ZurAsept™ provides prevention of intra-luminal catheter-related bloodstream infections for non-dialysis patients. 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.
In the recent AZEPTIC™ clinical trial in hemodialysis patients, an initial product formulation demonstrated a significant reduction in infection related events with a favorable patency and safety profile in hemodialysis central lines compared to the current standard of care (Heparin). In addition, the FDA has reviewed and approved files and data related to pre-clinical testing, CMC, safety, manufacturing and stability testing of this initial formulation.
There are currently no FDA approved catheter injection therapies designed to help prevent infections in central venous catheter lines. Zurex Pharma is establishing a new class of therapy with ZurAsept where no competitor currently exists. Market projections suggest annual revenue potential in the range of $600,000,000 for central venous catheter applications.
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ZuraLac™ is specifically formulated to sanitize and protect teats from mastitis causing organisms, and protect teat skin tissue from harsh environmental conditions.
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