CorMedix Inc. Expands Access to DefenCath Through New Agreement

CorMedix Inc. Enters New Commercial Partnership

CorMedix Inc. (NASDAQ: CRMD), a dedicated biopharmaceutical firm specializing in the development of therapeutic products for severe conditions, has announced a remarkable advance in its mission. The company recently formed a multi-year commercial supply agreement with a significant global healthcare provider to distribute its product, DefenCath (taurolidine and heparin), across various medical facilities in the U.S.

Targeting Healthcare Excellence

The newly established agreement marks a strategic step for CorMedix as the healthcare provider involved administers services to over 2,000 clinics nationwide. The company aims to prioritize the use of DefenCath for approximately 4,000 patients whose clinical needs rank highest. This focus illustrates CorMedix's commitment to addressing urgent medical needs through accessible and effective treatment options.

Regulatory Milestones Achieved

DefenCath has been making significant strides since receiving NDA approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) on November 15, 2023. Its commercialization commenced successfully within inpatient settings on April 15, 2024. Moreover, on July 1, 2024, outpatient reimbursement for DefenCath was activated by the Center for Medicare & Medicaid Services (CMS), which enabled CorMedix to begin fulfilling orders by mid-July. Shipments stemming from this latest agreement are anticipated to commence in the fourth quarter of the year, which is a promising sign for both patients and healthcare providers alike.

CEO Insights and Future Vision

Joseph Todisco, the CEO of CorMedix, shared his enthusiasm: "I am very excited that this agreement with one of the premier healthcare services providers in the U.S. will provide access to DefenCath for thousands of adult patients at risk for catheter-related bloodstream infections. It builds upon the progress we have made with smaller customers over the last few months." This remark not only highlights the importance of the partnership but also reinforces the company’s dedication to improving patient outcomes.

Understanding DefenCath and Its Importance

DefenCath, a vital player in the fight against catheter-related bloodstream infections (CRBSI) among patients undergoing chronic hemodialysis, is recommended specifically for adults who require treatment through a central venous catheter (CVC). Its targeted application makes it essential for both the healthcare system and patient care strategies.

Safety Considerations

It is crucial for potential users to note that DefenCath is contraindicated for individuals with known heparin-induced thrombocytopenia (HIT) or hypersensitivity to any of the product's ingredients, including taurolidine and heparin. In instances of adverse reactions, immediate cessation of the medication and appropriate supportive measures should be taken. For any safety concerns regarding DefenCath, stakeholders can communicate with CorMedix directly at 1-888-424-6345 or file reports to the FDA at 1-800-FDA-1088.

About CorMedix Inc.

CorMedix Inc. is on the forefront of biopharmaceutical innovation, focusing on the development and commercialization of therapeutic solutions aimed at preventing and treating critical health conditions. Following the FDA's approval of DefenCath on November 15, 2023, the company expanded its focus to outpatient settings by starting commercial activities on July 1. Notably, CorMedix is also exploring further development of DefenCath as a catheter lock solution for additional patient demographics, showcasing the company’s commitment to broadening access to essential medical treatments.

Frequently Asked Questions

What is DefenCath?

DefenCath is a therapeutic product designed to reduce catheter-related bloodstream infections in patients undergoing hemodialysis.

What recent agreement did CorMedix announce?

CorMedix announced a multi-year commercial supply contract for DefenCath with a global healthcare provider.

When did CorMedix receive FDA approval for DefenCath?

CorMedix received NDA approval for DefenCath on November 15, 2023.

What are the key safety concerns with DefenCath?

DefenCath is contraindicated for patients with heparin-induced thrombocytopenia or known hypersensitivity to its components.

How can I contact CorMedix for safety concerns?

For safety concerns, you can reach CorMedix at 1-888-424-6345 or report to the FDA at 1-800-FDA-1088.

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