August 22, 2008
Ash Access Technology Completes AZEPTIC Trial for Zuragen(TM) Injection
Ash Access Technology, Inc., a privately held specialty pharmaceutical / medical device company focused on the development and commercialization of proprietary products to improve infection control and vascular access outcomes, announced today that the last patient enrolled in the AZEPTIC Trial for Zuragen(TM) Injection has completed the study. The pivotal AZEPTIC Trial is a randomized study evaluating the efficacy and safety of Zuragen(TM) Injection in significantly reducing the incidence of catheter-related bloodstream infection (CRBSI) in patients requiring the use of a central venous catheter (CVCs) for hemodialysis. The trial enrolled over 400 patients at 25 dialysis facilities across the United States. Portions of the AZEPTIC Trial were financed through grants awarded by the National Institutes of Health (NIH) and the Indiana 21st Century Technology Fund.
Zuragen(TM) Injection is a non-antibiotic, antimicrobial / antithrombotic therapy that is administered into a patient's catheter at the conclusion of each hemodialysis session. The product's unique components have demonstrated a novel synergy which has led to significant and rapid efficacy against a broad spectrum of bacteria and fungus as well as complete elimination of biofilm in pre-clinical studies.
"We are very grateful to the patients and study sites that participated in the AZEPTIC Trial. The efforts of all the team members who joined us in this endeavor are to be commended. 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," noted Bob Truitt, President and CEO of Ash Access Technology, Inc.
The Centers for Disease Control has identified CRBSI as 1 of its 7 major healthcare challenges because of an estimated 200,000 to 400,000 episodes annually in the United States. Studies have shown that mortality rates associated with CRBSI range from 12 - 25% while the Centers for Medicare and Medicaid Services (CMS) reports the annual healthcare costs for treating these infections exceed $3 billion. In addition, recent reports from the NNIS and CDC continue to show rapidly increasing rates of resistance of some of the more common pathogens associated with CRBSI to antibiotics (Methicillin and, more recently, Vancomycin).
"Zuragen(TM) Injection was developed to address a significant unmet medical need -- reducing the incidence of life-threatening catheter-related bloodstream infections. With an escalation in the incidence of CRBSI, alarming issues reported with heparin as well as the new CMS IPPS ruling to no longer reimburse hospitals for vascular access device related infections, I would anticipate Zuragen(TM) Injection becoming a very important infection control resource in the dialysis community and acute care settings," said Dr. Stephen Ash, Chairman and Director, Research and Development.
About Ash Access Technology, Inc.
Ash Access Technology, Inc. is a privately held specialty pharmaceutical / medical device company focused on the development and commercialization of proprietary products and devices to improve vascular access and infection control outcomes. The Company's diverse product portfolio includes innovative hemodialysis and peritoneal dialysis catheters and novel antimicrobial therapeutics being developed for the prevention and treatment of catheter related bloodstream infection (CRBSI) and surgical sites infection (SSI). Ash Access Technology is located in Lafayette, Indiana in the INOK Business Center.
The statements made in this document contain certain forward-looking statements that involve a number of risks and uncertainties. Words such as "expects,""intends,""anticipates,""plans,""believes,""seeks,""estimates," or variations of such words and similar expressions, are intended to identify such forward-looking statements. Investors are cautioned that actual events or results may differ from the Company's expectations. In addition to the matters described above, the ability of the Company to develop its products, future actions by the FDA or other regulatory agencies, results of pending or future clinical trials, overall economic conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, as well as other risk factors may affect the actual results achieved by the Company.
SOURCE: Ash Access Technology, Inc.