Earlier this month, RW Search had the pleasure of speaking with Dr. Steven LeBoeuf, President and Co-Founder of Valencell, and leader in transforming the science of wearable biometrics. Steven is a powerhouse in his field, with an extensive background in technology-related sectors. His passion for personalised, wearable healthcare has undoubtedly contributed to Valencell’s impressive success. Having founded in 2006, alongside Dr. Mike Aumer, and Dr. Jesse Tucker, US-based Valencell has since grown to become a leader in the wearable biometrics space, with 100 patents, plus more than 50 patents pending. The company is providing ground-breaking solutions globally to consumers through its protected biosensor technology.

Initially, Valencell ventured into the fitness space, with its PerformTek® PPG technology enabling wearables and hearables to continuously measure biometrics such as heart rate, blood oxygen levels, heart rate variability, respiration rate, and other parameters for health and fitness assessment. This technology can be integrated into products designed by consumer electronics manufacturers, mobile device and accessory makers, medical device, sports and fitness, and hearing aid companies. Currently, more than 40 companies utilise Valencell’s technology and intellectual property, which has been commercialized in wearable devices made by companies including Bose, Suunto, LG, Samsung, Sana Health, and SunTech Medical.

At present, huge opportunities exist to ease the burden of blood pressure monitoring and reduce the cost of healthcare with non-invasive sensor technology embedded in devices people wear every day. Through innovative R&D and validated technologies, Valencell is now transforming the science of wearable biometrics to democratize sophisticated and accessible health outcomes with the world’s first cuffless calibration-free blood pressure monitoring technology. BP technology can be built into a range of passive form-factors worn in the ear, on the finger, and on the wrist which makes it significantly easier for people to monitor their BP regularly. Valencell is now pursuing FDA clearance for this technology to help manufacturers to embed it in their devices moving forwards with the clearance process.

No alt text provided for this image
Having significantly improved the quality of customers’ lives for 15 years, Valencell has continued to use its expertise to expand and diversify globally, and we were lucky enough to hear the perspective of the President himself who began by introducing himself.

My name is Dr. Steven Lebeouf and I’m one of the founders and President of Valencell. We started all the way back in 2006, way before the iPhones and Fitbit’s and we focused on the wearables marketplace, where we realised at the time that this market didn’t exist. We had this vision of people being able to track their fitness and to be able to improve their health with feedback that is personalised to their own bodies and the things they do every day. As time has gone on, we have continued to grow in this space, and we started off mostly in the sports and fitness category because that’s where the demand was initially, and now we’ve grown into the medical space.

No alt text provided for this image
So, first of all; what led you to work within the wearables market?

It’s a good question to ask because we started all the way back in 2006 so why would anyone think about this market back then? When we started Valencell, we viewed this from the perspective of what big problems can we solve with breakthrough technology? We were all industry scientists and engineers, and we weren’t as passionate about using existing technology to solve problems. We were much more passionate about solving bigger problems where this technology certainly did not exist.

Healthcare costs were so high already, they were only going to get worse, and prevention can certainly curtail a lot of these concerns. Exercising some of the greatest medicine and showing people the benefits of how it’s improving their health by providing them with feedback for their therapeutics which may involve changing diet or exercise. We saw this as a huge opportunity as the technology didn’t exist and when we started in this space there were no wearables besides chest straps. If we hadn’t built this technology, the industry would have been 5 years off, so I’m proud that we did that.

We saw an opportunity to add to that platform, and in 2009/2010 we started looking into blood pressure and it took us a long time to realise all the mistakes we made in doing that. Then, when we figured that out it was a huge data collection effort. The dream of solving this problem with breakthrough technology is really what got us excited about pursuing it.

So, could you tell our readers a bit more about how you go about intensive testing for the BP monitoring technology?

There are two parts to how we do that. Firstly, we collect a ton of data to build the models. For blood pressure, we’ve collected somewhere around 15-20 thousand data sets where we create these models. Once the models are created, we must then validate them on data sets for a range of different people.

The validation process in the case of blood pressure monitoring is a little bit easier for us because we didn’t have to develop a new standard, as there were standards that had already existed. However, there are some caveats, because our technology is cuffless and calibration-free, we do have to go through different types of testing that a blood pressure cuff would not have to do.

We make sure that in our testing we capture diversity in the validation through testing people of different physicality, ages, gender, ethnicity, etc. such that we know this will really work at any time. When developing a technology that provides the marketplace with a biometric that is based on indirect measurement, you must get past these additional hurdles to prove to the market that the technology is highly accurate.

Do you see this technology being used alongside Smart Phones?

Yes, and that’s part of the big vision is here. This technology is already much more convenient than using traditional blood pressure cuffs. Additionally, the ability to track your blood pressure multiple times in the day on a smartphone, while you’re in different environments and different circadian rhythms is incredibly useful.

If you don’t know that your blood pressure is increasing at certain times in the day, and if that damage continues, you’re at incredible risk of premature death, premature stroke, and a bunch of comorbidities associated with hypertension which will eventually lead to much higher health care costs. Being able to measure BP at multiple intervals of the day is critically important to keep things under control. The challenge now is how we can make this accurate enough to take care of the current public health situation.

So, what type of competitors do you face in the blood pressure market?

So, the medical field is very used to current blood pressure cuff data, and any time there’s a new technology they rightly should be concerned about it. Competing against false information is an issue and there are companies who might say they have something validated and then it’s tested in the field and doesn’t really work. Many times, our partners will take our technology and pair it against one of these technologies that claim to be validated and this stuff just doesn’t work.

However, there are other folks who are working with PPG or optical-based wearable technology to accurately track blood pressure as well as a cuff. So, the companies we were aware of that are working on this are taking a very different approach to Valencell.

Valencell’s approach is to measure this PPG information based on the core technology that we’ve had for a long time. On top of that, we have a machine learning model that connects the dots between this PPG information and blood pressure. The way competitive companies are pursuing it is very different. Typically, what they do is pulse transit time, also sometimes called pulse arrival time depending on some specifics, but those devices must be calibrated. We don’t believe that’s an ideal way to measure blood pressure. The only way to solve this public health issue is to have a blood pressure technology that people can wear and doesn’t require calibration in order to work – there are currently no other companies that are pursuing that approach.

With the increasing demand for portable and wearable devices, what have been the main challenges faced in the development of Valencell’s BP monitoring technology?

Overwhelmingly by far, the biggest challenge is making sure that the accuracy is good enough to meet that of a cuff. Because if it isn’t – you really are screwing people over. There are two big issues that can arise from this, and the FDA and health systems are keenly aware of them. One of them is if someone is hypertensive and you get it wrong and if they keep living their lives as they did before it’s a huge risk to their health.

Another challenge that is equally as difficult as telling someone they have a problem when they don’t, and they go to the doctor and it’s like who do they believe, the doctor or this device? Every time a patient may go to the doctor because they think something is wrong, it will cost the system money and bog everything down. Because healthcare is so ridiculously expensive now, you have to improve public health while at the same time, reducing costs to impact the system. So, it’s really important that the accuracy of our technology is as precise as a cuff.

Can you tell us about the other technologies that Valencell offers within the Med-Tech space?

So, the inbounds that come through our website are heavily tilted towards companies that need a way to get blood pressure technology into their wearable device that is as accurate as a cuff. There’s a huge unmet need from a technology perspective so a lot of folks are directed towards this. We also have a technology that accurately tracks your breathing rate as you go about your daily life which is very different than for example an Oura Ring or a Whoop Device where they look at how your heart rate is changing while you sleep, and then get your estimated respiration rate for that purpose. We actually can track it as you go about your day which has interest from the marketplace as well but is still nothing compared to blood pressure. We’ve also been developing some technology that can tell you which category your blood sugar level is in, for example, if you’re in a high, low, or normal category and whether you’re moving in and out of those categories. That has a lot of public health value.

So, there are a bunch of different health technologies that we’ve already developed and are developing that are increasingly more relevant for the medical community. But when you think about the scarcity of blood pressure monitors like ours, the fact that it’s also by far the most developed of the new technologies we have is why there’s a lot of interest in us right now.

What is your process to commercialisation in the US and then, are you looking to gain CE approval in Europe?

We have to get CE approval in Europe. The first approach is with the US which is typically the hardest nut to crack. We have a lot of European customers who are integrating our technology into hearing aids, and of course, measuring the blood pressure of that population is even more important. With the FDA right now, the challenge has been that the protocols that you use to measure the accuracy for a blood pressure cuff are very fixed, but this is a new type of technology, and they had the protocols in place to validate cuffless monitors.

We make things a little harder on ourselves at times because we don’t want a solution to get past the gold gate unless it really does what it’s supposed to do. And so, right now we are honing in on the exact protocol that needs to be validated and our timeline is to get that confirmed in the first half of next year. Then, our customers can take what we have developed, and they can create their own product without having to go through the same process that we had to go through because the technology is already validated.

And finally, what’s on the horizon for Valencell? What can we expect to see in the next 5 years?

I’ll tell you what I’d love to see in the marketplace and how Valencell can contribute somehow. Whether it’s us making the device, or one of our partners, I see an opportunity for a counter-trend in wearables. I realise that our customers are continually developing advanced wrist-worn devices that have advanced screens on them and multimedia features for sound and music, making payments, etc. Almost like a Swiss army knife worn on your wrist for lack of a better term.

I see an opportunity for almost the opposite though. An incredibly low-profile worn device, almost like a Livestrong band. It would be so low profile that you could wear it next to your favourite watch and all it does is accurately track your biometrics relative to the health platform. And that way if it breaks it’s affordable and easily replaceable. The value to you is your own data and your doctor having access to that data to improve your health uniquely. It’s very much the opposite of what the marketplace is doing today. I think it could happen and when I think about 10 years from now, it’s hard for me to imagine a world where that’s not the case. One of our challenges is how we can make that vision happen.

To conclude, it is evident that Valencell is driving a revolution in the wearables market, presenting the next generation of tracking health care. Now with the world’s first calibration-free, cuffless blood pressure monitoring system, Valencell is offering a life-changing and accessible solution at the highest level of quality for customers. Dr. LeBoeuf’s experience in the wearables industry is undoubtedly an engine of growth for their expansion as a company, and having witnessed his passion for resolving public health issues through innovative and cutting-edge technology, I feel that Valencell is set to become a key player in the blood pressure monitoring market.