CorMedix Inc. Announces CMS Grants TDAPA to DefenCath

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CorMedix Inc. announced that CMS granted TDAPA to DefenCath, a critical step for the company's outpatient launch in July 2024. DefenCath is approved by the FDA to reduce CRBSIs in adult patients with kidney failure.

Healthcare Financial Analyst

The CMS's decision to grant DefenCath Transitional Drug Add-On Payment (TDAPA) status is a positive development for CorMedix, as it facilitates additional reimbursement for their product. This can significantly boost CorMedix's revenue potential, particularly considering that dialysis is an ongoing treatment and DefenCath is designed for patients in a chronic setting. For investors, this implies a potentially enhanced revenue stream starting July. Revenue implications should become clearer after the outpatient launch, with the first real test being the Q3 financial results. Typically, products with TDAPA status see improved adoption rates within their functional category due to the removal of cost barriers for providers.

Pharmaceutical Market Analyst

TDAPA status not only augments financial incentives for providers but also serves as an indirect marketing tool, signaling CMS's recognition of the product's clinical benefits and innovation. The preventable nature of catheter-related bloodstream infections (CRBSIs) positions DefenCath as a preemptive healthcare measure, which could lead to wide acceptance in the outpatient dialysis market. Investors should monitor peer adoption and physician endorsements post-launch, as these will be indicative of the product's long-term market footprint. Furthermore, considering the dialysis market is a specialized niche with a high cost burden, DefenCath's uptake could alleviate some of the financial strains on the healthcare system, potentially leading to policy-driven demand acceleration.

Health Policy Expert

For those looking to gauge the future policy landscape, the CMS's rapid action on CorMedix's application reflects a possible shift towards supporting innovative treatments in the dialysis space. This could be a harbinger for policy trends favoring more proactive treatments in other chronic disease areas. From an investor perspective, understanding these shifts is key, as they signal potential areas of growth and can inform strategic investment decisions. Products that align with policy goals are likely to receive favorable coverage decisions in the future, creating a more predictable operating environment for companies like CorMedix.

BERKELEY HEIGHTS, N.J., April 19, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced that the Center for Medicare & Medicaid Services (CMS) has determined that DefenCath^® meets the criteria for a Transitional Drug Add-On Payment (TDAPA) in the anti-infective functional category, beginning on July 1, 2024. The TDAPA program currently provides for five years of additional payment reimbursement beyond the ESRD bundled rate to outpatient providers, and aligns with CorMedix’s upcoming outpatient launch in July.

Joseph Todisco, Chief Executive Officer of CorMedix commented, “CMS determination of TDAPA eligibility for DefenCath is a critical step toward ensuring this innovative preventative drug product is available for patients in the outpatient dialysis setting. We are pleased that CMS was able to take timely action on our application for a July 1st effective date, and we intend to work closely with outpatient dialysis providers to ensure proper TDAPA implementation.”

DefenCath (taurolidine and heparin) catheter lock solution (CLS) is approved by the U.S. Food and Drug Administration (FDA) to reduce the incidence of catheter-related bloodstream infections (CRBSIs) in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (HD-CVC). To learn more about DefenCath, visit DefenCath.com.

DefenCath^® (taurolidine and heparin)
IMPORTANT SAFETY INFORMATION

These highlights do not include all the information needed to use DefenCath safely and effectively. See full prescribing information for DefenCath.

LIMITED POPULATION: DefenCath is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients.

DefenCath is contraindicated and has warnings and precautions in patients with:

• Known heparin-induced thrombocytopenia (HIT).
• Known hypersensitivity to any drug products in DefenCath, including taurolidine, heparin or the citrate excipient or pork products.

If exposure to either of the above occurs, discontinue use of DefenCath and institute appropriate supportive measures.

To report any safety concerns including suspected adverse reactions, contact CorMedix Inc. at 1-888-424-6345 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please see the full Prescribing Information.

About CorMedix

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 and launched in inpatient settings in April 2024. CorMedix anticipates the commercial launch of DefenCath 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.

Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
(617) 430-7576

FAQ

What did CorMedix announce regarding DefenCath?

CorMedix announced that CMS granted TDAPA to DefenCath in the anti-infective functional category, starting on July 1, 2024.

What is the significance of the TDAPA program for CorMedix?

The TDAPA program provides five years of additional payment reimbursement beyond the ESRD bundled rate to outpatient providers, aligning with CorMedix's upcoming outpatient launch in July.

What is DefenCath approved for by the FDA?

DefenCath is approved by the FDA to reduce the incidence of CRBSIs in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter.

Who is the Chief Executive Officer of CorMedix?

Joseph Todisco is the Chief Executive Officer of CorMedix.