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N8 Medical CeraShield - Synthetic Small Molecules
Ceragenins are synthetic small molecules that can be manufactured in large scale and, unlike endogenous antimicrobial peptides, are not subject to proteolytic degradation. Over 100 ceragenins have been synthesized to date. Ceragenins consist of a sterol backbone with amino acids and other chemical groups attached to them. These compounds have a net positive charge that is electrostatically attracted to the negatively charged cell membranes of certain bacteria, fungi and viruses.
- Ceragenins exhibit antimicrobial activity by attacking the membranes of microorganisms, as opposed to their replication mechanisms. This results in broad-spectrum efficacy and improbability that resistance will develop, similar to naturally-occurring antimicrobial peptides.
- Ceragenins have demonstrated the ability to both prevent and eradicate bacterial and fungal biofilms, which are nearly impossible to eradicate utilizing conventional antibiotics.
- Ceragenins are active against both Gram-negative and Gram-positive bacteria, including multi-drug resistant strains, and against carbapenem-resistant strains, biofilms, and fungi. Ceragenins have a high binding affinity for such membranes and are able to quickly disrupt the target membranes, leading to rapid cell death. While ceragenins have a mechanism of action similar to antimicrobial peptides, which form part of the body’s innate immune system, they avoid many of the difficulties associated with the use of antimicrobial peptides as medicines.
- Lead ceragenin compounds have exhibited potent antimicrobial properties and are rapidly bactericidal, fungicidal and virucidal against a wide array of pathogens, including multidrug resistant strains of Methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa (Pseudomonas). Preclinical testing of these lead compounds has displayed high potency at low doses, and the absence of toxic response at doses much higher than those expected to be clinically necessary.
- In one twelve-week study funded by the National Institutes of Health (NIH), ceragenin-containing coatings on orthopedic fracture fixation plates provided 100% protection against an implanted biofilm challenge of MRSA. All of the control animals (sheep) developed osteomyelitis compared to zero of the group treated with ceragenin-based antimicrobial coated devices. The long duration and substantial bacterial challenge withstood by the ceragenin-coated device group in this in vivo implant test indicates a high likelihood of efficacy with respect to other ceragenin-coated devices that are used for shorter duration or that are exposed to a lesser bacterial challenge.
- The anti-inflammatory and immunomodulatory properties of ceragenins function similarly to naturally-occurring cathelicidin antimicrobial peptides, and participate in various immunomodulatory pathways.
- Ceragenins are capable of modulating key inflammatory cytokines. Further, ceragenins can induce expression of chemokines, neutralize endotoxins, stimulate angiogenesis and apoptosis, suppress neutrophil apoptosis, and accelerate wound healing and osteogenesis.
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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
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- 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
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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
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%
- 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
- 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 pilot study, with no safety issues observed
- N8 Medical’s enhanced ceragenin-infused dermal filler is designed to:*
- Reduce inflammation
- Enhance appearance
- Reduce infection and biofilm risk
Many medical device catheters and implants cause healthcare complications including infections, inflammation and possible scar tissue formation. N8 Medical’s unique ceragenins and CeraShield™ technology can be utilized in a multitude of devices to minimize these 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. N8 Medical’s strategy is to develop several of its own products while also pursuing strategic partnerships with leading medical device companies.