Next standard of care in Hospital Acquired Infection (HAI) prevention
CeraShield™
Biofilm-resistant endotracheal tube
Designed to reduce ventilator associated respiratory infections (VARI)
and significantly lower overall cost of care
Medical device-associated biofilms pose a serious threat to human health and lead to nosocomial infections
New strategies are urgently needed
Up to 80% of microbial infections in the human body involve biofilm formation, especially in hospital settings, which greatly promotes the incidence rate and mortality 1,2
Over 6 million potential deaths from nosocomial infections worldwide each year 3
60–70% of nosocomial
infections are associated
with biomaterials or implants 4
Ordinary medical devices allow millions of pathogenic CFUs to grow within hours and act as a reservoir of infectious agents, leading to inflammation and infection.
The resistance of bacteria in biofilms to antibiotics can be 10–1,000X that of the corresponding planktonic cells. 5
The rates of horizontal plasmid transfer were several orders of magnitude higher in the biofilms
than in liquid cultures of the same organisms. 6
1. Jamal, M.; Ahmad, W.; Andleeb, S.; Jalil, F.; Imran, M.; Nawaz, M.A.; Hussain, T.; Ali, M.; Rafiq, M.; Kamil, M.A. Bacterial biofilm and associated infections. J. Chin. Med. Assoc. 2018, 81, 7–11.
2. Khatoon, Z.; McTiernan, C.D.; Suuronen, E.J.; Mah, T.-F.; Alarcon, E.I. Bacterial biofilm formation on implantable devices and approaches to its treatment and prevention. Heliyon 2018, 4, e01067.
3. Gyawali B, Ramakrishna K, Dhamoon AS. Sepsis: The evolution in definition, pathophysiology, and management. SAGE Open Med. 2019;7:2050312119835043. Published 2019 Mar 21. doi:10.1177/2050312119835043.
4. Yasir, M.; Willcox, M.D.P.; Dutta, D. Action of Antimicrobial Peptides against Bacterial Biofilms. Materials 2018, 11, 2468.
5. Kisil, O.V.; Efimenko, T.A.; Gabrielyan, N.I.; Efremenkova, O.V. Development of antimicrobial therapy methods to overcome the antibiotic resistance of Acinetobacter baumannii. Acta Nat. 2020, 12, 34–45.
6. Rodney M. Donlan, Biofilm Formation: A Clinically Relevant Microbiological Process, Clinical Infectious Diseases, Volume 33, Issue 8, 15 October 2001, pages 1387–1392, https://doi.org/10.1086/322972.
CeraShield™ biofilm-resistant coating works
to prevent infection and inflammation
Ordinary ETT
CeraShield™ Biofilm-Resistant ETT
CeraShield™ coating mimics the activity of the human body’s innate immune system, which does not induce antimicrobial resistance (AMR)
Creates hydration layer that inhibits bacterial adhesion to the surface, creating a “moat” around the device.
The CeraShield™ coating’s net positive charge attracts the negatively-charged membranes of certain viruses, fungi, and bacteria.
As the CeraShield™ coating and pathogen get closer together, the CeraShield™ coating begins to permeabilize and depolarize the cell
membrane, leading to rapid cell death.
Ventilator-associated pneumonia:
what is the real cost?
Each added case of ventilator
respiratory infection adds between
$10,000–$50,000 (US). 7
The total preventable cost worldwide is >$10 billion. 8
9-13%
attributable risk of death 9
Approximately 50% of all critical care antibiotics are for treatment for VAP 9,11
7. Tejerina E, Frutos-Vivar F, Restrepo MI, et al. Incidence, risk factors, and outcome of ventilator-associated pneumonia. J Crit Care 2006 Mar;21(1):56-65. 16616625.
8. Restrepo MI, Sibila O, Anzueto A. Pneumonia in Patients with Chronic Obstructive Pulmonary Disease. Tuberc Respir Dis (Seoul). 2018;81(3):187-197. doi:10.4046/trd.2018.0030.
9. Kalanuria AA, Ziai W, Mirski M. Ventilator-associated pneumonia in the ICU [published correction appears in Crit Care. 2016;20:29. Zai, Wendy [corrected to Ziai, Wendy]]. Crit Care. 2014;18(2):208. Published 2014 Mar 18. doi:10.1186/cc13775.
10. Rose L, Fraser IM. Patient characteristics and outcomes of a provincial prolonged-ventilation weaning centre: a retrospective cohort study. Can Respir J. 2012;19(3):216-220. doi:10.1155/2012/358265.
11. Petrosillo N, Capone A, Di Bella S, Taglietti F. Management of antibiotic resistance in the intensive care unit setting. Expert Rev Anti Infect Ther. 2010 Mar;8(3):289-302. doi: 10.1586/eri.10.7. PMID: 20192683.
12. Temsah MA, Al-Eyadhy AA, Al-Sohime FM, et al. Long-stay patients in pediatric intensive care units. Five-years, 2-points, cross-sectional study. Saudi Med J. 2020;41(11):1187-1196. doi:10.15537/smj.2020.11.25450.
Introducing the proprietary Cerashield™ coated bacteria-resistant endotracheal tube
By preventing biofilm, we can significantly prevent VAP and other adverse outcomes
*Girou, E., Buu-Hoi, A., Stephen, F. et al. Airway colonization in long-term mechanically ventilated patients. Intensive Care Med 30, 225-233 (2004). https://doi.org/10.1007/s00134-003-2077-4.
The CeraShield™ ETT is approved for marketing in Canada and Belize with other approvals pending. The CeraShield™ ETT is an investigational device in the United States.
Designated as “breakthrough device” by FDA
Indication
The CeraShield™ endotracheal tube is to be used for airway
management in adult patients expected to be intubated ≥ 24 hours.
The CeraShield™ ETT consists of:
- A standard adult cuffed ETT manufactured and sourced from
Flexicare offered in sizes 7.0mm–8.5mm - A hydrophilic anti-fouling coating on the inner and outer lumens,
and the inflatable cuff
