IMMEDIATE FIT USING INNOVATIVE TECHNOLOGY PROSTHETIC SYSTEMS

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ABSTRACT The principal business interest, iFIT Prosthetics LLC ® with STTR funding, created a new transtibial prosthetic device and demonstrated its safety, comfort, and function. In contrast to conventionally made prosthetic limbs, the iFIT prosthesis is easily fit and aligned on the residual limb in a single session. Due to its substantial adjustability and customized inner liner, the iFIT device is a comfortable prosthesis that easily accommodates limb volume changes. Made of injection-molded, advanced polymer materials, it can be mass produced at a significant cost advantage compared to conventional devices. This Commercialization Readiness Pilot (CRP) program grant would come at a critical time for our business, as we are ready to accelerate large-scale commercialization for this unique prosthesis. This funding will allow us to develop processes and manufacturing procedures to fully comply with regulations for sales to the Centers for Medicare and Medicaid Services (CMS), the Veterans Affairs (VA) Health systems, private insurers, and prosthetists. We will complete international standards (ISO 10328) testing for the production devices. We will expand and refine our business capabilities by making new socket sizes and shapes to fit a broader range of patients with both transtibial and transfemoral limb loss. A prospective two-month clinical trial with 40 subjects will be conducted to compare the iFIT prosthesis to conventional devices. To enhance market acceptance, we will refine the inner liner and enhance the outer socket appearance. Our close collaboration with Advanced Design Concepts (ADC) and its engineering team has been highly successful in developing this product. ADC has the manufacturing capabilities to produce the iFIT prosthesis commercially. iFIT Prosthetics is on the cusp of commercializing a completely unique new type of prosthesis. The modular and mass produced nature of this new adjustable device holds great promise for improving access to affordable prosthetics and enhancing the quality of life for persons with lower limb amputations in the United States and internationally.