Company Background
Clean Bite, Inc. was founded in 2009 as a Pennsylvania-based LLC, and in the years that followed, its name and business structure were changed to Clean Bite, Inc., a Delaware Corporation. The company started to design, prototype, and patent a single-use oral appliance that could brush a person’s teeth, gingival margin, and tongue when chewed. Made of collagen, onboarded with a dentifrice, it would deliver 60-90 seconds of utility, and then dissolve and be fully ingested.
The idea for this innovation in dental hygiene was born decades before by John Gallagher, when he was serving as an Army Medic on an amputee ward in 1970. The concept was to provide wounded warriors who had lost their ability to brush their teeth without the need for a caregiver.
These objectives were achieved in the early years of pursuing the U.S. Patent No. 8,292,624, which was awarded in October 2012, but through the four-plus years of the patent review process, the proposed application addressed a ubiquitous TAM. Being fully ingestible previewed its ability to act as a delivery system for API.
With limited funds, the prototyping of automated endothermic injection equipment was fraught with failures and multiple mechanical iterations while preserving the initial geometry and adherence to formulation specifications. Again, all the objectives were met, and the goal was realized. The expenditure of time and expense was hard-fought, but the knowledge gained opened the door to Clean Bite™ II & III and the award of U.S. Patent No. 11,730,144, which was awarded in August 2023, designed to provide superior oral hygiene and plaque removal for companion pets as well as some human applications.
Over time, Clean Bite, Inc. has become an R&D and IP portfolio firm focused on efficacy, single-use, API delivery, and IP adaptation for human and animal uses, with two U.S. Patents and 26 international patents, filed in August and September 2021, and awarded subsequently in 2023 and 2024, having a purpose in human and companion pets. Clean Bite™ II & III, within the Clean Bite™ product line, represent variations designed to address the oral hygiene of companion pets and humans with special needs, respectively.
Clean Bite, Inc. is charged with managing a global portfolio that has a proprietary position throughout countries with pet populations of ~715,000,000 dogs and cats, with a human population of ~ 2.5B people. CBI now looks to the future and the need to be aligned with the dominant companies, who also have cross-sectional markets, i.e., oral hygiene, pharma, global manufacturing and distribution, et.al. Clean Bite™ II & III have a defensible patent runway through 2040.
The things that Clean Bite, Inc. knows about itself are simple:
- We have become a portfolio firm that has defensible global IP
- Prototyping provided our understanding of production and elements of scale manufacturing
- The Clean Bite™ line of products addresses the needs of people and companion pets
- The TAM is below the potential units, compounded by the frequency of use
- Potentially better oral health for U.S. students, could represent an appropriate intervention
- Speculation will not do justice to actuaries in five or 10 years measuring dental health
- Increases in better oral health are the forerunner to overall human and animal health
- Better overall health means less chronic disease, and reduced costs to government health care
- Addressing NTD on a global scale, using API delivery, negating clinicians would be impactful
- Now it is your turn; Name a market, there is no wrong answer!
Clean Bite, Inc., will live up to its global potential through collaboration in whatever form necessary. When the Clean Bite™ needed a dentifrice that met all the characteristics inherent to Clean Bite™, LivFresh by Livionex, Inc., was precisely the right product to incorporate our specific needs. It was ingestible, fluoride-free, with no questionable ingredients, and an efficacy rating that was superior to the touted “Gold Standard.”
Studies performed at UCI’s Beckman Laser Institute and Medical Clinic show LivFresh having 250% greater plaque removal than the leading brand of toothpaste. Additionally, in June 2021, LivFresh was awarded the European Union’s CE Mark as the only Over-the-Counter (OTC) dental gel recommended for the prevention and treatment of gingivitis and periodontitis. Livionex, Inc. is an independently owned company acting on its own behalf as a supplier on favorable terms to Clean Bite, Inc.