New Publication regarding Ceragenin CSA-131’s Potent Efficacy against fungal pathogen Candida auris, a New Serious Global Health Threat
DUBLIN, OHIO – April 5, 2018 – N8 Medical, LLC today announced a peer-reviewed publication in The Journal of Antimicrobial Chemotherapy with U.S. Centers for Disease Control and Prevention (CDC) co-authors of promising efficacy data regarding the activity of ceragenin CSA-131 against 100 strains of Candida auris (C. auris) collected from around the world.
C. auris is a highly virulent and lethal pathogen of key clinical concern in hospitals and particularly among patients in the intensive care unit (ICU). As many of these patients are already seriously ill, C. auris can have an estimated mortality rate as high as 60% internationally. C. auris is able to attach to indwelling medical devices, such as endotracheal tubes and urinary catheters.
To address this important problem, N8 Medical’s first application of CSA-131 is in its drug-eluting CeraShield™ endotracheal tube (ETT). The prolonged use of ETTs in the ICU is often life-saving, but life-threatening infections and complications occur in a significant portion of patients.
C. auris and other Candida fungal infections in ETTs are of high clinical concern and can lead to patient morbidity and mortality. Recent research shows that up to 80% of ETTs are colonized by Candida spp., mostly Candida albicans. Although C. auris is still rare in the United States, it continues to spread in healthcare facilities and officials have called C. auris a potential “catastrophic threat” to our nation’s health. C. auris infections have the potential to spread rapidly—some hospitals outside the U.S. report C. auris infection rates among candidemia patients in the ICU are up to 30%.
N8 Medical is optimistic that its CeraShield™ ETT will be able to significantly reduce the incidence of deadly infections such as C. auris in the ICU. C. auris is often multi-drug resistant and difficult to identify. Outbreaks in healthcare settings in the UK and Spain have required closure of hospital wards to help eradicate this pernicious pathogen.
FDA has designated the CeraShield™ ETT as a “breakthrough device” according to the criteria specified in Section 515B of the Food, Drug and Cosmetic Act. This designation provides prioritized review to premarket submissions on the CeraShield ETT.
“The year 2018 marks the 100- year anniversary of the Great Influenza Pandemic that killed at least 50 million persons worldwide in a span of 24 weeks. We do not know what might trigger a future deadly pandemic, but the situation with C. auris is worrisome. We are thankful to CDC for providing this valuable testing and we plan to work closely with FDA and other governmental institutions in bringing this promising compound to the clinic,” stated Carl Genberg, Chief Executive Officer of N8 Medical.
Dr. Paul B. Savage, Professor of Chemistry and Biochemistry at Brigham Young University (Provo, UT) and inventor of CSA-131, co-authored the paper with Shawn Lockhart of the Mycology Branch of the CDC. The publication is entitled “Ceragenins are active against drug-resistant Candida auris clinical isolates in planktonic and biofilm forms” and is available online at: https://academic.oup.com/jac/advance-article-abstract/doi/10.1093/jac/dky085/4960903.
ABOUT N8 MEDICAL
N8 Medical, LLC, headquartered in Dublin, Ohio, is a rapidly-growing, privately-held biotechnology company developing a platform of drug-eluting medical devices designed to have significant, life-saving clinical impact through reduction of infection, related complications and mortality. N8 Medical’s drug-eluting CeraShield™ technology is based upon novel drugs called ceragenins (also referred to as CSAs), that are small molecule, non-peptide, functional mimetics of naturally-occurring antimicrobial peptides that provide multi-faceted benefits. There are over 75 peer-reviewed journal articles regarding the ceragenin technology. Key publications are available at www.N8Medical.com.
CAUTION: In the United States, the CeraShield™ Endotracheal Tube has not been granted marketing approval by FDA and is an investigational device that is not available for commercial sale. These statements have not been evaluated by FDA.
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