Commercialization of TrueContour Custom Diabetic Foot Orthoses

Project Summary DIApediaLLCfunded by the National Institutes of Health SBIR programhas developed an advanced diabetic foot orthosis systemDIApedia s TrueContourcustom diabetic foot orthosesCDFOare designed by combining the patient s unique foot shape with customized offloading modifications of the orthosis surface that are based on the patient s unique measured plantar pressureTrueContourCDFOs have been clinically tested in head to head studies against diabetic shoe inserts currently approved by Medicare asbest practiceand have been shown tooperate differently by significantly reducing plantar pressure via precise placement of offloading orthosis modificationsOwings et alandprovide significant therapeutic distinction in reducing ulceration byfold in patients at elevated risk for development of a diabetic plantar ulcerUlbrecht et alThe proposed project will address the remaining key cost drivers in the commercial scale manufacturing and distribution of the TrueContourCDFOSpecificallyimprovements to the orthosis design process and development of lower cost foot pressure measurement hardware will enable DIApedia and its commercialization partner to introduce the TrueContourCDFO product to the therapeutic footwear marketplaceFor the first timetherapeutic footwear providers and their patients will have access to custom diabetic foot orthoses with demonstrated clinical efficacy in the prevention of foot ulcer recurrenceWe will collaborate with our commercialization partner and other key vendors to execute our work plan which is focused on completion of the following late stage development activitiesACreate TrueContourcustom insole design functionality in a commercial CADCAM software applicationBDevelop and test a low costhigh resolution plantar pressure measurement systemCIntegrate TrueContourCDFO with our commercial partner s in clinic patient data acquisition system