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OFFICIAL RELEASE
Ash Access Technology Completes AZEPTIC Trial for Zuragen™ Injection
Final Data Collection and Statistical Analysis Ongoing; Results Available in Coming Weeks
AUGUST 22, 2008 7:52 AM EST (Lafayette, Indiana) - - - 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™ 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 (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™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™ 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™ 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 Technlogy, 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 a unique antimicrobial therapeutics being developed for the prevention and treatment of catheter related bloodstream infection (CRBSI) and surgical site infection (SSI). Ash Access Technology is located in Lafayette, Indiana in the INOK Business Center.
Safe Harbor
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.
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