Ash Access Technology (United States)

In course of developing an anticoagulant and antibacterial catheter lock solution, we demonstrated that the components and alcohol formed an effective skin antiseptic. Ash Access formed a sister company to focus on development and clinical trials of this skin preparation and exchanged intellectual property for part ownership. Zurex Pharma now has Food and Drug Administration (FDA) approval on the new pre-operative skin preparation, ZuraGard™, and has made successful steps toward production and marketing of the product. The steps toward FDA approval, the size of the market, and user needs are clearer for a second product in the field than for the first.

When sodium citrate is used as an anticoagulant catheter lock the best concentration is 7%, since this provides a density approximately the same as blood. Our laboratory found that the addition of methylene blue and parabens greatly augmented antibacterial properties. Ash Access sponsored a randomized clinical trial in 400 dialysis patients with tunneled CVC, and this showed a significant decrease in incidence of catheter-related bloodstream infection (CRBSI) defined by stringent criteria. The FDA decided that the study missed its primary endpoint, and that the product was mis-classified, so they did not give approval to market. The licensee decided not to appeal to the decision to the physician panel and ended support of the project. Rights to market the catheter lock eventually returned to Ash Access.

Dual-lumen "acute" central venous catheters (CVC) for dialysis were developed in the 1970s and tunneled "chronic" CVC in the 1980s. Fibrous sheathing of these catheters diminished the patency after weeks to months of use. Double catheters like Canaud/Tesio worked better and longer than single body catheters but were tedious to place. I decided that the optimal CVC design would be a single body that split into two tips within the vena cava. The "Ash Split Cath(TM) " was developed in cooperation with a company focused on dialysis access catheters, and quickly became widely used around the world. However, the patent did not prevent other companies from marketing split-tip catheters. A disagreement on the terms of a royalty agreement further weakened the relationship between the marketing company and our R&D company.