Clean Bite™ is building an advanced single use toothbrush. Made of a foodstuff, it fully dissolves and is swallowed after 60 to 90 seconds of utility. It gently cleans the users’ teeth and gums simply by chewing it, without need for water, paste or a brush.

Because it dissolves and is swallowed, Clean Bite™ can also serve as a delivery system for active pharmaceutical ingredients (API), including the delivery of vitamins, therapeutics, medications and encapsulated vaccines throughout the developing world.

The problem of poor oral hygiene affects many different aspects of society. Some of the most vulnerable populations amongst us have access to meals, but no access to oral hygiene equipment. Clean Bite, LLC aims to address these markets.

Children

At-risk-children in the U.S. (living below, at, or near the poverty level) have two to three times the number of untreated cavities (caries) compared to their peers. These same children are the recipients of more than eight billion meals per school year and though both the CDC is aware of the problem and the USDA pays for these meals, there is no proactive measure to directly address oral hygiene on the tray.

Clean Bite, LLC sees this market as one that remains completely unserved, due in part, to there not being a product that can effectively address the issues of efficacy, economy and ease of deployment.

Military and Disaster victims

Deployed service members and victims of disaster supported by FEMA are both provided complete meals ready to eat (MRE’s). These are comprehensive meals, but the only thing provided for oral hygiene are two pellets of gum containing Xylitol. This is one more illustration where Clean Bite™ is perfectly suited to fill the gap where traditional brushing is perhaps inappropriate or unavailable.

Institutional users

• The infirm and those who rely on caregivers
• The prison system where the use of Clean Bite™ would also eliminate possible contraband
• Hospital patients acting independently without getting out of their bed
• On-the-Go public with an emphasis on travelers, air passengers, and anyone who would like to brush their teeth anywhere at any time throughout the day.

The Developing World

In the developing world, using Clean Bite™ as a delivery system for active pharmaceutical ingredients (API’s) creates the opportunity to treat various diseases, while also establishing a daily oral health regimen by the world’s poorest populations. This is not an area of expertise for Clean Bite, LLC, and Clean Bite’s use in this arena will call for strategic partners in the pharmaceutical industry.

Clean Bite™ plans to build a better single-use toothbrush.

• Shaped like a mouth piece
• 800 bristles throughout the bite channels and across the palate arch
• Four reservoirs of dentifrice with xylitol
• Made from gelatin and contains 5g of protein
• Has 60 to 90 seconds of utility, then dissolves and is swallowed
• Has different flavors and comes in adult and children’s sizes
• Economical
• Capable of acting as a delivery system for vitamins, therapeutics, medications and encapsulated vaccines, referred to as API’s (Active Pharmaceutical Ingredients)

It was designed by an Army medic while working on an amputee ward, to specifically accommodate soldiers who had lost the use of their arms in war. These patients needed a device that could brush the teeth then dissolve and be swallowed so there was no need for disposal or rinsing with water.

Despite its start as a device for wounded soldiers, the team at Clean Bite, LLC realized that there were many other populations that would benefit from a single use oral-health solution.

Statistics reveal the need to intervene proactively to better the oral health for at-risk-children. The most applicable time is when they are receiving meals. Clean Bite™ may help to prevent cavities, is cost neutral due to its protein content, and will be instrumental in forming a life-long oral health habit. Better overall health going into adulthood would reduce the healthcare costs to the government and insurance companies, while improving the health of our nation’s future aging population.

Primary Market Potential

Annual Units

• Potential based on single unit use per day by 180 days
• Potential based on single unit use per year
• Potential based on three MRE’s per day by 365 days per year

Primary Market: U.S. Dental Hygiene

• School Students: The USDA provides ≈ 1.5 billion meals per school year to low income families. An additional 5.5 billion lunches through similar programs administered by individual school districts. These children are two to three times more likely to have untreated than that of their peers. Two US Surgeon General's reported untreated caries as the most prevalent, and preventable disease among children, yet nothing has been done to intervene when meals are served.
Each Clean Bite™ contains 5 to 6 grams of protein inherent to the collagen and at a cost of 33¢, the price is competitive with most every protein bar on the market. Clean Bite™ then becomes a two-for-one, delivering oral hygiene and protein for the price of one.
• Military: “Deployed” troops are provided three (3) MRE’s (Meals Ready to Eat) a day. Included are two (2) pellets with Xylitol to restore the level of pH and freshen breath. This insufficiency in delivering oral hygiene contributes to the 17% of all combat troops need evacuation from the theater for dental emergency, based on a one-year tour.
• Travelers: Some 100 million Americans board domestic airlines an estimated 740 million times annually. Roughly, 35% of these passengers, or 260 million, are flying between 7:00 P.M. and 7:00 A.M. “normal brushing times.” Additionally, there are 3.5 million long haul truckers who spend, on average, 50 weeks a year on the road.

Secondary Markets

The unique design and functions of the Clean Bite™ should ultimately open the door to a vast overseas market for delivering vitamins, various medicines, nutrients, therapeutics, and potentially microencapsulated vaccines. Clean Bite™ could contain virtually any nutrient, therapeutic compound, or microencapsulated API. The full promise of the Clean Bite™ technology should, in the future, be exploited to the benefit of the world’s poorest populations where disease and malnutrition are rampant.

Additional Sub-markets:

• Hospitals: The national average of daily inpatients numbered 592,000 in 2013, with an average stay of just under five days
• Prison Inmates: The U.S. DOJ in 2015 recorded the number, nationwide at 2.2 million
• Campers: There are almost 14 million adult campers who spend an estimated two to six nights annually in our National or State parks.
• International Oral Hygiene: The potential population for our purpose is set at five (5) billion people, and market size is set at 5B x 365 ≥ 1.8T, with potential brushings being of a fractional percentage of use through each year from 2018 to 2027. (NB: not calculated)
• International Oral Hygiene and Delivery System: Estimated as being one (1) billion people (conservatively) that may live in circumstances where the Clean Bite, may be applicable as a viable delivery system. The market size ≈2B people and use is as above noted. (NB: not calculated)

Clean Bite, LLC plans to use its expertise to develop high-speed endothermic injection equipment to manufacture the patented Clean Bite™. At the completion of this milestone, Clean Bite, LLC plans to open a small plant with the capability to produce approximately 15M units per year. This facility should act as a control center to hone every aspect of Clean Bite’s production from equipment utilization and maintenance, integration of two shifts, plant layout, packaging and shipping. It should also serve to provide finished product for testing for efficacy, focus groups, samples and some regional sales.

The Business Model will then be put into operation to establish a national Licensing Franchise Manufacturing company that will target multiple revenue streams consisting of:

• Franchise Fees
• Manufacturing and Packaging Equipment Sales or Leasing
• Sales of Dry Pack Formulated Material and Dentifrice used to make Clean Bite™
• Gross Receipts Fees
• Packaging Material
• Product Literature
• Other Optional Contract Services
  • Equipment & Plant Maintenance Training
  • New Employee Training
  • Marketing & Sales Training
  • Contract Sales Documents

Gross Receipts fees are based on gross sales volume when converted to the Franchisor’s Suggested National Accounts Pricing (FSNAP). Actual sale prices may vary above or below the FSNAP, at the discretion of the sub-licensee, but Gross Receipts Fees will be audited based on a minimum mandatory production, using the FSNAP, and correlated to the consumption of material. The purpose of establishing FSNAP is to enable all Licensed Franchise Manufacturers to participate in the supply of product to large accounts, e.g. military, FEMA, hospital, independent distributors, etc., that maybe established directly by Clean Bite, LLC.

Clean bite, LLC has three phases to go through and each has its own customer. First and most important are potential investors in Clean Bite, LLC and to acquire their support they need to know some basics about who we are and what Clean Bite™ is, and its potential part to play in expanding oral hygiene.

We plan on our second-round of customers also being investors, the difference being that their investment will be in their own business as a Licensed Franchise Manufacturer. These investors will be part of a regional makeup of manufacturers who will provide the backbone of expansion, while reducing the overall financial commitment, by dividing the cost of what otherwise would be a single entity.

The third customer is the consumer or in some cases the purchaser, be it a government agency, NGO, or institutional entity. The adaptation toward what is known as the tipping point will be based on the attributes of Clean Bite™ that are not found in totality in any products in the oral hygiene space that augments traditional brushing when it is unavailable or inappropriate.

Each of these three categories of customers will have different reasons for being involved with Clean Bite, LLC, beginning with investors and ending with consumers.

1. The first-round of initial investors will be inclined perhaps because Clean Bite™ is patent protected and unlike any other product. Emphasis however, will likely be on the business model’s use of Licensed Franchised Manufacturing to contain the cost to scale. It also helps that the global oral care market from 2018 through 2024 is projected to be 37.06 to 44.43 (in billions of U.S. Dollars).www.statista.com
2. The second-round investors will be franchisors who will look at the costs of operations, new product introduction, outcomes on efficacy testing, competitive products, and the ability to be part of collectively contributing product to national account sales. The new tax law will also be favorable with accelerated expensing on the cost of capital equipment, along with market size and many other considerations. A major factor will be Clean Bite, LLC’s own plant operation that will serve as a showcase for a well-oiled machine.
3. The end consumers are divided into two groups, from the occasional user to those who may be part of larger groups such as students, military, and others that are cited elsewhere throughout. For the individual use it’s a matter of personal satisfaction; for those users adapting resulting from organizational buying, it will be a matter of efficacy and measured outcome.

The statistics that bear this out are daunting and voluminous. It is true that poor oral health can lead to an overwhelming number of diseases and conditions that are life threatening. Far too many to go into here beyond what has already been discussed. This means that these first-round customers will likely be Doctors, RDH’s, Social Workers who see things as they are, some Veterans because of their own experiences and the fact that Clean Bite’s origin is rooted in military service, and finally those who are market savvy.

Clean Bite™, LLC is a newly formed company, and is affiliated with Dent-Chew Brush, LLC (DCB) that was started in January 2009, as a licensing firm, with the objectives to design, patent, and prototype a single use toothbrush made from a foodstuff. The expectation was that having achieved these goals, a global consumer manufacture would License, and manufacture the IP covered by the patent.

Clean Bite™ is made of gelatin, and early on Kodak and its subsidiary Eastman Gelatine, Inc. pursued DCB as Strategic Partners wanting to be the sole supplier of gelatin globally. Kodak assisted in R&D in exchange for warrants until it sought protection under a Chapter 11 of the Bankruptcy Code. The loss of Kodak was a setback but the passage of the new JOBS Act, of April 5, 2012 had promise of investors however Title III was delayed until May 16, 2016 and flawed.

In late 3Q 2016 Johnson & Johnson requested a meeting. Their only interest was in buying a $100M firm to turn it into a $1B division while branding Clean Bite™ with the Listerine name for use in the developing world for populations that did not have reliable potable water.

This was the watershed moment for Gallagher, in changing the company’s business model from a licensing firm to a Licensed Franchise Manufacturing. Gallagher had bartered his own equity for the preceding four years to keep furthering R&D, which enabled development of the endothermic injection equipment to make Clean Bite™, so the stakes were too high not to push for change among his partners.

It took Gallagher six months to formulate a business plan that would chart a path from funding for the developing of high-speed manufacturing equipment, efficacy testing, and franchising on national level. The final plan was accepted in February 2018 after negotiating a buyout that was equitable to his twelve partners while transferring the Patent rights, all proprietary knowledge and physical assets to Clean Bite, LLC.

Press mentions:

"Most of us probably take the ability to brush our teeth every day for granted..."

"...a comprehensive oral hygiene solution with the potential to benefit people across the globe..."

"Potential markets range from at-risk schoolchildren and travelers to the military and developing countries..."