Project Grant R33HL168741

NON-INVASIVE, CONTINUOUS BLOOD PRESSURE MONITORING FOR PRENATAL MATERNAL HEALTH - PROJECT SUMMARY/ABSTRACT -- NON-INVASIVE, CONTINUOUS BP MONITORING FOR PRENATAL MATERNAL HEALTH HYPERTENSIVE DISORDERS AFFECT UP TO 15% OF PREGNANCIES AND CAN LEAD TO SERIOUS COMPLICATIONS FOR BOTH MOTHER AND CHILD. PREECLAMPSIA IS THE MOST SEVERE HYPERTENSIVE DISORDER DURING PREGNANCY. IN ADDITION TO BEING THE SECOND LEADING CAUSE OF MATERNAL MORTALITY WORLDWIDE, IT IS RESPONSIBLE FOR UP TO 2.6 MILLION PREMATURE BIRTHS AND ABOUT 0.5 MILLION INFANT DEATHS EACH YEAR. TIMELY INTERVENTION CAN MITIGATE THE IMPACT OF GESTATIONAL HYPERTENSION BUT REQUIRES CLOSE MONITORING OF BLOOD PRESSURE (BP) WHICH IS DIFFICULT TO ACHIEVE OVER THE WEEKS OF LATE PREGNANCY WHERE THE PATIENT IS AT GREATEST RISK. THERE IS A CRITICAL NEED FOR A BP MONITORING DEVICE FOR PRENATAL CARE THAT IS COMFORTABLE, ACCURATE, AND EASY TO USE. PYRAMES HAS DEVELOPED A COMFORTABLE WEARABLE DEVICE TO COLLECT ARTERIAL PULSE WAVEFORM DATA TO MONITOR BP IN REAL TIME USING A COMBINATION OF CAPACITIVE PULSE SENSING AND MACHINE LEARNING TECHNIQUES. THE TECHNOLOGY WAS PIONEERED BY OUR CO-FOUNDER/ADVISOR, STANFORD PROF. ZHENAN BAO, AND IS EXCLUSIVELY LICENSED TO PYRAMES. 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 USE AND NON-INVASIVELY RECORDS WAVEFORM DATA SIMILAR TO AN ARTERIAL LINE, WHILE AVOIDING THE DIFFICULTIES AND RISKS OF PLACING AND MAINTAINING AN ARTERIAL LINE. IT CAN PROVIDE RESULTS COMPARABLE TO GOLD STANDARD ARTERIAL LINE MONITORING WITHOUT PERTURBING THE PATIENTS FOR MORE TIMELY AND ACCURATE MEASUREMENTS THAN POSSIBLE WITH CUFFS. PYRAMES' BOPPLI DEVICE FOR INFANTS IS BASED ON THIS TECHNOLOGY AND RECEIVED FDA BREAKTHROUGH DEVICE DESIGNATION. IT IS IN PILOT PRODUCTION AND IS CURRENTLY FDA REVIEW BASED ON DATA FROM A MULTI-SITE PIVOTAL STUDY TO COLLECT PULSE WAVEFORM DATA FROM PRETERM NEONATES IN THE NICU WITH AN ARTERIAL LINE IN PLACE, WITH A PRIMARY OBJECTIVE OF MEASURING BP WITHIN THE FDA GUIDELINES FOR ACCURACY. THE OBJECTIVE OF THE R61 PHASE IS TO EXTEND PYRAMES' PLATFORM TO MONITOR PREGNANT WOMEN. THIS GOAL WILL BE CONSENTING EXPECTANT MOTHERS RECEIVING BLOOD PRESSURE MEASUREMENTS DURING OFFICE VISITS OR WHEN HOSPITALIZED BEFORE DELIVERY. WE WILL USE THE DATA COLLECTED IN THE PROPOSED STUDY TO REFINE THE ARTIFICIAL NEURAL NETWORKS USED TO EXTRACT BP VALUES FROM THE PYRAMES PULSE WAVEFORM DATA WITH A FOCUS ON OBTAINING MORE ACCURATE RESULTS FOR PREGNANT WOMEN. OUR SUCCESS METRIC FOR THIS STUDY ON EXPECTANT MOTHERS WILL BE TO EXCEED THE QUALITY AND ACCURACY OF OUR PRELIMINARY MODELS FOR THESE WOMEN. WE ALSO PLAN TO DETERMINE IF THE PULSE WAVEFORM SHAPE CAN SERVE AS A TIMELY BIOMARKER OF HYPERTENSIVE DISORDERS THAT CAN OCCUR DURING PREGNANCY. THE R33 PHASE WILL INCLUDE A FOLLOW-UP IRB-APPROVED VALIDATION STUDY USING THE DEVICE AND MODELS FROM THE R61 PHASE TO POSITION OUR DEVICE FOR FDA CLEARANCE AND TO SCALE UP TO PILOT PRODUCTION OF THIS DEVICE.