Wearable, Non-invasive, Continuous Blood Pressure Monitors for Maternal Health

Votes: 7
Views: 213
Medical

PyrAmes is a digital health company focused on fundamentally transforming health care delivery through continuous blood pressure (BP) monitoring that is accurate, wireless and non-invasive. Our wearable devices’ comfort and ease-of-use will enable better BP management for patients from newborns to seniors. Blood pressure is a critical biomarker for many medical conditions affecting the lives of 100M’s of people. Tighter BP control can lead to better outcomes for the 116M American adults suffering from hypertension. Frequent BP measurements are needed for critical or emergency care, home medical management for stroke or cardiac patients, and monitoring of women at risk of hypertension disorders of pregnancy such as preeclampsia.

Current BP monitoring includes inserting an invasive arterial line (high risk; requires highly-trained clinicians; appropriate only for in-hospital settings) and intermittent measurements using inflatable BP cuffs (cumbersome; sparse data; fraught with patient compliance issues). Automated cuff devices (ABPMs) are inconvenient and uncomfortable (and painful for some) and carry risk of tissue damage.

Our technology has been used successfully on patients ranging from newborns to adults 89+ years old. Our device provides timely data to treat patients at risk of rapid changes in BP which can lead to stroke or multiple organ failure, while removing the pain and risk of the current standards of care at lower cost and increased patient compliance. It also offers the possibility of remote monitoring for caregivers.

The FDA recently granted 510(k) market clearance as a Class II medical device for our lead product Boppli® (K223873), for neonates undergoing critical care. Our Bosimi® and Bosimi@Home® platforms extend our technology to the adult population, currently focusing on maternal health for mothers during the important prenatal and critical 6-8 week postpartum periods, funded in part by the NIH RADx Tech for Maternal Health Challenge. Hypertensive disorders of pregnancy (HDP) affect nearly 15% of pregnancies and can lead to serious complications both during pregnancy and after birth, with 75% to 97% of maternal deaths related to preeclampsia and 70% of maternal deaths resulting from hypertension occurring during the postpartum period. Women with pregnancies complicated by HDP experience higher lifetime risk of maternal cardiometabolic disease, sepsis, and hemorrhage. More effective BP monitoring can help mitigate these risks.

Our wearable device uses paper-thin capacitive sensors to capture pulse waveforms processed with neural networks to produce BP values that meet the FDA’s accuracy guidelines. Its passive measurements with a comfortable band and an easy-to-use app will improve compliance to provide more effective care. In volume, our devices can be manufactured using roll-to-roll processes and could be integrated into smartwatch bands. The electronics costs will be similar to low-end fitness bands, encouraging adoption of PyrAmes’ technology across a broad range of applications.

Our go-to-market strategy is to launch products in multiple markets including non-invasive alternatives to arterial lines, emergency medical monitoring, non-invasive ambulatory monitoring, and home health monitoring.

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  • ABOUT THE ENTRANT

  • Name:
    Xina Quan
  • Type of entry:
    team
    Team members:
    • Xina Quan
    • Zhenan Bao
    • Keith Drake
    • Doug Halperin
    • Junjun Liu
    • Art Muir
    • Peter Noymer
    • Dave Richardson
    • Thomas Roxlo
    • Will Sutherland
  • Patent status:
    patented