BEDMINSTER, N.J., Jan. 21, 2016 /PRNewswire/ -- 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 that an clinical abstract highlighting key data from the Company's landmark post-approval surveillance study has been accepted for publication in the peer-reviewed American Journal of Kidney Diseases, and will be presented as a poster during the National Kidney Foundation® 2016 Spring Clinical Meetings, held April 27 – May 1, 2016, in Boston, Massachusetts.
The Neutrolin® Usage Monitoring Program (NUMP) examined the use of CorMedix's commercialized product in Europe, Neutrolin, an anti-infective solution for the prevention of catheter-related blood infections and thrombosis, which are the major complications observed in patients undergoing hemodialysis. The results to be published compare the reduced rates of these catheter-related complications with routine use of Neutrolin as a novel catheter lock solution versus historical benchmark rates.
"We are proud to continue gaining recognition by the global medical community for our novel anti-infective solution," said Randy Milby, Chief Executive Officer, CorMedix. "Publication of our clinical work in a peer-reviewed medical journal not only adds validation to our product, but also provides significant, broad exposure among potential Neutrolin users worldwide. We look forward to providing the full study analysis when our clinical poster is presented in the spring."
Neutrolin is a novel formulation of taurolidine, citrate and heparin 1000 units/ml that provides a combination preventative solution that decreases the threat of infection and thrombosis. Neutrolin keeps catheters operating safely and efficiently by optimizing catheter blood flow, while minimizing catheter-related infection rates for oncology, hemodialysis, and intensive care patients. To date, Neutrolin has no reported human resistance. Neutrolin has CE mark approval for use in the European Union and CorMedix initiated a Phase 3 clinical program in the United States in December 2015. The U.S. Food and Drug Administration (FDA) has designated Neutrolin as a Qualified Infectious Disease Product (QIDP), which provides an additional five years of market exclusivity in addition to the five years granted for a New Chemical Entity.
Of note is the recent release of the end stage renal disease Prospective Payment System final rule from the Centers for Medicare & Medicaid Services (CMS), as it proposed an approach to pay for new drugs that suggests the agency is open to considering alternative reimbursement schemes for products that have been designated as priorities by the FDA under the GAIN Act or the QIDP Act. CorMedix will be working with CMS to discuss Neutrolin specifically, and hopes to position it favorably in light of its potential to reduce infections and lower healthcare system costs.
About The National Kidney Foundation® 2016 Spring Clinical Meetings
The National Kidney Foundation 2016 Spring Clinical Meetings offer an extraordinary networking and learning opportunity for kidney health care professionals. Participants will enjoy a cutting-edge program presenting the newest developments related to all aspects of nephrology practice. Taught by internationally acclaimed faculty, the program features specialized courses, interactive workshops and lively debates. For more information visit: https://www.kidney.org/spring-clinical
About CorMedix Inc.
CorMedix Inc. is an emerging commercial-stage biopharmaceutical company that 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. CorMedix initiated a Phase III clinical study in the United States in December 2015. CorMedix enjoys a solid patent portfolio, and expanding product pipeline, and Neutrolin enjoys the important benefits of Fast Track status as well as a Qualified Infectious Disease Product designation. The initial and any subsequent products under development will seek to address significant unmet needs in the United States and in the rest of the world. For more information visit: www.cormedix.com.
For Investors & Media:
Maureen McEnroe: (914) 588-1873
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 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 cost, timing and results of the Phase 3 trial 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 ability to obtain reimbursement for Neutrolin from governmental and group health plans; 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; obtaining additional financing to support CorMedix's research and development and clinical activities and operations;; 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.