Safebeat Inc

NOVEL, AUTOMATED MOBILE HEART RHYTHM ANALYSIS TECHNOLOGY TO START ANTIARRHYTHMIC MEDICATIONS SAFELY AT HOME - PROJECT ABSTRACT THIS PROPOSAL PROVIDES ADDITIONAL OBJECTIVES TO ADVANCE THE RESEARCH AND ENTREPRENEURIAL SKILLS OF THE POSTDOCTORAL CANDIDATE AND THE PARENT AWARD, WHICH AIMS TO IMPROVE CARDIOVASCULAR OUTCOMES AND QUALITY OF LIFE FOR ATRIAL FIBRILLATION (AF) PATIENTS BY ALLOWING THEM TO SAFELY START PROVEN ANTIARRHYTHMIC DRUGS (AADS). AF IS THE MOST COMMON HEART RHYTHM DISORDER (>38M CASES WORLDWIDE) AND CAUSES SIGNIFICANT MORBIDITY AND MORTALITY. AADS REDUCE MORTALITY UNLIKE OTHER AF DRUGS, BUT ACCESS IS RESTRICTED BY A THREE-DAY HOSPITALIZATION REQUIRED TO START THESE ORAL DRUGS. THIS IS DUE TO A RARE (<0.6%) HEART RHYTHM SIDE EFFECT THAT MAY REQUIRE DEFIBRILLATION AND CAN BE AVOIDED BY HEART RHYTHM ANALYSIS. DURING A “DRUG LOAD” HOSPITALIZATION, CORRECTED QT (QTC) INTERVALS FROM PATIENT ELECTROCARDIOGRAMS (ECGS) ARE MANUALLY MEASURED AND TRACKED, AS QTC CHANGES PREDICT ADVERSE RESPONSES TO AADS. FOR AF PATIENTS AT LOW RISK OF PROARRHYTHMIA, THE COST AND RISKS OF HOSPITALIZATION MAY OUTWEIGH THE BENEFITS. SAFEBEAT DEVELOPED THE FIRST MACHINE LEARNING ALGORITHM TO PRODUCE VISUALLY VERIFIABLE QTC MEASUREMENTS FOR ANY ECG FORMAT, ENABLING EASY REVIEW OR MODIFICATION FROM A MOBILE PHONE. THE HIGH QTC ACCURACY (5±7 MS) ENABLED THE ALGORITHM TO RECOMMEND AAD DOSING WITH 95% ACCURACY COMPARED TO PHYSICIANS. THIS PROPOSAL IS SUPPORTED BY CARDIAC MONITORING DEVICE MANUFACTURERS, HOSPITAL SYSTEMS, AND KEY OPINION LEADERS IN CARDIOLOGY DUE TO SIGNIFICANT COST SAVINGS, IMPROVED LONG-TERM AF MONITORING, AND EXPANDED AAD ACCESS. THE GOALS OF THIS PROPOSAL ARE FACILITATED BY 1) ASSESSMENT OF PATIENT AND PROVIDER INTERACTION FOR REFINEMENT OF THE SAFEBEAT PLATFORM, 2) EVALUATE PATIENT AND ECG CHARACTERISTICS AS PREDICTORS OF PHARMACOLOGICAL CARDIOVERSION USING AAD THERAPY TO DETERMINE THE BEST CANDIDATES FOR USE OF THE PLATFORM, AND 3) PERFORM LONGITUDINAL FOLLOW UP OF STUDY PARTICIPANTS FOR USABILITY AND EFFICACY DATA.

A NOVEL, SMARTWATCH-ENABLED, AUTOMATED MOBILE HEART RHYTHM ANALYSIS TECHNOLOGY TO START ANTIARRHYTHMIC MEDICATIONS SAFELY AT HOME - ABSTRACT BY 2030, MORE THAN 12 MILLION AMERICANS WILL SUFFER FROM ATRIAL FIBRILLATION (AF), A HEART ARRHYTHMIA WHICH DRAMATICALLY INCREASES MORTALITY AND RISK OF STROKE. CLASS III ANTIARRHYTHMIC DRUGS (SOTALOL, DOFETILIDE) PRESCRIBED TO TREAT AF REDUCE BOTH MORBIDITY AND MORTALITY, BUT ACCESS TO THEM IS RESTRICTED BY THE HOSPITALIZATION PERIOD REQUIRED TO INITIATE THEM. DURING THIS TIME, PATIENT’S HEARTS ARE MONITORED BY ECG TO OBSERVE POST-DRUG EFFECTS OF 6 CONSECUTIVE DRUG DOSAGES OVER 3 DAYS ON THE CORRECTED QT INTERVAL (QTC) OF THE ECG. THIS INTERVAL IS THE PRIMARY DETERMINANT OF TORSADES DE POINTES (TDP) RISK; TDP IS A RARE BUT LIFE-THREATENING FAST VENTRICULAR RHYTHM WHICH CAN BE PROVOKED BY AADS. SAFEBEAT RX INC. DEVELOPS TECHNOLOGY THAT ALLOWS LOW-RISK ATRIAL FIBRILLATION PATIENTS TO REPRODUCE THIS ‘DRUG LOADING’ PROCEDURE OUTSIDE A HOSPITAL, AND THEREBY START HEART RHYTHM MEDICATIONS SAFELY AT HOME BY TITRATING DRUG EFFECTS TO QTC CHANGES – THE SAFEBEAT KIT ANALYZES POST-DRUG ECGS TAKEN BY PATIENTS AT HOME VIA A MACHINE LEARNING ALGORITHM, AND SENDS THE DATA TO THE RELEVANT PHYSICIANS, WHO CAN MODIFY OR CONTINUE DRUG DOSAGES AS REQUIRED. ONE SIGNIFICANT BUT UNRESOLVED PROBLEM IS THAT HEART RHYTHMS HAVE A STRONG CIRCADIAN VARIABILITY, OFTEN OF THE SAME MAGNITUDE AS DRUG EFFECTS THEMSELVES, WHICH IS NOT MEASURED OR MODELED DURING DRUG INITIATION. WE HYPOTHESIZE THAT A SMARTWATCH WITH ECG MEASUREMENT CAPABILITIES CAN BE USED TO DIFFERENTIATE THESE CIRCADIAN EFFECTS FROM DRUG EFFECTS BY TAKING SEVERAL MEASUREMENTS A DAY. SPECIFICALLY, (1) CIRCADIAN EFFECTS IN AF PATIENTS CAN BE MEASURED WITH TRADITIONAL CARDIAC TELEMETRY MODELS (2) A SMARTWATCH CAN REPRODUCE THIS MODEL AND DEMONSTRATE CLINICALLY EQUIVALENT MEASUREMENTS, AND (3) THESE MEASUREMENTS WILL BE STRAIGHTFORWARD AND ACCEPTABLE FOR PATIENTS. HAVING ESTABLISHED THESE, A PLANNED PHASE II WILL CONTINUE WITH FULL CLINICAL VALIDATION SUFFICIENT TO APPLY FOR FDA 510K CLEARANCE FOR A CIRCADIAN-ADJUSTED QTC MODEL OF DRUG SAFETY MONITORING. SAFEBEAT RX INC. IS THE FIRST COMPANY TO OFFER AN IN-HOME, REMOTE MONITORING ALTERNATIVE TO DRUG LOAD HOSPITALIZATION. AT MAXIMAL ADOPTION, THE ANNUAL US BEACHHEAD MARKET OF LOW-RISK, EARLY-ADOPTING PATIENTS IS CALCULATED AT $1.7B FOR AF ALONE. THE COMPANY HAS FILED KEY IP AROUND THIS PROPOSITION AND HAS LICENSING AGREEMENTS WITH HARDWARE COMPANIES TO ENABLE SUCCESSFUL SCALING TO SERVE THE GROWING AF POPULATION.