Project Grant R44HL158374

DEVELOPMENT OF A NOVEL CUFF-LESS WRIST WEARABLE CONTINUOUS BLOOD PRESSURE MONITOR - PROJECT SUMMARY THERE IS AN UNMET CLINICAL NEED FOR AN ACCURATE, STANDALONE, CONTINUOUS NON-INVASIVE BLOOD PRESSURE (CNIBP) MONITOR. CURRENT NON-INVASIVE, OCCLUSIVE ARM CUFF-BASED BP TECHNOLOGIES ARE INACCURATE AND PROVIDE ONLY SINGLE- POINT BP MEASUREMENTS. IN US HOSPITALS, THERE ARE CLOSE TO 44 MILLION IN-PATIENT ADMISSIONS AND SURGERIES PER YEAR THAT REQUIRE BP MONITORING, BUT PERIODIC CUFF-BASED MEASURES LEAD TO MONITORING GAPS AND POORER OUTCOMES, INCLUDING 300,000 PREVENTABLE CARDIAC ARRESTS PER YEAR. IN HOSPITALS, CONTINUOUS BP MONITORING CAN BE ACHIEVED WITH INVASIVE INTRA-ARTERIAL PRESSURE (IAP) MONITORING, BUT WITH SIGNIFICANT RISKS. APART FROM CRITICAL CARE AND OTHER HOSPITAL SETTINGS, CNIBP TECHNOLOGY HAS BROADER APPLICATION IN 103 MILLION AMERICANS WITH HYPERTENSION, A LEADING CAUSE OF STROKE AND HEART ATTACKS. INITIAL MARKET FOCUS FOR DYNOCARDIA IS TO DEVELOP STANDALONE CNIBP ALTERNATIVE TO IAP AND ARM CUFF-BASED DEVICES FOR USE IN INTENSIVE CARE UNITS AND OPERATING ROOMS. DYNOCARDIA'S VITRACK® IS THE FIRST STANDALONE, CUFF-LESS, WRIST WEARABLE DEVICE FOR CNIBP MONITORING. COMPARED TO OTHER CNIBP TECHNOLOGIES, THE ADVANTAGES OF VITRACK INCLUDE: (1) NEW METHOD FOR CONTINUOUS MEASUREMENT OF BP WITHOUT A CUFF: VITRACK USES SKIN FORCE/DISPLACEMENT INFORMATION TO PROVIDE A DIRECT, CONTINUOUS MEASUREMENT OF SYSTOLIC AND DIASTOLIC BP. THIS METHOD IS ANALOGOUS TO THE GOLD STANDARD AUSCULTATORY METHOD IN WHICH THE PHYSICIAN MEASURES SYSTOLIC AND DIASTOLIC BP DIRECTLY WITH AN ARM CUFF AND STETHOSCOPE (SOUND) AT A SINGLE TIME POINT, BUT VITRACK MEASURES CONTINUOUSLY; (2) ACCURACY: AT LEAST AS ACCURATE AS THE GOLD STANDARD (3) NOVEL TECHNOLOGY: FIRST-OF-ITS-KIND CUFF-LESS, WEARABLE TECHNOLOGY; (4) VERSATILITY: ALSO MEASURES RESPIRATORY, HEART RATE OTHER HEMODYNAMIC PARAMETERS; AND (5) EASE OF USE: UTILIZES A CAMERA-BASED OPTOMECHANICAL SENSOR THAT CAN LOCK PULSATION AUTOMATICALLY WITHOUT NEED FOR PRECISE PLACEMENT. IN SBIR PHASE 1-LIKE PRECLINICAL STUDIES, USING THE FULLY AUTOMATED LAB PROTOTYPE, IN LARGE AND SMALL ANIMAL STUDIES, VITRACK CORRELATED ONE-TO ONE (R2= 0.96) WITH INVASIVE IAP. IN CLINICAL STUDIES OF 80 OUTPATIENTS OVER A WIDE RANGE OF BPS, VITRACK MET FDA EQUIVALENCY STANDARDS FOR MEASURING BP AND IN FURTHER OUTPATIENT STUDIES, CONTINUOUSLY MEASURED BEAT-TO-BEAT BP RELIABLY, DEMONSTRATING ITS FEASIBILITY AS A STANDALONE CNIBP MONITOR. THE GOAL OF THIS DIRECT TO PHASE II PROPOSAL IS TO REFINE THE CURRENT PROTOTYPE TO BUILD CLINICAL STUDY DEVICES AS PER ISO13485 DESIGN CONTROLS AND THEN ASSESS CLINICAL PERFORMANCE IN HUMAN SUBJECTS TO PRODUCE AN OPTIMIZED COMMERCIALLY VIABLE VITRACK DEVICE FOR USE IN CRITICAL CARE SETTINGS. THE OUTCOME OF THIS STUDY WILL ESTABLISH VITRACK AS THE FIRST STANDALONE, WEARABLE CNIBP ALTERNATE TO IAP AND ENABLE NEXT PHASE FUNDING TO BUILD THE PRODUCTION EQUIVALENT VITRACK WRIST DEVICES, AS A PRELUDE TO FINAL CLINICAL VALIDATION AND FDA 510(K) CLEARANCE.