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The number of outstanding shares of the registrant s common stock was 79,050,395 as of March 2, 2026.
Our primary focus has been commercializing DefenCath (taurolidine and heparin), in the U.S., which we launched in 2024 in the hemodialysis setting.
The Melinta Portfolio supports a multi-channel strategy of delivering anti-infectives for serious gram-positive, gram-negative and fungal infections within hospitals and the hospital ecosystem, including emergency departments, outpatient clinics and home infusion care, and provides synergy opportunities to drive growth for DefenCath.
Business Strategy Our corporate strategy is focused on increasing stockholder value by maximizing the value of our current portfolio, with promotional efforts focused on DefenCath, REZZAYO, MINOCIN IV and VABOMERE.
In addition, we seek to create additional value through the pursuit of expanded indications for both DefenCath, for the reduction of central line associated bloodstream infection ( CLABSI ) in adult patients receiving total parental nutrition ( TPN ), and REZZAYO in the prophylaxis of invasive fungal infections in adult patients that are immune compromised.
We also engage in the pursuit of business development opportunities that could be highly synergistic with our existing or future sales infrastructure deployment.
Promoted Commercial Products DefenCath On November 15, 2023, we announced that the FDA approved the new drug application ( NDA ) for DefenCath, an antimicrobial catheter lock solution ( CLS ) (a formulation of taurolidine 13.5 mg/mL, and heparin 1000 USP Units/mL) indicated to reduce the incidence of catheter-related bloodstream infections ( CRBSI ) in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter ( CVC ).
We launched DefenCath commercially in April 2024 in the inpatient setting and July 2024 in the outpatient hemodialysis setting, and it is the largest contributor to our net sales.
1 Bloodstream infections resulting from the use of central venous catheters known as CLABSIs and a subset of them, referred to as CRBSIs, can result in significant morbidity and increased rates of hospital admissions, readmissions, and mortality.
is up to $2.3 billion, with approximately 80,000 CRBSI episodes and up to 28,000 deaths per year (Pronovost et al., The New England Journal of Medicine , 2006).
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The number of outstanding shares of the registrant s common stock was 65,181,771 as of March 23, 2025.
Our primary focus is commercializing our lead product, DefenCath (taurolidine and heparin), in the U.S.
CorMedix launched the product commercially in April 2024 in the inpatient setting and July 2024 in the outpatient hemodialysis setting.
DefenCath is an FDA approved antimicrobial catheter lock solution ( CLS ) (a formulation of taurolidine 13.5 mg/mL, and heparin 1000 USP Units/mL) indicated to reduce the incidence of catheter-related bloodstream infections ( CRBSI ) in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter ( CVC ).
It is indicated for use in a limited and specific population of patients.
CRBSIs, a clinically confirmed subset of the epidemiological surveillance term, central line associated bloodstream infection ( CLABSI ), can lead to treatment delays and increased costs to the healthcare system when they occur due to extended and often repeat hospitalizations, need for IV antibiotic treatment, long-term anticoagulation therapy, removal/replacement of the CVC, related treatment costs, as well as increased mortality.
We believe DefenCath can address a significant unmet medical need.
Following the submission of a duplicate New Technology Add-On Payment ( NTAP ) application to Centers for Medicare and Medicaid Services ( CMS ), CMS issued the Inpatient Prospective Payment System ( IPPS ) 2024 proposed rule that includes a NTAP per hospital stay for DefenCath.
This NTAP represents reimbursement to inpatient facilities of 75% of the wholesaler acquisition cost ( WAC ) price per 3 mL vial, and an average utilization of 19.5 vials per hospital stay.
The final IPPS rule amended as of October 1, 2024 to reflect the current WAC of $249.99 per 3ml vial resulting in a potential maximum NTAP of $3,656.10.