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FDA Grants N8 Medical’s Request for Breakthrough Device Designation for its CeraShield™ Endotracheal Tube

DUBLIN, OHIO – 3 May, 2017 – N8 Medical, LLC (N8 Medical), a privately-held medical device company developing novel solutions for the prevention of hospital-acquired infections from multidrug-resistant pathogens, announced that the United States Food and Drug Administration (FDA) has approved the company’s request to designate its CeraShield™ endotracheal tube as a “breakthrough device” pursuant to the recently-enacted 21st Century Cures Act.  A “breakthrough device” is a device that may prevent or treat a life-threatening or irreversibly debilitating disease or condition.  

Each year over four million patients in the U.S. are hospitalized in intensive care units (ICU) and require intubation with an endotracheal tube attached to a ventilator to assist in breathing. Bacteria and fungi quickly grow on these tubes and may lead to serious respiratory infections and other severe complications. N8 Medical supported its filing with the FDA with recent data from the U.S. Centers for Disease Control and Prevention (CDC) demonstrating that the antimicrobial compound contained in the CeraShield™ Endotracheal Tube inhibited growth of all 100 strains of Candida auris—an emerging, highly-lethal fungal infection. While Candida auris outbreaks have occurred overseas previously, they have only recently arisen in U.S. hospitals in Boston and New York City. N8 Medical also supplied FDA with peer-reviewed, published data demonstrating efficacy against multidrug-resistant bacterial strains, such as colistin-resistant Pseudomonas and Acinetobacter. Colistin is typically regarded as the antibiotic of last resort for critical infections among hospitalized patients.

The 21st Century Cures Act enables companies to use a combination of premarket and postmarket approval studies to meet the requirements for a faster pathway toward approval. This significantly expedites access for U.S. patients and their physicians to innovative medical devices. The statute was enacted in January 2017 for medical devices that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions, such as ventilator-associated pneumonia, ventilator-associated tracheobronchitis and other respiratory infections associated with endotracheal tube and ventilator use.

Ceragenins are mimics of molecules found within the human body’s own innate immune system, and were invented by Dr. Paul B. Savage, The Reed Izatt Professor of Chemistry and Biochemistry at Brigham Young University (BYU, Provo, Utah).  There are over 40 peer-reviewed journal articles regarding ceragenin technology, and the technology is protected by issued patents through the mid-2030s.  BYU has licensed the ceragenin technology to N8 Medical for certain fields of use, including application to medical devices.

The N8 Medical CeraShield™ Endotracheal Tube is a specially-modified endotracheal tube that has been coated with a proprietary ceragenin compound formulation designed to prevent bacterial and fungal growth on the tube’s surfaces.  Patients who require mechanical ventilation in the ICU are intubated with endotracheal tubes to provide oxygen to the patient’s lungs to assist with breathing.  Within hours of intubation, bacteria and fungi may start to grow on the tube and form microbial aggregations known as biofilms.  Biofilms consist of millions of bacteria and/or fungi that are nearly impossible to eradicate using ordinary antibiotics.

Once a mature biofilm forms on an endotracheal tube, fragments may break apart and migrate to the lower respiratory tract, causing problematic, potentially lethal respiratory infections.  Such infections are referred to as nosocomial or hospital-acquired infections.  Nosocomial infections associated with the use of endotracheal tubes are among the most common and most deadly of nosocomial infections.  According to the U.S. Department of Health and Human Services (HHS), nosocomial infections claim the lives of nearly 100,000 U.S. patients each year and add billions of dollars to the annual healthcare expenditures in the United States and globally.  Approximately 70% of such nosocomial infections are believed to be related to the use of indwelling medical devices. Indwelling devices provide a “protected” breeding ground for bacteria and fungi that can lead to these life-threatening infections.  Neonates, the elderly and immunocompromised patients are at highest risk for such infections.

Particularly concerning is the emergence of multidrug-resistant pathogens, such as colistin-resistant strains of Pseudomonas aeruginosa and Acinetobacter baumannii, as well as the above-mentioned recently identified highly lethal fungus, Candida auris. Candida auris has been the subject of a CDC nationwide alert in June 2016 to healthcare institutions.  CDC recently tested CSA-131, the ceragenin in the CeraShield™ Endotracheal Tube, against CDC’s collection of 100 clinical isolates of Candida auris from around the world that represent four separate genetic clusters.  Many of these isolates are highly-resistant to fluconazole, a potent anti-fungal agent, and some are resistant to all commercially available antifungals.  The CDC testing found that CSA-131 was active against all 100 strains of Candida auris with a maximum Minimum Inhibitory Concentration (MIC) of 1 micrograms/ml for all strains, and some strains with MICs of 0.5 micrograms/ml.

The CeraShield™ medical device coating technology is applicable to a broad range of medical devices commonly colonized with pathogenic bacteria and fungi, including devices for urology, vascular access, cardiology, orthopedics, and ear nose and throat (ENT), as well as other respiratory devices such as tracheostomy tubes. N8 Medical is working to pursue broad application of its CeraShield™ coating technology to create best-in-class antimicrobial medical devices designed to reduce the morbidity and, mortality and high costs and use of resources associated with hospital-acquired infections worldwide—both through independent commercialization efforts and through collaboration and partnering opportunities.

“Among the potential benefits of the ceragenin technology are that it may reduce mortality, cost of care and improve clinical outcomes for ICU patients requiring mechanical ventilation, as well as slow or prevent the development of new antimicrobial resistant bacterial and fungal strains,” said Carl Genberg, Chief Executive Officer of N8 Medical LLC.   Ronald Bracken, N8 Medical’s President and Chief Operating Officer, a medical device industry veteran and formerly Vice President of Research and Development for C.R. Bard (NYSE: BCR) stated: “As someone who has developed and brought to market antimicrobial medical devices for over 20 years, I believe that the CeraShield™ technology is unparalleled in its broad spectrum antimicrobial, antifungal and anti-inflammatory activity and I look forward to working with FDA to expedite the approval of this truly breakthrough device.”

“The breakthrough designation is an incredible opportunity to accelerate the path to approval in the United States, and we are honored that our endotracheal tube has been confirmed to meet the FDA’s requirements for this designation,” said David J. Richards, Chairman of the Board of N8 Medical. “We now look forward to working closely with the FDA to try to reduce the time to get innovative devices to the patients that need them, while still maintaining the high standards of safety, efficacy and scientific validity required by the program.”

Professor Michael Niederman, Chairman of N8 Medical’s Scientific Advisory Board and Associate Division Chief, Clinical Director, Pulmonary and Critical Care, New York Presbyterian, Weill Cornell Medical Center, said “In clinical practice, we regularly observe that despite high levels of antibiotic use, some mechanically ventilated patients in the ICU still go on to develop complications such as ventilator associated pneumonia and ventilator associated tracheobronchitis, which may lead to poor clinical outcomes, including death.  There is a great need to find new approaches to protect and treat such patients that will reduce the need for systemic antibiotic therapy while improving patient outcomes.”

About the global health threat posed by antimicrobial resistance

The modern age of antibiotic therapy began with the discovery and introduction of penicillin.  Penicillin was rightly regarded as a “wonder drug” or “magic bullet” as patients at death’s door in hospitals were cured of their infections and sent home to resume normal lives.  However, widespread use of the drug led to the development of new strains of bacteria resistant to penicillin.  A modified form of penicillin—methicillin—was thereafter developed, and similarly widespread use of that drug led to highly virulent methicillin-resistant staph aureus (MRSA).  Widespread use of other antibiotics has also led to the emergence of deadly multidrug-resistant strains.  The World Health Organization (WHO) and other health agencies have repeatedly warned that we may be entering a “post-antibiotic” age and the end of the modern era of antibiotic therapy due to the lack of development of new effective antibiotics.

Prior to the introduction of modern antibiotics, infections were a leading cause of death in the United States and elsewhere.  The lack of antibiotic therapy for newly-emerging antibiotic resistant strains is posing a serious threat to global health. According to a study commissioned by David Cameron, the UK’s former prime minister, if urgent action is not taken to develop new countermeasures by 2050, the annual worldwide death rate may reach 10 million persons per year, with a loss of global economic production between now and 2050 of $100 trillion.  N8 Medical believes that its CeraShield™ coating technology is poised and ideally-suited to address this major worldwide health concern, and particularly compatible for medical device coating approaches due to the properties of the ceragenin molecules.

CAUTION: In the United States, the CeraShield™ Endotracheal Tube has not been granted marketing approval by FDA.

Contact:

Carl Genberg
Chief Executive Officer
N8 Medical, LLC
(877) 686-3338, Ext. 22 (PDT)
carlgenberg@n8medical.com
www.N8medical.com

Media Contact
Company Name: N8 Medical LLC
Contact Person: Carl Genberg
Email: carlgenberg@n8medical.com
Phone: 702 285 5740
Country: United States
Website: www.N8Medical.com

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