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FDA Notifies Ash Access Technology, Inc. of Approved IDE for AAT-023, an Investigational Antimicrobial / Antithrombotic Therapy for the Prevention of Catheter Related Bloodstream Infections

Tuesday, March 22, 2005 10:52 AM EST - - - (Lafayette, Indiana) The FDA has approved a pivotal clinical trial for AAT-023, a novel antimicrobial / antithrombotic therapy, for the prevention of catheter-related bloodstream infection developed by Ash Access Technology, Inc., a Lafayette, Indiana company.

“The FDA had approved a prior formulation of the therapy in May of 2004 for use in a clinical trial designed to study the safety and efficacy compared with heparin, (the industry standard). The Company chose to delay the start of the trial because we felt we could further refine the formulation to be an even more effective and faster-acting antimicrobial therapy,” says Roland Winger, Vice President, Engineering and Quality Assurance. “Having reached the targets we wanted, we resubmitted our formula to the FDA, and are pleased that we have been approved to proceed with the clinical trial using the updated formulation which we are calling AAT-023.”

Heparin is the defacto industry standard therapy that is injected into catheters primarily as an anticoagulant. In contrast, AAT-023 is designed not only as an anticoagulant to reduce clotting, but also as antimicrobial to eliminate bacterial growth as well as eradicate any biofilm buildup between uses of a central venous catheter. The clinical trial is designed to prove the efficacy and safety of AAT-023 vs. heparin in the prevention of catheter-related bloodstream infections as well as maintaining catheter patency (flow rates). The patient population that will be enrolled in the pivotal study will be patients who are receiving hemodialysis via a chronic, tunneled central venous catheter.

Due to the inherent challenges of heparin therapy (bleeding, allergic reactions, leakage from catheter lumens and lack of an antimicrobial or anti-biofilm effect) and the significant rise in the incidence of CRBSI, high morbidity and mortality rates as well as the tremendous financial burden associated with its treatment, the company was determined to address this significant unment medical. Ash Access Technolgy, Inc. has been working on therapeutic options and formulations for the past five years.

“Heparin is used over 397,000 times a day, worldwide in dialysis setting and infusion applications alone. We feel that if we can provide an innovative, new therapy that not only prevents a catheter from clotting, but also helps prevent deadly catheter-related bloodstream infections as well as biofilm buildup then we can have a significant impact on reducing a patient’s risk of acquiring an infection and the associated morbidity and mortality rates. In addition, we feel this novel therapy may help contain the escalating costs of treating infections acquired in the hospital or at home when using a catheter,” says Robert B. Truitt, President and CEO of Ash Access Technology, Inc. “We are excited to begin this clinical trial, so we can validate the efficacy, safety and impact of AAT-023. If AAT-023 outperforms heparin in our pivotal clinical trial to the degree we've seen in our lab tests, we feel we have the potential to create a paradigm in the standard of care with a significant upside for the patient population plagued by increased infection risks, the medical community providing their care as well as our organization.”

The company is currently working to identify candidates for clinical trial sites. Enrollment of the 400 patients to participate in the study will begin shortly thereafter. The clinical trial will last for 26 weeks for each patient on either heparin or AAT-023, with a subsequent 26-week follow-up period for AAT-023 patients. STATKING Consulting, Inc., a Fairfield, Ohio company, specializing in data related services and statistical analysis for clinical trials will be retained for this trial.

Ash Access Technology, Inc. is a privately-held company founded to develop antimicrobial and vascular access technologies, devices and methodologies to combat the deadly and expensive problem of catheter-related bloodstream infections, with an emphasis on prevention. Dr. Stephen A. Ash, Chairman and Director, Research and Development, is a practicing Nephrologist with the Arnett Clinic in Lafayette, Indiana, and is a world-recognized researcher and patent holder in extracorporeal devices, sorbent chemistry, and vascular and peritoneal access devices. Ash Access Technology is located in Lafayette, Indiana in the INOK Business Center.

This press release contains forward-looking statements, which if not based on historical facts, involve risks and uncertainties. Our actual results may differ materially from the results or events stated in the forward-looking statements, including, but not limited to, certain events not within the Company's control.