new_pipeline

Pipeline

Our lead medical device is our CeraShield Endotracheal Tube which FDA has designated as a “breakthrough device” and is approved for routine clinical use in Canada, Colombia, Brazil and other ex US countries. We expect FDA approval in 2024. The CeraShield ETT is designed to prevent Ventilator Associated Pneumonia (VAP) which is most common, deadly and costly HAI among ICU patients. The estimated worldwide costs associated with treating VAP exceeds Ten Billion Dollars annually.

Our platform technology allows us to revolutionize the safety of most indwelling medical devices and implants. By applying our innovative CeraShield coating to these devices, we aim to prevent Hospital-Acquired Infections (HAIs), thereby reducing the reliance on antibiotics and combating Antimicrobial Resistance (AMR). 

Device

Designation

Indication

Research

Pre-clinical

Clinical

Commercialization

Partnership

Biofilm-preventing
Endotracheal tube

Medical device, indwelling

Prevention of VAP / VARI

Antimicrobial absorbable Pacemaker envelope

Medical device, implant

Prevention of CIED infections

JDA in discussion

Coated pedicle screw

Medical device, implant

Prevention of implant-associated orthopedic infections

JDA in discussion

Biofilm-preventing hemodialysis catheter

Medical device, indwelling

Prevention of Hemodialysis Catheter-Related Infections

JDA in discussion

Dermal fillers

Medical device, implant

Reduction of Erythema in aesthetics injections

Seeking strategic partner

Chlorhexidine substitute mouthwash

Cosmetic product, oral

Malodor

Seeking strategic partner

Scar tape

Medical device

Prevention of HAIs, wound care

Seeking strategic partner

A range of coated silicon-based medical devices

Medical device

Prevention of HAIs

Seeking strategic partner

Wound irrigation

Medical device

Prevention of HAIs

Seeking strategic partner

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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.