Kovar Corporation

WIRELESS WITHDRAWAL DETECTION AND MONITORING SYSTEM FOR NEONATAL ABSTINENCE SYNDROME. - PROJECT SUMMARY NEONATAL ABSTINENCE SYNDROME (NAS) IS AN OPIOID WITHDRAWAL SYNDROME THAT DEVELOPS SHORTLY AFTER BIRTH TO IN UTERO-EXPOSED NEONATES. THE COST OF NAS IS HIGH: NEWBORNS WITH NAS ARE TYPICALLY RECEIVE CARE IN THE NEONATAL INTENSIVE CARE UNIT (NICU), WHERE THE DAILY COST OF CARE IS HIGH. NEARLY 22,000 INFANTS ARE BORN WITH NAS EACH YEAR AT A COST OF $1.5 BILLION 1. MOREOVER, MEDICATION-BASED INTERVENTIONS FOR THE TREATMENT OF NAS, USED IN UP TO 80% OF OPIOID-EXPOSED INFANTS, CARRY THEIR OWN RISKS OF TOXICITY AND DRUG INTERACTIONS 2. DESPITE THE MEDICAL COST, HIGH SOCIETAL IMPACT OF NAS, AND THE RISKS OF TREATMENT, THE TOOLS TO ASSESS THE SEVERITY OF NAS CAN BE SUBJECTIVE AND SUFFER FROM EXAMINER BIAS 3. THERE IS AN URGENT NEED FOR INNOVATIVE NEW METHODS TO DIAGNOSE NAS AND ASSESS THE EFFICACY OF RESPONSES TO TREATMENT. FLEXIBLE, LOW-COST WEARABLE DEVICES (WORN ON THE SKIN) THAT CAN REPORT MEASURES OF SYSTEMIC BIOCHEMICAL AND BIOMECHANICAL PROCESSES OFFER A SIMPLE AND ECONOMICAL SOLUTION. IN NAS, SURGES OF SYMPATHETIC NERVOUS SYSTEM ACTIVITY PRODUCE INCREASED HEART RATE, SKIN CONDUCTANCE, UNSTABLE TEMPERATURE, AND TREMOR. THESE MANIFEST IN INCREASED INFANT SWEATING, SEIZURES, TREMORS, UNSTABLE BODY TEMPERATURE, AND MORE—EVENTS THAT MUST CONTINUALLY MONITORED AND ASSESSED BY NURSES. THE UNSUPERVISED, OBJECTIVE DETECTION/QUANTIFICATION OF THE BODILY RESPONSE OF NEONATES SUFFERING FROM NAS COULD DRIVE THE DEVELOPMENT OF NEW, OBJECTIVE SCORING TOOLS THAT CAN GUIDE THE INITIATION, INTENSITY, AND DURATION OF THERAPIES FOR NAS2. SUCH TOOLS COULD SIGNIFICANTLY REDUCE MEDICAL COSTS AND IMPROVE PATIENT OUTCOMES BY REDUCING PATIENT TIME IN NICU, REDUCING NURSE LOAD, IMPROVING OUTPATIENT MONITORING, AND HELPING TO ASSIST IN THE OPTIMIZATION OF PATIENT TREATMENTS. CRITICALLY, WE BELIEVE SUCH A TOOL MAY BE ABLE TO OBJECTIVELY CAPTURE EVENTS THAT MAY GO UNNOTICED BY NURSES OR WHILE THE INFANT IS SLEEPING (MINOR TREMORS, POOR OXYGENATION, TEMPERATURE FLUCTUATIONS, DEHYDRATION). THIS PROPOSAL SEEKS TO DEVELOP, ASSESS, AND COMMERCIALIZE INTERLINKED, INFANT-TARGETED WEARABLE BIOSENSOR- SYSTEMS CAPABLE OF AUTOMATED DIGITAL SCORING, CONTINUOUSLY MONITORING THE BIOCHEMICAL, PSYCHOLOGICAL AND ENVIRONMENTAL TO BIOPHYSICAL PARAMETERS OF OPIOID-DEPENDENT NEONATES WHILE PROVIDING SUGGESTIVE TREATMENT FOR NAS. OUR TEAM AND PARTNERS HAVE OUTSTANDING EXPERIENCE IN ALL AREAS NECESSARY TO THIS INVESTIGATION TO DEVELOP A COMMERCIAL GRADE WEARABLE WRISTBAND MONITORING KIT THAT INCLUDES: (1) INFANT WEARABLE WRISTBAND, (2) IMAGING CAMERA (3) RECHARGING STATION, (4) TABLET APP, AND (5) PATIENT PORTAL TAILORED FOR PROFESSIONAL HEALTHCARE PROVIDERS. OUR BUSINESS UNIT HAS EXTENSIVE NIH FUNDED EXPERIENCE IN WEARABLE BIOSENSING, IN THE DETECTION OF SYMPATHETIC NERVOUS SYSTEM ACTIVITY IN OPIOID WITHDRAWAL, PEDIATRICS, BUSINESS DEVELOPMENT, AND INTELLECTUAL PROPERTY. OUR ACADEMIC PARTNERS HAVE BROAD EXPERIENCE IN NOVEL BIOSENSOR DEVELOPMENT.

WIRELESS WEARABLE WITH AI ANALYTICS FOR MONITORING NEONATAL ABSTINENCE SYNDROME (NAS) - PROJECT SUMMARY NEONATAL ABSTINENCE SYNDROME (NAS) IS AN OPIOID WITHDRAWAL SYNDROME THAT DEVELOPS SHORTLY AFTER BIRTH TO IN UTERO-EXPOSED NEONATES. NEWBORNS WITH NAS TYPICALLY RECEIVE CARE IN THE NEONATAL INTENSIVE CARE UNIT (NICU), WHERE THE DAILY COST OF CARE IS HIGH, COSTING $2.5 BILLION PER THE 22,000 INFANTS BORN WITH NAS AND AN AVERAGE COST OF $79 937.75 PER BABY ANNUALLY [47]. ALTHOUGH THERE ARE MEDICATION-BASED INTERVENTIONS FOR THE TREATMENT OF NAS, WHICH ARE USED IN UP TO 80% OF OPIOID-EXPOSED INFANTS, THESE TREATMENTS CARRY THEIR OWN RISKS OF TOXICITY AND DRUG INTERACTIONS [48]. DESPITE THE STEEP MEDICAL COSTS AND THE RISKS OF TREATMENT, CURRENT TOOLS TO ASSESS THE SEVERITY OF NAS ARE SUBJECTIVE AND SUFFER FROM EXAMINER BIAS, RESULTING IN POORER CLINICAL OUTCOMES, SUCH AS LONGER LENGTHS OF STAY IN THE NICU, FOR THESE BABIES [4]. THERE IS AN URGENT NEED FOR INNOVATIVE NEW METHODS TO RELIABLY DIAGNOSE NAS AND THOROUGHLY ASSESS THE EFFICACY OF RESPONSES TO TREATMENT. REKOVAR HAS WORKED DILIGENTLY TO DEVELOP NEOMONKI (NEONATAL MONITORING KIT), A SIMPLE ECONOMICAL SOLUTION TO OBJECTIVELY ASSESS AND TREAT NAS. NEOMONKI IS AN AFFORDABLE, WEARABLE MONITORING DEVICE THAT CONTINUOUSLY REPORTS MEASURES OF BEHAVIORAL AND PHYSIOLOGICAL SYMPTOMS CORRELATING TO NAS THAT MAY OTHERWISE GO UNNOTICED TO HEALTHCARE PROFESSIONALS. NEOMONKI CONSISTS OF WIRELESS WEARABLE WRISTBANDS FITTED WITH BIOSENSOR TECHNOLOGY, A TABLET FITTED WITH REKOVAR’S HEALTHCARE PORTAL ENHANCED WITH ROBUST ENCRYPTION/DATA COLLECTION CAPABILITIES, A CHARGING DOCK STATION WHICH POWERS THE TABLET AND ALLOWS EASY ACCESS TO RECHARGE THE WRISTBANDS, A CAMERA ATTACHED TO THE DOCK STATION TO ANALYZE IMAGING PROPERTIES, AND A PORTABLE CART WHICH HOLDS THE DOCK STATION AND ALLOWS FOR EASY REPOSITIONING OF NEOMONKI. NEOMONKI WILL REVOLUTIONIZE NEONATAL HEALTHCARE WITH A CUTTING-EDGE AI (ARTIFICIAL INTELLIGENCE) CLINICAL ALGORITHM THAT ANALYZES BIOSENSOR AND IMAGING DATA TO DELIVER PREDICTIVE NAS ANALYTICS AND ENHANCE DIAGNOSTIC DECISION-MAKING. REKOVAR HAS SUCCESSFULLY PURSUED SEVERAL OBJECTIVES TO ENHANCE THE PERFORMANCE OF NEOMONKI, INCLUDING SIZE REDUCTION AND IMPROVED FUNCTIONALITY AND SAFETY FEATURES. REKOVAR HAS ALSO MADE STRIDES IN IMPROVING NEOMONKI’S SOFTWARE GRAPHICAL USER INTERFACE, ENSURING THAT IT IS USER-FRIENDLY AND FUNCTIONAL. HOWEVER, THE DEVICE'S SUCCESS DEPENDS ON THE DEVELOPMENT OF THE AI ALGORITHM FOR ASSESSING PATIENT SYMPTOMS AND PRESCRIBING APPROPRIATE TREATMENTS. THIS PROPOSAL REVOLVES AROUND THE COLLECTION OF DATA IN CLINICAL TRIALS TO DEVELOP, OPTIMIZE, AND REFINE AN ALGORITHM FOR ASSESSING NAS SYMPTOMS IN NEONATAL PATIENTS WITH THE NEOMONKI. THIS WILL BE DONE IN TWO PHASES: I) THE INITIAL DATA COLLECTION AND PUBLICATION ON THE ADVANTAGES OF CONTINUOUS MONITORING IN NAS NEONATES USING NEOMONKI, THE DEVELOPMENT OF AN AI ALGORITHM TO AUTOMATE SYMPTOM SCORING WITH HIGH ACCURACY, AND THE PREPARATION FOR AN FDA DE NOVO SUBMISSION FOR THE NEOMONKI WEARABLE. AND II) VALIDATING THE AI ALGORITHM THROUGH A SECOND CLINICAL TRIAL, CONDUCTING A PILOT STUDY TO ESTABLISH THE NEOMONKI DEVICE'S EFFECTIVENESS IN IMPROVING CLINICAL OUTCOMES, EXPANDING THE AI ALGORITHM TO INCLUDE FNASS SCORING WITH HIGH ACCURACY, AND ACHIEVING FDA DE NOVO APPROVAL FOR THE NEOMONKI SYSTEM. THESE CLINICAL TRIALS WILL COMPARE THE PERFORMANCE OF NEOMONKI AGAINST THE CURRENTS STANDARDS OF CARE USED BY PARTICIPATING HOSPITALS. A KEY MILESTONE OF THIS STAGE OF THE PROJECT IS TO ASSESS WHETHER THE OPTIMIZED AUTOMATED DIGITAL SCORING AND SUGGESTED TREATMENT ALGORITHM CAN IMPROVE CLINICAL OUTCOMES, SHORTEN HOSPITAL STAYS, AND DECREASE DAILY COSTS. ACHIEVING THIS MILESTONE WILL ALLOW NEOMONKI TO BE USED COMMERCIALLY TO AUTOMATE DIGITAL ASSESSMENTS AND TREAT PATIENTS.

WIRELESS WITHDRAWAL DETECTION AND MONITORING SYSTEM FOR NEONATAL ABSTINENCE SYNDROME.

REAP RENEWABLE ENERGY SYSTEM (RES) GRANT UNRESTRICTED AMOUNT

ANNUAL PROGRAMMATIC FUNDING WITH FOCUS ON ENTREPRENEURSHIP FOR THE AMERICAN CORNER VUKOVAR.

FUND TO SUPPORT PROGRAMS IMPLEMENTED AT THE AMERICAN CORNER VUKOVAR.

FUNDS TO SUPPORT PROGRAMS IMPLEMENTED IN THE AMERICAN CORNER VUKOVAR.

COVERING EXPENSES FOR THE PURCHASE OF THE NEW EQUIPMENT AND IMPROVEMENT IN THE AMERICAN CORNER VUKOVAR.

AC VUKOVAR ENGAGEMENT ON A WIDE ARRAY OF ISSUES WILL HELP THE MISSION'S EFFORTS IN EURO-ATLANTIC INTEGRATION.

YOUTH PROGRAMS ON LEADERSHIP AND EXCHANGE OPPORTUNITIES; AND AMERICA 250 CELEBRATIONS.

REAP RENEWABLE ENERGY SYSTEM (RES) GRANT $20K AND LESS

AMERICAN CORNER VUKOVAR WILL FOSTER UNDERSTANDING OF MEDIA LITERACY AND ENTREPRENEURIAL SPIRIT.

FUNDS TO SUPPORT PROGRAMS IMPLEMENTED IN AMERICAN CORNER VUKOVAR.

GRANT PROVIDED FUNDS TO PURCHASE A PC TO BE USED AT THE LIBRARY FOR EDUCATIONAL PURPOSES.