#298 - 🚀 New solution for non-invasive blood pressure monitoring in the NICU

Hello friends 👋

In this Tech Tuesday episode, Ben and Daphna welcome Xina Quan, co-founder and CEO of PyrAmes, to introduce a groundbreaking neonatal device: the Boppli. Developed from Stanford research, the Boppli is a non-invasive, wearable blood pressure monitor that provides continuous, real-time readings—without the need for cuffs or arterial catheters.

FDA-cleared for babies under five kilograms, the Boppli uses a soft, adhesive-free band that wraps gently around an extremity. Backed by 3,400 hours of clinical validation, the Boppli has shown accuracy approaching that of invasive arterial lines according to the team at Pyrames.

Ben and Daphna explore how this innovation could reshape blood pressure monitoring for hypotensive and unstable neonates. Quan shares her vision of the Boppli becoming as commonplace as pulse oximetry in NICUs—empowering care teams with precise, painless data they can finally trust.

As she puts it, “Half the battle is having good data—this is a way to finally get it.”

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Short Bio: Xina is the Co-founder & CEO of PyrAmes peuramess, a start-up based on Stanford Prof. Zhenan Bao's research on electronic skin.  For over 40 years, she has led interdisciplinary teams that have transformed advanced materials research into innovative commercial products, first at AT&T Bell Labs and then at several startups in Silicon Valley.  Xina has SB and SM degrees from MIT and a PhD from Princeton, all in Chemical Engineering. She is a registered patent agent with the US Patent Office with more than 30 patents.

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The transcript of today's episode can be found below 👇

Ben Courchia (00:00.942)

Hello everybody, welcome back to the Incubator Podcast. We are back today for a new episode of Tech Tuesday. Daphna, how are you this morning?

Daphna Yasova Barbeau (00:09.543)

We love when we have Tech Tuesday, especially Tech Tuesday that was a product presented at Delphi. That's always fun.

Ben Courchia (00:18.092)

Yeah, I mean, we got to meet our guest today at the Delphi Conference. I think it's a very interesting device that she's going to present to us. So let's introduce our guest. We are joined today by Xena Quan. Xena, thank you for making the time. Welcome to the Incubator podcast.

Xina Quan - PyrAmes (00:36.232)

Thank you.

Ben Courchia (00:37.572)

You are the co-founder and CEO of Paramus, a startup based on Stanford's Professor Zinan Baoz research. And you're here today to present to us a device that is called the Boply. Can you tell us a little bit what is the Boply?

Xina Quan - PyrAmes (00:56.392)

Sure. The Bobbly is a wearable blood pressure monitor that allows you to continuously and non-invasively measure blood pressure. Here's an example. This is the device that we had FDA cleared for babies up to five kilograms. And it has an array of sensors that fit very lightly against the skin. And you can wrap it around the arm or the leg of the baby.

Ben Courchia (01:19.492)

And for the people who are just listening to the audio version of this podcast, it looks a little bit like some of the pulse oximetry tools that we have in the NICU, a little padded sort of band that wraps around an extremity. it's...

Daphna Yasova Barbeau (01:27.879)

Hmm?

Daphna Yasova Barbeau (01:37.369)

And even less so, it's not, there's no adhesive, right? It's kind of, yeah.

Ben Courchia (01:40.046)

There's, yeah, and it's,

Xina Quan - PyrAmes (01:40.584)

Right, there's no adhesive. Some of the nurses we've worked with describe it as being very much like a posy band, if you're familiar with that phrase. And it's actually marketed, the base material is marketed for ID bands for neonatal patients.

Ben Courchia (01:58.212)

And so it's very interesting because obviously blood pressure monitoring, especially in the NICU, is a topic that is fiercely debated because obviously we feel that we don't have a good understanding of the meaning of the numbers we're getting. And so the ability to have better data obviously is the first step in understanding blood pressure changes in neonates and maybe potentially understanding how we can manage these a little bit better. So right now,

You were mentioning that the BAPLI is a non-invasive way of measuring blood pressure. Currently, in most units around the country, probably people using a blood pressure cuff if they're using non-invasive monitoring. How does the BAPLI differ from just the traditional blood pressure cuff that people might be using currently?

Xina Quan - PyrAmes (02:47.88)

So the Bobbly has been designed so that it can update its data about once per second. And it can do this continuously for this particular device, as long as the batteries last for about 72 hours. We can also make the batteries last longer if you update less frequently than once per second. But it allows you to get data much more similar to what you would get with an arterial catheter than what you would get with a cuff.

Ben Courchia (03:17.124)

And so what's interesting about that is that the device itself probably tries to get closer to what is actually the gold standard of blood pressure measurements, which is an invasive arterial catheter. And so it might actually be an amazing alternative to invasive blood pressure monitoring, because it would then allow you to get that type of quality of data from a non-invasive tool. How do you?

support this claim that you are able to get as close to an invasive arterial blood pressure monitor from this non-invasive device.

Xina Quan - PyrAmes (03:56.744)

Yeah, we've done two studies today. The first one was a single site feasibility study with our collaborators at Stanford. And we tested, I guess that one had 81 patients against arterial catheter data. And so about six to eight hours of data per patient. But what we submitted to the FDA was actually 3,400 hours of data on 79 patients where we had the device on for up to 72 hours on each of these 79 patients.

And so we compared our data simultaneously against arterial line data.

Ben Courchia (04:32.118)

And how close were you able to get? Do you have this data by chance for us?

Xina Quan - PyrAmes (04:39.514)

Yeah, so the two parameters we look at are the mean arterial pressure and I'm sorry, the mean average error and also the standard deviations. And so the FDA likes the mean average error to be less than plus or minus five millimeters of mercury, which I understand is very high for NICU patients and standard deviation to be less than eight.

And so we measure, we output mean arterial pressure, diastolic and systolic pressure. And in all cases, mean average error range from, let's see, was minus 0.8 for SBP and 1.4 for DBP and 0.7 millimeters mercury for MAP. So we're quite close. Standard deviations are about five for MAP and DBP. SBP, have a bit more variance.

Daphna Yasova Barbeau (05:15.751)

Mmm.

Ben Courchia (05:22.456)

Mm-hmm.

Xina Quan - PyrAmes (05:32.52)

It's about 7.7. But of course, even if we look at the art line data, there's a lot more variance and a lot more error in the SBP values.

Daphna Yasova Barbeau (05:46.597)

That's interesting. I think those are numbers that we can tolerate, we can manage. Thank you for sharing that. I wonder, what are the best populations for kind of the BOPLY to address? So what sorts of babies need this level of blood pressure monitoring?

Xina Quan - PyrAmes (06:04.424)

So where we've seen the most interest from clinicians like you has been for the premature babies who right now you would need to put an art line in place because of hemodynamic instability. A lot of these babies tend to be very hypotensive. And I guess the concern is that they will get increasingly hypotensive with time. And so we find that we are actually quite good with the tiny guys. We've gone down to 0.4 kilograms.

And also I think the youngest one to date is about 22 weeks one day, gestational age at birth.

So we're most comfortable with the smaller guys, I think. And where people have talked about using it, a number of places, one of them is that if you have difficulties placing an art line, then we are a nice alternative. Or if you think there's going to be a delay before you can get the art line in place. Or if you want to transition the child off an art line earlier, then we can provide that bridge until you're confident that your cuff measurements could hold.

Daphna Yasova Barbeau (06:45.383)

Mm-hmm.

Daphna Yasova Barbeau (06:54.471)

Thank you.

Daphna Yasova Barbeau (07:04.775)

Thank you.

Daphna Yasova Barbeau (07:12.583)

I love that and I had questions about the lower limit, but you've explained that. Thank you so eloquently. Do you ever see a time where this might replace art lines altogether?

Xina Quan - PyrAmes (07:24.59)

Obviously, we would love for that to happen. I know that a lot of facilities, once you have an art line in place, then they depend on that for the blood draws, which that we still can't do. But it seems like there are a lot of applications where people have their between whether or not they would want to place an art line. And so I think for those cases, we provide a potential option.

The other place that has surprised me when we started working with hospitals is how much the nurses like using it instead of a cuff. Because as several of them have said, it doesn't make the baby mad. They could put it on, they leave it on, and then just look at the blood pressure whenever they need it, as opposed to having to wake up the baby and disturb them and then wonder whether or not the number is correct or not. And so it surprised me because we really thought that

we have positioned ourselves as an alternative to art lines. And I'm just finding that, well, we'd rather use instead of cuffs. Really interesting.

Ben Courchia (08:34.467)

I think this is very interesting because obviously as we are talking about this device, it doesn't inflate or deflate like a cuff as you just mentioned. I'm just wondering, as we're talking about the Boply, as we're talking about the mission, why is it important for you to see this product succeed? I I know that you and the rest of the team at Pyramus are very passionate. Can you tell us why this is an issue that matters to you?

and why you believe that this device is important.

Xina Quan - PyrAmes (09:07.506)

Well, one of the things that we've done is we've talked to a lot of patients and a lot of caregivers and clinicians about blood pressure measurements over the last few years. And it's always surprised me that the standard of care, nobody likes them. Arterial catheters, they've got all these potential complications and they hurt the patient. And then on the other side, cuffs, a number of people have described them as random number generators.

that you can take the measurements, you never, there's always this level of uncertainty about them. And so I've talked to people who suffer from hypertension and they talk about how, you know, they don't like taking cuff measurements because they hurt and it feels odd.

and then they tense up before they even take it. And so then the numbers they get, they sound high, and so they take it multiple times until maybe they get a number they like. And so it's hard to believe that one could actually treat the underlying blood pressure disorders when you can't trust any of your numbers. And that's half the battle for blood pressure control or blood pressure management is that there are ways, known ways of how you can...

control people's blood pressure, but you're missing the data that you need to really do it well. And so I think our device gives you that opportunity to get that data in a painless way and an easy to use way so people will actually collect data. And that's half the battle.

Ben Courchia (10:49.13)

You mentioned earlier that the device has received FDA approval. I am just curious about at this stage of development, what are the next steps for the BAPLI and what are you hoping to accomplish in the next year or two?

Xina Quan - PyrAmes (11:05.935)

Well, obviously, I'd like to keep the doors of the company open. So we'd love it if people would start buying the devices and using them and help us understand. We've taken data on about 200 babies to date now, but we obviously have not seen all the possible cases that.

that you all see in your everyday practices. And so we'd like to take a lot more data with a lot more partners and make sure that we are actually meeting the needs of the full population, not just these subsets of hospitals we've worked with. My dream someday is that this becomes as ubiquitous as pulse ox is today. We feel that there are very few downsides to using a device like ours and that it would help you provide

Ben Courchia (11:49.752)

Mm-hmm.

Xina Quan - PyrAmes (11:53.98)

better data to improve your care for your patients.

Ben Courchia (11:58.692)

Thank you for that. mean, we're going to put all the information for people who might be interested in getting in touch with you and maybe trying out the BOPLY in their unit in the episode show notes. Thank you so much for making the time to come on the podcast for sharing this great new solution for something that definitely has frustrated neonatologists and nurses in the NICU for some time. And we wish you the best of luck and more success to come.

Xina Quan - PyrAmes (12:28.328)

Thank you very much. And thank you for this opportunity to talk about the Bopley. It excites us a lot. So thank you very much.

Ben Courchia (12:34.18)

You're welcome. pleasure.

Daphna Yasova Barbeau (12:34.279)

Our pleasure.