accurate blood pressure monitoring via PPG without the need for calibration using a cuff. Not FDA-cleared and not for sale in the US, Valencell’s Fingertip Blood Pressure Monitor solution will use PPG sensors to measure blood flow patterns, plus proprietary A.I. algorithms developed from PPG datasets comprising thousands of patients, along with physical characteristics (age, weight, height, and biological sex) to calculate a blood pressure measurement. At the heart of Valencell’s blood pressure monitoring solution is a novel machine-learning model trained by tens of thousands of datasets from thousands of diverse human participants over the course of several years.”
“Valencell has evolved from a developer/supplier of sensor technology for fitness wearables to a digital health technology solution brand for the management of chronic diseases.”
Significant Milestones
What have been some of Valencell’s most significant milestones? Dr. LeBoeuf cited:
“2006 – First foundational patents filed
2009 – First commercial licensing engagement
2010 – First venture funding
2014-present – Launch of dozens of Valencell-powered consumer products
2018 – Global collection of PPG-BP datasets from thousands of human participants
2020 – Strategic relationships developed with medical brands
2022 – First prototypes of Valencell’s Fingertip B.P. solution
2023 – Clinical validation study kickoff for Valencell’s Fingertip BPM solution.”
Customer Success Stories
Upon asking Dr. LeBoeuf about customer success stories, he replied:
“Valencell’s sensor technology has been licensed to dozens of companies and embedded in millions of wearable devices around the world, ranging from earbuds, hearing aids, wristbands, leg bands, smartwatches, virtual reality systems, headbands, and more. Valencell’s proven inventions, sensor technology, and algorithms can be found in tens of millions of wearable and hearable devices throughout the world, in over 90 products, for companies such as Samsung, Suunto, Bose, Jabra, Huawei, and Sony.”
Funding/Revenue
After asking Dr. LeBoeuf about funding, he revealed that the company is a venture-backed enterprise.
“Valencell’s investors include Best Buy, Halma, GII Fund, TDF, Sonion, and WSJ Joshua Fund. Our company has also been supported by millions in government grants from the National Institutes of Health (NIH), the National Science Foundation (NSF), and the North Carolina Board of Science, Technology & Innovation. Clinical collaborators have included the Duke Center for Living, North Carolina Research Campus, Campbell University, and numerous industry leaders in medical solutions and pharma.”
Total Addressable Market
What total addressable market (TAM) size Valencell is pursuing? Dr. LeBoeuf assessed:
“The global blood pressure monitors market size was valued at $1.60 billion in 2022. The market is projected to grow from $1.73 billion in 2023 to $3.10 billion by 2030, exhibiting a CAGR of 8.8% during the forecast period (Source).”
“However, the bigger picture is that making blood pressure monitoring easier and more convenient will open up a bigger opportunity in digital health. The market for hypertension management is well above $40B, and Valencell believes a digital health solution that combines easy and convenient monitoring with digital therapeutics will positively transform this marketplace and unlock larger market opportunities than B.P. monitoring alone.”
Differentiation From The Competition
What differentiates Valencell from its competition? Dr. LeBoeuf affirmed:
“In short, Valencell will be differentiated by patents, products, and regulatory clearance. Valencell owns key patents that protect its approach to AI-based BP monitoring via PPG. Moreover, Valencell’s product concept is thoroughly novel and focused on a B.P. monitoring solution that consumers actually like to use. As another key element of differentiation, the FDA requires that companies earn a 510(k) clearance to commercialize their alternative to the B.P. cuff in the United States and achieving this clearance with a new cuffless solution poses a high barrier-to-entry to competitors.”
“Valencell’s inventive spirit and innovative team continue to challenge conventional thinking about technology limitations as we develop new digital health solutions aimed at helping improve people’s overall health and well-being. Where others have given up developing novel approaches to chronic disease management, we are tackling it head-on with our Fingertip Blood Pressure Monitor – a cuffless, calibration-free blood pressure device at the fingertip that is easy-to-use, convenient, quick, quiet, and pain-free for regular spot-check measurements. Adherence leads to better disease management and health outcomes, which is challenging with existing blood pressure devices on the market today. B.P. cuffs can be painful, difficult to properly size/fit, and challenging to position correctly, leading to inaccurate measurement readings, thus discouraging regular monitoring. Valencell aims to improve B.P. spot check adherence, chronic disease management, and health outcomes through advanced technology solutions unlike anything on the market today.”
Future Company Goals
What are some of Valencell’s future company goals? Dr. LeBoeuf concluded:
“Valencell plans to launch Valencell Health, its direct-to-consumer, over-the-counter digital health / medical device brand that addresses chronic disease management through easy-to-use solutions. The first product will be the Fingertip Blood Pressure Monitor for B.P. spot check, followed by additional incorporated biometrics and digital therapeutics.”
