BERKELEY HEIGHTS, N.J. - CorMedix Inc. (NASDAQ:CRMD), a biopharmaceutical company, announced today that its product DefenCath has been approved for additional payment reimbursement under the Transitional Drug Add-On Payment (TDAPA) program by the Center for Medicare & Medicaid Services (CMS). This decision, effective July 1, 2024, is significant for the upcoming outpatient launch of DefenCath, designed to reduce infections in dialysis patients.
DefenCath (taurolidine and heparin) catheter lock solution has been approved by the U.S. Food and Drug Administration (FDA) to decrease the incidence of catheter-related bloodstream infections in adults with kidney failure who are on chronic hemodialysis via a central venous catheter.
The TDAPA status will provide five years of additional payment to outpatient providers beyond the End-Stage Renal Disease (ESRD) bundled rate. Joseph Todisco, CEO of CorMedix, expressed that the CMS's timely action on their application is a crucial step towards making this preventative drug available for patients in the outpatient dialysis setting.
CorMedix anticipates that DefenCath will be commercially available in outpatient settings starting in July 2024, following its initial launch in inpatient settings this month. The company also plans to explore the use of DefenCath in other patient populations.
DefenCath is indicated for a specific group of patients and carries contraindications and warnings, including for those with known heparin-induced thrombocytopenia or hypersensitivity to the drug's components. Adverse reactions or safety concerns can be reported to CorMedix or the FDA.
The company, which specializes in the development and commercialization of therapeutic products for the prevention and treatment of life-threatening conditions, views the CMS's determination as an essential development in their commercial strategy.
This information is based on a press release statement from CorMedix Inc. Investors are advised that forward-looking statements involve risks and uncertainties and are encouraged to consult the company's SEC filings for further details.
InvestingPro Insights
As CorMedix Inc. (NASDAQ:CRMD) gears up for the outpatient launch of its DefenCath product, investors may be considering the financial health and market performance of the company. Based on real-time data from InvestingPro, CorMedix holds a market capitalization of $298 million. Despite a challenging profitability outlook, with analysts not expecting the company to be profitable this year, the stock has experienced a strong return over the last month, surging by 41.51%. This momentum extends over the last three months, with a price total return of 66.26%.
InvestingPro Tips for CRMD reveal a mixed financial position. On the positive side, the company maintains more cash than debt on its balance sheet, and its liquid assets exceed short-term obligations, suggesting a degree of financial resilience. However, CorMedix suffers from weak gross profit margins and has not been profitable over the last twelve months. Additionally, the stock price movements are notably volatile, which could be a point of consideration for risk-averse investors.
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