Not listed
A MOBILE HEALTH APPLICATION TO DETECT ABSENCE SEIZURES USING HYPERVENTILATION AND EYE-MOVEMENT RECORDINGS - RESEARCH STRATEGY 1. EXECUTIVE SUMMARY OF PREDICATE SBIR PHASE I GRANT AND TEAM THE OVERALL GOAL OF OUR PREDICATE SBIR PHASE I GRANT IS TO VALIDATE THE EYSZ MOBILE HEALTH (MHEALTH) APPLICATION AND DEVELOP ALGORITHMS TO DIAGNOSE AND MONITOR CHILDHOOD ABSENCE EPILEPSY (CAE) IN THE CLINICAL SETTING. EYSZ, INC. IS DEVELOPING A MOBILE HEALTH (MHEALTH) APPLICATION AND ALGORITHMS TO REMOTELY DIAGNOSE AND MONITOR CAE TO IMPROVE OUTCOMES. CURRENTLY, ABSENCE SEIZURES ARE CHALLENGING TO IDENTIFY,LEADING TO DIAGNOSTIC DELAYS AND DIFFICULTY MEASURING TREATMENT EFFICACY. UNTREATED SEIZURES PLACE CHILDREN AT RISK FOR ACCIDENTAL INJURY AND LEARNING LOSS. THE GOLD STANDARD FOR SEIZURE DETECTION IS VIDEO EEG (VEEG), BUT IT IS EXPENSIVE, LIMITED TO CLINICAL SETTINGS, AND HARD TO ACCESS. AS A RESULT, CLINICIANS RELY ON SELF-REPORTS, DESPITE STUDIES SHOWING PATIENTS REPORT ONLY 6% OF ALL ABSENCE SEIZURES, AND CAREGIVERS REPORT ONLY 14%. EVEN PRIMARY CARE PROVIDERS HAVE DIFFICULTY IDENTIFYING ABSENCE SEIZURES AND RELY ON VEEG, REFERRING 5 PATIENTS FOR EVERY 1 DIAGNOSED. ONCE DIAGNOSED WITH CAE, CHILDREN ARE STARTED ON ANTI-SEIZURE MEDICATIONS (ASM), WHICH RESULT IN SEIZURE FREEDOM IN LESS THAN 60% OF CHILDREN. HOWEVER, NO NEW TREATMENTS HAVE BEEN APPROVED SINCE THE 1990S, PARTIALLY DUE TO DIFFICULTY MEASURING SEIZURES.4 OTHER STRATEGIES TO MONITOR SEIZURES, SUCH AS AMBULATORY EEG, LACK THE SENSITIVITY AND SPECIFICITY OF VEEG, AND CAN ADD TO THE STIGMA OF PEOPLE WITH EPILEPSY. THUS, THERE IS A CRITICAL NEED FOR A REMOTE DIAGNOSTIC/MONITORING TOOL FOR ABSENCE SEIZURES. THE AIM OF THE SBIR PROPOSAL IS TO TEST AND FURTHER DEVELOP AN MHEALTH APP THAT USES (1) SUPERVISED GUIDED HYPERVENTILATION (HV), WITH (2) EYE MOVEMENT AND FACIAL BIOMETRIC DATA TO MONITOR SEIZURE SUSCEPTIBILITY AND TREATMENT RESPONSES IN CAE. ACHIEVING THESE GOALS WILL DECREASE COSTS OF CARE, MORBIDITY, AND MORTALITY AND IMPROVE QUALITY OF LIFE FOR THOSE WITH CHILDHOOD ABSENCE EPILEPSY. CAE IS THE MOST COMMON PEDIATRIC EPILEPSY SYNDROME, AFFECTING 10-17% OF ALL CHILDREN WITH EPILEPSY. SEIZURES OCCUR MANY TIMES DAILY AND CONSIST OF BRIEF LOSSES OF CONSCIOUSNESS (LOC), WITH IMMEDIATE RETURN TO BASELINE AWARENESS AND ACTIVITY. SEIZURES TYPICALLY MANIFEST AS STARING SPELLS, SOMETIMES WITH RHYTHMIC EYE BLINKING OR MOTOR AUTOMATISMS. AS LOC MAY OCCUR AT ANY TIME WITHOUT WARNING, ABSENCE SEIZURES HAVE A SIGNIFICANT IMPACT ON QUALITY OF LIFE (QOL), AND ACCIDENTAL INJURY IS COMMON, WITH 20% OF YOUNG ADULTS-3% PER YEAR-SUFFERING AN INJURY DURING A SEIZURE. THE CLINICAL COURSE OF CAE IS VARIABLE, AND REMISSION RATES ARE FAR LOWER THAN IN OTHER IDIOPATHIC EPILEPSIES. IN FIVE PROSPECTIVE COHORT STUDIES, ONLY 57-74% ACHIEVED SEIZURE FREEDOM. THUS, THERE IS A CRITICAL NEED FOR NEW THERAPEUTICS FOR ABSENCE EPILEPSY AND BETTER TOOLS FOR MONITORING THERAPEUTIC RESPONSES. THE CURRENT STANDARD OF CARE FOR MEASURING TREATMENT OUTCOMES IS SELF-REPORTED DATA. LARGE-SCALE CLINICAL TRIALS, INCLUDING THOSE TESTING NEW ANTISEIZURE MEDICATIONS, POPULATION-BASED ASSESSMENTS, AND OTHER EPIDEMIOLOGICAL STUDIES ALSO USE SELF-REPORTING TO DETERMINE OPTIMAL THERAPY REGIMENS. CRITICALLY, HOWEVER, MULTIPLE CLINICAL STUDIES SHOW PATIENT SEIZURE COUNTS PROVIDE INACCURATE INFORMATION. PATIENTS REPORT ONLY 6% OF ALL EXPERIENCED ABSENCE SEIZURES, WHEREAS CAREGIVERS REPORT ONLY 14%. IN A RECENT STUDY EXAMINING SELF-DOCUMENTATION OF ABSENCE SEIZURES BY ADULTS WITH IDIOPATHIC GENERALIZED EPILEPSY, INACCURATE SEIZURE COUNTS WERE FOUND TO SUBSTANTIALLY IMPACT OUTPATIENT MANAGEMENT AND TREATMENT. THE GOLD STANDARD FOR DETECTING AND CHARACTERIZING SEIZURE ACTIVITY IS A NEUROLOGIST READING OF A VEEG. IN THE HOME SETTING, WHERE > 99% OF SEIZURES OCCUR, VEEG IS NOT READILY AVAILABLE BECAUSE OF POOR PATIENT ACCEPTABILITY, POOR DETECTION CAPABILITY, HIGH COST AND CONTINUED RELIANCE ON ASYNCHRONOUS REVIEW. THE FDA HAS APPROVED TWO NON-EEG-BASED DEVICES TO DETECT CONVULSIVE SEIZURES, BUT THESE ARE RESPONSIBLE FOR ONLY 80% SENSITIVITY AND SPECIFICITY COMPARED WITH THE MAJORITY AGREEMENT OF 3 INDEPENDENT EPILEPTOLOGISTS REVIEWING VEEG. AIM 3. DEVELOP ML METHODS THAT USE FACIAL BIOMETRICS AND EYE TRACKING DATA TO QUANTITATE SEIZURES. OUR PROPOSED I-CORP TEAM WILL INCLUDE THE FOLLOWING 3 MEMBERS, WHO ARE COMMITTED TO THE TIME REQUIREMENTS OF THE PROGRAM. MEMBER NAME ROLE RACHEL KUPERMAN, MD PI/PD PARTH AMIN C-LEVEL CORPORATE OFFICER (COO) TRACEY FISHER INDUSTRY EXPERT 2. I-CORPS TEAM AND PROJECT PLAN THE AIM OF OUR PREDICATE SBIR PHASE I GRANT IS TO VALIDATE THAT A CLINICIAN READ OF THE VIDEO FROM THE EYSZ MHEALTH APP IS EQUIVALENT TO VIDEO EEG READ AND DEVELOP AI BASED ALGORITHM FOR SEIZURE IDENTIFICATION. ACHIEVING THESE AIMS WILL SIGNAL SUCCESSFUL COMPLETION OF PHASE I AND OUR READINESS TO TRANSITION TO PHASE II. THE LEARNINGS FROM THE PHASE I GRANT WILL BE INCORPORATED INTO THE APP TO IMPROVE USABILITY AND ALLOW FOR THE APP TO BE TESTED IN THE HOME ENVIRONMENT, AND VALIDATE OUR SEIZURE DETECTION ALGORITHM AS WE WORK TOWARDS FDA CLEARANCE AND COMMERCIALIZATION READINESS. THE EYSZ TEAM PARTICIPATED IN THE NIH I-CORP PROGRAM DURING OUR PREVIOUS SBIR PHASE 1 GRANT. WHILE THE RESULTS OF THE SBIR WERE TECHNICALLY SUCCESSFUL, THE DATA COLLECTED DURING THE I-CORP PROGRAM INFORMED OUR DECISION TO PIVOT FROM A CONTINUOUS USE WEARABLE EYE TRACKING GLASS TO AN INTERMITTENT USAGE SMARTPHONE BASED APP TO BETTER MEET THE CUSTOMER AND MARKET NEEDS. GIVEN THE SIGNIFICANT PIVOT, OUR GOAL WITH THIS NIH I-CORP IS TO WORK TOWARDS COMMERCIAL READINESS BY REFINING OUR BUSINESS MODEL INCLUDING: REIMBURSEMENT STRATEGY, BUSINESS/PRICING MODELS, AND UNDERSTANDING THE PURCHASING PROCESS AS WE WORK TOWARDS FDA CLEARANCE. OUR PROPOSED I-CORPS TEAM WILL INCLUDE THE FOLLOWING 3 MEMBERS. MEMBER NAME ROLE RACHEL KUPERMAN, MD PI/PD PARTH AMIN C-LEVEL CORPORATE OFFICER TRACEY FISHER INDUSTRY EXPERT THE TEAM, WHICH HAS BEEN COLLABORATING SINCE FEBRUARY 2020, HAS DEMONSTRATED EXPERTISE IN CLINICAL RESEARCH, PRODUCT DEVELOPMENT, AND COMMERCIALIZATION. THE FOLLOWING IS A SUMMARY OF THEIR EXPERTISE: RACHEL KUPERMAN, MD (PI/PD) LEADS THE MANAGEMENT TEAM AND CLINICAL RESEARCH. RACHEL IS A NEUROLOGIST WITH DUAL CERTIFICATION IN EPILEPSY AND NEUROLOGY AND HAS OVER 10 YEARS' EXPERIENCE DIRECTING THE CLINICAL EPILEPSY AND RESEARCH PROGRAMS AT UCSF BENIOFF CHILDREN'S HOSPITAL, OAKLAND. SHE IS ALSO THE INVENTOR OF THE CORE TECHNOLOGY AND HAS A STRONG BACKGROUND IN CLINICAL RESEARCH, HAVING SERVED AS THE PI ON MULTIPLE CLINICAL TRIALS, INCLUDING BEING THE PI FOR MULTIPLE SBIR PHASE I GRANTS. HER UNDERGRADUATE DEGREE IN PHYSICS FROM UCSD, AND HER NEUROLOGY AND NEUROPHYSIOLOGY TRAINING AT COLUMBIA AND UCSF, HAVE HELPED HER BRIDGE THE CLINICAL/COMPUTATIONAL DIVIDE. EARLY IN HER CAREER, DR. KUPERMAN WAS IDENTIFIED AS A LEADER AT CHILDREN'S HOSPITAL, WHERE SHE WAS INVITED TO PARTICIPATE IN THE UCSF PHYSICIAN LEADERSHIP PROGRAM IN 2011. DR. KUPERMAN WAS AWARDED $80K IN GRANTS FROM UCSF, INCLUDING THE JUNIOR INVESTIGATOR AWARD FOR RESEARCH, TOWARDS DEVELOPMENT OF HER PATENT. SHE WAS RECOGNIZED BY THE EPILEPSY FOUNDATION OF NORTHERN CALIFORNIA WITH THE VOLUNTEER OF THE YEAR AWARD IN 2016. DR. KUPERMAN WAS A FALL 2018 FELLOW AT UC BERKELEY LAW FORM AND FUND, WHICH FOCUSES ON THE CORE LEGAL, FINANCIAL, AND ORGANIZATIONAL ASPECTS OF STARTING AND SCALING A BUSINESS. SHE HAS SINCE RECEIVED THE FEROLYN FELLOWSHIP AWARD FROM THE FOGARTY INSTITUTE FOR INNOVATION, WHICH PROVIDES MENTORING TO RISING MEDTECH LEADERS WITH A PASSION TO TRANSFORM HEALTHCARE. PARTH AMIN, OUR CHIEF OPERATING OFFICER, BRINGS 20 YEARS OF MEDICAL DEVICE EXPERIENCE, INCLUDING HAVING WORKED FOR GLOBAL HEALTHCARE COMPANIES SUCH AS SIEMENS HEALTHINEERS, VARIAN MEDICAL SYSTEMS, AND OMNICELL. HE HAS HELD A VARIETY OF PIVOTAL ROLES IN THE AREAS OF PRODUCT MANAGEMENT, PROGRAM MANAGEMENT, AND ALLIANCE MANAGEMENT WHILE SUCCESSFULLY ATTAINING OBJECTIVES RELATED TO INNOVATION, PRODUCT DEVELOPMENT, REVENUE, AND MARKET SHARE GROWTH. HIS EXPERTISE IN PRODUCT DEVELOPMENT AND ALLIANCES, WITH AN EMPHASIS ON GO-TO-MARKET STRATEGIES INVOLVING PARTNERED SOLUTIONS, HAS ALLOWED US TO START IDENTIFYING AND ESTABLISHING KEY TECHNOLOGY, CLINICAL, AND COMMERCIAL PARTNERS, WHO IN TURN WILL ENABLE US TO TRANSLATE THIS MEANINGFUL INNOVATION INTO A COMMERCIALLY VIABLE PRODUCT. AS PART OF 3-2 DUAL DEGREE PROGRAM, MR. AMIN HOLDS A BE IN ELECTRICAL ENGINEERING FROM WASHINGTON UNIVERSITY AND B.S IN PRE-ENGINEERING FROM BIRMINGHAM-SOUTHERN COLLEGE. TRACEY FISHER IS AN ACCOMPLISHED BUSINESS EXECUTIVE WITH OVER 20 YEARS OF GLOBAL HEALTHCARE MARKETING EXPERIENCE. SHE HAS BUILT AND LED MARKETING TEAMS THAT HAVE LAUNCHED MEDICAL DEVICE PRODUCTS AND BRANDS THAT BECAME GLOBAL MARKET LEADERS AND GENERATED OVER $1B IN REVENUE, WHILE WORKING AT SIEMENS HEALTHINEERS AND VARIAN MEDICAL SYSTEMS. THROUGH COLLABORATION WITH PATIENT ADVOCACY, GOVERNMENT ADVOCACY, REGULATORY, REIMBURSEMENT, SALES, AND PRODUCT TEAMS SHE HAS DEFINED BUSINESS/PRICING MODELS AND VALUE PROPOSITIONS TO BUILD SUCCESSFUL NEW PRODUCT INTRODUCTION AND MARKETING STRATEGIES AND OVERSEE THE EXECUTION. WITH HER EXPERTISE AND GUIDANCE, WE ARE CONFIDENT THAT WE WILL ACHIEVE OUR AIMS FOR THE NIH-I CORPS PROGRAM. DURING THE EARLY STAGES OF OUR COMPANY FORMATION, WE PARTICIPATED IN THE NATIONAL SCIENCE FOUNDATION (NSF) I-CORPS PROGRAM, WHICH WAS EXTREMELY BENEFICIAL IN HELPING US UNDERSTAND THE EPILEPSY ECOSYSTEM AND CRAFT OUR INITIAL VALUE PROPOSITION. AT THAT TIME, OUR TEAM PERFORMED 111 INTERVIEWS OF PATIENTS, FAMILY MEMBERS, PHYSICIANS, PAYORS, PHARMACEUTICAL RESEARCHERS, COMPETITORS AND POTENTIAL COLLABORATORS. DURING OUR PREVIOUS NIH I-CORP PROGRAM WE COMPLETED OVER 100 INTERVIEWS THAT SIGNIFICANTLY CHANGED THE COURSE OF OUR PRODUCT AND RESEARCH. SINCE THE NIH PROGRAM, WE HAVE HAD AN ADDITIONAL PRE-SUB MEETING WITH THE FDA, COMPLETED OUR INITIAL CLINICAL STUDY AND PIVOTED TOWARDS A PRODUCT WITH BETTER MARKET FIT. BASED ON THE INTERACTIONS WITH OUR PARTNERS, AND CLINICAL COLLABORATORS, WE HAVE REFORMULATED OUR VALUE PROPOSITION, PURSUED ADDITIONAL PATENTS AND REFINED OUR REGULATORY AND REIMBURSEMENT STRATEGY. THE OVERALL GOAL OF PARTICIPATING IN THE NIH I-CORPS IS TO TAKE OUR VISION AND VALUE PROPOSITION AND ADD THE GRANULARITY WHICH WILL ALIGN OUR CLINICAL RESEARCH MILESTONES, REGULATORY STRATEGY, IP STRATEGY,REIMBURSEMENT STRATEGY AND FUNDRAISING MILESTONES, ULTIMATELY LEADING TO SUCCESSFUL COMMERCIALIZATION STRATEGY WHICH WILL POSITION US TO OBTAIN VENTURE FUNDING AND A PHASE II SBIR. WE PARTICULARLY NEED TO DO ADDITIONAL RISK MITIGATION AROUND OUR REVENUE MODEL, WHICH FOCUSES ON USE OF EXISTING REIMBURSEMENT CODES AND POSSIBLY APPLYING FOR ADDITIONAL CODES, OBTAINING PAYMENT FROM PAYERS, AND ENSURING OUR UNIT COSTS AND CHANNEL PARTNERS ARE ALIGNED FOR SCALING GROWTH. A STRUCTURED, HEALTHCARE-FOCUSED PROGRAM LIKE THAT OFFERED BY NIH I-CORPS WOULD BUILD UPON THE TREMENDOUS WORK TO DATE AND SET THE COMPANY UP FOR SUCCESS AS WE ADVANCE OUR CURRENT NIH-FUNDED INITIATIVE TO THE NEXT PHASE OF DEVELOPMENT. OUR TEAM IS IDEALLY POSITIONED TO HAVE MAXIMAL BENEFIT FROM THE NIH I-CORPS PROGRAM. OUR SBIR PHASE I GRANT HAS ALLOWED US TO DEVELOP AND ALIGN AS A TEAM FROM A TECHNICAL PERSPECTIVE. THE I-CORPS PROGRAM WILL ENABLE US TO EXPAND OUR CURRENT TECHNICAL FOCUS TO PRE-COMMERCIALIZATION TOPICS. WE BELIEVE THAT CUSTOMER DISCOVERY INTERVIEWS AND THE LEAN LAUNCHPAD SYSTEM ARE A TIMELY, STRUCTURED METHOD TO ASSIST OUR COMPANY AS WE MAKE THIS TRANSITION FROM OUR PREVIOUS POSITION AND HAVE BENEFITED US GREATLY IN THE PAST. COMMERCIAL POTENTIAL THROUGH > 200 CUSTOMER DISCOVERY INTERVIEWS SUPPORTED BY THE NSF + NIH I-CORPS PROGRAM AND CONTINUED CUSTOMER DISCOVERY INTERVIEWS - WITH EPILEPSY PATIENTS, CLINICIANS, PHARMACEUTICAL COMPANIES, EEG MANUFACTURERS, AND PATIENT ADVOCACY GROUPS - WE ARE CONFIDENT IN THE COMMERCIALIZATION POTENTIAL OF OUR TECHNOLOGY. BY ESTABLISHING AND GROWING A PARTNER ECOSYSTEM, WE ARE MINIMIZING COMMERCIAL RISKS WHILE EXPANDING OUR COMMERCIAL OPPORTUNITIES. WHILE OUR INITIAL PLAN WAS TO PARTNER WITH EYE TRACKING MANUFACTURERS, OUR NEW PRODUCT FOCUSES ON USING EXISTING SMARTPHONE TECHNOLOGY REDUCING MANY OF THE HURDLES THAT WE IDENTIFIED DURING OUR PREVIOUS I-CORP. IN PARTICULAR IT WILL SIGNIFICANTLY REDUCE OUR TIME TO MARKET, DECREASE THE FUNDING REQUIREMENTS, IMPROVE USER SATISFACTION AND SIGNIFICANTLY SIMPLIFY DISTRIBUTION. LASTLY, PHARMACEUTICAL COMPANIES HAVE EXPRESSED STRONG INTEREST, AS SHOWN BY FINANCIAL INVESTMENTS AND PLANNED CLINICAL PARTNERSHIPS TO USE OUR SOLUTION TO ASSESS THE EFFICACY OF ANTICONVULSANTS IN CLINICAL STUDIES. EYSZ HAS RECEIVED GRANT SUPPORT FROM GREENWICH BIOSCIENCES. UCB PHARMA, THE LARGEST EPILEPSY DRUG DEVELOPER, HAS ALSO INVESTED IN EYSZ. WE ARE FOCUSED ON THE CLINICAL CARE MARKET. IN THE DIGITAL HEALTH SPACE, COMMERCIALIZATION RELIES HEAVILY ON DEVELOPING A REIMBURSEMENT STRATEGY. WE PLAN ON LEVERAGING EXISTING CPT CODES INCLUDING BEHAVIORAL HEALTH CODES, REMOTE MONITORING CODES AND NONSPECIFIC NEURODIAGNOSTIC CODES. THIS PLANNING HAS BEEN COMPLICATED BY RECENT COVID-RELATED CHANGES IN TELEHEALTH AND REMOTE MONITORING REIMBURSEMENT, BUT WE ARE REASSURED THAT THE HEADWINDS TOWARDS ADDITIONAL COVERAGE ARE SUPPORTING OUR REIMBURSEMENT STRATEGY. WE ESTIMATE THE OVERALL U.S. MARKET OPPORTUNITY TO BE AROUND $3.4 BILLION DOLLARS, GIVEN THE DIRECT COSTS ASSOCIATED WITH EPILEPSY. WITH OUR INITIAL FDA CLEARANCE FOR ABSENCE SEIZURES, WE EXPECT TO CAPTURE 5% OF THE MARKET ($170M) IN 5 YEARS. TARGET CUSTOMER FOR THE CLINICAL CARE MARKET, OUR END USER WILL BE PEDIATRICIANS AND NEUROLOGISTS AT A LEVEL 3 + 4 EPILEPSY CENTER. WE UNDERSTAND THAT PURCHASING DECISIONS ARE NOT SOLELY MADE BY CLINICIANS, BUT THEY ARE INFLUENTIAL IN THE DECISION-MAKING PROCESS. AS PART OF THE I-CORPS PROGRAM, WE AIM TO BETTER UNDERSTAND HOW PRODUCTS ARE RECOMMENDED FOR PURCHASING BY NEURO SERVICE LINE MANAGERS, AND PEDIATRIC MANAGERS, HOW REIMBURSEMENT DECISIONS ARE MADE BY PAYORS, HOW BEST TO REACH INFLUENCERS AND DECISION-MAKERS, AND THE LEVEL OF INTEGRATION WITH EXISTING WORKFLOW REQUIRED TO FACILITATE ADOPTION. CLINICAL NEED AND CURRENT ALTERNATIVES MORE THAN 70 MILLION PEOPLE WORLDWIDE-INCLUDING ~1% OF THE U.S. POPULATION-SUFFER FROM EPILEPSY, A DEBILITATING, UNPREDICTABLE CHRONIC CONDITION IN WHICH ABNORMAL ELECTRICAL ACTIVITY IN THE BRAIN PRODUCES PHYSICAL DISTURBANCES INCLUDING LOSS OF CONSCIOUSNESS (LOC) AND/OR CONVULSIONS. EPILEPSY IS ASSOCIATED WITH DISABILITY, REDUCED QUALITY OF LIFE, AND AN ELEVATED RISK OF COMORBIDITIES, INCLUDING SEIZURE-RELATED INJURIES; RESPIRATORY, CARDIOVASCULAR, AND NEUROLOGIC DYSFUNCTIONS; AND PSYCHOLOGICAL CONDITIONS SUCH AS ANXIETY AND DEPRESSION. OUTCOMES INCLUDE LONG-TERM DISABILITY AND INCREASED RISK OF MORTALITY, AND EPILEPSY ACCOUNTS FOR 0.5% OF THE GLOBAL BURDEN OF DISEASE BASED ON YEARS OF LIFE LOST (YLL) AND YEARS LOST TO DISABILITY (YLD). GLOBALLY, THE COSTS ASSOCIATED WITH EPILEPSY ARE STAGGERING. IN THE U.S. ALONE, DIRECT COSTS HAVE MORE THAN DOUBLED IN LESS THAN A DECADE-FROM $12B TO $28B-WHILE OUTCOMES HAVE NOT IMPROVED FOR ALMOST 3 DECADES. IN ADDITION, EPILEPSY ACCOUNTS FOR MORE THAN 1 MILLION EMERGENCY DEPARTMENT (ED) VISITS AND OVER 280,000 HOSPITAL ADMISSIONS ANNUALLY IN THE U.S., WITH AGGREGATE HOSPITAL COSTS FOR EPILEPSY TOTALING APPROXIMATELY $2.5 BILLION. SEIZURES REPRESENT THE KEY SYMPTOM OF EPILEPSY AND THE PRIMARY TARGET OF EPILEPSY TREATMENT. DETECTION OF SEIZURES IS THE FIRST STEP IN CHOOSING AN APPROPRIATE TREATMENT REGIMEN, AND APPROPRIATE ANTICONVULSANTS CAN DECREASE SEIZURES BY 50%. UNFORTUNATELY, CURRENT DETECTION TECHNOLOGIES ARE IMPRACTICAL OR HAVE LIMITED EFFECTIVENESS OUTSIDE OF CLINICAL SETTINGS, AS DESCRIBED BELOW: SELF-REPORTING/OBSERVATION: AS FOR MANY OTHER CHRONIC CONDITIONS, EPILEPSY PATIENTS ARE OFTEN ASKED TO KEEP A SEIZURE DIARY. CRITICALLY, HOWEVER, PATIENT-REPORTED SEIZURE COUNTS DO NOT PROVIDE ACCURATE INFORMATION. STUDIES HAVE SHOWN THAT DURING VIDEO EEG, CAREGIVERS AND PATIENTS FAIL TO RECOGNIZE MORE THAN 50% OF SEIZURES. IN ADDITION, CONSTANT SEIZURE OBSERVATION SUBSTANTIALLY REDUCES QUALITY OF LIFE DUE TO LOSS OF SLEEP, SCHEDULE DISRUPTION, AND ANXIETY ABOUT MISSING SEIZURE ACTIVITY. THUS, BOTH PATIENTS AND CLINICIANS ARE AWARE OF THE NEED FOR A FEASIBLE AMBULATORY TECHNIQUE FOR THE OBJECTIVE DETECTION AND REGISTRATION OF SEIZURES. OUTPATIENT EEG: THERE HAVE BEEN MANY ATTEMPTS TO CONVERT THE GOLD STANDARD OF EEG PLUS VIDEO OBSERVATION INTO A LESS BURDENSOME MOBILE PLATFORM. TO DATE, HOWEVER, VIDEO EEG REMAINS EXPENSIVE, LARGELY
$55.0k 3/14/24 Not listed
A MOBILE HEALTH APPLICATION TO DETECT ABSENCE SEIZURES USING HYPERVENTILATION AND EYE-MOVEMENT RECORDINGS - RESEARCH STRATEGY 1. EXECUTIVE SUMMARY OF PREDICATE SBIR PHASE I GRANT AND TEAM THE OVERALL GOAL OF OUR PREDICATE SBIR PHASE I GRANT IS TO VALIDATE THE EYSZ MOBILE HEALTH (MHEALTH) APPLICATION AND DEVELOP ALGORITHMS TO DIAGNOSE AND MONITOR CHILDHOOD ABSENCE EPILEPSY (CAE) IN THE CLINICAL SETTING. EYSZ, INC. IS DEVELOPING A MOBILE HEALTH (MHEALTH) APPLICATION AND ALGORITHMS TO REMOTELY DIAGNOSE AND MONITOR CAE TO IMPROVE OUTCOMES. CURRENTLY, ABSENCE SEIZURES ARE CHALLENGING TO IDENTIFY,LEADING TO DIAGNOSTIC DELAYS AND DIFFICULTY MEASURING TREATMENT EFFICACY. UNTREATED SEIZURES PLACE CHILDREN AT RISK FOR ACCIDENTAL INJURY AND LEARNING LOSS. THE GOLD STANDARD FOR SEIZURE DETECTION IS VIDEO EEG (VEEG), BUT IT IS EXPENSIVE, LIMITED TO CLINICAL SETTINGS, AND HARD TO ACCESS. AS A RESULT, CLINICIANS RELY ON SELF-REPORTS, DESPITE STUDIES SHOWING PATIENTS REPORT ONLY 6% OF ALL ABSENCE SEIZURES, AND CAREGIVERS REPORT ONLY 14%. EVEN PRIMARY CARE PROVIDERS HAVE DIFFICULTY IDENTIFYING ABSENCE SEIZURES AND RELY ON VEEG, REFERRING 5 PATIENTS FOR EVERY 1 DIAGNOSED. ONCE DIAGNOSED WITH CAE, CHILDREN ARE STARTED ON ANTI-SEIZURE MEDICATIONS (ASM), WHICH RESULT IN SEIZURE FREEDOM IN LESS THAN 60% OF CHILDREN. HOWEVER, NO NEW TREATMENTS HAVE BEEN APPROVED SINCE THE 1990S, PARTIALLY DUE TO DIFFICULTY MEASURING SEIZURES.4 OTHER STRATEGIES TO MONITOR SEIZURES, SUCH AS AMBULATORY EEG, LACK THE SENSITIVITY AND SPECIFICITY OF VEEG, AND CAN ADD TO THE STIGMA OF PEOPLE WITH EPILEPSY. THUS, THERE IS A CRITICAL NEED FOR A REMOTE DIAGNOSTIC/MONITORING TOOL FOR ABSENCE SEIZURES. THE AIM OF THE SBIR PROPOSAL IS TO TEST AND FURTHER DEVELOP AN MHEALTH APP THAT USES (1) SUPERVISED GUIDED HYPERVENTILATION (HV), WITH (2) EYE MOVEMENT AND FACIAL BIOMETRIC DATA TO MONITOR SEIZURE SUSCEPTIBILITY AND TREATMENT RESPONSES IN CAE. ACHIEVING THESE GOALS WILL DECREASE COSTS OF CARE, MORBIDITY, AND MORTALITY AND IMPROVE QUALITY OF LIFE FOR THOSE WITH CHILDHOOD ABSENCE EPILEPSY. CAE IS THE MOST COMMON PEDIATRIC EPILEPSY SYNDROME, AFFECTING 10-17% OF ALL CHILDREN WITH EPILEPSY. SEIZURES OCCUR MANY TIMES DAILY AND CONSIST OF BRIEF LOSSES OF CONSCIOUSNESS (LOC), WITH IMMEDIATE RETURN TO BASELINE AWARENESS AND ACTIVITY. SEIZURES TYPICALLY MANIFEST AS STARING SPELLS, SOMETIMES WITH RHYTHMIC EYE BLINKING OR MOTOR AUTOMATISMS. AS LOC MAY OCCUR AT ANY TIME WITHOUT WARNING, ABSENCE SEIZURES HAVE A SIGNIFICANT IMPACT ON QUALITY OF LIFE (QOL), AND ACCIDENTAL INJURY IS COMMON, WITH 20% OF YOUNG ADULTS-3% PER YEAR-SUFFERING AN INJURY DURING A SEIZURE. THE CLINICAL COURSE OF CAE IS VARIABLE, AND REMISSION RATES ARE FAR LOWER THAN IN OTHER IDIOPATHIC EPILEPSIES. IN FIVE PROSPECTIVE COHORT STUDIES, ONLY 57-74% ACHIEVED SEIZURE FREEDOM. THUS, THERE IS A CRITICAL NEED FOR NEW THERAPEUTICS FOR ABSENCE EPILEPSY AND BETTER TOOLS FOR MONITORING THERAPEUTIC RESPONSES. THE CURRENT STANDARD OF CARE FOR MEASURING TREATMENT OUTCOMES IS SELF-REPORTED DATA. LARGE-SCALE CLINICAL TRIALS, INCLUDING THOSE TESTING NEW ANTISEIZURE MEDICATIONS, POPULATION-BASED ASSESSMENTS, AND OTHER EPIDEMIOLOGICAL STUDIES ALSO USE SELF-REPORTING TO DETERMINE OPTIMAL THERAPY REGIMENS. CRITICALLY, HOWEVER, MULTIPLE CLINICAL STUDIES SHOW PATIENT SEIZURE COUNTS PROVIDE INACCURATE INFORMATION. PATIENTS REPORT ONLY 6% OF ALL EXPERIENCED ABSENCE SEIZURES, WHEREAS CAREGIVERS REPORT ONLY 14%. IN A RECENT STUDY EXAMINING SELF-DOCUMENTATION OF ABSENCE SEIZURES BY ADULTS WITH IDIOPATHIC GENERALIZED EPILEPSY, INACCURATE SEIZURE COUNTS WERE FOUND TO SUBSTANTIALLY IMPACT OUTPATIENT MANAGEMENT AND TREATMENT. THE GOLD STANDARD FOR DETECTING AND CHARACTERIZING SEIZURE ACTIVITY IS A NEUROLOGIST READING OF A VEEG. IN THE HOME SETTING, WHERE > 99% OF SEIZURES OCCUR, VEEG IS NOT READILY AVAILABLE BECAUSE OF POOR PATIENT ACCEPTABILITY, POOR DETECTION CAPABILITY, HIGH COST AND CONTINUED RELIANCE ON ASYNCHRONOUS REVIEW. THE FDA HAS APPROVED TWO NON-EEG-BASED DEVICES TO DETECT CONVULSIVE SEIZURES, BUT THESE ARE RESPONSIBLE FOR ONLY 80% SENSITIVITY AND SPECIFICITY COMPARED WITH THE MAJORITY AGREEMENT OF 3 INDEPENDENT EPILEPTOLOGISTS REVIEWING VEEG. AIM 3. DEVELOP ML METHODS THAT USE FACIAL BIOMETRICS AND EYE TRACKING DATA TO QUANTITATE SEIZURES. OUR PROPOSED I-CORP TEAM WILL INCLUDE THE FOLLOWING 3 MEMBERS, WHO ARE COMMITTED TO THE TIME REQUIREMENTS OF THE PROGRAM. MEMBER NAME ROLE RACHEL KUPERMAN, MD PI/PD PARTH AMIN C-LEVEL CORPORATE OFFICER (COO) TRACEY FISHER INDUSTRY EXPERT 2. I-CORPS TEAM AND PROJECT PLAN THE AIM OF OUR PREDICATE SBIR PHASE I GRANT IS TO VALIDATE THAT A CLINICIAN READ OF THE VIDEO FROM THE EYSZ MHEALTH APP IS EQUIVALENT TO VIDEO EEG READ AND DEVELOP AI BASED ALGORITHM FOR SEIZURE IDENTIFICATION. ACHIEVING THESE AIMS WILL SIGNAL SUCCESSFUL COMPLETION OF PHASE I AND OUR READINESS TO TRANSITION TO PHASE II. THE LEARNINGS FROM THE PHASE I GRANT WILL BE INCORPORATED INTO THE APP TO IMPROVE USABILITY AND ALLOW FOR THE APP TO BE TESTED IN THE HOME ENVIRONMENT, AND VALIDATE OUR SEIZURE DETECTION ALGORITHM AS WE WORK TOWARDS FDA CLEARANCE AND COMMERCIALIZATION READINESS. THE EYSZ TEAM PARTICIPATED IN THE NIH I-CORP PROGRAM DURING OUR PREVIOUS SBIR PHASE 1 GRANT. WHILE THE RESULTS OF THE SBIR WERE TECHNICALLY SUCCESSFUL, THE DATA COLLECTED DURING THE I-CORP PROGRAM INFORMED OUR DECISION TO PIVOT FROM A CONTINUOUS USE WEARABLE EYE TRACKING GLASS TO AN INTERMITTENT USAGE SMARTPHONE BASED APP TO BETTER MEET THE CUSTOMER AND MARKET NEEDS. GIVEN THE SIGNIFICANT PIVOT, OUR GOAL WITH THIS NIH I-CORP IS TO WORK TOWARDS COMMERCIAL READINESS BY REFINING OUR BUSINESS MODEL INCLUDING: REIMBURSEMENT STRATEGY, BUSINESS/PRICING MODELS, AND UNDERSTANDING THE PURCHASING PROCESS AS WE WORK TOWARDS FDA CLEARANCE. OUR PROPOSED I-CORPS TEAM WILL INCLUDE THE FOLLOWING 3 MEMBERS. MEMBER NAME ROLE RACHEL KUPERMAN, MD PI/PD PARTH AMIN C-LEVEL CORPORATE OFFICER TRACEY FISHER INDUSTRY EXPERT THE TEAM, WHICH HAS BEEN COLLABORATING SINCE FEBRUARY 2020, HAS DEMONSTRATED EXPERTISE IN CLINICAL RESEARCH, PRODUCT DEVELOPMENT, AND COMMERCIALIZATION. THE FOLLOWING IS A SUMMARY OF THEIR EXPERTISE: RACHEL KUPERMAN, MD (PI/PD) LEADS THE MANAGEMENT TEAM AND CLINICAL RESEARCH. RACHEL IS A NEUROLOGIST WITH DUAL CERTIFICATION IN EPILEPSY AND NEUROLOGY AND HAS OVER 10 YEARS' EXPERIENCE DIRECTING THE CLINICAL EPILEPSY AND RESEARCH PROGRAMS AT UCSF BENIOFF CHILDREN'S HOSPITAL, OAKLAND. SHE IS ALSO THE INVENTOR OF THE CORE TECHNOLOGY AND HAS A STRONG BACKGROUND IN CLINICAL RESEARCH, HAVING SERVED AS THE PI ON MULTIPLE CLINICAL TRIALS, INCLUDING BEING THE PI FOR MULTIPLE SBIR PHASE I GRANTS. HER UNDERGRADUATE DEGREE IN PHYSICS FROM UCSD, AND HER NEUROLOGY AND NEUROPHYSIOLOGY TRAINING AT COLUMBIA AND UCSF, HAVE HELPED HER BRIDGE THE CLINICAL/COMPUTATIONAL DIVIDE. EARLY IN HER CAREER, DR. KUPERMAN WAS IDENTIFIED AS A LEADER AT CHILDREN'S HOSPITAL, WHERE SHE WAS INVITED TO PARTICIPATE IN THE UCSF PHYSICIAN LEADERSHIP PROGRAM IN 2011. DR. KUPERMAN WAS AWARDED $80K IN GRANTS FROM UCSF, INCLUDING THE JUNIOR INVESTIGATOR AWARD FOR RESEARCH, TOWARDS DEVELOPMENT OF HER PATENT. SHE WAS RECOGNIZED BY THE EPILEPSY FOUNDATION OF NORTHERN CALIFORNIA WITH THE VOLUNTEER OF THE YEAR AWARD IN 2016. DR. KUPERMAN WAS A FALL 2018 FELLOW AT UC BERKELEY LAW FORM AND FUND, WHICH FOCUSES ON THE CORE LEGAL, FINANCIAL, AND ORGANIZATIONAL ASPECTS OF STARTING AND SCALING A BUSINESS. SHE HAS SINCE RECEIVED THE FEROLYN FELLOWSHIP AWARD FROM THE FOGARTY INSTITUTE FOR INNOVATION, WHICH PROVIDES MENTORING TO RISING MEDTECH LEADERS WITH A PASSION TO TRANSFORM HEALTHCARE. PARTH AMIN, OUR CHIEF OPERATING OFFICER, BRINGS 20 YEARS OF MEDICAL DEVICE EXPERIENCE, INCLUDING HAVING WORKED FOR GLOBAL HEALTHCARE COMPANIES SUCH AS SIEMENS HEALTHINEERS, VARIAN MEDICAL SYSTEMS, AND OMNICELL. HE HAS HELD A VARIETY OF PIVOTAL ROLES IN THE AREAS OF PRODUCT MANAGEMENT, PROGRAM MANAGEMENT, AND ALLIANCE MANAGEMENT WHILE SUCCESSFULLY ATTAINING OBJECTIVES RELATED TO INNOVATION, PRODUCT DEVELOPMENT, REVENUE, AND MARKET SHARE GROWTH. HIS EXPERTISE IN PRODUCT DEVELOPMENT AND ALLIANCES, WITH AN EMPHASIS ON GO-TO-MARKET STRATEGIES INVOLVING PARTNERED SOLUTIONS, HAS ALLOWED US TO START IDENTIFYING AND ESTABLISHING KEY TECHNOLOGY, CLINICAL, AND COMMERCIAL PARTNERS, WHO IN TURN WILL ENABLE US TO TRANSLATE THIS MEANINGFUL INNOVATION INTO A COMMERCIALLY VIABLE PRODUCT. AS PART OF 3-2 DUAL DEGREE PROGRAM, MR. AMIN HOLDS A BE IN ELECTRICAL ENGINEERING FROM WASHINGTON UNIVERSITY AND B.S IN PRE-ENGINEERING FROM BIRMINGHAM-SOUTHERN COLLEGE. TRACEY FISHER IS AN ACCOMPLISHED BUSINESS EXECUTIVE WITH OVER 20 YEARS OF GLOBAL HEALTHCARE MARKETING EXPERIENCE. SHE HAS BUILT AND LED MARKETING TEAMS THAT HAVE LAUNCHED MEDICAL DEVICE PRODUCTS AND BRANDS THAT BECAME GLOBAL MARKET LEADERS AND GENERATED OVER $1B IN REVENUE, WHILE WORKING AT SIEMENS HEALTHINEERS AND VARIAN MEDICAL SYSTEMS. THROUGH COLLABORATION WITH PATIENT ADVOCACY, GOVERNMENT ADVOCACY, REGULATORY, REIMBURSEMENT, SALES, AND PRODUCT TEAMS SHE HAS DEFINED BUSINESS/PRICING MODELS AND VALUE PROPOSITIONS TO BUILD SUCCESSFUL NEW PRODUCT INTRODUCTION AND MARKETING STRATEGIES AND OVERSEE THE EXECUTION. WITH HER EXPERTISE AND GUIDANCE, WE ARE CONFIDENT THAT WE WILL ACHIEVE OUR AIMS FOR THE NIH-I CORPS PROGRAM. DURING THE EARLY STAGES OF OUR COMPANY FORMATION, WE PARTICIPATED IN THE NATIONAL SCIENCE FOUNDATION (NSF) I-CORPS PROGRAM, WHICH WAS EXTREMELY BENEFICIAL IN HELPING US UNDERSTAND THE EPILEPSY ECOSYSTEM AND CRAFT OUR INITIAL VALUE PROPOSITION. AT THAT TIME, OUR TEAM PERFORMED 111 INTERVIEWS OF PATIENTS, FAMILY MEMBERS, PHYSICIANS, PAYORS, PHARMACEUTICAL RESEARCHERS, COMPETITORS AND POTENTIAL COLLABORATORS. DURING OUR PREVIOUS NIH I-CORP PROGRAM WE COMPLETED OVER 100 INTERVIEWS THAT SIGNIFICANTLY CHANGED THE COURSE OF OUR PRODUCT AND RESEARCH. SINCE THE NIH PROGRAM, WE HAVE HAD AN ADDITIONAL PRE-SUB MEETING WITH THE FDA, COMPLETED OUR INITIAL CLINICAL STUDY AND PIVOTED TOWARDS A PRODUCT WITH BETTER MARKET FIT. BASED ON THE INTERACTIONS WITH OUR PARTNERS, AND CLINICAL COLLABORATORS, WE HAVE REFORMULATED OUR VALUE PROPOSITION, PURSUED ADDITIONAL PATENTS AND REFINED OUR REGULATORY AND REIMBURSEMENT STRATEGY. THE OVERALL GOAL OF PARTICIPATING IN THE NIH I-CORPS IS TO TAKE OUR VISION AND VALUE PROPOSITION AND ADD THE GRANULARITY WHICH WILL ALIGN OUR CLINICAL RESEARCH MILESTONES, REGULATORY STRATEGY, IP STRATEGY,REIMBURSEMENT STRATEGY AND FUNDRAISING MILESTONES, ULTIMATELY LEADING TO SUCCESSFUL COMMERCIALIZATION STRATEGY WHICH WILL POSITION US TO OBTAIN VENTURE FUNDING AND A PHASE II SBIR. WE PARTICULARLY NEED TO DO ADDITIONAL RISK MITIGATION AROUND OUR REVENUE MODEL, WHICH FOCUSES ON USE OF EXISTING REIMBURSEMENT CODES AND POSSIBLY APPLYING FOR ADDITIONAL CODES, OBTAINING PAYMENT FROM PAYERS, AND ENSURING OUR UNIT COSTS AND CHANNEL PARTNERS ARE ALIGNED FOR SCALING GROWTH. A STRUCTURED, HEALTHCARE-FOCUSED PROGRAM LIKE THAT OFFERED BY NIH I-CORPS WOULD BUILD UPON THE TREMENDOUS WORK TO DATE AND SET THE COMPANY UP FOR SUCCESS AS WE ADVANCE OUR CURRENT NIH-FUNDED INITIATIVE TO THE NEXT PHASE OF DEVELOPMENT. OUR TEAM IS IDEALLY POSITIONED TO HAVE MAXIMAL BENEFIT FROM THE NIH I-CORPS PROGRAM. OUR SBIR PHASE I GRANT HAS ALLOWED US TO DEVELOP AND ALIGN AS A TEAM FROM A TECHNICAL PERSPECTIVE. THE I-CORPS PROGRAM WILL ENABLE US TO EXPAND OUR CURRENT TECHNICAL FOCUS TO PRE-COMMERCIALIZATION TOPICS. WE BELIEVE THAT CUSTOMER DISCOVERY INTERVIEWS AND THE LEAN LAUNCHPAD SYSTEM ARE A TIMELY, STRUCTURED METHOD TO ASSIST OUR COMPANY AS WE MAKE THIS TRANSITION FROM OUR PREVIOUS POSITION AND HAVE BENEFITED US GREATLY IN THE PAST. COMMERCIAL POTENTIAL THROUGH > 200 CUSTOMER DISCOVERY INTERVIEWS SUPPORTED BY THE NSF + NIH I-CORPS PROGRAM AND CONTINUED CUSTOMER DISCOVERY INTERVIEWS - WITH EPILEPSY PATIENTS, CLINICIANS, PHARMACEUTICAL COMPANIES, EEG MANUFACTURERS, AND PATIENT ADVOCACY GROUPS - WE ARE CONFIDENT IN THE COMMERCIALIZATION POTENTIAL OF OUR TECHNOLOGY. BY ESTABLISHING AND GROWING A PARTNER ECOSYSTEM, WE ARE MINIMIZING COMMERCIAL RISKS WHILE EXPANDING OUR COMMERCIAL OPPORTUNITIES. WHILE OUR INITIAL PLAN WAS TO PARTNER WITH EYE TRACKING MANUFACTURERS, OUR NEW PRODUCT FOCUSES ON USING EXISTING SMARTPHONE TECHNOLOGY REDUCING MANY OF THE HURDLES THAT WE IDENTIFIED DURING OUR PREVIOUS I-CORP. IN PARTICULAR IT WILL SIGNIFICANTLY REDUCE OUR TIME TO MARKET, DECREASE THE FUNDING REQUIREMENTS, IMPROVE USER SATISFACTION AND SIGNIFICANTLY SIMPLIFY DISTRIBUTION. LASTLY, PHARMACEUTICAL COMPANIES HAVE EXPRESSED STRONG INTEREST, AS SHOWN BY FINANCIAL INVESTMENTS AND PLANNED CLINICAL PARTNERSHIPS TO USE OUR SOLUTION TO ASSESS THE EFFICACY OF ANTICONVULSANTS IN CLINICAL STUDIES. EYSZ HAS RECEIVED GRANT SUPPORT FROM GREENWICH BIOSCIENCES. UCB PHARMA, THE LARGEST EPILEPSY DRUG DEVELOPER, HAS ALSO INVESTED IN EYSZ. WE ARE FOCUSED ON THE CLINICAL CARE MARKET. IN THE DIGITAL HEALTH SPACE, COMMERCIALIZATION RELIES HEAVILY ON DEVELOPING A REIMBURSEMENT STRATEGY. WE PLAN ON LEVERAGING EXISTING CPT CODES INCLUDING BEHAVIORAL HEALTH CODES, REMOTE MONITORING CODES AND NONSPECIFIC NEURODIAGNOSTIC CODES. THIS PLANNING HAS BEEN COMPLICATED BY RECENT COVID-RELATED CHANGES IN TELEHEALTH AND REMOTE MONITORING REIMBURSEMENT, BUT WE ARE REASSURED THAT THE HEADWINDS TOWARDS ADDITIONAL COVERAGE ARE SUPPORTING OUR REIMBURSEMENT STRATEGY. WE ESTIMATE THE OVERALL U.S. MARKET OPPORTUNITY TO BE AROUND $3.4 BILLION DOLLARS, GIVEN THE DIRECT COSTS ASSOCIATED WITH EPILEPSY. WITH OUR INITIAL FDA CLEARANCE FOR ABSENCE SEIZURES, WE EXPECT TO CAPTURE 5% OF THE MARKET ($170M) IN 5 YEARS. TARGET CUSTOMER FOR THE CLINICAL CARE MARKET, OUR END USER WILL BE PEDIATRICIANS AND NEUROLOGISTS AT A LEVEL 3 + 4 EPILEPSY CENTER. WE UNDERSTAND THAT PURCHASING DECISIONS ARE NOT SOLELY MADE BY CLINICIANS, BUT THEY ARE INFLUENTIAL IN THE DECISION-MAKING PROCESS. AS PART OF THE I-CORPS PROGRAM, WE AIM TO BETTER UNDERSTAND HOW PRODUCTS ARE RECOMMENDED FOR PURCHASING BY NEURO SERVICE LINE MANAGERS, AND PEDIATRIC MANAGERS, HOW REIMBURSEMENT DECISIONS ARE MADE BY PAYORS, HOW BEST TO REACH INFLUENCERS AND DECISION-MAKERS, AND THE LEVEL OF INTEGRATION WITH EXISTING WORKFLOW REQUIRED TO FACILITATE ADOPTION. CLINICAL NEED AND CURRENT ALTERNATIVES MORE THAN 70 MILLION PEOPLE WORLDWIDE-INCLUDING ~1% OF THE U.S. POPULATION-SUFFER FROM EPILEPSY, A DEBILITATING, UNPREDICTABLE CHRONIC CONDITION IN WHICH ABNORMAL ELECTRICAL ACTIVITY IN THE BRAIN PRODUCES PHYSICAL DISTURBANCES INCLUDING LOSS OF CONSCIOUSNESS (LOC) AND/OR CONVULSIONS. EPILEPSY IS ASSOCIATED WITH DISABILITY, REDUCED QUALITY OF LIFE, AND AN ELEVATED RISK OF COMORBIDITIES, INCLUDING SEIZURE-RELATED INJURIES; RESPIRATORY, CARDIOVASCULAR, AND NEUROLOGIC DYSFUNCTIONS; AND PSYCHOLOGICAL CONDITIONS SUCH AS ANXIETY AND DEPRESSION. OUTCOMES INCLUDE LONG-TERM DISABILITY AND INCREASED RISK OF MORTALITY, AND EPILEPSY ACCOUNTS FOR 0.5% OF THE GLOBAL BURDEN OF DISEASE BASED ON YEARS OF LIFE LOST (YLL) AND YEARS LOST TO DISABILITY (YLD). GLOBALLY, THE COSTS ASSOCIATED WITH EPILEPSY ARE STAGGERING. IN THE U.S. ALONE, DIRECT COSTS HAVE MORE THAN DOUBLED IN LESS THAN A DECADE-FROM $12B TO $28B-WHILE OUTCOMES HAVE NOT IMPROVED FOR ALMOST 3 DECADES. IN ADDITION, EPILEPSY ACCOUNTS FOR MORE THAN 1 MILLION EMERGENCY DEPARTMENT (ED) VISITS AND OVER 280,000 HOSPITAL ADMISSIONS ANNUALLY IN THE U.S., WITH AGGREGATE HOSPITAL COSTS FOR EPILEPSY TOTALING APPROXIMATELY $2.5 BILLION. SEIZURES REPRESENT THE KEY SYMPTOM OF EPILEPSY AND THE PRIMARY TARGET OF EPILEPSY TREATMENT. DETECTION OF SEIZURES IS THE FIRST STEP IN CHOOSING AN APPROPRIATE TREATMENT REGIMEN, AND APPROPRIATE ANTICONVULSANTS CAN DECREASE SEIZURES BY 50%. UNFORTUNATELY, CURRENT DETECTION TECHNOLOGIES ARE IMPRACTICAL OR HAVE LIMITED EFFECTIVENESS OUTSIDE OF CLINICAL SETTINGS, AS DESCRIBED BELOW: SELF-REPORTING/OBSERVATION: AS FOR MANY OTHER CHRONIC CONDITIONS, EPILEPSY PATIENTS ARE OFTEN ASKED TO KEEP A SEIZURE DIARY. CRITICALLY, HOWEVER, PATIENT-REPORTED SEIZURE COUNTS DO NOT PROVIDE ACCURATE INFORMATION. STUDIES HAVE SHOWN THAT DURING VIDEO EEG, CAREGIVERS AND PATIENTS FAIL TO RECOGNIZE MORE THAN 50% OF SEIZURES. IN ADDITION, CONSTANT SEIZURE OBSERVATION SUBSTANTIALLY REDUCES QUALITY OF LIFE DUE TO LOSS OF SLEEP, SCHEDULE DISRUPTION, AND ANXIETY ABOUT MISSING SEIZURE ACTIVITY. THUS, BOTH PATIENTS AND CLINICIANS ARE AWARE OF THE NEED FOR A FEASIBLE AMBULATORY TECHNIQUE FOR THE OBJECTIVE DETECTION AND REGISTRATION OF SEIZURES. OUTPATIENT EEG: THERE HAVE BEEN MANY ATTEMPTS TO CONVERT THE GOLD STANDARD OF EEG PLUS VIDEO OBSERVATION INTO A LESS BURDENSOME MOBILE PLATFORM. TO DATE, HOWEVER, VIDEO EEG REMAINS EXPENSIVE, LARGELY
$137.3k 2/23/24