The goal of this proposal is to develop, evaluate and enable the commercialization of an advanced percutaneous access device (PAD) appropriate for use in chronic home treatment modalities that require long- term body access, such as total parenteral nutrition, drug delivery, ambulatory peritoneal dialysis, and heart assist devices. The new PAD will improve upon our first generation ViaDermTM PAD, which demonstrated multiyear stability in animal studies. The two major challenges in PAD design are controlling epidermal proliferation and reducing mechanical stress at the device-tissue interface. The first generation PAD addresses these problems, but because the PAD neck is coated with cultured autologous fibroblasts, it requires 2-3 weeks of preparation before implantation. The proposed improvements are expected to increase long- term stability and eliminate or reduce preparation time, thus enhancing the commercial potential of the ViaDermTM access device. In Phase I studies, we will: a) evaluate surface modifications to enhance the affinity of the skin contacting surface for fibroblasts; and b) evaluate alternate materials and geometries to significantly increase the compliance of the skin contacting surface. Based on these results, the ViaDermTM PAD will be redesigned and undergo long-term testing in swine in Phase II to qualify it for human trial.
The ViaDerm 2 percutaneous access device, represents a core technology adaptable for use in home therapies which require long-term body access. A safe and effective device will enable expansion of the current $50 million market. L.VAD Technology expects to commercialize its product by entering into strategic partnerships with the firms providing the high profit margin supplies for such modalities as parenteral nutrition and peritoneal dialysis.
