ZuraGard™ provides prevention of extra-luminal or “exit site” wound CRBSI. Catheter-related blood stream infections (CRBSI) are one of seven major healthcare challenges identified by the CDC. It is reported that up to 400,000 cases occur annually resulting in patient death with mortality rates between 12% to 25%, and costs to treat one case range from $25,000 to $55,000.
CRBSI results in prolonging the intensive care unit stay by 5 to 7 days and typically require surgical removal and replacement of the catheter. A recent CMS report from FY 2007 estimated that charges incurred for vascular access related infections were over $3 billion with approximately $103,000 attributable cost per infection.
The major vascular access markets and catheter use continue to grow at about 6% per year. The main drivers of growth are the aging patient population who are more prone to chronic diseases and require more critical care, and an increase in drug treated cancer therapies which will continue to drive central venous catheters, PICC lines and implantable ports.
There are approximately 6,000,000 central line catheters placed each year in the US alone resulting in over 100,000,000 catheter lock and exit site treatments. The current standard of care for intra-luminal catheter lock is “sub-standard” as the only two products approved by the FDA for catheter use are saline and heparin. Of the 400,000 CRBSI, it is estimated that there is a 50 / 50 split between intra-luminal and extra-luminal derived infections.
ZuraGard™ was formulated from the Zurex antimicrobial technology platform and designed to be a safe and effective topical skin antiseptic. Pilot clinical testing on 36 patients in a controlled setting, under the latest FDA TFM protocol requirements, demonstrated efficacy results which significantly exceeded FDA's targets for market approval and there were no observable or reported safety issues. Zurex management believes ZuraGard™ has a significant opportunity to clinically outperform the current market leading products and drive additional value and differentiation through a patent protected compound and applicator.
New Ag Products
ZuraLac™ is specifically formulated to sanitize and protect teats from mastitis causing organisms, and protect teat skin tissue from harsh environmental conditions.
Zurex Pharma's corporate office is located in the Middleton Industrial Park. Specific comments or questions may be submitted online through our contact page.