CeraShield™ ETT

Breakthrough CeraShield™ ETT Highlights

N8 Medical’s initial product will be a ceragenin-eluting CeraShield endotracheal tube designed to address a myriad of complications in mechanically-ventilated patients. These patients often develop respiratory infections, which can lead to sepsis and multi-organ failure.

  • CeraShield™ ETT is designed to provide multiple anticipated benefits*

    • Prevent or reduce microbial colonization and biofilm growth on the ETT surface, thereby reducing length of hospital stay and risk of infection and death
    • Anti-inflammatory activity that may reduce inflammatory cytokine-related adverse events
    • Reduce friction damage to the tracheal mucosa
    • Several additional potential benefits
  • Prevention of Candida colonization and Candida co-colonization with bacteria

    • Candida colonization of ETTs is a growing problem in critically-ill patients,with about 50% of ETTs are colonized by Candida spp.
    • Co-colonization of ETTs with Candida and Pseudomonas, S. aureus and/or A. baumannii leads to increased virulence and higher mortality rates
    • Ceragenins have demonstrated promising efficacy against Candida and the particularly virulent Candida auris, which has a mortality rate of over 60% and is viewed as a catastrophic threat by the Centers for Disease Control and Prevention (CDC)
    • CeraShield ETT is anticipated to prevent or reduce the risk of Candida colonization and co-colonization of Candida with other bacteria
  • CeraShield™ ETT presents a significant market opportunity

    • CeraShield™ ETT represents over $500 million in market opportunity worldwide
      • Approximately 86% of hospital-associated pneumonia is linked with mechanical ventilation, and respiratory infections associated with mechanical ventilation may account for up to 60% of all deaths due to HAIs
      • Approximately 8% to 28% of critical care patients develop respiratory infection or pneumonia, with each incidence of respiratory infection associated with mechanical ventilation estimated to generate an increased cost of $20,000 to $40,000 in the developed world
      • In developing countries, the incidence of respiratory infection associated with mechanical ventilation ranges from 15% to 60% and added costs (from published data) range from $6,000 (Turkey) to $12,000 (Argentina)
    • Clinical evidence should lead to rapid adoption of CeraShield™ ETT device as demonstrated in drug-eluting stent (DES) market
      • Multiple parallels between CeraShield™ ETT device as demonstrated in drug-eluting stent (DES), expected to lead to similar adoption pattern
      • Intensivist driver of adoption
      • ICU outcomes important to hospital reputation and payments
    • N8’s CeraShield ETT Granted “Breakthrough Designation” by FDA
      • A “breakthrough” technology is one that FDA believes has the potential to prevent life-threatening or irreversibly debilitating diseases or conditions
      • Path to faster approval with less burdensome pre-market requirements
      • Clinical evidence of efficacy may be provided via post-approval studies using the approved product
      • Expedited PMA approval would enable N8 Medical to market product in countries that require a pre-condition of local approval

Figure 3. Scanning electron microscopy images of ETT surfaces:  A: biofilm of C. auris (383) on an uncoated tube after 14 days (daily inoculation);  B: surface of a CeraShield™ ETT after 14 days (daily inoculation with C. auris);  C: mixed species biofilm of MRSA and PA01 on an uncoated tube after 48 h;  D: surface of a CeraShield™ ETT after 48 h (inoculation with MRSA and PA01);  E: mixed species biofilm of PA01 and C. auris on an uncoated tube after 48 h;  F: surface of a CeraShield™ ETT after 48 h (inoculation with PA01 and C. auris).

*CAUTION: IN THE UNITED STATES, THE CERASHIELD™ ENDOTRACHEAL TUBE HAS NOT BEEN GRANTED MARKETING APPROVAL BY FDA, AND IS AN INVESTIGATIONAL DEVICE AND NOT AVAILABLE FOR COMMERCIAL SALE. THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION.