IFIT PROSTHETICS, LLC — Department of Health and Human Services STTR Phase II: NIA

Description

DESCRIPTION provided by applicant The goal of iFIT Prosthetics LLC r and its founder was to create and commercialize a modular immediate fit fully adjustable transtibial prosthesis system suitable for mass production using high strength polymer materials that are injection molded at a fraction of the cost of conventionally made prostheses This goal was achieved and now the aims of this Phase IIB competitive renewal are to i complete injection mold manufacture for the remaining sizes of transtibial sockets to make a full line of transtibial prostheses to fit most amputees ii develop processes and manufacturing procedures to comply with federal CMS Durable Medical Equipment regulations and FDA Device regulations iii complete international standards ISO durability testing for all components iv develop similar devices for transfemoral amputees and v conduct a more rigorous comparative effectiveness study between our devices and conventionally manufactured prostheses The final design can be fit onto the amputeeandapos s residual limb using only a few hand held tools Our device is comfortable light in weight highly functional and can be aligned while remaining on the patient This system is compatible with a large number of commercially available prosthetic feet and silicone pin suspension systems Our collaboration with Advanced Design Concepts ADC and their engineering team has been highly successful in developing this product The principal business interest in this study iFIT Prosthetics LLC r is well poised to carry out the aims of ths Phase IIB two year competitive renewal Commercialization of this American made innovative consumer centered cost effective alternative to the current state of prosthetic fabrication holds great promise to increase access to prosthetic devices and to improve the quality of life for the large and growing number of persons with transtibial and transfemoral amputations domestically and internationally PUBLIC HEALTH RELEVANCE The business interest in this Phase IIB STTR application iFIT Prosthetics LLC holds the patent to a newly developed modular immediate fit fully adjustable transtibial prosthesis system suitable for mass production using high strength polymer materials that are injection molded at a fraction of the cost of conventionally made prostheses Commercialization of this American made innovative high quality consumer centered cost effective alternative to the current state of prosthetic fabrication holds great promise to increase access to prosthetic devices and to improve the quality of life of the large and growing number of persons with transtibial and transfemoral amputations domestically and internationally