JD Durkin: Say hello to Dr. Jeffrey Durmer, Chief Medical Officer at Happy Health. Dr. Durmer, nice to see you here today. This is a big one, and I need you to help me better understand it.
Happy Health has just received FDA clearance for its Happy Ring. It monitors health metrics, things like heart rate, blood oxygen, et cetera. Why is FDA clearance for something like this such a big deal, in particular for something like blood pressure?
Dr. Jeffrey Durmer: Yeah, well, actually, we’ve had a couple of FDA clearances already for sleep apnea detection and also for the ring itself to actually monitor your health. But this is a brand-new FDA clearance, and it’s the first of its kind in medicine, where actually a wearable device that is a medical device as well can now be used to cufflessly and calibrationlessly monitor your blood pressure throughout the day and the night.
So it’s an opportunity to actually open a window into an area that we have really very little to no information on a regular basis in medicine.
JD Durkin: Dr. Durmer, walk me through how this would work, what this would look like for a would-be patient or a client of yours getting the ring, the piece of hardware, but also the relationship, in theory, that client would have with the information being gathered.
Dr. Jeffrey Durmer: Yeah, absolutely. So the Happy Ring itself is something that you can get just by going online to our website. You scan your finger, you can get the ring in the size of finger that you prefer, so you don’t have to actually get a kit and try it on.
And then the device shows up and you wear it. That period of time that you wear the device allows us to collect data continuously on your blood pressure, your sleep, your daytime activity, and then correlate that all with your medical information that you provide us as becoming a Happy patient in the Happy Health program.
And that allows us then to contextualize and also provide you with risk analyses for cardiovascular disease, sleep disorders, metabolic disease and even brain health. And that also allows us then to get you a number of different potential risk-mitigating therapeutics through our 50-state physician network.
JD Durkin: I would have to imagine being able to monitor this information overnight is a really unique and incredibly important value-add to this entire conversation. What can that do that, let’s say, a more traditional doctor’s office reading might not be able to do?
Dr. Jeffrey Durmer: Yeah, it’s a really good point because actually, even in our validation studies, multiple clinical trials we did, we used an arterial line to compare against the Happy Ring.
And it turns out to be absolutely within under one millimeter of mercury difference between diastolic and systolic, which is incredibly accurate. And this is continuous, so it shows the change in blood pressure across the day and night.
And it turns out we know about 50% of Americans have hypertension, but a very small number of people know they actually have it. And it turns out that of the people that even know they have hypertension, 30% to 50% of them have nocturnal hypertension that often goes unreported.
And the same thing is true for people with chronic diseases like diabetes or kidney disease, even obstructive sleep apnea. The vast majority, 70% to 80% of those folks, also have nocturnal hypertension that never gets diagnosed.
This is a way to actually diagnose it continuously and show where your blood pressure is actually causing disease and increasing your risk for cardiovascular disease in the long run.
JD Durkin: Fascinating developments. Dr. Durmer, I’ve got about 30 seconds left. Where do you most hope the technology can go from where you are today?
Dr. Jeffrey Durmer: Yeah, I think this is the future of wearables converging with medical device construct. We are a medical device, a Class II medical device, in a sense masquerading as a wearable because it’s easy to wear longitudinally.
And this is going to allow doctors to manage patients in the home with risk mitigation before the diseases actually surface. So if we see hypertension, if we see AFib, if we see these other issues like sleep apnea, we can treat it and get ahead of disease that those things cause down the line.
JD Durkin: Dr. Jeffrey Durmer, Chief Medical Officer at Happy Health. Dr. Durmer, you’re welcome back here to make the case anytime. It’s good to see you.
