CorMedix Inc. to Present Post-Market Clinical Utility Data from Neutrolin® Usage Monitoring Program on May 23, 2016
Data to be Presented at the 53rd Joint Congress of the European Renal Association – European Dialysis and Transplant Association
Bedminster, NJ – April 12, 2016 – CorMedix Inc. (NYSE MKT: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced that Dr. Christoph Wanner, Professor of Medicine and Director of Nephrology at the University of Wurzburg, will deliver an oral presentation 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 ” at the 53rd ERA-EDTA Congress to be held May 21-24, 2015, in Vienna, Austria.
Randy Milby, CorMedix CEO, said, "The Neutrolin Usage Monitoring Program data has produced valuable insights from real world use in the EU, where Neutrolin is approved for the reduction of catheter-related blood stream infections and thrombosis. We’ve shared some general data from the program, which has demonstrated positive results consistent with our trials that appear to validate Neutrolin’s clinical utility. We look forward to presenting a more formal analysis to this esteemed gathering of nephrologists."
Data published in the abstract will be embargoed until the time of the presentation on Monday, May 23, 2016.
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.
For Investors & Media:
CorMedix
Maureen McEnroe, CFA: Maureen@machealthcare.com; (914) 588-1873
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D.: jdrumm@tiberend.com; (212) 375-2664
Janine McCargo: jmccargo@tiberend.com; (646) 604-5150
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; 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; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; 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.
