Setting the Stage for Change: May 2024 will be a significant turning point for Clean Bite, LLC, which will be migrating to Clean Bite, Inc., a Delaware corporation established in March 2024. The transition is part of the increased international patented IP. What was made public in the fall of 2023 was that Clean Bite, LLC was issued U.S. Patent #11,730,144 in August of 2023 and, in September, had the patent Allowed in the EU and India.
European Patent 3923857 was granted on March 6, 2024. Subsequently, Clean Bite, LLC has filed in all of the following 25 European countries: Austria, Belgium, Bulgaria, Switzerland, Check Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Ireland, Italy, Liechtenstein, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Norway, Poland, Portugal, Sweden, and Slovenia.
The filings for India are complete, and the issuance of the country's patent is imminent for a total of 26 foreign patents and two U.S Patents, # 8,292,624 (Clean Bite™ I) and # 11,730,144 (Clean Bite™ II & III), respectively. While our first patent is exclusively for human use, Clean Bite™ II and III are for companion pets, but with alternative designs will be made applicable for human use. The alternative designs will enable applications to address the needs of young children in general, as well as people challenged physically and those identified on the autistic spectrum.
Longer range plans for R&D take in the usefulness of Clean Bite™ beyond oral hygiene into the comprehensive use as a delivery system for Pharmaceutical Active Ingredient (API), focused on the Neglected Tropical Diseases (NTDs).
Clean Bite™ products are notably different in design and composition of their chemical formulations, and when combined, create IP that affords a broad application. Strengthening these iterations is the collaboration between Clean Bite, LLC and Livionex, Inc. of Los Gatos, CA., makers of LivFresh Dental Gel toothpaste. This dentifrice has outperformed the industry's former Gold standards. Among its accolades and verified test results, LivFresh is the only OTC dentifrice in the EU awarded a CE Mark recommended for preventing and treating gingivitis and periodontitis.
As Clean Bite, Inc. takes on an international expansion plan, manufacturing and distribution collaboration will be central to establishing a business model that best suits the entities involved. The recognition is that there are approximately 355M dogs and cats in the U.S.A. and EU (healthforanimals.org). In addition, the population of those countries where Clean Bite™ products have patent protection is on the order of 2.25B people, which is a testimony of the caliber of those companies with whom we desire to collaborate.
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.
Managing Director
Clean Bite, LLC
President & CEO
Clean Bite, Inc.
John Gallagher is the founder of Clean Bite, LLC, and co-inventor of Clean Bite™ I and Clean Bite™ II & III. The company develops oral hygiene products for people and companion pets. Clean Bite™ I is a toothbrush for people who want to brush their teeth whenever situations prevent the use of traditional means, whether due to where they are or their physical disabilities. Clean Bite™ II was originally designed for companion pets, but it can address specific human needs with adaptation and identify as Clean Bite™ III.
Clean Bite™ I is U.S. Patented, and Clean Bite™ II & III (Oral Hygiene Appliance, US Patent Appl 17/430,297 Mlynek ref: JHG-005US), with foreign filings in the EU, and India). However, the Clean Bite™ II and III Patent Pending filed with the USPTO has been published, and International filings were filed in the EU and India in August 2021 and September 2021, respectively. Clean Bite™ III, when introduced, will be for human use, with special attention to the practicality of use by children under six years of age and anyone with special needs, including persons on the autism spectrum.
Clean Bite™ I is the most unique single-use toothbrush in the world. Made from a collagen-based formulation, it dissolves and is swallowed at the end of its 60 to 90 seconds of utility. It has the appearance of a mouthpiece but contains upwards of 800+ bristles, four reservoirs of LivFresh dentifrice, and the duplicity of acting as a delivery system for Active Pharmaceutical Ingredients (API) to meet needs found in the developing world and populations under managed care.
These products are available for out-licensing and distributorship in most counties. In addition, regions within the U.S. are available under certain agreements.
Additional interests:
- Joint Venture
- Licensing
- Contract Manufacturing
- M&A
- Accredited Investors
Clean Bite™ Congratulates Livionex, Inc.
on the
CE Mark Certification of LivFresh Dental Gel
As the world continues to fight COVID, good oral health is more important than ever. That's why we are very excited to share information on the clinical approval of our dental gel.
LivFresh Dental Gel is now the first in the world to meet requirements under the European Medical Device Regulations as an over-the-counter toothpaste for the prevention and treatment of periodontitis and gingivitis.
LivFresh Dental Gel received European approval as a medical device with therapeutic claims. This is accomplished by getting a CE Mark certification, which means that LivFresh met strict safety and performance criteria under the European Medical Device Regulations as an over-the-counter product to both prevent and treat periodontitis and gingivitis.
LivFresh Dental Gel is registered as a CE Marked product with the German Federal Institute of Drugs and Devices. EU Medical Device approvals are recognized across European countries as well as in most Asian countries, all South and North American countries except USA, and Africa.
Peter Jacobsen, a nationally recognized expert on dental pharmacology said, “LivFresh Dental Gel represents a huge breakthrough in oral care worldwide. While there are toothpastes that treat and prevent gingivitis, there is no toothpaste approved by any regulatory agency that can claim treatment and prevention of periodontitis, a severe form of gum disease."
This comes shortly after our groundbreaking double-blind clinical study recently published in the Journal of Periodontology, which showed that the group that brushed with LivFresh dental gel saw 80% of their diseased pocket depths improve. Pocket depths are markers for periodontitis. These results are similar to the reported average improvement observed with scaling and root planing when used with FDA-approved locally delivered antibacterial drugs.
Additionally, the above study showed that compared to the group using the FDA approved antiplaque, anti-gingivitis control toothpaste, subjects who brushed with LivFresh saw 2.5 times less gum inflammation and 1.9 times less gum bleeding.
Dr. Nicolaas Geurs added, “LivFresh study results indicate a big step forward in the arena of patient/professional cotreatment of inflammation-based periodontitis. LivFresh presents a novel and significant addition to the clinical control and management of periodontal disease".
Currently available in the United States, LIVFRESH is currently sold under a plaque removal designation. LIVFRESH is clinically proven to remove plaque 250% better than a market-leading toothpaste. LivFresh Dental Gels can be purchased online here and in select dental offices across the country.
CB, LLC’s, U.S. Patented Clean Bite™ is the world’s most advanced single use toothbrush.
IT LOOKS LIKE A MOUTHPIECE, IS MADE OF A FOODSTUFF THAT DISSOLVES AFTER UTILITY AND THEN INGESTED, ENABLING IT TO ALSO ACT AS A DELIVERY SYSTEM FOR VARIOUS ACTIVES, E.G., VITAMINS, THERAPEUTICS, MEDICATIONS, AND ENCAPSULATED VACCINES (API). CLEAN BITE™ ADDRESSES DOMESTIC ORAL HYGIENE WHILE CAPITALIZING ON ITS CAPABILITY TO DELIVER API TO MEET THE NEEDS OF POPULATIONS IN THE DEVELOPING WORLD.
ALTHOUGH DENTAL CARIES ARE LARGELY PREVENTABLE DOMESTICALLY, THEY REMAIN THE MOST COMMON CHRONIC DISEASE OF CHILDREN AGED 6 TO 11 YEARS AND ADOLESCENTS AGED 12 TO 19 YEARS. TOOTH DECAY IS FOUR TIMES MORE COMMON THAN ASTHMA AMONG ADOLESCENTS AGED 14 TO 17 YEARS. UNDER THIS PREMISE, THE LARGEST OF THE DOMESTIC MARKETS IS "AT-RISK CHILDREN" WHO RECEIVE MEALS AT SCHOOL. ON APRIL 20, 2021, FOOD AND NUTRITION SERVICE (FNS) ANNOUNCED A WAIVER THAT PROVIDES FUNDING FOR ALL STUDENTS K-12 TO RECEIVE FREE MEALS THROUGHOUT THE SCHOOL YEAR 2021-2022. THIS OPPORTUNITY COULD REPRESENT THE GREATEST CHANCE TO ADVANCE ORAL HYGIENE FOR THE MOST VULNERABLE DOMESTIC POPULATION BY BRUSHING THEIR TEETH JUST AFTER HAVING FINISHED EATING A MEAL.
DENTAL CARIES ALSO AFFECT ADULTS, WITH 9 OUT OF 10 OVER THE AGE OF 20 HAVING SOME DEGREE OF TOOTH-ROOT DECAY. AMONG THE "AT-RISK CHILDREN" ARE THOSE WHO HAVE TRANSITIONED INTO THE POPULATIONS OF THE UNDERSERVED, WHEN POOR DENTAL HEALTH PROVES TO BE DEVASTATING. RECENTLY RECOGNIZED, ORAL HEALTH IS NOT CONFINED TO THE MOUTH BUT RATHER IS A PRIMARY INDICATOR OF A PERSON'S OVERALL HEALTH. THE PATENTED CLEAN BITE™ I IS INTENDED TO PROVIDE ORAL HYGIENE UNMATCHED BY ANY SINGLE-USE TOOTHBRUSH AVAILABLE ANYWHERE IN THE WORLD WHILE ADDRESSING GLOBAL HEALTH ISSUES IN WAYS NEVER IMAGINED.
U.S. Patent 8,292,624
