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IMAGING BACTERIAL INFECTIONS IN VIVO: FIRST IN MAN STUDIES - PROJECT SUMMARY/ABSTRACT INFECTION IS THE MAJOR COMPLICATION OF VIRTUALLY ALL MEDICAL DEVICES. IT IS ESTIMATED THAT 2 MILLION PATIENTS ACQUIRE A NOSOCOMIAL INFECTION IN THE US EVERY YEAR AND THE CDC ESTIMATES THAT THE FINANCIAL IMPACT OF THESE INFECTIONS EXCEEDS 5 BILLION DOLLARS ANNUALLY. AT LEAST HALF OF THESE INFECTIONS ARE DIRECTLY ASSOCIATED WITH MEDICAL DEVICES. MOST COMMONLY, THE DIAGNOSIS OF AN INFECTION ASSOCIATED WITH A MEDICAL DEVICE IS MADE ON THE BASIS OF CLINICAL CRITERIA INCLUDING THE PHYSICAL EXAM AND MICROBIAL CULTURES, WHICH IS PROBLEMATIC BECAUSE IT CAN ONLY DETECT LATE STAGE INFECTIONS THAT ARE CHALLENGING TO TREAT. DIRECTLY IMAGING BACTERIAL INFECTIONS HAS BEEN DIFFICULT AS CURRENT IMAGING TECHNOLOGIES (E.G., ULTRASOUND, CT, MRI, PET) ARE LIMITED TO IMAGING EITHER SOFT TISSUE CHANGES OR INFLAMMATION CONSISTENT WITH, BUT NOT DIAGNOSTIC OF, INFECTION. MICROBIAL MEDICAL INC. IS AN EMERGING COMPANY FOCUSED ON THE DEVELOPMENT OF NOVEL IMAGING AND ANTIBIOTIC COMPOUNDS THAT WILL LEAD TO IMPROVED PATIENT CARE IN THE DIAGNOSIS AND THERAPY OF BACTERIAL INFECTIONS. THE CURRENT TECHNOLOGY TO BE ADDRESSED IN THIS PROPOSAL IS A NEW MALTODEXTRIN FLUORINE-18 IMAGING AGENT THAT WILL BE ABLE TO DETECT INFECTIONS ASSOCIATED WITH ORTHOPEDIC IMPLANTS BY PET IMAGING. THE GOAL OF THIS PROPOSAL IS TO PERFORM FIRST IN MAN STUDIES MH18F. WE HAVE SELECTED IMAGING OF INFECTIONS ASSOCIATED WITH ORTHOPEDIC IMPLANTS AS AN INITIAL BUSINESS STRATEGY. IF SUCCESSFUL, THE TECHNOLOGY COMMERCIALIZED WILL ALLOW CLINICIANS TO IDENTIFY PATIENTS WITH BACTERIAL INFECTIONS AT AN EARLIER STAGE, PERMITTING TREATMENT, AND THUS REDUCE MORBIDITY, MORTALITY AND HEALTHCARE COSTS.

IMAGING BACTERIAL INFECTIONS IN VIVO: FIRST IN MAN STUDIES - PROJECT SUMMARY/ABSTRACT INFECTION IS THE MAJOR COMPLICATION OF VIRTUALLY ALL MEDICAL DEVICES. IT IS ESTIMATED THAT 2 MILLION PATIENTS ACQUIRE A NOSOCOMIAL INFECTION IN THE US EVERY YEAR AND THE CDC ESTIMATES THAT THE FINANCIAL IMPACT OF THESE INFECTIONS EXCEEDS 5 BILLION DOLLARS ANNUALLY. AT LEAST HALF OF THESE INFECTIONS ARE DIRECTLY ASSOCIATED WITH MEDICAL DEVICES. MOST COMMONLY, THE DIAGNOSIS OF AN INFECTION ASSOCIATED WITH A MEDICAL DEVICE IS MADE ON THE BASIS OF CLINICAL CRITERIA INCLUDING THE PHYSICAL EXAM AND MICROBIAL CULTURES, WHICH IS PROBLEMATIC BECAUSE IT CAN ONLY DETECT LATE STAGE INFECTIONS THAT ARE CHALLENGING TO TREAT. DIRECTLY IMAGING BACTERIAL INFECTIONS HAS BEEN DIFFICULT AS CURRENT IMAGING TECHNOLOGIES (E.G., ULTRASOUND, CT, MRI, PET) ARE LIMITED TO IMAGING EITHER SOFT TISSUE CHANGES OR INFLAMMATION CONSISTENT WITH, BUT NOT DIAGNOSTIC OF, INFECTION. MICROBIAL MEDICAL INC. IS AN EMERGING COMPANY FOCUSED ON THE DEVELOPMENT OF NOVEL IMAGING AND ANTIBIOTIC COMPOUNDS THAT WILL LEAD TO IMPROVED PATIENT CARE IN THE DIAGNOSIS AND THERAPY OF BACTERIAL INFECTIONS. THE CURRENT TECHNOLOGY TO BE ADDRESSED IN THIS PROPOSAL IS A NEW MALTODEXTRIN FLUORINE-18 IMAGING AGENT THAT WILL BE ABLE TO DETECT INFECTIONS ASSOCIATED WITH ORTHOPEDIC IMPLANTS BY PET IMAGING. THE GOAL OF THIS PROPOSAL IS TO PERFORM FIRST IN MAN STUDIES MH18F. WE HAVE SELECTED IMAGING OF INFECTIONS ASSOCIATED WITH ORTHOPEDIC IMPLANTS AS AN INITIAL BUSINESS STRATEGY. IF SUCCESSFUL, THE TECHNOLOGY COMMERCIALIZED WILL ALLOW CLINICIANS TO IDENTIFY PATIENTS WITH BACTERIAL INFECTIONS AT AN EARLIER STAGE, PERMITTING TREATMENT, AND THUS REDUCE MORBIDITY, MORTALITY AND HEALTHCARE COSTS.