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CorMedix Inc. Announces Commercial Agreement With Top Tier Dialysis Provider

Key Takeaway: CorMedix Inc. has announced a significant commercial supply contract with a leading midsized dialysis provider for its product DefenCath, aimed at reducing catheter-related bloodstream infections. Following FDA approval granted on November 15, 2023, CorMedix has already begun the commercialization of DefenCath in inpatient settings as of April 2024 and expects to launch in outpatient clinics in July 2024. This agreement will enhance patient access in over 500 national dialysis facilities, aligning with the company's commitment to infection reduction.

Market Sentiment Analysis

POSITIVE FACTORS

  • CorMedix has secured a multi-year commercial supply contract with a top tier dialysis provider.
  • DefenCath is set to be available in over 500 dialysis facilities nationwide, expanding access for patients.
  • Commercialization in outpatient clinics is expected to begin in July 2024, further increasing patient access.

Full Press Release Details

BERKELEY HEIGHTS, N.J., May 28, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing therapeutic products for life-threatening diseases and conditions, today announced that it has entered into a multi-year commercial supply contract with a top tier midsized dialysis provider for the supply of DefenCath® (taurolidine and heparin).
CorMedix received NDA approval of DefenCath® under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) on November 15, 2023, and began commercialization of the product in the inpatient setting on April 15th. The Company expects to begin commercialization in outpatient dialysis clinics in July. CorMedix is committed to building meaningful long-term relationships with dialysis providers that are dedicated to innovation and infection reduction. This agreement will allow for patients to have access to DefenCath at more than 500 dialysis facilities located nationally.
“I am pleased with the progress we are making in our discussions with outpatient dialysis providers, and solidifying this agreement ensures that potentially thousands of patients at risk for a catheter related bloodstream infection will have access to DefenCath,” says CorMedix CEO, Joseph Todisco. “Utimately our goal is to ensure the broadest access possible to this important infection reduction mechanism.”
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath®, which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and anticipates launch in outpatient settings in July 2024. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. For more information visit: www.cormedix.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 of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, 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. 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 Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, 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.

Frequently Asked Questions

What is DefenCath® used for?

DefenCath® is used for infection reduction in patients at risk of catheter-related bloodstream infections.

When was DefenCath® approved by the FDA?

DefenCath® received FDA approval on November 15, 2023, under the Limited Population Pathway.

When will DefenCath® be available in outpatient clinics?

DefenCath® is expected to launch in outpatient dialysis clinics in July 2024.

How many dialysis facilities will have DefenCath®?

DefenCath® will be accessible at over 500 dialysis facilities nationwide.

What is CorMedix's focus as a biopharmaceutical company?

CorMedix focuses on developing therapeutic products for life-threatening conditions and diseases.

Last updated: May 28, 2024