DefenCath® (taurolidine and heparin) catheter lock solution 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.

CORMEDIX INC. ANNOUNCES PARTNERSHIP WITH THE LEAPFROG GROUP

December 4, 2023

– CorMedix to advocate for patient safety and infection prevention as part of
Leapfrog’s Partners Advisory Committee

Berkeley Heights, NJ – December 4, 2023 – CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced an agreement with The Leapfrog Group, an independent national watchdog organization of employers and other purchasers focused on health care safety, whereby CorMedix Inc. will become a member of the Leapfrog Partners Advisory Committee.  

The Partners Advisory Committee is a platform for the creation, implementation and evaluation of initiatives that advance the Leapfrog and organizations’ alike mission for patient safety and promote a shared accountability for patient safety and well-being. As a Leapfrog partner, CorMedix will advise the Leapfrog board and management on industry and policy trends and help shape the organization’s long-term strategic vision.  

“An alliance between The Leapfrog Group and CorMedix brings together two organizations both focused on a common goal: improving patient safety and quality of care across the U.S. healthcare system,” said Joseph Todisco, Chief Executive Officer, CorMedix. “CorMedix is dedicated to developing solutions that reduce the risk of healthcare associated infections, in particular catheter-related bloodstream infections (CRBSIs). About 250,000 CRBSIs occur annually among U.S. patients with an intravascular device, and one in four patients who acquire these infections die. It is important we all come together and advocate for patients who suffer from these preventable infections, in addition to managing their already challenging health conditions.”  

“We are proud to join with CorMedix to improve patient safety in the United States. We need their insights and expertise more than ever. Every American deserves the highest quality health care, and together with CorMedix we can achieve our shared vision for excellence,” said Leah Binder, Leapfrog president and CEO.  

In November, CorMedix announced that the U.S. Food and Drug Administration (FDA) approved DefenCath® (taurolidine and heparin) catheter lock solution (CLS) to reduce the incidence of CRBSIs for the limited population of adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter. DefenCath is the first and only FDA-approved antimicrobial CLS in the U.S. and was shown to reduce the risk of catheter related bloodstream infections (CRBSIs) by up to 71% in a Phase 3 clinical study. 

Indication and Important Safety Information for DefenCath 

DefenCath was approved pursuant to the limited population for antibacterial and antifungal drugs (LPAD) pathway established by the 21st Century Cures Act to address unmet needs of patients with serious bacterial and fungal infections.  In addition, FDA designated DefenCath as a Qualified Infectious Disease Product (QIDP) established by the Generating Antibiotic Incentives Now (GAIN) Act that supports development of antibacterial and antifungal products that treat serious or life-threatening infections. FDA approved DefenCath to reduce the incidence of catheter-related bloodstream infections in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter.  It is indicated for use in a limited and specific population of patients. The safety and effectiveness of DefenCath have not been established for use in populations other than adult patients with kidney failure receiving chronic HD through a CVC.  

DefenCath contains taurolidine, a thiadiazinane antimicrobial and heparin, an anticoagulant, which can induce thrombocytopenia or HIT, and is contraindicated and should not be used in patients with known HIT or hypersensitivity to taurolidine, heparin or citrate.  It is not intended for systemic administration. DefenCath must be aspirated from the catheter and discarded prior to the initiation of the next hemodialysis session. 

The mean age of patients in LOCK-IT-100 was 61 years, 58% of patients identified as male, 42% identified as female, 63% as white and 30% as black or African-American.  Patients with diabetes at baseline accounted for 70% of patients and the mean body mass index was 30.  The majority of patients had been receiving hemodialysis for 12 months or fewer.  The location of the CVC was the jugular vein in 92% of patients. 

The most frequently reported adverse reactions occurring in ≥ 2% of patients in LOCK-IT-100 using DefenCath as a catheter lock solution were hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia.  Adverse reactions leading to death occurred in 5% (18/398) of patients in the DefenCath arm and 5% (21/399) in the heparin arm.  Adverse reactions leading to discontinuation of study drug occurred in 17% (69/398) in the DefenCath arm and 18% (72/399) in the heparin arm.  

The safety and effectiveness of DefenCath have not been established for use in populations other than adult patients with kidney failure receiving chronic hemodialysis through a CVC.  DefenCath is not intended for systemic administration and therefore maternal use is not expected to result in fetal exposure to the drug and breast feeding is not expected to result in exposure of the infant.  No animal reproduction study was conducted with DefenCath.  The safety and effectiveness of DefenCath have not been established in pediatric patients.  No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients. 

See full prescribing information for additional details on safety and risks associated with DefenCath. 

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 developing its lead product DefenCath®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the original New Drug Application (NDA) received priority review in recognition of its potential to address an unmet medical need. DefenCath was approved by the FDA on November 15, 2023 and the Company has indicated an estimated initial launch in 1Q 2024. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations, and the Company is working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers.  For more information visit: www.cormedix.com. 

About The Leapfrog Group 

Founded in 2000 by large employers and other purchasers, The Leapfrog Group is a national nonprofit organization driving a movement for giant leaps for patient safety. The flagship Leapfrog Hospital Survey and new Leapfrog Ambulatory Surgery Center (ASC) Survey collect and transparently report hospital and ASC performance, empowering purchasers to find the highest-value care and giving consumers the lifesaving information, they need to make informed decisions. The Leapfrog Hospital Safety Grade, Leapfrog’s other main initiative, assigns letter grades to hospitals based on their record of patient safety, helping consumers protect themselves and their families from errors, injuries, accidents, and infections.  

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. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, including, but not limited to, CorMedix’s future financial position, financing plans, future revenues, projected costs and the sufficiency of our cash and short-term investments to fund our operations 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, including:  the risks and uncertainties related to market conditions; CorMedix’s ability to manage its cash resources and the impact on current, planned or future research; and the ability to achieve commercial launch in Q1 2024. These and other risks are described in greater detail in CorMedix’s filings with the SEC, 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 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
daniel@lifesciadvisors.com 
(617) 430-7576  

Media Contact:
Christopher Hippolyte
Syneos Health Communications
(646) 822-6070
Christopher.hippolyte@syneoshealth.com