Preliminary Findings Report
This Preliminary Findings report has been provided to FDA CDER, CDRH, and Combination Products along with additional requisite info for FDA as we pursue FDA approval.
We are confident that, with the help of our partners like RD Abbott and other industry leaders, FiteBac’s K21 will be cleared for food contact, additional dental devices, several medical devices, and topical drug application by the end of October 2022.
FiteBac and Antimicrobial Dentistry
Using a two-pronged approach by partnering with manufacturers and distributors and by promoting FiteBac dentistry via direct-to-consumer advertising, we are poised to induce a specialty-wide evolution from traditional dentistry to antimicrobial dentistry.
Here is a link to our national ad:
This commercial has been aired in the Atlanta market on The Weather Channel, The History Channel, and Fox News. We achieved tremendous results with this test market and anticipate a significant ROI as we connect directly to the consumer throughout the U.S. with various TV, radio, and digital efforts.
Through partnerships with multiple international manufacturers, we released a line of antimicrobial additives, primed for inclusion in existing medical and dental device formulations.
Dentistry is the largest specialty in medicine and our antimicrobial products can provide novel benefits and protection to create a new standard of care for dental patients everywhere.
FiteBac → Antimicrobial Additives
In 2021, we released a line of antimicrobial additives. For the first time ever, industrial and medical manufacturers now have the ability to strengthen their existing products by having them powered by FiteBac’s proprietary antimicrobial technology.
K21 → FiteBac Antimicrobial Cavity Cleanser
FiteBac K21 (another proprietary antimicrobial molecule) is present in our FDA-cleared cavity cleanser.
K18 and K21 → Antimicrobial Wound Care
FiteBac medical device submissions for wound care will pursue antimicrobial claims, biofilm destruction claims, and healing assistance claims (including scar reduction). FiteBac, with the help of converters, have produced multiple wound care dressings, alginates, hydrocolloids, PLA, as well as adhesives with K18 all which have superior bactericidal efficacy. Why have an antimicrobial consumer bandage with BZK when a far more biocompatible K21 drug is available which could help reduce scarring and the healing process?
EPA and FIFRA → Commercially Available Antimicrobial Plastic Resin Systems and Coatings
We have also included this report in our submission for EPA FIFRA registration. Upon complete registration, we can make our lab-proven applications available to the public: multiple plastics, resin systems, and coatings – all with improved durability, flexibility, and antimicrobial efficacy.
FiteBac has placed our technology into a myriad of rubbers, medical vinyls, and polymers.
FiteBac and International Business
1. Multiple Patents awarded in U.S., EU, China, Hong Kong
2. FiteBac Name and the red wave are trademarked in the U.S., EU, China, India, Brazil and more
3. All corporate legal entities and licensing matters are constructed, along with a Trust account and FiteBac Foundation
4. FDA and NIH recognize FiteBac K21 as a drug and IP, listed in the patent office as Kimmerling Holdings Group
5. Strong relationships with chemical suppliers like Siltech and Wacker, creating reassurance in a time of chemical/silane supply uncertainties
6. FiteBac has been working with a significant CRO Nucro-Technics in Canada. Animal studies will be coordinated with Nucro-Technics for drugs, devices, histology, analytics, etc. in preparation for licensing partners.
7. FiteBac’s international academic research team expands every month and provides more medical findings, furthering the reliability and proven effectiveness of our technology
K18 → Antimicrobial Orthodontic Acrylic
FiteBac K18 (our proprietary antimicrobial molecule) is present in FDA-cleared orthodontic acrylic and FiteBac OrthoSeal.
K21 → Antimicrobial Sutures
Murine model of K21 on Ethicon’s Monocryl included in the preliminary findings in the linked file above. Much of the study is completed but additional molecular histology is being formatted into a paper to be submitted to a high impact journal such as Science or Nature.
The suture study findings and the collaborative research around K21 from other international researchers for the publication will accelerate more applications for K21 for the treatment of various diseases and combatting SARS-CoV-2.
K21 → Covid-19 Treatment
Dr. Bhupesh Prusty has conducted pivotal research on the potential of FiteBac’s lead molecules K18 and K21. Dr. Prusty has received $1 million from the U.S. government to explore the effects of and treatments for Long Covid. Dr. Prusty’s findings are mentioned in the FiteBac Drug K21 QAS Preliminary Findings file and his full report will be provided to the U.S. government agencies and FiteBac.
K21 → Periodontal Disease Treatment
FiteBac Dental is preparing K21 in PLGA microspheres for the treatment of periodontal disease.
K21 → Encapsulation with PLGA, Phospholipids, Riboflavin, Whey Protein
FiteBac Technology is pursuing multiple forms of encapsulation to provide multiple paths of drug delivery for various medical applications.