Rins

SERUM HEPCIDIN IMMUNOASSAY: LABORATORY TO MARKETPLACE

ASSESSMENT OF YOUTH INTERVENTIONS IN ASEMBO AND GEM NYANZA, PROVINCE, KENYA

NOVEL POINT-OF-CARE DEVICE FOR URINARY HEPCIDIN TO DETECT IRON DEFICIENCY IN CHILDREN AND ADOLESCENTS - SUMMARY/ABSTRACT IRON DEFICIENCY (ID) IS A LEADING CAUSE OF ANEMIA WORLDWIDE AND AFFECTS MORE THAN 17 MILLION CHILDREN IN THE US ALONE. HOWEVER, IT IS NOW RECOGNIZED THE EVEN WITHOUT ANEMIA, ID ADVERSELY AFFECTS COGNITIVE DEVELOPMENT, ENDOCRINE FUNCTION, AND PHYSICAL AND BEHAVIORAL GROWTH AND DEVELOPMENT IN CHILDREN. WHILE ANEMIA IN THE US IS PREVALENT IN 3.4% OF CHILDREN AGES 0.5-4 YEARS OLD, THE PREVALENCE OF NON-ANEMIC ID IS MUCH GREATER, ESTIMATED TO BE 15.1% IN CHILDREN FROM 12-23 MONTHS AND 16.5% FROM 2-5 YEARS. IDEALLY, A NON-INVASIVE POINT-OF-CARE (POC) DEVICE TO CONFIDENTLY DIAGNOSE ID WOULD BE OF GREAT INTEREST TO PEDIATRICIANS. HEPCIDIN-25 HAS BEEN SHOWN TO BE THE PRINCIPAL REGULATOR OF SYSTEMIC IRON HOMEOSTASIS. MEASUREMENT OF SERUM HEPCIDIN IS A RELIABLE MARKER FOR ASSESSMENT OF IRON STATUS AND CAN PROVE A VALUABLE INDICATOR OF PHYSIOLOGIC ID IN ADULTS AND CHILDREN. URINARY HEPCIDIN IS STRONGLY CORRELATED WITH SERUM HEPCIDIN AND WOULD SERVE AS AN EXCELLENT MARKER TO DIAGNOSE ID IN CHILDREN AND ADOLESCENTS EMPLOYING THE NON-INVASIVE POC DEVICE THAT WE PROPOSE TO COMMERCIALIZE. INTRINSIC LIFESCIENCES (ILS) IS REQUESTING DIRECT TO PHASE II FUNDING TO CONTINUE COMMERCIALIZATION OF A MULTIPLEXED POC LATERAL FLOW ASSAY (LFA) TO QUANTIFY URINARY HEPCIDIN NORMALIZED TO URINARY CREATININE. WE HAVE SUCCESSFULLY COMPLETED PROOF OF PRINCIPLE RESEARCH RESULTING IN A WORKING PROTOTYPE OF THE LFA. TO ACHIEVE THIS MILESTONE, ILS CONTRACTED WITH A LOCAL SAN DIEGO COMPANY, NANOCOMPOSIX (NCX), TO UTILIZE THEIR ULTRA-BRIGHT GOLD NANOSHELL TECHNOLOGY TO DRAMATICALLY ENHANCE DIAGNOSTIC SENSITIVITY. READER SELECTION WILL BE A CRITICAL NEXT STEP IN THE COMMERCIAL DEVELOPMENT OF THIS DEVICE. END USER DESIGN INPUT WILL ASSIST IN SELECTING A SUITABLE STRIP READER FOLLOWED BY OPTIMIZATION OF LATERAL FLOW STRIP GEOMETRY FOR DEPLOYMENT IN A CASSETTE COMPATIBLE WITH THE SELECTED READER. THE HEPCIDIN AND CREATININE ASSAYS WILL BE MULTIPLEXED ON A SINGLE STRIP, FURTHER OPTIMIZATION FOR SENSITIVITY AND PRECISION WILL BE UNDERTAKEN AND VALIDATION OF THE POC DEVICE WILL FOLLOW FDA INDUSTRY GUIDELINES FOR BIOANALYTICAL METHOD VALIDATION. OUR PEDIATRIC CLINICAL COLLABORATORS WILL BETA TEST THE LFA POC PROTOTYPE DEVICE IN A RESEARCH CAPACITY TO ASSESS DESIGN CONTROL SUITABILITY BEFORE LARGE SCALE MANUFACTURING. CONCURRENTLY, ILS WILL PROCURE MATCHED SERUM AND URINE SAMPLES AND PERFORM RECEIVER OPERATOR CHARACTERISTIC CURVE ANALYSIS TO ASSESS THE DIAGNOSTIC STRENGTH OF THE POC PROTOTYPE DEVICE TO PREDICT ID. DURING PRE-COMMERCIALIZATION PHASE IIB FOLLOW-ON FUNDING, THE DEVICE WOULD BE TESTED IN A MULTI-CENTER CLINICAL TRIAL AND THE RESULTS SUBMITTED TO THE FDA FOR 510(K) CLEARANCE.

MONOCLONAL SANDWICH ELISA FOR SERUM ERYTHROFERRONE FOR CLINICAL ASSESSMENT OF INEFFECTIVE ERYTHROPOIESIS

TOWARDS INTRA-OPERATIVE GUIDANCE IN BRAIN TUMOR SURGERY USING REAL-TIME RESTING-STATE FUNCTIONAL MRI - SUMMARY RESTING-STATE FUNCTIONAL MRI (RSFMRI) IS A RAPIDLY DEVELOPING TASK-FREE APPROACH FOR PRESURGICAL MAPPING. IT CAN COMPLEMENT TASK-BASED FUNCTIONAL MRI (TFMRI) IN PATIENTS WHO HAVE DIFFICULTIES PERFORMING TASKS AND EFFICIENTLY MAP RESTING STATE NETWORKS (RSNS) IN REGIONS THAT ARE NOT TYPICALLY MAPPED WITH TFMRI DUE TO TIME CONSTRAINTS, SUCH AS FRONTAL CORTEX. IT HAS THE POTENTIAL TO PROVIDE ITERATIVE INTRA-OPERATIVE GUIDANCE DURING PROGRESSIVE RESECTION, ENABLES CONNECTOME MAPPING IN ANESTHETIZED PATIENTS, AND HOLDS PROMISE FOR INTRA-OPERATIVE GUIDANCE OF MINIMALLY INVASIVE SURGERY WHERE INTRA-OPERATIVE ELECTROCORTICAL MAPPING MAY NOT BE POSSIBLE. TO ACHIEVE CLINICAL ACCEPTANCE, RSFMRI ANALYSIS NEEDS TO BE HIGHLY TOLERANT TO HEAD MOVEMENT, PHYSIOLOGICAL SIGNAL PULSATION, LESION-RELATED CHANGES OF FUNCTIONAL NEURO-ANATOMY AND CEREBROVASCULAR UNCOUPLING; AND PROVIDE DATA QUALITY CONTROL METRICS DURING THE ONGOING SCAN. INTRA-OPERATIVE GUIDANCE ADDITIONALLY REQUIRES AUTOMATED ONLINE MAPPING OF RSNS AND TOLERANCE TO INTRA-OPERATIVE BRAIN SHIFTS. THERE ARE CURRENTLY NO FDA-APPROVED RSFMRI TOOLS AVAILABLE FOR PRESURGICAL MAPPING. HERE, WE PROPOSE A FULLY AUTOMATED, HIGHLY SENSITIVE AND COST-EFFECTIVE REAL-TIME RSFMRI ANALYSIS TECHNOLOGY ON A HIGH-PERFORMANCE WORKSTATION FOR PRESURGICAL AND INTRAOPERATIVE MAPPING. THE PROJECT BUILDS ON TURBOFIRE, A POWERFUL REAL-TIME TFMRI AND RSFMRI ANALYSIS SOFTWARE TOOL FOR HIGH-SPEED FMRI, THE SUCCESS OF A PRIOR PHASE I STTR STUDY IN 12 BRAIN TUMOR PATIENTS THAT SHOWED CLINICALLY ACCEPTABLE CONCORDANCE OF REAL-TIME HIGH-SPEED MULTI-ECHO RSFMRI WITH TFMRI, AND INTRA-OPERATIVE ELECTROCORTICAL STIMULATION (ECS); AND OUR EXPERIENCE WITH INTRA-OPERATIVE RSFMRI IN ANESTHETIZED BRAIN TUMOR PATIENTS. THIS TECHNOLOGY PROVIDES ONLINE RSFMRI MAPPING, ELIMINATING TIME-CONSUMING POSTPROCESSING, AND SEAMLESS INTEGRATION INTO PRESURGICAL PLANNING AND INTRA-OPERATIVE MRI. THIS METHODOLOGY WILL HAVE SIGNIFICANT CLINICAL AND COMMERCIAL POTENTIAL FOR A WIDE RANGE OF NEUROLOGICAL AND PSYCHIATRIC APPLICATIONS BEYOND PRE-SURGICAL MAPPING IN PATIENTS WITH BRAIN TUMORS. IT OPENS UP FUNCTIONAL BRAIN MAPPING TO PATIENT POPULATIONS THAT HAVE BEEN DIFFICULT TO STUDY IN THE PAST.

VALIDATION OF ALCOHOL EXPOSURE BIOMARKERS VIA AFFINITY MASS SPECTROMETRY

HEPCIDIN LATERAL FLOW DEVICE FOR PREDICTION OF ACUTE KIDNEY INJURY

MS BASED APPROACHES FOR DIABETES BIOMARKER DISCOVERY

PUBLIC CHARTER SCHOOLS

PORTABLE TMS-EEG DEVICE FOR BEDSIDE DETECTION OF COVERT CONSCIOUSNESS - PROJECT SUMMARY DISORDERS OF CONSCIOUSNESS (DOC) DUE TO SEVERE BRAIN INJURY AFFECT MORE THAN ONE MILLION PEOPLE WORLDWIDE EACH YEAR. WITHDRAWAL OF LIFE-SUSTAINING THERAPY (WLST) IS THE CAUSE OF ~80% OF DEATHS IN PATIENTS WITH DOC IN INTENSIVE CARE UNIT (ICU) SETTINGS; YET WLST DECISIONS ARE OFTEN MADE BY FAMILIES AND CAREGIVERS WITHOUT A CLEAR UNDERSTANDING OF THEIR LOVED ONE’S STATE OF CONSCIOUSNESS OR POTENTIAL FOR RECOVERY. OVER THE LAST TWENTY YEARS, THE PHYSICIAN-SCIENTISTS WHO FOUNDED INTRINSIC POWERS, INC. AND THE PI DEVELOPED AND VALIDATED A METHOD COMBINING TRANSCRANIAL MAGNETIC STIMULATION (TMS) WITH ELECTROENCEPHALOGRAPHY (EEG) THAT HAS UNPRECEDENTED SENSITIVITY AND SPECIFICITY (>95%) TO DIAGNOSE COVERT CONSCIOUSNESS. HOWEVER, THIS METHOD REQUIRES LENGTHY DATA ACQUISITION AND PROCESSING WITH 60 EEG CHANNELS, WHICH MAKES IT IMPRACTICAL IN ICU SETTINGS. IN THE PRESENT STTR, INTRINSIC POWERS AND THE PI AND HER TEAM PROPOSE TO FILL THIS GAP BY DEVELOPING PRESENCE, A NEW PORTABLE TMS-EEG DEVICE COMBINING A NEW COMPLEXITY ALGORITHM, PRESENCE-IP1.0, COMPUTED IN REAL-TIME WITH 21 ELECTRODES AND WITHOUT THE NEED FOR AN MRI, COMBINED WITH A PORTABLE DATA ACQUISITION SYSTEM INTEGRATED INTO A WHEELABLE CART, THAT WILL MAXIMIZE THE CLINICAL UTILITY FOR THE ICU. IN THIS PHASE 1 STTR, WE PROPOSE TO: 1) REFINE THE PRODUCT VISION AND VALUE PROPOSITIONS FOR THE USE OF PRESENCE IN THE ICU; AND 2) VALIDATE THE ACCURACY OF THE NEW PRESENCE-IP1.0 ALGORITHM ON A PROSPECTIVE DATASET. OUR PRODUCT VISION AND VALUE PROPOSITION (AIM 1) WILL BE REFINED THROUGH SYSTEMATIC SEMI-STRUCTURED INTERVIEWS OF END-USERS AND STAKEHOLDERS TO DEFINE HOW PRESENCE WILL HELP TO GUIDE CLINICAL DECISION-MAKING AND TO ASCERTAIN THE OPTIMAL TRADE-OFF BETWEEN ACCURACY AND USER-FRIENDLINESS TO MAXIMIZE CLINICAL UTILITY (AIM 1). OUR MILESTONE FOR AIM 1 WILL BE THE COLLECTION OF 100 SEMI-STRUCTURED INTERVIEWS. IN PARALLEL, WE WILL VALIDATE THE ACCURACY OF PRESENCE- IP1.0 TO DETECT CONSCIOUSNESS IN A PROSPECTIVE SAMPLE OF 30 SUBJECTS (HALF FROM ETHNIC MINORITIES) ACQUIRED WITH TMS COMBINED WITH 21 EEG CHANNELS DURING WAKEFULNESS AND SLEEP (AIM 2). OUR MILESTONE FOR AIM 2 WILL BE TO SHOW THAT PRESENCE-IP1.0 CAN ACHIEVE CLINICALLY USEFUL ACCURACY (AS DETERMINED BY USER FEEDBACK FROM AIM 1) TO DIFFERENTIATE CONSCIOUS FROM UNCONSCIOUS STATES IN THE PROSPECTIVE DATASET. FINALLY, FOR AIM 3, WE WILL HOLD A PRESUBMISSION MEETING WITH THE FDA. THE WORK PERFORMED IN THIS PHASE I STTR WILL OPEN THE WAY TO PHASE II MULTI-CENTRIC ICU STUDIES TO VALIDATE THE DIAGNOSTIC AND PROGNOSTIC UTILITY OF PRESENCE IN THE ICU. WE EXPECT PRESENCE TO BECOME WIDELY USED, TRIGGERING A TRANSFORMATIVE SHIFT IN THE CARE OF DOC PATIENTS IN THE ICU BY ENABLING PHYSICIANS TO DETECT CONSCIOUSNESS AND PREDICT PATIENTS’ RECOVERY EVEN IN DIFFICULT CASES QUICKLY AND PRECISELY. SUCH INNOVATIVE TECHNOLOGY WILL SIGNIFICANTLY DECREASE BURN-OUT OF FAMILIES AND CAREGIVERS AND REDUCE COSTS OF CARE THANKS TO A DECREASED LENGTH OF ICU STAYS AND A MORE EFFICIENT DISTRIBUTION OF LIMITED LIFE-SAVING ICU RESOURCES.

ASSISTANCE TO FIREFIGHTERS GRANTS

EMERGENCY COMMUNITY WATER ASST. GRANT - APPROPRIATED(ECWAG-A) - 500,000 LIMIT

SERUM HEPCIDIN IMMUNOASSAY: LABORATORY TO MARKETPLACE

SBIR PHASE I: MICROBIOME FOR IMPROVING SALT STRESS TOLERANCE IN CROPS

PRINTED NANO CU AND NISI CONTACTS AND METALLIZATION FOR SOLAR CELL MODULES

REAP RENEWABLE ENERGY SYSTEM (RES) GRANT UNRESTRICTED AMOUNT

QUANTITATIVE MASS SPECTROMETRIC IMMUNOASSAYS FOR POPULATION PROTEOMICS

CLINICAL REAL-TIME RESTING STATE FMRI

VALUE- ADDED AGRICULTURAL PRODUCT MARKET DEVELOPMENT GRANTS

THE PURPOSE OF THIS AGREEMENT IS TO PROVIDE FEDERAL FINANCIAL ASSISTANCE TO CONDUCT DEPOPULATION, DISPOSAL OF FLOCKS, CLEANING AND DISINFECTION OF P

RAPTOR IINVENTORY NEST SURVEY (RINS)

ASSISTANCE TO FIREFIGHTERS GRANT

BLM UTAH RAPTOR NEST INVENTORY AND MONITORING

REAP ENERGY EFFICIENCY IMPROVEMENT (EEI) GRANT UNRESTRICTED AMOUNT

THE PURPOSE OF THIS AGREEMENT IS TO PROVIDE FEDERAL FINANCIAL ASSISTANCE TO CONDUCT DEPOPULATION, DISPOSAL OF FLOCKS, CLEANING AND DISINFECTION OF P

REAP RENEWABLE ENERGY SYSTEM (RES) GRANT UNRESTRICTED AMOUNT

SEC. 9007 REAP-ENERGY EFFICIENCY IMPROVEMENTS GRANTS (MAN)

BLM UTAH RAPTOR NEST INVENTORY AND MONITORING

VALUE- ADDED AGRICULTURAL PRODUCT MARKET DEVELOPMENT GRANTS

SEC. 9007 REAP-ENERGY EFFICIENCY IMPROVEMENTS GRANTS (MAN)

BLM UTAH RAPTOR NEST INVENTORY AND MONITORING

THE TAX COUNSELING FOR THE ELDERLY (TCE) PROGRAM OFFERS FREE TAX HELP TO INDIVIDUALS WHO ARE AGE 60 OR OLDER. THIS SERVICE WILL BE OFFERED CONVENIEN

THIS GRANT SUPPORTS THE COSTS INCURRED TO IMPLEMENT MEASURES TO RESPOND TO THE NOVEL CORONAVIRUS 2019 (COVID-19), WHICH MAY INCLUDE WORKPLACE SAFETY, MARKET PIVOTS, RETROFITTING FACILITIES, TRANSPORTATION, WORKER HOUSING, AND MEDICAL EXPENSES. IT PROVIDES NEEDED RELIEF TO THE FOOD PROCESSORS, DISTRIBUTORS, FARMERS MARKETS, AND PRODUCERS FOR THEIR COSTS INCURRED BETWEEN JANUARY 27, 2020, THE DATE UPON WHICH THE PUBLIC HEALTH EMERGENCY WAS DECLARED BY THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICE (HHS) UNDER SECTION 319 OF THE PUBLIC HEALTH SERVICE ACT, AND DECEMBER 31, 2021. BENEFICIARIES INCLUDE THE EMPLOYEES OF THE FOOD PROCESSORS, DISTRIBUTORS, FARMERS MARKETS, AND PRODUCERS.

GRANT IS ISSUED TO PAY FOR COSTS RELATED TO AMERICAN PHOTOGRAPHERS MARCIA RESNICK AND VICTOR BOCKRIS' PARTICIPATION IN THE 2010 COPENHAGEN PHOTO FEST

SMALL, RURAL SCHOOL ACHIEVEMENT PROGRAM

APPLICATION FOR SMALL, RURAL SCHOOL ACHIEVEMENT PROGRAM

DOMESTIC WATER GRANTS - REGULAR