1. DefenCath shows 72% reduction in CRBSI, 70% in hospitalizations. 2. Study involves over 3,000 patients monthly at US Renal Care facilities. 3. CORMedix aims for long-term reimbursement with Medicare Advantage. 4. Data could offer significant cost savings for healthcare payors. 5. CEO highlights importance in discussions with customers and payers.
FAQ
Why Very Bullish?
The strong efficacy data for DefenCath could drive demand and reimbursement opportunities, similar to historical performance of breakthroughs in medical devices that reduced infection rates considerably.
How important is it?
The significant reduction in infection rates aligns with CRMD's strategic goals and could enhance financial stability via reimbursement.
Why Long Term?
While immediate results appear positive, broader adoption and reimbursement may take time; historically, it takes years for new therapies to penetrate these markets fully.
CorMedix Therapeutics Reports Encouraging Interim Results from DefenCath Real-World Evidence Study
Date: December 18, 2025 | Source: GlobeNewsWire
Overview of the Study
CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on life-threatening medical conditions, has announced promising interim results from its ongoing real-world evidence study of DefenCath. This study, conducted in collaboration with U.S. Renal Care (USRC), evaluates the effectiveness of DefenCath in adult hemodialysis patients who use central venous catheters.
The study was initiated upon the outpatient commercial launch of DefenCath in July 2024 and aims to assess catheter-related bloodstream infections (CRBSI) and subsequent hospitalizations over a two-year period. Notably, over 3,000 patients are currently using DefenCath each month at USRC facilities.
Significant Findings on Infection Prevention
As of September 30, 2025, CorMedix’s preliminary analysis of approximately 7,000 patients shows a remarkable 72% reduction in CRBSI incidents and a 70% decrease in hospitalizations related to these infections compared to historical data. These reductions stand to benefit patients significantly, especially within the vulnerable dialysis population.
- Reduction in CRBSI: 72%
- Reduction in Related Hospitalizations: 70%
- Annual Cost of CRBSI for CMS: Over $3 billion
- Average Cost per CRBSI-related Hospitalization: Approximately $63,000
- Maximum Cost considering complications: Up to $110,000
Implications for Healthcare Costs
The findings from this study imply substantial cost savings for healthcare payors and the broader community. These striking results could lead to a significant reduction in healthcare expenses linked to CRBSI in end-stage renal disease (ESRD) patients, thereby supporting healthcare systems financially.
Statements from Leadership
Joseph Todisco, CEO of CorMedix, emphasized, “We are proud to share these interim results and appreciate the collaborative efforts of USRC in ensuring patient access to DefenCath. We are leveraging this data in negotiations with payors to enhance access and establish long-term reimbursement with Medicare Advantage.”
Geoffrey A. Block, MD, associated with USRC, highlighted a commitment to innovative therapies, stating, “We are encouraged by the reduction in serious infections and hospitalizations demonstrated in these preliminary results.”
Paul T. Conway of the American Association of Kidney Patients (AAKP) pointed out the critical need to reduce risks for hemodialysis patients: “This new information about DefenCath is vital for protecting highly vulnerable dialysis patients from infections.”
Future Studies and Data Collection
In addition to CRBSI rates, the study will also assess secondary data points including missed treatment sessions, antibiotic usage, and tPA utilization, with further updates anticipated as the research progresses. CorMedix’s preliminary findings from this comprehensive study are expected to reinforce positive outcomes from the LOCK-IT 100 clinical study, which formed the basis for the FDA approval of DefenCath used for ESRD patients.
About CorMedix Therapeutics
CorMedix Therapeutics is dedicated to developing and commercializing therapeutic solutions for severe health conditions. The company is actively marketing DefenCath (taurolidine and heparin) to prevent CRBSI in hemodialysis patients. Following the acquisition of Melinta Therapeutics in August 2025, CorMedix is also expanding its portfolio with various anti-infective medications.
Forward-Looking Statements
This announcement contains forward-looking statements that involve risks and uncertainties. CorMedix suggests that actual results may materially differ from projections due to various factors. Investors are advised to consider the potential discrepancies as outlined in the company’s filings with the SEC.