DefenCath® (taurolidine and heparin) catheter lock solution is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients.

CORMEDIX INC. ANNOUNCES STRATEGIC INITIATIVE WITH BOSTON MEDICAL CENTER TO REDUCE HEALTH DISPARITIES IN PATIENTS AT RISK FOR BLOODSTREAM INFECTIONS

June 15, 2023

Berkeley Heights, NJ – June 15, 2023 – CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced its first-of-kind strategic initiative with Boston Medical Center to enhance patient safety and reduce health disparities in structurally marginalized populations at risk for bloodstream infections while undergoing dialysis.

It is estimated that 25 – 33% of chronic hemodialysis patients with catheters will experience Catheter Related Bloodstream Infections (CRBSIs) and are three times more likely to experience serious complications, including high mortality rates, within the first few months of dialysis due to CRBSIs. CRBSIs disproportionately impact minority and low-income patient populations on dialysis, who may experience a higher rate of central venous catheter (CVC) use, resulting in higher medical costs, prolonged hospital stays, increased antimicrobial resistance and higher mortality. This real-world data initiative will evaluate the use of a novel antimicrobial catheter lock solution to reduce the incidence of CRBSIs in patients receiving dialysis through a CVC. The goal of this initiative is to increase healthy outcomes for patients disproportionately impacted by CRBSIs.

CorMedix and Boston Medical Center will assess the incidence and scope of CRBSIs, care inequities in patients experiencing CRBSIs, total potential costs of treatment, and CRBSI-related readmissions. This assessment will form the baseline from which CorMedix and Boston Medical Center will evaluate the impact that infection prevention can have on reducing the health disparities that structurally marginalized patient populations often face.

Boston Medical Center, the largest essential hospital in New England, provides world-class care to all, with an emphasis on clinical excellence and health equity. With one million patient visits annually and unique community partnerships designed to empower patients and help communities thrive, Boston Medical Center is committed to improving the health of communities.

“For dialysis patients, the consequences of acquiring a bloodstream infection – in terms of prolonged days in the hospital, lives lost and the financial strain that the long-term sequelae of infection places on the continuum of care – are already well documented,” said Joseph Todisco, chief executive officer of CorMedix. “We are setting out to prove in a real-world setting that we can also prevent them from happening in the first place with DefenCath™.”

“High-quality, equitable, cutting-edge care is central to the mission of Boston Medical Center,” said Dr. Megan Bair-Merritt, chief scientific officer at Boston Medical Center. “We are excited by the opportunity to work closely with CorMedix and our community dialysis partners to explore new technologies to prevent infections, which are a big threat to communities of color that are undergoing dialysis.”

About CorMedix

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on developing its lead product DefenCath™, a novel, non-antibiotic antimicrobial solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the original New Drug Application (NDA) received priority review in recognition of its potential to address an unmet medical need. QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also committed to conducting a clinical study in pediatric patients using a central venous catheter for hemodialysis when the NDA is approved, which will add an additional six months of marketing exclusivity when the study is completed.  The Company received a second Complete Response Letter from the FDA last August related to deficiencies at both its primary contract manufacturer and its supplier of heparin API.  After receiving guidance from FDA at a Type A meeting in April of 2023, the NDA for DefenCath was resubmitted.  CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations, and the Company is working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers.  For more information visit: www.cormedix.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, 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, including, but not limited to, statements regarding the ability of the Company’s DefenCath NDA resubmission to be classified as Class 2 and the timing of review, CorMedix’s future financial position, financing plans, future revenues, projected costs and the sufficiency of our cash and short-term investments to fund our operations 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 resources needed to secure approval of the NDA for DefenCath from the FDA;  the risks and uncertainties of the relationships with the additional CMO and supplier of heparin; the ability to submit a supplement to CorMedix’s NDA; the ability to secure final FDA approval prior to July 1, 2024; the risks and uncertainties associated with CorMedix’s ability to manage its limited cash resources and the impact on current, planned or future research; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; and the ability to retain and hire necessary personnel to staff our operations appropriately. 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.

CorMedix Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
(617) 430-7576

CorMedix Media Contact:

Christopher Hippolyte
Syneos Health
(646) 822-6070

Boston Medical Center Contact:

Dave Kibbe
Boston Medical Center
(617) 638-8499