Full Press Release Details
INC. announces commercial AND REiMBURSEMENT updates
NJ - January 30, 2024 - 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 updates related to
its business and anticipated launch of DefenCath .
Joseph Todisco, CorMedix
CEO, commented, "This determination by CMS is in line with our base case expectations, and we are very pleased to have a timely
decision from the agency that allows CorMedix to commence commercialization of DefenCath based on the timelines we have communicated.
We have received significant inbound interest from both inpatient facilities as well as outpatient dialysis providers as to the utilization
of DefenCath, and this reimbursement clarity allows us to move forward with negotiating direct procurement agreements for the product.
I look forward to providing additional commercial updates in the upcoming months as CorMedix brings this important novel drug product
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 , a novel, non-antibiotic antimicrobial solution
approved to reduce the incidence of catheter-related bloodstream infections in the limited population of adult patients with kidney failure
receiving chronic hemodialysis through a central venous catheter. 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 initial inpatient
launch date of April 15, 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.
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, the commercial launch of DefenCath, including the timing of availability of DefenCath for inpatient and
outpatient settings and the ability to staff a field team in time for commercial launch, DefenCath eligibility for TDAPA, CMS implementation
of TDAPA on July 1st, the interest in DefenCath by health systems, 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, including the commercial
launch of DefenCath, 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 the ability to
have sufficient DefenCath available for commercial launch, CorMedix's ability to contract with health systems for the use of DefenCath,
market conditions, CorMedix's ability to manage its cash resources and the impact on current, planned or future research. 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.