• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    Vascular Surgeon Imprisoned and Fined for Decade-Long Healthcare Fraud

    Remote Monitoring, Digital Health Help Advance Wound Care Treatment

    MLM Biologics Developing Wound Infection Prevention Device for Military

    NovaScan, PHC Corporation Working on Skin Cancer Detection Device

    Ur24Technology Granted Medicare Reimbursement for External Catheter System
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Checking Up on Surgical Robotics

    Building a Network: How Synchron Is Developing a New Device—and a New Market

    Six Lessons Learned on Developing a Strong Company Culture

    As Hiring Slows, Companies Look Inward to Fulfill Talent Needs

    Artificial Intelligence: Medtech Opportunity or Health Danger?
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Cirtec Medical

    Medbio LLC

    JBC Technologies

    Fusion Biotec Inc.

    Halkey-Roberts Corporation
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    3 Key Elements to Consider When Managing a Medtech Sales Force

    Tech-Enabled Virtual Speech Therapy Improves Speech & Communication Skills

    Practical Strategies for Digitization and Integration in Medtech Manufacturing

    Sensors: The Heart of Minimally Invasive Equipment Technology

    Optimizing UX for the Internet of Medical Things
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Cirtec Medical

    Medbio LLC

    JBC Technologies

    Fusion Biotec Inc.

    Halkey-Roberts Corporation
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    FDA Designates N8 Medical's CeraShield Endotracheal Tube as a Breakthrough Device

    Device is a specially-modified endotracheal tube coated with a proprietary ceragenin compound formulation.

    N8 Medical LLC04.24.17
    The U.S. Food and Drug Administration (FDA) has agreed to designate NA Medical LLC's CeraShield endotracheal tube as a breakthrough device pursuant to the recently enacted 21st Century Cures Act. A breakthrough device is a product that may prevent a life-threatening or irreversibly debilitating disease or condition.  
     
    Each year more than 4 million Americans hospitalized in intensive care units (ICUs) require the use of an endotracheal tube attached to a ventilator to help them breathe. Bacteria and fungi quickly grow on these tubes and may lead to potentially deadly respiratory infections and other severe complications. N8 supported its filing with FDA with recent data from the U.S. Centers for Disease Control and Prevention (CDC) showing that the antimicrobial compound in the CeraShield endotracheal tube can inhibit growth of all 100 strains of candida auris—an emerging highly lethal fungal infection. While Candida auris infections have been found overseas, they have only recently been found in U.S. hospitals with recent outbreaks in Boston, Mass., and New York, N.Y. N8 also supplied the FDA with peer-reviewed published data showing efficacy against multidrug resistant bacterial strains such as colistin resistant pseudomonas and acinetobacter. Colistin is regarded as the antibiotic of last resort.
     
    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 and ventilator associated tracheobronchitis as well as other respiratory infections.
     
    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 in Provo, Utah. There are more than 40 peer-reviewed journal articles on the ceragenin technology, and the technology is protected by issued patents through 2033. Brigham Young has licensed the ceragenin technology to N8 Medical for certain fields of use, including application to medical devices.
     
    The N8 Medical’s 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 the patients’ 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 and are almost impossible to eradicate through use of ordinary antibiotics.

    “Among the potential benefits of the 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, CEO of N8 Medical LLC.  
     
    Once a mature biofilm forms  on an endotracheal tube, fragments may break apart and migrate to the lower respiratory tract causing difficult to treat, potentially lethal respiratory infections. Such infections are called 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 Americans each year and add billions to the annual healthcare expenditures in the United States and globally.  Approximately 70 percent 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 immune compromised 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 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 has 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 and representing 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 urology, vascular access, cardiology, orthopedics, and ear vents, as well as other respiratory devices such as tracheostomy tubes as these devices may also be colonized with pathogenic bacteria and fungi.
     
    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, added, “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 to have been chosen to be among the small handful of devices that have met the FDA’s requirements for this designation,” said David J. Richards, N8 Medical's board chairman. “We now look forward to working closely with the FDA to try to reduce the time to get devices to the patients that need them, while still maintaining the high standards of safety, efficacy and scientific validity required by the program.”
     
    The modern age of antibiotic therapy began with the discovery and introduction of penicillin. Penicillin in 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 methicillin 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 and other health agencies have repeatedly warned that humanity may be entering a “post-antibiotic” age and could be at 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 United Kingdom’s former prime minister, if urgent action is not taken to develop new countermeasures, the annual worldwide death rate may reach 10 million persons per year by 2050, with a loss of global economic production between $100 trillion by 2050. N8 Medical believes that its CeraShield coating technology is poised and ideally-suited to address this major worldwide health concern. 

    “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," said Professor Michael Niederman, chairman of N8 Medical’s Scientific Advisory Board and associate division chief, clinical director of pulmonary and critical care at New York Presbyterian /Weill Cornell Medical Center. "Here 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.”
     
    In the United States, the CeraShield endotracheal tube is limited by law to investigational use only.

    N8 Medical LLC is a privately-held company developing novel solutions for the prevention of hospital-acquired infections from multidrug-resistant pathogens.
    Related Searches
    • mechanical
    • medical device
    • research
    • healthcare
    Suggested For You
    Phillips-Medisize Names New VP Phillips-Medisize Names New VP
    Four Takeaways from Recent Regulatory Audit Changes Four Takeaways from Recent Regulatory Audit Changes
    FDA Clears First Whole Slide Imaging System for Digital Pathology FDA Clears First Whole Slide Imaging System for Digital Pathology
    Collaborating on Custom Materials Development Collaborating on Custom Materials Development
    Extractable/Leachable Chemistry Testing Strategies for Medical Devices Extractable/Leachable Chemistry Testing Strategies for Medical Devices
    ASTM Guide Supports Cleaning Protocols for Reusable Medical Devices ASTM Guide Supports Cleaning Protocols for Reusable Medical Devices
    Software’s Coming of Age Software’s Coming of Age
    Four Common Misperceptions of Accelerated FDA Approval Four Common Misperceptions of Accelerated FDA Approval
    Pace of Medtech M&A Activity Not Likely to Abate in 2017 Pace of Medtech M&A Activity Not Likely to Abate in 2017
    FDA Approves Increase in Number of Clinical Sites for E-QURE’s Pivotal Trial of BST Device FDA Approves Increase in Number of Clinical Sites for E-QURE’s Pivotal Trial of BST Device
    Magnetic Latches for Medical Devices Magnetic Latches for Medical Devices
     FlowAid Receives FDA Clearance for the FA100 SCCD FlowAid Receives FDA Clearance for the FA100 SCCD
    Capillus Laser Therapy Caps Receive FDA Clearance for Over-the-Counter Use Capillus Laser Therapy Caps Receive FDA Clearance for Over-the-Counter Use
    FDA Clears Voxello FDA Clears Voxello's Speech Generation Device
    Clariant/SICPA PLASTIWARD Anti-Counterfeiting System Makes U.S. Debut Clariant/SICPA PLASTIWARD Anti-Counterfeiting System Makes U.S. Debut

    Related Breaking News

    • Phillips-Medisize Names New VP

      Phillips-Medisize Names New VP

      Michael Ratigan has been appointed vice president of global sales.
      Phillips-Medisize 05.18.17

    • Four Takeaways from Recent Regulatory Audit Changes

      Four Takeaways from Recent Regulatory Audit Changes

      ...
      Alexa Sussman, Content Marketing Writer, EtQ 05.01.17

    • Diagnostics | Digital Health | Electronics | Software & IT
      FDA Clears First Whole Slide Imaging System for Digital Pathology

      FDA Clears First Whole Slide Imaging System for Digital Pathology

      Philips IntelliSite Pathology Solution cleared for primary diagnostic use.
      U.S. Food and Drug Administration 04.13.17


    • Materials | R&D & Design
      Collaborating on Custom Materials Development

      Collaborating on Custom Materials Development

      OEMs and contractors can engage with materials suppliers for custom formulations and product development.
      Deepak Prakash, Vancive Medical Technologies 04.03.17

    • Testing
      Extractable/Leachable Chemistry Testing Strategies for Medical Devices

      Extractable/Leachable Chemistry Testing Strategies for Medical Devices

      ...
      Matthew R Jorgensen, Ph.D., and Thor Rollins, BS, Nelson Laboratories; Allison Komiyama, Ph.D., RAC, AcKnowledge RS 04.03.17

    Loading, Please Wait..

    Trending
    • Philips Names New Supervisory Board Chairman
    • A New Approach To Post-Market Surveillance
    • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
    • FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech
    • Vascular Surgeon Imprisoned And Fined For Decade-Long Healthcare Fraud
    Breaking News
    • Vascular Surgeon Imprisoned and Fined for Decade-Long Healthcare Fraud
    • Remote Monitoring, Digital Health Help Advance Wound Care Treatment
    • MLM Biologics Developing Wound Infection Prevention Device for Military
    • NovaScan, PHC Corporation Working on Skin Cancer Detection Device
    • Ur24Technology Granted Medicare Reimbursement for External Catheter System
    View Breaking News >
    CURRENT ISSUE

    May 2023

    • Computer Concepts for Medical Device Design
    • IVD Manufacturers Are Being Put to the Test
    • The New State of Medtech Outsourcing
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Premium Label & Packaging Solutions Receives Safe Quality Food (SQF) Certification
    Inulinase Enzymes May Benefit Gut Symptoms of FODMAP Digestion
    Verdure Sciences’ Boswellia Ingredient Receives USP Verification
    Coatings World

    Latest Breaking News From Coatings World

    BASF Celebrates 10 Years of its Northeast Research Alliance in the U.S.
    BCF Elects Sharon Harte Its First Female President
    OQ Chemicals Launches Cost-Cutting Program and Organizational Realignment in Germany
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Vascular Surgeon Imprisoned and Fined for Decade-Long Healthcare Fraud
    Remote Monitoring, Digital Health Help Advance Wound Care Treatment
    MLM Biologics Developing Wound Infection Prevention Device for Military
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Catalent Adds New Cryogenic Capabilities at Japanese Facility
    Lifecore Biomedical Enters into $150M New Financing Deal
    WuXi Biologics Receives 2023 ISPE Facility of the Year Award
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    How Robots & Artificial Intelligence are Transforming Unilever's Material Innovation Factory
    Top 10 Most Popular Hair Care Brands in the U.S.—Ranked by Searches
    Aloette Cosmetics Launches Daily Mineral Shield Sunscreen
    Happi

    Latest Breaking News From Happi

    Kérastase Donates $25,000 to The Trevor Project
    Aveda Launches Hypernature Artist Collection
    Amika Leads as the Most Popular Hair Care Brand in the US: Curl Centric
    Ink World

    Latest Breaking News From Ink World

    BCF Elects Sharon Harte First Female President in Its History
    Weekly Recap: INX Digital, Mexar and hubergroup Top This Week’s Stories
    Richnerstutz AG Acquires an EFI VUTEk Q5r Superwide Roll-to-Roll Printer
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Mactac acquires Label Supply, Beontag grows and more
    Sun Chemical releases Spring 2023 Regulatory Newsletter
    Tageos unveils new RAIN RFID inlays
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: Corman, Tosama Develop Biodegradable Plastic Tampon Applicator, Trevira Changes Name
    Suominen Appoints SVP, Transformation Management Office
    Minnesota Signs PFAS Ban in Consumer Products
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    AlloSource Launches AlloMend Duo Acellular Dermal Matrix
    TendoNova Inks Partnership With AcCELLerated Biologics
    Stryker Achieves First Surgeries Using Q Guidance System with Cranial Guidance Software
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Partner Workshops Start Solliance 2.0
    Weekly Recap: Smart Skis, Universal Display Top This Week’s Stories
    Wiliot Appoints Antony Yousefian as VP of Climate & Circularity

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login