Wearable Continuous Blood Pressure Monitors

Votes: 8
Views: 211
Medical

PyrAmes is a digital health company focused on fundamentally transforming health care delivery through continuous blood pressure monitoring that is accurate, wireless, and non-invasive. Our devices’ comfort and ease-of-use will enable better BP management for patients from newborns to seniors. Our wearable devices provide a comfortable and easy-to-use alternative to intermittent cuff measurements with the timeliness and accuracy of invasive arterial catheters (IALs), at reduced cost, and risk of pain and complications.

Blood pressure (BP) 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 pregnant women at risk of hypertension disorders of pregnancy such as preeclampsia.

To measure blood pressure, standard BP cuffs only provide spot measurements and can be time-consuming and difficult to self-administer. While frequent measurement with automated cuff devices (ABPMs) is recommended by the AHA , they are inconvenient and uncomfortable (and painful for some) and carry risk of tissue damage. ABPMs are prescribed for fewer than 1% of suspected hypertensives; patients generally are unwilling to use them for more than 24 hours. Most important, intermittent cuff measurements may not be sufficient for critical care where the status of a patient can change from minute to minute.

Continuous BP can be monitored using an IAL inserted into the artery to directly measure changes in BP, but carry risk of serious complications such as infection, bleeding, blood clots, nerve damage, and amputation, particularly for children with smaller arteries. Requiring highly skilled medical staff and equipment, they are generally only used in ICU settings.

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.

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. Our first product for neonates is in pilot production and a multi-site pivotal validation study for 510(k) submission to the FDA. Products for adult inpatient and outpatient applications, including home monitoring, are under development.

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  • ABOUT THE ENTRANT

  • Name:
    Xina Quan
  • Type of entry:
    team
    Team members:
    Xina Quan, Ph.D.
    Zhenan Bao, Ph.D.
    Keith Drake, Ph.D.
    Doug Halperin
    Weyland Leong
    Junjun Liu, Ph.D.
    Art Muir, MBA
    Peter Noymer, Ph.D.
    Dave Richardson
    Thomas Roxlo, Ph.D.
    Will Sutherland
  • Software used for this entry:
    MatLab
  • Patent status:
    patented