CorMedix Proprietary Antimicrobial Technology to be Featured at 14th Annual South Beach Symposium

BEDMINSTER, NJ / ACCESSWIRE / February 10, 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 that Z. Paul Lorenc, MD, FACS, a world-renowned board certified aesthetic plastic surgeon on the faculty of Weill-Cornell University Medical College, will give a presentation at the 14th Annual South Beach Symposium highlighting observations gathered from in vitro tests examining the efficacy of suture materials incorporated with CorMedix’s proprietary antimicrobial, taurolidine, against clinically significant microorganisms. Dr. Lorenc’s presentation will take place on February 12, 2016.

Taurolidine is the active ingredient in CorMedix’s lead product, Neutrolin(R) an anti-microbial, anti-infective solution for the prevention and treatment of catheter-related blood stream infections. Several Phase 2 studies showed that Neutrolin reduced infection rates by 70 – 100%. Taurolidine is not an antibiotic, and therefore, bacterial resistance against taurolidine has never been observed.

Based on taurolidine’s profile, Dr. Lorenc sought to examine whether integrating taurolidine into the matrix of a monofilament or multifilament suture could reduce surgical site infections. In a Zone of Inhibition Test, a qualitative in vitro method used by researchers who develop antimicrobial textiles, surfaces, and liquids to measure antibiotic resistance and industrially to test the ability of solids and textiles to inhibit microbial growth, taurolidine integrated sutures were tested against major common human pathogens Pseudomonas aeruginosa, Staphylococcus epidermidis, and Staphylococcus aureus. The study demonstrated that taurolidine-loaded fibers resist growth of bacteria in the vicinity of fibers. The study also showed that taurolidine-loaded fibers have the ability to kill representative microorganisms that have clinical significance.

Randy Milby, CorMedix CEO, said, “We recognize that taurolidine could offer benefits not currently available in marketed antimicrobial sutures, creating opportunities for possible expansion. While our focus remains on advancing our therapeutic Neutrolin through clinical studies toward FDA approval, we’re exploring opportunities to jointly develop taurolidine-integrated devices to fight infections on another front.”

Dr. Lorenc stated, “Across specialties, there’s a significant need to control and protect against surgical site infections upon closure with sutures. In the United States alone, between 500,000 and 750,000 surgical site infections occur annually. As a practicing aesthetic plastic surgeon, I was excited to see taurolidine’s encouraging performance in Zone of Inhibition testing. Taurolidine’s antimicrobial properties distinguish it from antibiotics, which are more susceptible to micro-organism resistance. This makes taurolidine-integrated meshes and closures a potentially exciting option for any surgeon who wants to protect the quality of their work against infection.”

About Neutrolin

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 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(R), 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 3 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:

CorMedix
Maureen McEnroe, CFA: (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 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(R) 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.

ReleaseID: 436671