SBIR-STTR Award

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. PROPOSED COMMERCIAL APPLICATIONS: 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

The goal of this proposal is to finalize the development and begin 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 heart assist devices for treatment of chronic heart failure, total parenteral nutrition, drug delivery, and ambulatory peritoneal dialysis. The PAD is pre-seeded with autologous fibroblasts derived from a small sample of the recipient's skin. Cell seeding improves the device's clinical performance, creating a seal impervious to fluids and microorganisms and minimizing the risk from infection. The purpose of this project is to develop a new PAD, improving upon the first generation ViaDerm TM PAD that demonstrated multiyear stability in animal studies and has been used with excellent results in a series of 9 patients receiving a heart assist device for a total of 1054 patient days. The in vitro results of Phase I demonstrated that fibronectin provided for the best cell retention on the surface of the PAD, however, were insufficient to conclude which of 2 substrates, polycarbonate or polyurethane, provided for optimal protection of the device/tissue interface. The work under this phase II SBIR will focus on: 1) optimizing the device by finalizing the selection of the substrate for the new device, 2) optimizing the cell seeding process by pre-coating the surface with fibronectin and minimizing the overall time required for preparation of the device to make it commercially attractive. The specific aims are to improve the instrumentation and techniques for PAD preparation and to test the device in a series of long-term animal studies. To commercialize this product, the company plans to enter into strategic partnerships with, or license to, major corporations selling supplies to patients in each market. The new PAD is likely to be a premium product, but its cost will be outweighed by benefits of reduced hospitalization, disability and loss of earnings and by improved quality of life