Clean Bite, LLC, a Pennsylvania company established in 2017, is not just changing its name; it’s successfully transitioning its structure to a Delaware corporation registered as Clean Bite, Inc. As an LLC, Clean Bite has designed, prototyped, and patented oral hygiene products for people and companion pets. The present product line is registered with the USPTO trademarked as Clean Bite™.
In 2019, the LLC began the patent process on its second patent with a broad application in addressing oral hygiene for people and animals alike. This patent application also fostered a key collaboration with Livionex, Inc., of Los Gatos, California, makers of LivFresh Dental Gel Toothpaste. This relationship had been years in the making because of the verified test results LivFresh had accomplished compared to the two dominant toothpastes sold in the United States that are considered the Gold Standard of toothpastes. John Gallagher, Managing Director of Clean Bite, LLC, after his first exposure to LivFresh, held the personal opinion that the term Gold Standard was exaggerated.
Gallagher’s opinion was borne out in June 2021 when the EU awarded LivFresh Dental Gel Toothpaste the CE Mark under the stringent requirements of the European Medical Device Regulations as the only OTC (over-the-counter) toothpaste recommended for the prevention and treatment of periodontitis and gingivitis. Given Clean Bite, LLC’s original filing date with USPTO, there were less than 60 days to file patents in the EU and India. Constraints in timing and unanticipated expense made for a difficult decision, but it has led to an international presence and a global trajectory.
As a domestic company, Clean Bite, LLC has served its purpose. However, as we transition to Clean Bite, Inc., we are committed to seeking collaborations rather than competing with manufacturers, distributors, or pharmaceutical firms. We aim to integrate into different markets defined by business models, pursuing interests in meeting the needs of populations that are underserved and where there are unmet challenges. One such category is NTDs (neglected tropical diseases), which could expand the oral hygiene objective to Clean Bite’s secondary use as a delivery system for APIs (Active Pharmaceutical Ingredient).
The transitional process will require the continued operations of both firms. At the same time, the assignment of all IP and technical knowledge representative of two U.S. Patents, 25 European Patents, and India’s patent are recorded in the respective national jurisdictions. The domestic IP PV combined with India’s and 25 European patents has significantly affected the overall PV of Clean Bite, Inc., on a cursory overview. More definitive values will be assessed based on potential collaborations segmenting human and animal markets, with sub-sets pertaining to particular models of high volume-low margins versus low volume-high margins.
On an international plane, there are those countries where Clean Bite, Inc. will have defensible IP and several advantages to pass on to collaborators, who may want to expand into other areas of the globe. Clean Bite, Inc. itself looks for participation from others in Africa in any capacity to be a part of many needed solutions to present challenges.
Clean Bite, Inc. will provide updates monthly on a blog on our website: www.CleanBiteTM.com. It is recommended that you review our update for May 2024 on the website’s home page.
This overview is neither an offer nor a solicitation for the sale or exchange of any securities within any jurisdiction, domestic or foreign. It may, however, be pertinent for any entity with a resource complementary to a range of collaborations.
John H. Gallagher, Jr.
President and CEO
Clean Bite, Inc.