DOSEOPTICS LLC — Department of Health and Human Services SBIR Phase I: NIBIB

Description

ABSTRACT Fluorescence guided surgeryFGSis a growing field with increasing adoptionhaving about a dozen companies with FDA cleared systems for perfusion imaging with indocyanine greenand leading surgical device companies now acquiring such systems for marketingAdvanced molecular probes are being tested in hundreds of ongoing clinical trials in FGSwith a combination of research grade and modified commercial systemsHowevereach FGS system suffers from low dynamic range and high background signals from a range of sourcesThe CMOLECULES camera has been systematically designed to solve these two key problemsby having high adaptive gaininherently high digital bit conversionand tight control over wavelength and temporal samplingSuppression of tissue autofluorescence and room light background signals are maximized through narrow band filtering with each of two camerasfurther processing the images for subtractive displayA unique patented technology for ultrafast time gated intensified camera work is utilized to further maximize the fluorescence to ambient backgroundusing specific detection that reaches the level of single photons per pixelThis system will be finalized in hardware and software with time gated LED lamps for fluorophore activationSystem comparison testing for the level of background suppression will be completed relative to other commercially available systemswith a goal ofx increase in contrast through enhanced background suppressionMolecular image testing will utilize a fluorescent protein affibody that is being studied at microdosesto image EGFR expression in human head and neck tumorsA confirmation of the ability to image fluorescent affibody at picomolar concentrations will be verified for maximal sensitivitySystem development and testing is a collaborative project between DoseOptics and Dartmoutheach of which have outstanding expertise in development of the technology and pilot human trialsrespectivelyThe team has a proven history of publishing their workleading the field of FGSand delivering products that are commercially translated NARRATIVE Fluorescence guided surgeryFGSwill be enhanced by the new C MOLECULES camera that has been systematically designed to have high adaptive gainand suppression of confounding background signal from tissue autofluorescence and room lightThe system is verified by imaging microdosesof cell surface receptor EGFR in preclinical trials