A novel, next-generation percutaneous access device (PAD) will be developed for the delivery of chronic and life-sustaining therapies requiring long-term access through the skin. PAD success requirements include skin tissue integration upon implantation providing the opportunity for prolonged, stable, infection-free access. This new design includes the incorporation of cell proliferative methods, avoiding the use of autologous fibroblast pre-coating associated with the Company's first generation PAD product, ViaDerm"""""""". The long-term objective is to develop, evaluate the effectiveness, and gain FDA clearance to commercialize the new ViaDerm-II for mechanical circulatory assistance, chronic peritoneal and hemodialysis catheter therapy, and other chronic venous access catheters used for drug and nutritional therapy. ViaDerm-II will address the market's expressed unmet need for a long-term, infection-resistant device that avoids the need for autologous fibroblast pre-coating, and is commercially packaged as a sterile, ready-to-use, off-the-shelf product. This Phase I application intends to complete the design modifications necessary to incorporate cell proliferative methods and to verify that the design meets its requirements using cell culture and computer modeling techniques. In addition, the new PAD system will be prototyped and surgeon review obtained for animal experiments planned in Phase II. Upon establishing feasibility of the ViaDerm-II concept in Phase I, Phase II of the proposal will focus on refining and evaluating the prototype system design. An appropriate animal model will be used to demonstrate both acute and chronic efficacy. The endpoint of Phase II will include the submission of an IDE application in support of a clinical validation study. The Company believes the healthcare significance and commercial potential to be high. It is estimated that several hundred thousand devices requiring reliable, long-term or prolonged percutaneous access are used every year. These patients suffer from heart failure, kidney failure, cancer and chronic digestive disorders. If successful, this improved PAD will not only improve the quality of life and reduce complications and costs associated with these existing patients, but provide a new skin access option for new therapies.
Commercial application of the research extends to chronic and life-sustaining therapies requiring long-term access through the skin, including end stage renal failure, heart failure, and cancer. The research has relevance to an estimated several hundred thousand devices implanted every year that require a reliable, long-term percutaneous access.
