NIH Awards $1.66 Million Grant to Evaluate Cerashield Coating to Reduce Orthopedic Implant Infections

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Mon Mar 30, 2009 7:00am EDT

DENVER--(Business Wire)--
Ceragenix Pharmaceuticals, Inc.("Ceragenix") (OTCBB:CGXP), a medical device
company focused on infectious disease and dermatology today announced that the
National Institutes of Health ("NIH") has awarded a $1.66 million grant to the
University of Utah to fund research evaluating a Cerashield coating to reduce
orthopedic implant infections. Roy Bloebaum, PhD, Research Professor at the
University of Utah and Career Scientist and Director, Bone and Joint Research
Laboratory of the Veterans Administration Hospital, Salt Lake City, is the
principal investigator on the grant. The grant will fund preclinical evaluation
of orthopedic implants coated with CSA-13, the active ingredient in Cerashield
coatings. Multiple in vitro tests have demonstrated that CSA-13 has potent
activity against a broad spectrum of strains of bacteria, including multidrug
resistant strains such as Methicillin Resistant Staph Aureus (MRSA), which are
associated with orthopedic implant infections. Paul B. Savage, PhD, Professor at
Brigham Young University and inventor of CSA-13 is a co-investigator on the
grant. 

According to the American Academy of Orthopedic Surgeons, approximately 766,000
Americans underwent surgery for hip, knee and shoulder replacements in 2002.
During typical procedures, surgeons remove an arthritic or damaged joint and
replace it with an artificial one. In about 1 to 2 percent of cases, the implant
gets infected, most commonly with Staphylococcus epidermidis. The bacteria
multiply, causing a slimy layer, or biofilm, to form around the implant which
acts as a physical and chemical barrier that resists antibiotics. The result is
additional surgery to clean the implant or replace it outright. Limited testing
to date performed at the University of Utah has shown that CSA-13 coated
orthopedic devices are able to rapidly kill bacteria and prevent the growth of
biofilms, and have also demonstrated good biocompatibility. 

"Based on our preliminary experience with orthopedic devices coated with CSA-13,
we believe that this approach has great promise in reducing the incidence of
orthopedic implant related infections and improving clinical outcomes," Dr.
Bloebaum said. "These infections are of great concern for our men and women in
the armed forces and for the civilian population as well. As our population
ages, more people require knee, hip or other orthopedic implants to regain
mobility." 

Steve Porter, Chairman and CEO of Ceragenix, stated: "NIH grant applications are
subject to intensive review by leading experts in the country and only a small
percentage of grants that are submitted ever receive funding. We are very
pleased that Dr. Bloebaum`s proposal merited this award. We believe that our
technology has the potential to significantly reduce orthopedic related
infections." 

About Ceragenix: 

Ceragenix Pharmaceuticals, Inc. is a medical device company focused on
infectious disease and dermatology. The Company has two base technology
platforms: Ceragenins for treatment of infectious disease and Barrier Repair for
the treatment of dermatological disorders including atopic dermatitis. Ceragenin
compounds are active against a broad range of Gram positive and negative
bacteria. We have used our Ceragenin technology to formulate Cerashield
antimicrobial coatings for medical devices. All Ceragenin and Cerashield
products are currently in the developmental stage. Ceragenix's patented Barrier
Repair technology, invented by Dr. Peter Elias, is the platform for the
development of EpiCeram which is currently being marketed by Promius Pharma (a
wholly owned subsidiary of Dr. Reddy`s Laboratories) in the United States under
an exclusive supply and distribution agreement. For additional information on
Ceragenix, please visit www.ceragenix.com. 

Forward Looking Statements For Ceragenix: 

This press release may contain forward-looking statements. These forward-looking
statements are subject to risks and uncertainties that may cause actual results
to differ materially from those expressed or implied by such forward-looking
statements, including, but not limited to, the following: the ability of the
Company to raise sufficient capital to finance its planned activities including
completing development of its Ceragenin technology; the ability of the Company
to meet its obligations under the supply and distribution agreement with Dr.
Reddy`s Laboratories including having sufficient working capital to fulfill
purchase orders within the timeframes required by the agreement; the ability of
the Company to service its outstanding convertible debt obligations; receiving
the necessary marketing clearance approvals from the United States Food and Drug
Administration (the "FDA"); successful clinical trials of the Company`s planned
products including the ability to enroll the studies in a timely manner, patient
compliance with the study protocol, and a sufficient number of patients
completing the studies; the ability of the Company to commercialize its planned
products; the ability of the Company to successfully manufacture its products in
commercial quantities (through contract manufacturers); market acceptance of the
Company`s planned products, the Company`s ability to successfully develop its
licensed compounds, alone or in cooperation with others, into commercial
products, the ability of the Company to successfully prosecute and protect its
intellectual property, general economic conditions in the United States and
elsewhere, and the Company`s ability to hire, manage and retain qualified
personnel. The aforementioned factors do represent an all inclusive list. Actual
results, performance or achievements could differ materially from those
contemplated, expressed or implied by the forward-looking statements contained
in this press release. In particular important factors that could cause actual
results to differ materially from our forward-looking statements including
general economic factors, business strategies, the state of capital markets,
regulatory conditions, and other factors not currently known to us, may be
significant, now or in the future, and the factors set forth in this press
release may affect us to a greater extent than indicated. All forward-looking
statements attributable to us or persons acting on our behalf are expressly
qualified in their entirety by the cautionary statements set forth in this press
release and in other documents that we file from time to time with the
Securities and Exchange Commission includingits Annual Report on Form 10-K for
the year ended December 31, 2008,Quarterly Reports on Form 10-Q and Current
Reports on Form 8-K to be filed in 2009. Except as required by law, we do not
undertake any obligation to update any forward-looking statement, whether as a
result of new information, future events or otherwise. 





Ceragenix Pharmaceuticals, Inc.
Steven Porter, 720-946-6440
Chairman and CEO
or
University of Utah Health Sciences
Office of Public Affairs
801-581-7387 

Copyright Business Wire 2009

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