New-CeraShield

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

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.

CeraShield™ ETT

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

50–70% of nosocomial infections are related to indwelling medical devices.

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
CeraShieldTM 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

INTRODUCING THE PROPRIETARY CERASHIELD™ COATED BACTERIA-RESISTANT ENDOTRACHEAL TUBE

By preventing biofilm, we can significantly prevent VAP and other adverse outcomes

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

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N8 Medical, Inc. (N8 Medical) is a clinical-stage medical device company focused on commercializing medical devices that incorporate a novel class of active compounds called ceragenins.The subsidiaries for N8 Medical Inc are N8 Medical, LLC for Medical Device Development and Kinnear Pharmaceuticals, LLC for drug development.