CorMedix Inc. Announces U.S. Inpatient Commercial Availability of DefenCath® (Taurolidine and Heparin)
15 Abril 2024 - 7:30AM
CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused
on developing and commercializing therapeutic products for
life-threatening diseases and conditions, today announced
DefenCath® (taurolidine and heparin) catheter lock solution (CLS)
is now commercially available for U.S. inpatient use.
DefenCath (taurolidine and heparin) 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).
Joseph Todisco, Chief Executive Officer of
CorMedix commented, “Today opens a new chapter for healthcare
providers, offering them an opportunity to reduce the risk of
CRBSIs in a patient population already vulnerable due to underlying
kidney failure. We are proud to provide an option for adult
patients who face the risk of CRBSIs. We look forward to expanding
the availability of DefenCath to the outpatient setting later this
year.”
The commencement of U.S. outpatient
commercialization of DefenCath is planned for July 1, 2024.
Outpatient commercial availability is contingent upon the Center
for Medicare & Medicaid Services (CMS) approval and
implementation of the DefenCath Transitional Drug Add-On Payment
Adjustment (TDAPA) application in accordance with the agency’s
publicly stated objective that CMS aims for an effective date for
applying the TDAPA for a particular product that is one quarter
after the effective date of the HCPCS code for the product. The CMS
Final HCPCS coding decision for DefenCath was published by CMS on
April 2nd, establishing a new HCPCS Level II code for DefenCath,
and CorMedix continues to work closely with CMS on the TDAPA
implementation process.
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, pending a timely implementation of TDAPA.
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 FerryManaging
DirectorLifeSci Advisors(617) 430-7576
CorMedix (NASDAQ:CRMD)
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