# Continuous Non-Invasive Blood Pressure Monitor for Neonates

> **NIH NIH R43** · PYRAMES, INC. · 2020 · $224,556

## Abstract

Summary/Abstract
Each year, about 5-18% of babies are born preterm, accounting for over 0.5M births in the US and 15M
globally. Many of these babies are admitted to Neonatal Intensive Care Units (NICUs) where the medical staff
generally have the option of using either invasive arterial lines (IALs) or inflatable-cuff non-invasive blood
pressure (NIBP) monitoring. The former introduces the risk of infection, tissue and nerve damage, and the
latter is less accurate, especially for hypotensive infants, and may add the risk of ischemic and nerve damage
upon repeated measurement. There is a clear need for a safer, continuous, and cost effective form of NIBP
measurement to meet the challenge of managing unhealthy blood pressures for neonates.
PyrAmes Inc. has developed a novel capacitive sensor technology that is paper thin and flexible and can
accurately detect blood pressure (BP). This sensor technology is part of a unique continuous BP monitoring
platform that provides accurate, lightweight and comfortable BP monitoring in a wireless, wrist-worn package
that is easy to use. The system uses lightweight neural networks to analyze pulse waveform data to provide
continuous determination of systolic, diastolic, and mean BP, heart rate, and their variabilities. The sensor is
easy to apply non-invasively and records pulsatile data similar to an arterial line, while avoiding the difficulties
of placing and maintaining an arterial line. This device can provide gold standard BP monitoring without
perturbing the patients for more accurate and relevant measurements.
The objective of this project is to extend the platform for use with term and pre-term neonates. This goal will be
accomplished through redesign of the sensor hardware and optimization of the data analytics software. We
will validate these modifications with clinical data from the NICU at Stanford University Medical Center.
In Phase I, we will miniaturize the electronics and modify the sensor array of a wrist-worn pulse wave monitor
to be sized more appropriately for neonates. We will validate the new device design by collecting NICU clinical
data from patients who have IALs in place in an IRB-approved study. From IAL and sensor data taken
simultaneously, we will determine ground truth values on a pulse-by-pulse basis and use these data in
conjunction with additional IAL data from historical databases to improve our sensor quality and predictive BP
models. Our success metric will be to equal or exceed the quality and accuracy of our data for adults.
Phase II will be a follow-up IRB-approved pivotal study using the device from Phase 1 to position our device for
FDA submission and clearance and scale up to pilot production of this device.

## Key facts

- **NIH application ID:** 9910153
- **Project number:** 1R43HD101175-01
- **Recipient organization:** PYRAMES, INC.
- **Principal Investigator:** Xina Quan
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $224,556
- **Award type:** 1
- **Project period:** 2020-04-06 → 2022-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9910153

## Citation

> US National Institutes of Health, RePORTER application 9910153, Continuous Non-Invasive Blood Pressure Monitor for Neonates (1R43HD101175-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9910153. Licensed CC0.

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