List of Press Releases
Ash Access Technology's PMA for Zuragen® Solution Accepted for Filing by FDA
CDRH Establishes May 15th, 2009 as PMA Filing Date
JUNE 24, 2009 7:45 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 Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has made a threshold determination that the premarket approval submission (PMA) for Zuragen® Solution is sufficiently complete to permit a substantive review and is therefore suitable for filing.
Zuragen® Solution is an antimicrobial / antithrombotic citrate-based solution designed to minimize catheter-related bloodstream infection (CRBSI) and to maintain patency in chronic central venous catheters (CVCs) between uses. A number of in vitro studies have shown that Zuragen® Solution is rapidly bactericidal and fungicidal. Additional flow chamber studies against sessile microorganisms within biofilm also demonstrated Zuragen® Solution’s antibacterial activity.
The safety and effectiveness of Zuragen® Solution was confirmed in the recently completed pivotal investigation (AZEPTIC). The AZEPTIC study was a multi-center, prospective, randomized, controlled clinical trial evaluating Zuragen® Solution for use as an antimicrobial catheter lock therapy in patients with a CVC for dialysis. The trial enrolled and treated 407 patients (201 Zuragen®Solution and 206 Heparin) at 25 dialysis centers in the United States.
“We are pleased with the decision of CDRH to file the PMA for Zuragen® Solution. The filing is confirmation that our submission was sufficiently complete. We look forward to continue working with the FDA in the coming months as they complete their review. Zuragen® Solution has tremendous potential to positively impact vascular access outcomes for the many patients who rely on central venous catheters and are at significant risk for CRBSI," said Dr. Stephen Ash, Chairman and Director, Research and Development 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 annual healthcare costs for treating these infections may exceed $3 billion. 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, Gentamycin and, more recently, Vancomycin).
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.
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.