SOLINAS MEDICAL INC. — Department of Health and Human Services SBIR Phase II: NHLBI

Description

Project Summary This Small Business Innovation Research Phase II project supports the development of an instantly sealing vessel protection platform with enhanced durability against needle sticks While Medicare spends over $ billion annually on the treatment for end stage renal disease greater than of its budget $ billion is spent treating preventable access related complications Many of these complications are directly or indirectly a result of repeated large bore needle cannulations and methods used to manage the access site after treatment The technology will be the first product to prophylactically serve the AV fistula market and creates an untapped market with greater than $ million in the U S This project will expand knowledge on methods to improve vascular access designed to address secondary complications instead of relying on conventional approaches of treating the complications after they have occurred Success of this research will increase understanding on methods of creating materials for applications where closure and re traversable access is desired The primary value proposition of the proposed technology is to offer a prophylactic means of protecting AV access systems that undergo rapid degeneration by reinforcing the site of repeated cannulation In an effort to support our commercialization launch the objective of the scientific aims is to demonstrate the clinical safety and effectiveness of the patch system in addressing persistent access related complications Specifically the scientific aim is to conduct a prospective clinical trial to evaluate the safety and efficacy of the patch technology in patients undergoing hemodialysis with an AVF Project Narrative This Small Business Innovation Research Phase II project supports the development of a vascular protection platform While Medicare spends over $ billion annually on the treatment of chronic kidney failure representing of its budget $ billion is spent on treating preventable secondary complications that stem from access related complications By protecting the vessel there is a potential to improve patient outcome and support clinical and healthcare policy objectives