Novel, Long-Term Percutaneous Access Device for Chronic Therapy

DESCRIPTION: A novel, next-generation percutaneous access device (PAD) focused on pre-emptively reducing catheter related exit site infection will be developed for the delivery of chronic, life-sustaining therapies requiring long- term access through theskin. ViaDerm II uses vacuum assist to remove exudate and proliferate dermal fibroblasts as soon as the catheter penetrates the skin. In addition it uses a device structure enabling stability and a surface treatment, shown to enable cell attachment in preclinical and human studies. The overall goal of this proposal is to develop, test and qualify the ViaDerm II for human use, and commercialize the product globally. ViaDerm LLC intends to enter into strategic partnerships with a market leader in each therapy: cardiac assist, dialysis, and chemo- or other therapies using central venous access. ViaDerm will work with partners to integrate market and sell ViaDerm's value-added technology with their existing and new product lines. ViaDerm II will address the market's expressed unmet need for a long-term, infection-resistant device that is commercially packaged as a sterile, off-the-shelf product. In Phase II, working in conjunction with industry partners, ViaDerm will focus on obtaining regulatory approvals and refine the product design based on initial clinical trial experience. The endpoint of Phase III will be full commercialization of the ViaDerm II in three target markets: cardiac assist, dialysis and central venous access. In parallel, ViaDerm expects to develop additional and new applications, expanding its family of PAD products. The significance and commercial potential of this proposal is substantial. 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, renal failure, cancer, and chronic digestive disorders. Foresight Science and Technology, Inc has provided a third party commercial assessment investigating the commercial interestand market impact potential of this technology. Foresight found that the total global addressable market for this technology is approximately US 2.35 billion and estimates ViaDerm LLC year five revenues to approach US 170 million based on 1.7 million units sold worldwide. If successful, this innovative PAD will not only improve the quality of life, reduce medical complications and healthcare costs associated with current therapies, but provide a pre-emptive, infection resistant new skin access option forthe development of new emergent therapies. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: In this Phase II SBIR ViaDerm LLC plans to develop and qualify for human use, an innovative percutaneous access device for use in catheter or drive line delivered life-sustaining therapies such as heart failure, dialysis and chemotherapy. Innovation lies in the use of vacuum assist in conjunction with a proprietary percutaneous access device known to encourage device-tissue attachment and accelerated healing. Combined with the use of negative pressure, this innovative second generation complements existing anti-microbial/biofilm approaches to meet an unmet clinical and societal need.