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

Rhea-AI Summary

CorMedix (Nasdaq: CRMD) reported interim results from its ongoing real‑world evidence study of DefenCath in adult hemodialysis patients with central venous catheters, conducted with U.S. Renal Care. Based on data through Sept 30, 2025 for ~7,000 patients in Year 1, DefenCath use showed a 72% reduction in catheter‑related bloodstream infections (CRBSI) and a 70% reduction in hospitalizations secondary to CRBSI versus historical controls. More than 3,000 patients per month are receiving DefenCath at USRC facilities. The company highlighted potential healthcare cost reductions given CMS estimates of >$3B annual CRBSI costs in ESRD and average CRBSI hospitalization costs of ~$63,000.

Positive

• 72% reduction in CRBSI versus historical controls
• 70% reduction in hospitalizations secondary to CRBSI
• Preliminary dataset covers ~7,000 patients in Year 1
• Routine use in >3,000 patients per month at USRC

Negative

• Interim results compared to historical controls, not randomized
• Study is ongoing (2‑year); results remain preliminary
• No quantified cost savings or formal payer decisions reported

Key Figures

CRBSI reduction 72% reduction DefenCath real-world evidence study vs historical controls through Sept 30, 2025

Hospitalization reduction 70% reduction Hospitalizations secondary to CRBSI in DefenCath real-world study

Monthly DefenCath patients More than 3,000 patients per month Adult hemodialysis patients at U.S. Renal Care facilities

Interim study population Approximately 7,000 patients Received at least one dose of DefenCath in Year 1 analysis

Study duration 2 years Planned evaluation period for real-world DefenCath outcomes

CRBSI-related CMS spend More than $3 billion per year Estimated CMS costs for CRBSI in ESRD population

Avg CRBSI hospitalization cost Approximately $63,000 per incident Estimated average cost per CRBSI-related hospitalization

High-end CRBSI cost Up to $110,000 per incident CRBSI hospitalization cost including other sequelae

Market Reality Check

$12.02 Last Close

Volume Volume 2,270,278 is below the 20-day average of 2,777,713 (relative volume 0.82). normal

Technical Price $11.45 is trading slightly above the $11.19 200-day moving average.

Peers on Argus

Peers show mixed moves (e.g., ABUS +0.43%, QURE +0.70%, MRVI -3.62%, UPB -3.67%), indicating stock-specific drivers for CRMD.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 12	Peer financial update	Neutral	+2.1%	Talphera reported Q3 2025 results and private placement with CorMedix.
Nov 12	Earnings beat/guidance	Positive	+2.1%	Q3 2025 revenue, net income and raised FY 2025 guidance driven by DefenCath and Melinta.
Oct 31	Earnings call notice	Neutral	-4.2%	Announcement of upcoming Q3 results call and pipeline updates including ReSPECT and REZZAYO.
Oct 23	Product designation win	Positive	+1.0%	DefenCath received Vizient Innovative Technology designation supporting commercial positioning.
Oct 20	Preliminary earnings raise	Positive	+19.4%	Preliminary Q3 2025 results and higher 2025 pro forma revenue and EBITDA guidance.

Pattern Detected

Recent CRMD-specific news, especially financial beats and product milestones, often coincided with positive price reactions, while logistical announcements saw weaker or negative moves.

Recent Company History

Over the last few months, CorMedix has shifted from preliminary guidance raises to reporting profitable Q3 2025 results, with DefenCath and the Melinta acquisition driving strong revenue and EBITDA. Product momentum was reinforced by an Innovative Technology designation for DefenCath and growing anti-infective portfolio visibility. Today’s real-world DefenCath data extends this narrative by adding large-scale effectiveness evidence to prior clinical and commercial milestones.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-10-07

$140,000 registered capacity

An effective S-3ASR filed on 2025-10-07 registers up to 6,323,833 existing-holder shares for resale. The company will receive no proceeds, and disclosed $140,000 of related legal fees and expenses.

Market Pulse Summary

This announcement highlights interim real-world evidence showing DefenCath reduced CRBSI by 72% and related hospitalizations by 70% in thousands of hemodialysis patients, reinforcing earlier LOCK-IT 100 trial results and recent commercial momentum. Investors may track further study readouts, secondary endpoints like antibiotic and tPA use, and payer discussions, including Medicare Advantage, while also considering the existing S-3ASR resale registration and recent insider activity disclosed in Form 4 filings.

Key Terms

real-world evidence medical

"announced interim results for the Company’s ongoing real-world evidence study"

Real-world evidence is information gathered from everyday sources like patient records, insurance claims, or everyday experiences, rather than controlled experiments or clinical trials. It helps investors understand how products or policies perform in real life, providing a more complete picture of their effectiveness and value beyond official tests. This type of evidence can influence decision-making by offering insights based on actual, everyday outcomes.

hemodialysis medical

"use of DefenCath in adult hemodialysis patients with central venous catheters"

Hemodialysis is a medical treatment that cleans a person’s blood when their kidneys can no longer do the job, by routing blood through a machine that filters out waste, excess fluid and adjusts salt levels—think of it as an external, mechanical kidney. It matters to investors because it drives demand for specialized machines, replacement filters, clinics, trained staff and related drugs, and is sensitive to reimbursement rules, treatment volumes and advances that can change costs or market share.

central venous catheters medical

"adult hemodialysis patients with central venous catheters"

A central venous catheter is a thin, flexible tube placed into a large vein near the neck, chest or groin to deliver medicines, fluids, nutrition, or to draw blood — like a dedicated highway for critical treatments and tests. Investors care because these devices drive steady hospital and clinic purchases, are tied to reimbursement and regulatory scrutiny, and carry infection and complication risks that can affect sales, liability, and demand for safer, higher‑margin alternatives.

catheter-related bloodstream infections medical

"assess rates of catheter-related bloodstream infections (CRBSI), as well as hospitalizations"

Catheter-related bloodstream infections are infections that occur when germs enter the bloodstream through a tube (catheter) placed into a vein to deliver fluids or medicine, similar to bacteria traveling into a home through a broken water pipe. They matter to investors because they can drive higher healthcare costs, trigger regulatory action, legal liability, reduced use of certain devices, and damage hospital or device-maker reputations—factors that can affect revenues and stock value.

tPA medical

"Secondary data points of missed treatment sessions, antibiotic utilization, and tPA utilization"

tPA (tissue plasminogen activator) is a medicine that helps dissolve blood clots by activating the body’s clot-breaking system; think of it as a chemical drain opener for blocked blood vessels. Investors care because tPA-related drugs and devices face strict approval, safety and usage rules that can drive sales, influence legal risk, and change the outlook for companies developing stroke and cardiovascular treatments.

Medicare Advantage financial

"establish long-term reimbursement with Medicare Advantage"

Medicare Advantage is a type of health insurance plan offered by private companies that covers services traditionally provided by government-run Medicare. Think of it as a bundled package that combines hospital, doctor, and other medical care into one plan, often with added benefits. For investors, it matters because the popularity and profitability of these plans can influence healthcare companies and the broader health insurance industry.

end-stage renal disease medical

"DefenCath for ESRD hemodialysis patients was based"

End-stage renal disease is the most severe form of kidney failure, where the kidneys can no longer filter waste and excess fluids from the body effectively. This condition often requires patients to undergo lifelong treatments like dialysis or a kidney transplant to survive. It matters to investors because it can impact healthcare costs, insurance coverage, and the demand for medical treatments and devices related to kidney care.

FDA approval regulatory

"on which the FDA approval of DefenCath for ESRD hemodialysis patients was based"

FDA approval is the U.S. Food and Drug Administration’s formal authorization for a drug, vaccine, or medical device to be marketed and sold after reviewers determine it meets standards for safety and effectiveness. For investors it’s a pivotal milestone because it opens the door to legal, large-scale sales and can sharply boost revenue potential while reducing regulatory uncertainty—like receiving a safety certificate that lets a new bridge carry traffic and tolls.

AI-generated analysis. Not financial advice.

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

FAQ

What interim CRBSI reduction did CorMedix report for DefenCath (CRMD) on Dec 18, 2025?

CorMedix reported a 72% reduction in catheter‑related bloodstream infections versus historical controls through Sept 30, 2025.

How much did DefenCath reduce hospitalizations in the CRMedix (CRMD) real‑world study?

The interim analysis showed a 70% reduction in hospitalizations secondary to CRBSI versus historical controls.

How many patients were included in CorMedix's Year 1 DefenCath interim dataset?

Approximately 7,000 patients who received at least one dose in Year 1 were included in the preliminary analysis.

How widely is DefenCath being used at U.S. Renal Care in 2025?

The company reported more than 3,000 patients per month receiving DefenCath on a routine basis at USRC facilities.

Does the DefenCath interim study provide quantified cost savings for Medicare or CMS?

No quantified cost‑savings were reported; the company referenced CMS estimates of >$3B annual CRBSI costs in ESRD as context.

Are CorMedix's DefenCath results from a randomized controlled trial?

No; the interim real‑world analysis compared outcomes to historical controls and the study is ongoing.