DENVER -- Ceragenix Pharmaceuticals, Inc. (OTCBB:CGXP) (the "Company"), a biopharmaceutical and medical device company focused on infectious disease and dermatology, today announced that it will be presenting data on its CeraShield(tm) antimicrobial medical device coating at the upcoming Medtech Insight conference "Investment In Innovation (In3) Europe: Bridging European and U.S. Medical Device Innovators, Investors and Companies." The conference will be held on April 28- 29, 2008 in Paris, France. The Company will present data from recent testing comparing the in vitro antimicrobial efficacy of developmental CeraShield(tm) coated urinary silicone catheters with commercially available urinary catheters that contain either silver or nitrofurazone when challenged with daily doses of E.coli, the most common pathogen associated with urinary tract infections. The use of urinary catheters is linked to the development of urinary tract infections which add over $450 million in hospital costs annually in the United States.
A prior published study by Belgian researchers in the journal European Urology examined whether use of a silver coated urinary catheter was able to reduce the rate of bacteriuria in men who required either short term or medium term use of a urinary catheter following surgery for treatment of prostate cancer. The study found that in men who required use of a urinary catheter for at least 14 days, that there was no significant difference in the rates of bacteriuria in those who received a standard uncoated urinary catheter and those who received the silver coated catheter (53% vs. 50%). The silver coated catheter did provide a significant reduction in bacteriuria in men who only required urinary catheterization of 5 days or less. Hence, there is an interest in technologies that may afford medium and long term protection against urinary tract infections. It is estimated that more than 900,000 Americans who require use of a urinary catheter develop a urinary tract infection annually.
The CeraShield(tm) coating is a polyurethane polymer that contains CSA-13, a Ceragenin(tm) compound that has been shown to have broad spectrum efficacy against gram-positive and gram-negative pathogens, including multidrug resistant strains. The Company has also recently released data regarding the in vitro efficacy of CeraShield(tm) coated endotracheal tubes which showed 21 days of efficacy in preventing bacterial colonization and biofilm formation when challenged with daily high inocula of Pseudomonas aeruginosa.
Steve Porter, Chairman and CEO of Ceragenix stated: "The recent decision by the Center for Medicare Services to no longer reimburse hospitals for hospital acquired urinary tract infections has generated increased interest in novel technological solutions to help reduce the incidence of such infections. We believe that our CeraShield(tm) antimicrobial treatment may offer significant advantages over existing technological approaches. We look forward to conducting the necessary additional testing to bring this promising technology to market."
About Ceragenix
Ceragenix Pharmaceuticals, Inc. is a biopharmaceutical and medical device company focused on infectious disease and dermatology. The Company has two base technology platforms; Ceragenins(TM) or ("CSAs") for treatment of infectious disease and Barrier Repair for the treatment of dermatological disorders including atopic dermatitis, neonatal skin disorders and others. Ceragenin(tm) compounds are active against a broad range of gram positive and negative bacteria. We have used our Ceragenin(tm) technology to formulate Cerashield(tm) antimicrobial coatings for medical devices. All Ceragenin(tm) and Cerashield(tm) 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 two prescription topical creams -- EpiCeram(r) and NeoCeram(tm). EpiCeram(r) has been cleared for marketing by the United States Food and Drug Administration ("FDA") and the Company has entered into an exclusive supply and distribution agreement with Dr. Reddy's Laboratories, Inc. ("DRL") for the marketing and sales of the product in the United States. The Company anticipates that DRL will launch EpiCeram(r) during the second half of 2008. For additional information on Ceragenix, please visit www.ceragenix.com.
FORWARD LOOKING STATEMENTS
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, but not limited to, delivering shelf stable product prior to the planned launch; the ability of the Company to satisfy its outstanding convertible debt obligations; receiving the necessary marketing clearance approvals from 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, 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 including its Annual Report on Form 10-K for the year ended December 31, 2007, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K to be filed in 2008. 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.