BEDMINSTER, NJ / ACCESSWIRE / May 5, 2016 / CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced today publication of a clinical abstract highlighting key data from the Company's landmark post-approval surveillance study of Neutrolin®. The abstract, titled, "A Novel Taurolidine Containing Catheter Lock Solution (CLS) Without Reported Antimicrobial Resistance, Reduces the Rates of Infection And Thrombosis in Hemodialysis Patients Enrolled In a Post-Approval Surveillance Study," is now available online in advance of CorMedix's poster presentation at the 1st Gulf Congress of Clinical Microbiology and Infectious Diseases, to be held May 4-7, 2016, in Dubai, United Arab Emirates.
Randy Milby, CorMedix CEO, said, "Bloodstream infections remain a primary concern for hospitals worldwide, given the number of patients with indwelling venous catheters required for vascular access in various settings including hemodialysis, oncology, critical care, parenteral nutrition, IV hydration and/or IV medications. This global need is reflected in the strong interest we're seeing among healthcare professionals who want to know more about Neutrolin's real world clinical performance in preventing catheter-related infections and thrombosis since receiving CE Marking in mid-2013. As we pursue U.S. FDA approval in our current Phase 3 clinical program, we will continue to seek to leverage key opportunities to highlight the clinical utility and value of Neutrolin for the global medical community, based on our positive clinical experience in Europe."
Christoph Wanner, M.D., Lead Author and Professor of Medicine, Head of Nephrology, Department of Medicine, Division of Nephrology and Scientific director, Clinical Trial Unit, at University Hospital of Würzburg, stated, "I am excited to share the findings of this post-approval surveillance study with this focused audience of infectious disease experts. Having generated further clinical evidence that Neutrolin, a non-antibiotic anti-microbial with no known resistance, appears to be a valuable clinical tool in the fight against costly and potentially life-threatening catheter-related bloodstream infections, I look forward to future results of the current Phase 3 clinical trial evaluating the safety and efficacy of Neutrolin in hemodialysis patients."
In the study, Dr. Wanner evaluated the use of Neutrolin, CorMedix's CE Marked anti-infective solution for the prevention of catheter-related blood infections (CRBSIs) and thrombosis, which are the major complications observed in patients undergoing hemodialysis with indwelling central venous catheters. Under the study, 199 hemodialysis patients at 19 hemodialysis centers in Germany were enrolled in the ongoing Neutrolin Use Monitoring Program (NUMP), representing 14,945 dialysis sessions over a 21-month period, for a total of 34,872 hemodialysis catheter days. These data demonstrated that use of Neutrolin is associated with 96.0% reduction in the rate of CRBSI and 96.6% reduction in thrombosis compared to published historical benchmarks of 3.5 CRBSIs and 2-3 episodes of thrombosis per 1,000 catheter days.
About CorMedix Inc.
CorMedix Inc. is an emerging commercial-stage biopharmaceutical company that initiated a Phase 3 clinical study of a novel anti-infective solution Neutrolin in hemodialysis patients in the United States in December 2015. The Company seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of infectious and inflammatory diseases. CorMedix's first commercial product in Europe is Neutrolin®, a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients, in addition to oncology patients, critical care patients, and patients receiving total parenteral nutrition, IV hydration, and/or IV medications. The FDA has granted Fast Track status to Neutrolin Catheter Lock Solution and also has designated Neutrolin as a Qualified Infectious Disease Product for oncology, hemodialysis, and critical care/intensive care patients, where catheter-related blood stream infections and clotting can be life-threatening. The initial and planned indications aim to address significant needs in catheter-based treatments in the U.S. and the rest of the world. For more information visit: www.cormedix.com.
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Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the results of studies regarding Neutrolin® conducted by us and others; the cost, timing and results of the planned Phase 3 trials for Neutrolin® in the U.S.; obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix's product candidates, including marketing of Neutrolin in countries other than Europe; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; the risks associated with the launch of Neutrolin in new markets; CorMedix's ability to enter into, execute upon and maintain collaborations with third parties for its development and marketing programs; CorMedix's ability to maintain its listing on the NYSE MKT; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources; the outcome of clinical trials of CorMedix's product candidates and whether they demonstrate these candidates' safety and effectiveness; CorMedix's ability to identify and enter into strategic transactions; CorMedix's dependence on its collaborations and its license relationships; achieving milestones under CorMedix's collaborations; CorMedix's dependence on preclinical and clinical investigators, preclinical and clinical research organizations, manufacturers, sales and marketing organizations, and consultants; and protecting the intellectual property developed by or licensed to CorMedix. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
SOURCE: CorMedix Inc.
ReleaseID: 439647
