IFIT PROSTHETICS, LLC — Department of Health and Human Services SBIR Phase II: N

Description

ABSTRACT The principal business interestiFIT Prosthetics LLCwith STTR fundingcreated a new transtibial prosthetic device and demonstrated its safetycomfortand functionIn contrast to conventionally made prosthetic limbsthe iFIT prosthesis is easily fit and aligned on the residual limb in a single sessionDue to its substantial adjustability and customized inner linerthe iFIT device is a comfortable prosthesis that easily accommodates limb volume changesMade of injection moldedadvanced polymer materialsit can be mass produced at a significant cost advantage compared to conventional devicesThis Commercialization Readiness PilotCRPprogram grant would come at a critical time for our businessas we are ready to accelerate large scale commercialization for this unique prosthesisThis funding will allow us to develop processes and manufacturing procedures to fully comply with regulations for sales to the Centers for Medicare and Medicaid ServicesCMSthe Veterans AffairsVAHealth systemsprivate insurersand prosthetistsWe will complete international standardsISOtesting for the production devicesWe 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 lossA prospective two month clinical trial withsubjects will be conducted to compare the iFIT prosthesis to conventional devicesTo enhance market acceptancewe will refine the inner liner and enhance the outer socket appearanceOur close collaboration with Advanced Design ConceptsADCand its engineering team has been highly successful in developing this productADC has the manufacturing capabilities to produce the iFIT prosthesis commerciallyiFIT Prosthetics is on the cusp of commercializing a completely unique new type of prosthesisThe 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 Project Narrative The principal business interestiFIT Prosthetics LLCwith STTR fundingcreated a new transtibial prosthetic device and demonstrated its safetycomfortand functionIn contrast to conventionally made prosthetic limbsthe iFIT prosthesis is easily fit and aligned on the residual limb in a single sessioniFIT Prosthetics is on the cusp of commercializing a completely unique new type of prosthesisThe modular and mass produced nature of this new 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