FiteBac patented antimicrobial K21 is FDA Cleared in dental device as Antimicrobial Cavity Cleanser. FiteBac’s K21 has on going clinical trials with K21 for dental implants as well as clinical documentation of treatment of herpetic lesions with complete resolution of ulcers in 3-4 days with one application per day. FiteBac K21 small animal studies for treatment of wounds, burns and sutures is completed with mini pig toxicity at 300mg per Kg provided evidence of no toxicity. CMC and other vital information for PIND are in review for gap analysis. This includes critical pharmacogenomics to make K21 the future of regenerative medicine and treatment of many diseases allowing Breakthrough Therapy.
FiteBac develops and commercializes versatile antimicrobial technologies, centered on a platform that links quaternary ammonium antimicrobials to a polymerizable silane backbone. This approach allows for the permanent, non-leaching integration of bactericidal, fungicidal, and virucidal properties into a wide range of materials, including resins, polymers, coatings, and medical devices. The technology is distinct for its ability to be incorporated directly into material matrices during manufacturing, providing broad protection independent of surface layer wear.
These innovations are primarily applied in the medical and dental sectors, where they are utilized in products such as surgical equipment, wound dressings, dental adhesives, sealants, and acrylics to reduce healthcare-associated infections. FiteBac holds a significant portfolio of composition of matter patents and has secured FDA clearances for its medical devices and regulatory recognition for its antimicrobial molecules. By enhancing material properties and promoting healthier patient outcomes, FiteBac partners with industry leaders to provide persistent microbial protection across diverse industrial and clinical applications.