N8 Medical Inc. Announces Published Testing Results Demonstrating its Antimicrobial Technology Does Not Cause Mutational Resistance

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CSA-13 retained potent antibacterial activity against Staph (Staphylococcus aureus) over the course of 30 serial passages.

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N8 Medical, Inc. (N8), an emerging company that focuses on novel antimicrobial coatings and antibiotic pharmaceutical products to prevent and treat hospital acquired infections, announced the electronic publication of a peer reviewed article entitled “In vitro evaluation of the potential for resistance to ceragenin CSA-13” in the Journal of Antimicrobial Chemotherapy. The authors, led by Dr. Paul B. Savage of Brigham Young University (Provo, UT) studied the effects of multiple exposures of sub-lethal doses of bacterial pathogens to several commonly used antibiotics along with CSA-13 to ascertain whether the bacteria were able to develop mutational resistance. One of the major healthcare concerns is the rising number of multidrug resistant bacteria that are no longer susceptible to available antibiotic therapy. Widespread use of antibiotics that inhibit the growth of bacteria but do not kill bacteria outright has led to the growth of surviving bacteria that are able to pass their ability to resist antibiotics to succeeding generations. CSA-13 is one of the class of ceragenin compounds that are exclusively licensed to N8 Medical for certain medical device and pharmaceutical applications. This study showed CSA-13 to be superior to other tested antibiotics (ciproflaxin, vancomycin and colistin) in that repeated exposure to bacteria did not generate any mutational resistance, even after 30 serial passages. In contrast to most other antibiotics, CSA-13 is able to rapidly kill bacteria through destruction of bacterial membranes. This mechanism of action mimics that used by key components of our body’s innate immune system. It is thought that this unique mechanism of action is responsible for CSA-13’s performance in this study.

“CSA-13 has been extremely effective in both in vitro and in vivo testing against almost all bacterial strains, including highly resistant strains. This study highlights one of the key advantages of the ceragenin class of compounds in that they are unlikely to generate mutational resistance,” said David J. Richards, Chief Executive Officer of N8 Medical. “We anticipate these results will further enhance our licensing and product development efforts.”

Carl Genberg, CTO of N8 Medical added “Every year nearly 2 million Americans acquire an infection while in the hospital and of those nearly 100,000 die. These deaths are more than those from breast and colon cancer combined. We believe that use of our novel coating will be a valuable tool for device manufacturers to combat this problem.”

A link to the article can be viewed on N8’s web site at http://www.N8medical.com.

N8 recently announced a separate collaborative effort with Hydromer, Inc., which will further advance its medical device coatings business. N8 also expects continued progress on drug development efforts for the treatment of Clostridium difficile, Shigella, Crohn’s disease, Cystic Fibrosis, and use in orthopedic applications, antibacterial surgical rinses and washes, among others. Testing to date has shown that CSA-13 is very effective in combating biofilms and a broad spectrum of microbes. The coating approach incorporating CSA-13 has the potential to significantly reduce hospital acquired infections (HAIs), and thus reduce morbidity and save patients’ lives while saving significant costs for healthcare systems worldwide. It is estimated that HAIs cost the U.S. healthcare system in excess of $30 billion annually. CSAs have exhibited potent antimicrobial properties and are rapidly bactericidal, fungicidal and virucidal against a wide array of pathogens, including multidrug resistant strains of Methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa. CSAs have also shown the ability to both prevent and eradicate bacterial and fungal biofilms, which are nearly impossible to eradicate utilizing conventional antibiotics.

About N8 Medical, Inc.: N8 Medical, Inc. is an emerging biomedical technology company focused on creating innovative medical devices and pharmaceuticals to effectively combat a broad spectrum of infectious diseases and other conditions, including those attributable to multidrug resistant bacteria and those that cause hospital acquired infections. N8 Medical’s core technology is a new class of patented, synthetic antimicrobial compounds known as CSAs. N8 Medical is a privately held entity, backed by private equity firm Empire Advisors, LLC, and is based in Columbus, Ohio with facilities at TechColumbus (http://www.techcolumbus.org). For additional information please visit the following Web-site: http://www.N8Medical.com

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David Richards
N8 Medical
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