CorMedix Therapeutics Announces Positive Data From Ongoing Real World Evidence Study of DefenCath

DefenCath® demonstrated a 72% reduction in CRBSI and 70% reduction in hospitalizations secondary to CRBSI

BERKELEY HEIGHTS, N.J., Dec. 18, 2025 (GLOBE NEWSWIRE) -- CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced interim results for the Company’s ongoing real-world evidence study being conducted in conjunction with U.S. Renal Care’s (USRC) use of DefenCath in adult hemodialysis patients with central venous catheters.

CorMedix and USRC commenced the real-world evidence study upon outpatient commercial launch in July 2024. The study is designed to demonstrate the impact of the broad use of DefenCath in a real-world setting and prospectively assess rates of catheter-related bloodstream infections (CRBSI), as well as hospitalizations secondary to these infections. The study is designed to evaluate these data points for two years. Currently, more than 3,000 patients per month are receiving DefenCath on a routine basis at USRC facilities. CorMedix conducted a preliminary analysis of interim data for approximately 7,000 patients having received at least one dose of DefenCath in Year 1.

Based on CorMedix’s analysis of the data available through September 30, 2025, compared to historical controls, use of DefenCath demonstrated an overall 72% reduction in CRBSI, and a 70% reduction in hospitalizations secondary to CRBSI. The Company believes this represents a meaningful reduction in risk in some of the most vulnerable patients as well as a significant source of cost savings to the healthcare community and payors. CMS spends more than $3 billion per year on costs associated with CRBSI in the ESRD patient population, as the average CRBSI-related hospitalization is estimated to cost approximately $63,000, and up to $110,000 per incident when accounting for other sequelae.

Joseph Todisco, CEO of CorMedix, commented, “We are proud to announce interim results for our ongoing real-world evidence study with our partners at USRC. As one of our earliest outpatient customers, they have undertaken a significant effort in working with us on this important long-term study and ensuring patient access to DefenCath to prevent CRBSIs in hemodialysis patients at risk. We are now utilizing this data in discussions with customers and payers as we seek to broaden access to DefenCath and establish long-term reimbursement with Medicare Advantage.”

Geoffrey A. Block, MD, FASN, Associate Chief Medical Officer and Senior Vice President of Clinical Research and Medial Affairs at U.S. Renal Care stated that, “Our organization is deeply committed to advancing innovative therapies for our patients, and we are encouraged by the reduction in both serious infections and hospitalizations demonstrated in these preliminary results.”

Paul T. Conway, Vice President and Chair of Policy for the American Association of Kidney Patients (AAKP) and a 48-year kidney patient stated, "Every kidney patient receiving hemodialysis understands the inherent and serious risks posed by catheter-related bloodstream infections, including repeat hospitalizations, exposure to powerful IV antibiotics, jeopardization of their transplant readiness and increased mortality. As the largest kidney patient organization in the nation, AAKP welcomes this new and compelling information about DefenCath and the opportunity to better protect highly vulnerable dialysis patients while simultaneously reducing infection incidents and hospital admissions. We believe this data also strongly reinforces the ongoing collaborations among healthcare providers, patient advocates and elected leaders committed to transforming status quo dialysis care by addressing the long-standing and unmet need for infection prevention measures that lower hospitalizations, reduce healthcare utilization and limit costs to taxpayers.”

Secondary data points of missed treatment sessions, antibiotic utilization, and tPA utilization are also being assessed and may be announced with additional real-world evidence data in the future. CorMedix believes these data from this large, prospective, ongoing real-world study further underscore the LOCK-IT 100 clinical study results on which the FDA approval of DefenCath for ESRD hemodialysis patients was based. The Company expects to continue to discuss with customers and payors, such as Medicare Advantage plans, to emphasize the economic value of long-term infection prevention in these patients.

About CorMedix

CorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath^® (taurolidine and heparin) for the prevention of catheter-related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products, including MINOCIN^® (minocycline) for Injection, REZZAYO^® (rezafungin), VABOMERE^® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA^® (delafloxacin), and KIMYRSA^® (oritavancin), as well as TOPROL-XL^® (metoprolol succinate).

CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition (TPN) and Pediatric Hemodialysis populations and also intends to develop DefenCath as a catheter lock solution for use in other patient populations. REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of IFD in adult patients undergoing allogeneic BMT. Topline results of the Phase III study for REZZAYO are expected in Q2 2026. For more information visit: www.cormedix.com or www.melinta.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, and Section 21E of the Exchange, as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements including, but not limited to statements regarding financial guidance, sales estimates, synergy estimates and timing, expectations and timing regarding clinical studies and development and expectations of CorMedix’s product pipeline, results of the real-world study, expectations regarding implementation and perceived benefits of CorMedix’s products. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K, 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 such forward-looking statements speak only as of the date of this press release. 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.

Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576

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