LAFAYETTE, Ind., Sept. 14 /PRNewswire/ -- Ash Access Technology, Inc. received official written notice that they have been awarded a fast-track SBIR grant from NIH to fund the imminent clinical trial of "MethLock(TM)," the company's antimicrobial and anti-biofilm catheter lock solution designed to prevent catheter-related bloodstream infections (CRBSI). 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 MethLock clinical trial, and then award a grant of this magnitude," explained Bob Truitt, President and CEO. 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. "To have the NIH recognize the importance of our catheter lock clinical trial, just reinforces our enthusiasm about the breakthroughs we expect MethLock to provide in the fight to prevent deadly and costly catheter-related bloodstream infections," said Mr. Truitt.
"We have been very optimistic about the grant request, and now that we have official notice, we find ourselves right on track for beginning this pivotal clinical trial in November," said Mr. Roland Winger, Clinical Trial Manager and Vice President Engineering and Quality Assurance at Ash Access Technology. "We have already retained STATKING Consulting, Inc., a Fairfield, Ohio company, as the Clinical Research Organization to provide data entry and statistical services for the trial and are in final negotiations with a key Site Management Organization."
The clinical trial is designed to study the safety and efficacy of MethLock as a catheter lock solution, compared with heparin, the de facto industry standard. The dominant catheter lock solution in the marketplace is currently heparin, which is primarily an anticoagulant. In contrast, MethLock is designed not only as an anticoagulant to minimize clotting, but as a new therapeutic class of catheter lock that also provides a strong antibacterial function to minimize bacterial growth and biofilm buildup between uses of a central venous catheter for dialysis. The clinical trial is designed to prove the safety and efficacy of MethLock as a viable and preferable catheter lock solution. The clinical trial will be conducted among chronic kidney disease (CKD) patients who are undergoing dialysis, according to plans 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. (http://www.ashaccess.com ) 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.
Keywords: Ash Access Technology, Inc., NIH grant, SBIR, NIDDK, catheters, dialysis, FDA clinical trial, CRBSI, catheter-related bloodstream infections, catheter lock solution, heparin, chronic kidney disease, CKD, infection prevention, antimicrobial, antibacterial, anti-biofilm, biofilm, biotechnology, medical device
Ash Access Technology, Inc.