LAFAYETTE, Ind., Feb. 11 /PRNewswire/ -- The FDA has approved a clinical trial for MethLock, a catheter lock solution developed by Ash Access Technology, Inc., a Lafayette, Indiana company focused on vascular access medical solutions to prevent catheter-related bloodstream infections (CRBSI).
"The clinical trial is designed to study the safety and efficacy of MethLock as a catheter lock solution, compared with heparin, the industry standard," says Mr. Roland Winger, Clinical Trial Manager and Director, Engineering and Quality Assurance at Ash Access Technology. "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 also with an antibacterial function to minimize bacterial growth 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 company reports that candidates for clinical trial sites will be finalized in the next few weeks, followed by enrollment of 400 patients slated to participate in the study. The clinical trial is expected to begin in March or April and last for 26 weeks, with a subsequent 26 week follow-up period for MethLock patients. STATKING Consulting, Inc., a Fairfield, Ohio company, specializing in data related services for clinical trials, will be retained as the Clinical Research Organization for this trial.
"This approval by the FDA to begin the clinical trial is an important step in bringing this product to the market," says Mr. Robert Truitt, President and CEO of Ash Access Technology, Inc. "We hope to eventually see MethLock contribute to reducing infections from CRBSI, which are responsible for thousands of deaths and cost the U.S. healthcare system in excess of $2.0B every year. Ash Access Technology is committed to saving lives and reducing healthcare expenses caused by CRBSI in both acute and chronic uses of central venous catheters. To that end, we have put tremendous resources behind MethLock as a key innovation that will bring our healthcare system -- and our company -- closer to that goal."
Ash Access Technology, Inc. is a company founded to develop vascular access technologies and methodologies to combat the deadly and expensive problem of catheter-related bloodstream infections. 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.
Ash Access Technology, Inc.