POLY ORTH INTERNATIONAL — Department of Health and Human Services SBIR Phase II: NICHD

Description

Research efforts of the Poly Orth International demonstrated feasibility of the novel Residuum Integration Prosthetic Technologyandquot to be used in direct skeletal attachment of limb prosthetics The technology includes a Skin and Bone Integrated Pylon SBIP which connects the residuum with external limb prosthesis and can be especially beneficial for patients who can not use traditional socket attachment of the prostheses As histopathology analysis after the study with small animals has demonstrated the SBIP is integrated not only with the residual bone but also with the residuumandapos s skin minimizing the risk of infection and secondary trauma The investigators developed an optimal porous titanium matrix and design of the Skin and Bone Integrated Pylon to maximize the ingrowth of bone and skin cells of the residuum to the SBIP without compromising strength of the implanted device The technological study on the process of manufacturing of the composite porous structure enforced with a permeable internal frame Parameters of the SBIPandapos s specification are protected by the US Patent During the proposed translational pre clinical study the animal trials will be conducted according to the FDA requirements to ensure smooth translation to the trials in humans It will include large animals and the implantation period up to months Inadequate prosthetic rehabilitation after limb amputation is a serious problem relevant to public health The public value of solving this serious problem is much more elevated when a country is at war Providing US amputees with infection safe and long lasting direct skeletal attachment of prostheses will improve the quality of their lives and eliminate the costs associated with the multiple fabrications adjustments and frequent failures of the prosthetic sockets