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8-K - CURRENT REPORT - CorMedix Inc. | crmd_8k.htm |
Exhibit 99.1
CORMEDIX INC. ANNOUNCES RESIGNATION OF MEMBER OF ITS BOARD OF
DIRECTORS
Berkeley Heights, NJ – January 16, 2019 – CorMedix Inc. (NYSE American:
CRMD), a biopharmaceutical company focused on developing and
commercializing therapeutic products for the prevention
and treatment of infectious and
inflammatory disease, today announced that Gary A. Gelbfish, MD
FACS has resigned his position as a member of the Board of
Directors, effective January 14, 2019. Dr. Gelbfish’s most
recent tenure on the board began in August 2017. He previously served on
CorMedix’s Board from December 2009 to June 2014, including a
term as Board Chairman from 2012 to June 2014.
Khoso
Baluch, CorMedix Chief Executive Officer and a member of the Board
stated, “We thank Gary for his service and guidance during
the LOCK-IT-100 study. He provided significant insight that
contributed to its successful completion. His expertise as a
practicing vascular surgeon has been invaluable as CorMedix focuses
its efforts on advancing its lead product Neutrolin® for the
prevention of catheter-related bloodstream infections in
hemodialysis patients. We respect Gary’s desire to focus now
on his other professional duties.”
Dr. Gelbfish commented, “I am grateful for the opportunity to
have played pivotal roles in CorMedix’s history as a member
of the Board and more recently with the data collection and interim
analysis efforts. Based on the highly significant results of the
interim analysis and the recommendations of the DSMB to terminate
the trial early, because efficacy had been demonstrated, I am
confident that after completing all of the regulatory requirements,
Neutrolin will enter clinical use. Ultimately, it will be of
significant public health benefit to greatly decrease rates of
catheter infections. As a vascular surgeon who treats many catheter
patients, it has been an honor to contribute to the advancement of
medicine and to develop new therapeutic and preventative
methods.”
The
Company has identified and is pursuing a number of qualified Board
candidates with recognized applicable expertise in drug development and FDA interaction who have
indicated they would be disposed to accept an invitation to join
the CorMedix Board, with the goal of bringing this process
to a successful conclusion in the near future.
About CorMedix
CorMedix Inc. is a biopharmaceutical company focused on developing
and commercializing therapeutic products for the prevention and
treatment of infectious and inflammatory diseases. The Company is
focused on developing its lead product Neutrolin®,
a novel, non-antibiotic antimicrobial solution designed to prevent
costly and dangerous bloodstream infections associated with the use
of central venous catheters, currently in Phase 3 development for
patients undergoing chronic hemodialysis. Such infections cost the
U.S. healthcare system approximately $6 billion annually and
contribute significantly to increased morbidity and mortality.
Neutrolin has FDA Fast Track status and is designated as a
Qualified Infectious Disease Product, which provides the potential
for priority review of a marketing application by FDA and
allows for 5 additional years of QIDP market exclusivity in the
event of U.S. approval. Neutrolin is already marketed as a CE
Marked product in Europe and other territories. In parallel,
CorMedix is leveraging its taurolidine technology to develop a
pipeline of antimicrobial medical devices, with active programs in
surgical sutures and meshes, and topical hydrogels. The
company is also 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
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,
future financial position, financing plans, future revenues and
projected costs 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 ability to identify and attract qualified directors;
the resources needed to terminate the Phase 3 trial and the costs
and time needed to submit a new drug application to the FDA; risks
related to obtaining FDA approval of the new drug application for
Neutrolin; the risks and uncertainties associated with
CorMedix’s ability to manage its limited cash resources and
the impact on current, planned or future research, including the
continued development of Neutrolin and research for additional uses
for taurolidine; obtaining additional financing to support
CorMedix’s research and development and clinical activities
and operations; relying on preclinical results that may not be
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.
Investor Contact:
Dan
Ferry
Managing
Director
LifeSci
Advisors
617-535-7746