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Ash Access Technology, Inc. Awarded a $2.7M SBIR Fast- Track Grant from NIH NIDDK to Fund the Pivotal Trial of the Company's innovative, flagship antimicrobial / antithrombotic therapy

Wednesday, September 14, 2005 11:45 AM EST - - - (Lafayette, Indiana) Ash Access Technology, Inc. received official written notice that they have been awarded a fast-track SBIR grant from NIH to fund the pivotal trial of "AAT023", the company's flagship antimicrobial / antithrombotic therapy designed to prevent catheter-related bloodstream infections (CRBSI) and eradicate biofilm. Dr. Stephen R. Ash is named as the Principal Investigator on the grant, awarded from the National Institute of Diabetes and Digestive Kidney Diseases (NIDDK).

"We are extremely excited about this award. We know that it is no small accomplishment to have a NIH sponsored peer-review panel carefully analyze the details of our plans surrounding the AAT-023 clinical trial and then award a grant of this magnitude," explained Bob Truitt, President and CEO. "To have the NIH recognize the importance of our research and pivotal trial reinforces our enthusiasm about the breakthroughs we expect AAT-023 to provide in the fight to prevent deadly and costly catheter-related bloodstream infections," said Mr. Truitt.

The Centers for Disease Control and Prevention (CDC) have recognized the alarming and growing rate of infection caused by the use of vascular access catheters and report that there are approximately 250,000 CRBSI incidents annually in the U.S. with reported mortality rates from 12% to 25% and treatment costs in excess of $2.0 billion each year.

"We have been very optimistic about the grant request and now that we have official notice we are excited to get the trial initiated," said Mr. Roland Winger, Clinical Trial Manager and Vice President Engineering and Quality Assurance at Ash Access Technology. "We have retained the services of STATKING Consulting, Inc., a Fairfield, Ohio company, to provide data entry and statistical services for the trial and are in final negotiations with a Contract Research Organization and Site Management Organization."

The clinical trial is designed to study the safety and efficacy of AAT-023 as a novel antimicrobial / antithrombotic therapy compared with heparin, the de facto industry standard. In contrast, AAT-023 is designed as a new therapeutic class that has demonstrated in pre-clinical tests excellent, broad spectrum (both gram positive and gram negative strains) antimicrobial efficacy and significant biofilm eradication between uses of a central venous catheters for dialysis. The clinical trial will be evaluating the safety and efficacy of AAT-023 as a new therapeutic option to prevent CRBSI and biofilm buildup as well as provide antithromotic properties similar to Heparin. The clinical trial will be conducted among chronic kidney disease (CKD) patients who are undergoing dialysis, according to a protocol approved by the FDA. The NIH grant will be awarded in two phases based on meeting short-term milestones in the first phase.

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 R. 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.