Cormedix Inc. Announces Strategic Initiative With Boston Medical Center to Reduce Health Disparities in Patients at Risk for Bloodstream Infections
2023年6月15日 - 9:30PM
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 its first-of-kind strategic initiative
with Boston Medical Center to enhance patient safety and reduce
health disparities in structurally marginalized populations at risk
for bloodstream infections while undergoing dialysis.
It is estimated that 25 – 33% of chronic hemodialysis patients
with catheters will experience Catheter Related Bloodstream
Infections (CRBSIs) and are three times more likely to experience
serious complications, including high mortality rates, within the
first few months of dialysis due to CRBSIs. CRBSIs
disproportionately impact minority and low-income patient
populations on dialysis, who may experience a higher rate of
central venous catheter (CVC) use, resulting in higher medical
costs, prolonged hospital stays, increased antimicrobial resistance
and higher mortality. This real-world data initiative will evaluate
the use of a novel antimicrobial catheter lock solution to reduce
the incidence of CRBSIs in patients receiving dialysis through a
CVC. The goal of this initiative is to increase healthy outcomes
for patients disproportionately impacted by CRBSIs.
CorMedix and Boston Medical Center will assess the incidence and
scope of CRBSIs, care inequities in patients experiencing CRBSIs,
total potential costs of treatment, and CRBSI-related readmissions.
This assessment will form the baseline from which CorMedix and
Boston Medical Center will evaluate the impact that infection
prevention can have on reducing the health disparities that
structurally marginalized patient populations often face.
Boston Medical Center, the largest essential hospital in New
England, provides world-class care to all, with an emphasis on
clinical excellence and health equity. With one million patient
visits annually and unique community partnerships designed to
empower patients and help communities thrive, Boston Medical Center
is committed to improving the health of communities.
“For dialysis patients, the consequences of acquiring a
bloodstream infection – in terms of prolonged days in the hospital,
lives lost and the financial strain that the long-term sequelae of
infection places on the continuum of care – are already well
documented,” said Joseph Todisco, chief executive officer of
CorMedix. “We are setting out to prove in a real-world setting that
we can also prevent them from happening in the first place with
DefenCath™.”
“High-quality, equitable, cutting-edge care is central to the
mission of Boston Medical Center,” said Dr. Megan Bair-Merritt,
chief scientific officer at Boston Medical Center. “We are excited
by the opportunity to work closely with CorMedix and our community
dialysis partners to explore new technologies to prevent
infections, which are a big threat to communities of color that are
undergoing dialysis.”
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. QIDP provides for an additional five years of
marketing exclusivity, which will be added to the five years
granted to a New Chemical Entity upon approval of the NDA. CorMedix
also committed to conducting a clinical study in pediatric patients
using a central venous catheter for hemodialysis when the NDA is
approved, which will add an additional six months of marketing
exclusivity when the study is completed. The Company received a
second Complete Response Letter from the FDA last August related to
deficiencies at both its primary contract manufacturer and its
supplier of heparin API. After receiving guidance from FDA at a
Type A meeting in April of 2023, the NDA for DefenCath was
resubmitted. 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, statements regarding the ability of
the Company’s DefenCath NDA resubmission to be classified as Class
2 and the timing of review, 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. Readers are
cautioned that actual results may differ materially from
projections or estimates due to a variety of important factors,
including: the resources needed to secure approval of the NDA for
DefenCath from the FDA; the risks and uncertainties of the
relationships with the additional CMO and supplier of heparin; the
ability to submit a supplement to CorMedix’s NDA; the ability to
secure final FDA approval prior to July 1, 2024; the risks and
uncertainties associated with CorMedix’s ability to manage its
limited cash resources and the impact on current, planned or future
research; obtaining additional financing to support CorMedix’s
research and development and clinical activities and operations;
preclinical results are not indicative of success in clinical
trials and might not be replicated in any subsequent studies or
trials; and the ability to retain and hire necessary personnel to
staff our operations appropriately. 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.
CorMedix Investor Contact:Dan FerryManaging
DirectorLifeSci Advisors(617) 430-7576
CorMedix Media Contact:Christopher
HippolyteSyneos Health(646) 822-6070
Boston Medical Center Contact:Dave KibbeBoston
Medical CenterContact info (617) 638-8499
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