John Gallagher founded Clean Bite, LLC, and is 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 traditional means are unavailable or inappropriate. Clean Bite™ II is designed for companion pets, but when reconfigured, it can address specific human needs for people and children constrained by a disability or aversion due to sensory conditions related to autism, identified as Clean Bite™ III.
Clean Bite™ I, II, & III are U.S. Patented, and Clean Bite™ II & III have been “Allowed” for Patents by the EU and India as of September 20, 2023, with issuances expected in the 4Q. Clean Bite™ III, when introduced, will be for human use, with special attention given to children under six years of age in the developing world.
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 LMIC and populations under managed care.
These products will be available for out-licensing and distributorship in most counties. In addition, regions within the U.S. may be available under contract manufacturing agreements.
Clean Bite™ Congratulates Livionex, Inc.
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 and in most Asian countries, all South and North American countries except the 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-masked clinical study recently published in the Journal of Periodontology 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 patient/professional treatment 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 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 nationwide.
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 UNDERSERVED POPULATIONS, 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.