CorMedix Announces Interim Results For Ongoing Real-World Evidence Study Being Conducted In Conjunction With USRC's Use Of DefenCath In Adult Hemodialysis Patients With Central Venous Catheters

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.

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.