Breakthrough CeraShield™ ETT Highlights
N8 Medical’s initial product will be the CeraShield™ endotracheal tube, designed to prevent biofilm fouling of the the tube’s surfaces. Biofilm on ETTs act as a reservoir of infectious agents and mature biofilms are linked to development of Ventilator Associated Pneumonia and other serious adverse events, including sepsis and death.
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 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 to $12,000
- 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 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
- CeraShield™ ETT represents over $500 million market opportunity worldwide
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).