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8-K - CURRENT REPORT - CorMedix Inc. | crmd_8k.htm |
Exhibit 99.1
CorMedix Inc. Appoints Gary Gelbfish, M.D., to Board of
Directors
Current Director Myron Kaplan Elected Chairman of the
Board
Bedminster, NJ – August 7, 2017 – 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 Gelbfish, M.D., has been appointed
unanimously to the company’s Board of Directors. Dr. Gelbfish
returns to CorMedix’s Board after previously serving from
December 2009 until June 2014, including a term as board chairman
from 2012 until June 2014. Most recently, Dr. Gelbfish served as a
Board observer, appointed by CorMedix’s largest shareholder,
Elliot Management.
In
addition, CorMedix board also unanimously elected current Director
Myron Kaplan as Chairman of the Board of Directors.
Khoso
Baluch, CorMedix Chief Executive Officer stated, “We are
excited to have Gary return to our Board as a full director. His
knowledge and history with the Company, as well as his expertise
and insight as a practicing vascular surgeon, are invaluable to
CorMedix as we focus our efforts on advancing our lead product
Neutrolin® for preventing
catheter-related bloodstream infections. I’m also pleased
that the board elected Myron to be its Chairman. We appreciate very
much his significant involvement with the Company over the past
year and his ongoing leadership as we seek to execute successfully
on multiple fronts in the future.”
Dr.
Gelbfish commented, “as a large shareholder of the Company, I
have continued to follow CorMedix and Neutrolin closely for the
past several years, I’m enthusiastic about re-joining the
Company’s Board. I’ve taken the opportunity presented
to me as an observer to become familiar with the leadership team,
and I have been particularly impressed with the dedication and
decision making shown by Khoso and Jack Armstrong, as well as
several key consultants, that have enabled the Company to make
great strides in the execution of the LOCK-IT-100 study. I look
forward to contributing at this pivotal stage to accelerate the
momentum the team has achieved and to help advance this much-needed
product candidate through late-stage clinical development and
potential FDA approval. The recently announced modifications to the
study design agreed to by the FDA and the significant increases in
enrollment and study events has increased my enthusiasm for
Neutrolin. They bring the Company’s stated goals within
reach. Lastly, continued significant blood stream infection and
morbidity in patients with catheters, as recently reported in a
2017 CDC study, highlight the continued great need for an
antimicrobial lock solution in the catheter dependent patient. This
is especially so in our current environment of increased
antimicrobial resistance.
Dr.
Gelbfish continued, “I also had the opportunity recently to
moderate CorMedix’s R&D Day event, and through my
participation I’ve become an enthusiastic supporter of
CorMedix’s taurolidine-based pipeline, particularly in the
medical device space where the pathway to commercialization is
clear and the time and cost required for FDA clearance is
significantly less than drug development. Antimicrobial sutures are
of particular potential as the need is recognized by the Centers
for Disease Control and the World Health Organization. I look
forward to participating in the advancement of multiple product
opportunities for CorMedix, beginning with
Neutrolin.”
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Mr.
Kaplan stated, “Since joining CorMedix’s Board in May
2016, I’ve focused on helping to refine and develop the
Company’s strategy and leadership and supporting the
Neutrolin Phase 3 clinical program. I’m pleased to continue
to provide oversight to the company’s development as Chairman
of the Board, and with the added insight and expertise of Dr.
Gelbfish and our other new and continuing board members, I believe
CorMedix is positioned to capitalize on the significant value
represented by Neutrolin and its robust taurolidine
pipeline.”
Dr.
Gelbfish has practiced vascular surgery since 1990, specializing
exclusively in treating hemodialysis patients. As such he has a
deep understanding and significant practical experience with
dialysis units and in the placement, care and complications of
central venous ports and catheters. He has published and lectured
widely on vascular access topics. Dr. Gelbfish graduated from
Columbia University College of Physician and Surgeons, is
fellowship trained in Vascular and Cardiovascular Surgery, is board
certified by the American Board of Surgery and is a Fellow of the
American college of Surgeons. He also has significant knowledge of
medical data collection and analysis and was a member of the
systems-engineering group in Medical Informatics at AT&T Bell
Labs. He is an Assistant Clinical Professor of Surgery at the Mount
Sinai School of Medicine in NYC. Dr. Gelbfish currently serves as
CEO and Chairman of Metrodora Therapeutics LLC, a clinical stage
biotechnology company with an active IND. Its biologic is
currently in Phase I trials for patients with anemia associated
with Crohn’s disease.
About CorMedix Inc.
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
continues to emphasis 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. Such infections cost the U.S. healthcare
system approximately $6 billion annually and contribute
significantly to increased morbidity and mortality. Neutrolin is
currently in a Phase 3 clinical trial in patients undergoing
chronic hemodialysis via a central venous catheter. The Company is
working on the design of a planned second Phase 3 clinical trial,
the conduct of, which, if approved, would be subject to sufficient
resources. 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
the FDA and allows for 5 additional years of QIDP market
exclusivity upon U.S. approval. It is already a CE Marked product
in Europe and other territories. 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,
including with respect to possible uses of taurolidine, 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 possible inability to capture sufficient CRBSI
events in the ongoing Phase 3 clinical trial for
Neutrolin® even with the
reported changes to that trial; the cost, timing and results of the
ongoing and planned Phase 3 trials for Neutrolin® in the U.S. and
the resources needed to commence and complete those trials; the
risks and uncertainties associated with CorMedix’s ability to
manage its limited cash resources and the impact on planned or
future research, including for additional uses for taurolidine;
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.
For Investors & Media:
Tiberend Strategic Advisors, Inc.
Joshua
Drumm, Ph.D.: jdrumm@tiberend.com; (212) 375-2664
Janine
McCargo: jmccargo@tiberend.com; (646) 604-5150
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