August 25, 2008
Ash Access Technology Completes Zuragen Injection Study
Ash Access Technology has announced that the last patient enrolled in the Azeptic trial for Zuragen injection has completed the study.
The pivotal Azeptic trial is a randomized study evaluating the efficacy and safety of Zuragen injection in significantly reducing the incidence of catheter-related bloodstream infection in patients requiring the use of a central venous catheter for hemodialysis.
The trial enrolled over 400 patients at 25 dialysis facilities across the US. Portions of the Azeptic trial were financed through grants awarded by the National Institutes of Health and the Indiana 21st Century Technology Fund.
Zuragen injection is a non-antibiotic, antimicrobial or antithrombotic therapy that is administered into a patient's catheter at the conclusion of each hemodialysis session.
Bob Truitt, president and CEO of Ash Access Technology, said: "Completion of the Azeptic trial is a significant milestone for Ash Access Technology and reaffirms our commitment to develop breakthrough products in infection control. We expect to analyze the data in the coming weeks and look forward to presenting it to the FDA shortly."