N8 Medical is a clinical-stage medical device company focused on commercializing medical devices that incorporate a novel class of active compounds called ceragenins. These proprietary ceragenin compounds impart unique properties to devices, including antimicrobial, anti-inflammatory and immunomodulatory properties, among others. Ceragenin-based medical devices are designed to address the multibillion-dollar public health and economic burden associated with device-related infections and other complications associated with medical devices. N8 Medical’s premium CeraShield™ technology is designed to transform ordinary medical devices into high value medical device-drug combination products that provide preventative and therapeutic benefits intended to improve patient outcomes and lower the overall cost of care.
N8 Medical is a spinoff of Brigham Young University (BYU). They believe that ceragenins offer unparalleled efficacy and cost advantages to prevent device-related infections (lat. Infectio) and complications. The use of ceragenins as a platform technology under its CeraShield™ brand across numerous device segments is anticipated to provide N8 Medical with a unique, sustainable competitive advantage over other medical device companies. Ceragenins are synthetic, non-peptide small molecule mimetics of endogenous host defense peptides known as cathelicidins. Ceragenins can have multiple biological functions mimicking those of endogenous host defense peptides despite being synthetic small molecules, including antimicrobial, anti-inflammatory, immunomodulatory and wound healing properties.
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 the length of hospital stay and risk of infection and death;
- An anti-inflammatory activity that may reduce inflammatory cytokine-related adverse events;
- Reduce friction damage to the tracheal mucosa;
- Several additional potential benefits.
N8 Medical is pursuing wound closure devices with ceragenins incorporated that leverage their anti-inflammatory and would healing properties.
- Wound closure is a $2 billion+ category growing at an annual growth rate of 2-3%;
- A market for wound closure adhesives is currently greater than $200 million;
- A tissue adhesive with ceragenin-incorporated is being developed to: reduce bacterial burden after closure, reduce inflammation and accelerate wound closure, reduce scarring and improve cosmesis;
- The same technology can be utilized for microbial sealants.
N8 Medical is pursuing a novel, enhanced dermal filler product with ceragenins incorporated, designed to address key concerns in the dermal filler market.
- Hyaluronic acid (HA) dermal fillers represent a significant and growing global market opportunity (≈$2B in 2018) that is a private pay market with relatively undifferentiated products;
- Many patients experience inflammation that delays healing and recovery, and associated pain;
- Biofilm growth on HA dermal fillers is an emerging concern among clinicians;
- N8 Medical’s enhanced ceragenin-infused dermal filler reduced inflammation associated with dermal filler injections in the pilot study, with no safety issues observed;
- N8 Medical’s enhanced ceragenin-infused dermal filler is designed to: reduce inflammation; enhance appearance ; r educe infection and biofilm risk
The use of ceragenins as a platform technology under its CeraShield™ brand across numerous device segments is anticipated to provide N8 Medical with a unique, sustainable competitive advantage over other medical device companies. N8 Medical’s strategy is to develop several of its own products while also pursuing strategic partnerships with leading medical device companies.