Modulated Imaging Inc. — Department of Health and Human Services SBIR Phase II: NIAMS

Description

Quantitative characterization of tissue structure and function is one of the most challenging problems in Medical ImagingOptical methods can potentially provide a single platform for imaging biological tissues with resolution and depth sensitivity from microns to centimeterslimited by fundamental light tissue interactionsUnder NIAMS Phase II SBIR fundingwe have built a platform wide field optical imaging system capable of measuring circulatory compromise in tissueOur underlying technology is based on Spatial Frequency Domain ImagingSFDInon contact multi spectral imaging method to measure tissue oxygenationedemaand scatteringAfter a series of pilot studieswe believe that our device is wellsuited for wound applicationsAs an exampleof theM diabetic population forms a preventable lower limb ulcer in their lifetime and resulting in $billion in annual expendituresUnder the new Commercial Readiness ProgramCRPwe propose necessary technical preparation to advance our technology from a device that measures circulatory compromise to a device that provides actionable information for wound applicationsa critical step for adoption in medical practiceTo achieve these goalswe propose regulatory strategy work and preparation to supportkapplications in wound careWe also propose design transfer work to migrate production to contract manufacturingThirdwe will work with consultants to navigate the reimbursement landscape for insertion into the health care systemFinallywe will use all this to support and plan for independent clinical studies that achieve our regulatory and reimbursement goalsAt the conclusion of the CRPwe anticipate that our company will be ideal candidate for external investment due to our work in reducing riskWe anticipate raising external funds to ramp up sales marketing for entry into the wound market and full commercialization of our technology in health care Quantitative characterization of tissue structure and function is one of the most challenging problems in Medical Imagingparticularly in wound careUnder the Commercial Readiness ProgramCRPwe propose necessary technical preparation to advance our technology that measures circulatory compromise to a commercial ready device that provides actionable information for wound careAt the conclusion of the CRPwe anticipate that we will be well positioned for medical commercialization