Project Grant SB1MH133465

Award Date 4/1/23
Completion Date 3/31/26
Dollars Obligated $6.4M
Federal Grant Program
93.242
Assistance Type
Project Grant
Place of Performance
St. Louis, MO 63108, USA
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FRAMEWISE INTEGRATED REAL-TIME MRI MONITORING (FIRMM) SOFTWARE COMMERCIALIZATION READINESS FOR CLINICAL CARE - PROJECT ABSTRACT/SUMMARY MOTION RELATED ARTIFACTS ARE A SIGNIFICANT SOURCE OF COST TO THE HEALTHCARE SYSTEM. WITH OVER 12,000 MRI SCANNERS IN THE U.S. AND ESTIMATES THAT $434,000 ARE LOST PER SCANNER EACH YEAR, MOTION IN MRIS IS COSTING OUR HEALTH CARE SYSTEM APPROXIMATELY $4B YEARLY. OUR FDA-CLEARED SOFTWARE SOLUTION FRAMEWISE INTEGRATED REAL- TIME MRI MONITORING (FIRMM) MITIGATES DATA LOST DUE TO MOTION. HOWEVER, THE MAJORITY OF PAYING CUSTOMERS SO FAR ARE ACADEMIC NEUROIMAGING RESEARCH CENTERS; IN ORDER TO ENSURE THE COMMERCIAL SUCCESS OF FIRMM, WE NEED TO EXPAND THE CUSTOMER BASE TO CLINICAL INSTITUTIONS. THE GOAL OF THIS CRP APPLICATION IS TO FILL GAPS IN FIRMM CLINICAL COMMERCIALIZATION SALES BY PARTNERING WITH SIEMENS AND BUILDING FUNCTIONALITY TO STREAMLINE CLINICAL USE OF FIRMM AND FIRMM-PIX. LEADING HOSPITALS HAVE EXPRESSED ENTHUSIASM TO USE FIRMM FOR CLINICAL CARE; HOWEVER, TWO MAIN BARRIERS TO CLINICAL ADOPTION REMAIN: A REDUCTION IN TECHNICIAN CRITICAL DECISION MAKING AND A SEAMLESS INTEGRATION INTO EXISTING CLINICAL WORKFLOWS. BOTH OF THESE BARRIERS CAN BE OVERCOME VIA SIEMENS' ACCESS-I, WHICH PROVIDES AN FDA APPROVED LICENSING AND AUTHENTICATION SCHEME TO ENABLE SECURE AND DIRECT OPERATION OF SIEMENS SYSTEMS FROM ANY 3RD PARTY VENDOR DEVICE. PAIRING THE FIRMM TABLET WITH SIEMENS' ACCESS-I MODULE WILL ALLOW FOR THE FIRMM TABLET TO RE-START A SCAN AUTOMATICALLY WHEN THE QUALITY IS LOW VIA A DIRECT INTERACTION WITH THE CLINICAL SCANNER, THUS SAVING TIME, EASING WORKFLOWS, AND STANDARDIZING DECISION MAKING FOR TECHNICIANS. INTEGRATING THE FIRMM TABLET WITH SIEMENS' ACCESS-I WILL LEAD TO A MORE SEAMLESS INTEGRATION INTO EXISTING WORKFLOWS; THUS REDUCING THE DISRUPTION TO EXISTING COMPLEX CLINICAL WORKFLOWS. IN ADDITION, INTEGRATING THE FIRMM TABLET WITH SIEMENS' ACCESS-I MODULE WILL FACILITATE THE WIDE-SPREAD ADOPTION OF FIRMM(-PIX) IN THE CLINICAL MARKET BY OBTAINING WIDESPREAD VISIBILITY VIA CO-MARKETING WITH SIEMENS HEALTHINEERS AND THEIR CATALOG. IMPORTANTLY, THIS PARTNERSHIP WITH SIEMENS IS PLANNED ONLY AS AN INITIAL STEP TO ESTABLISHING CLINICAL COMMERCIALIZATION SALES. ALTHOUGH SIEMENS IS THE LEADING MRI MANUFACTURER, GE AND PHILIPS COMBINE WITH SIEMENS TO ACCOUNT FOR ALMOST 90% OF THE MRI MARKET. THE PROPOSED ACTIVITIES IN THIS CRP WILL FORM THE BASIS OF FUTURE WORK TO ESTABLISH SIMILAR PARTNERSHIPS WITH GE AND PHILIPS. OVERALL, THIS CRP IS PERFECTLY POSITIONED TO PUT FIRMM AND ITS SUBSEQUENT PRODUCTS ON A PATHWAY TO LONG-TERM SUCCESS.

Posted 3/29/23, 12:00 AM