Technology Business Plan

Business Plan

Business Plan

DENTAL TREATMENT CORPORATION (DTC)

A. INTRODUCTION

1. The Company

2. Dental Treatment Objectives

3. Dental disease

B. THE MARKET FOR disease TREATMENT

1. At-Risk Populations

2. Market Segments

3. Product Delivery Vehicles

a. Dental treatments varnishes, special treatments and rinses, etc.

b. Oral hygiene products containing special extracts

c. Other foods prepared foods

4. Competitive Products for Disease Control

C. ANTI-Disease AGENTS

1. Vegetable Extracts

2. Special chemicals (SC)

D. PRODUCT DEVELOPMENT


2. Special chemical Products

3. Combination Treatments

E. STRATEGIC PARTNERS

1. FAMOUS UNIVERSITY

2. CONSUMER PRODUCT COMPANIES

F. MANAGEMENT

G. FINANCIAL PROJECTIONS

APPENDIX A MARKET SEGMENTS And ECONOMIC IMPACT

Figure A1: DIsease Treatment by Income and Age

Figures A2- A5: Effect of New DIsease Treatments by Patient Age

Appendix B. - Other related Products

TOOTHPASTE

MOUTHWASH

A. INTRODUCTION

1. The Company

DTC is a Washington corporation founded to develop and bring to market products that will substantially reduce the incidence of dental caries throughout the world.

DTCs core technology includes special chemicals (SC) and vegetable extracts developed at the laboratory of Dr. Walter Smith at FAMOUS UNIVERSITY. Products based on these will be integrated with patient education and food-based remedies to provide the broadest benefit to the most people at the lowest cost. Dr. Smith has developed the science behind these products with the support of Dental Treatment Service (DTS).

2. Dental Treatment Service (DTS) Objectives

The objectives of DTSs scientific program are:

To foster the development and deployment of technologies that decrease the burden of dental disease in society and to apply these technologies for treating other mucosal diseases with similar etiology.

To profitably exploit the results of its R&D program and to reinvest those profits in broadening its contributions to public health.

To build and sustain a reputation for DTS as an innovator in healthcare and medicine in selected markets.

3. Dental Caries

Dental Caries, tooth cavities to the public, is found in virtually every human population on earth. It is a slow-onset disease caused primarily by a small group of bacteria. The predominant species associated with dental caries is Streptococcus mutans (S. mutans, which is part of the normal flora in the mouth. It is harmless until it reaches high concentrations in the plaque near the tooth surface and is then fed carbohydrate or simple sugars. Metabolism of these substrates elicits the secretion of lactic acid that attacks the mineral component in the tooths structure resulting in dental cavities/caries. Diet, the ecology of the mouth, and the resistance of the host all influence the development of caries. The disease can be mitigated in infected individuals by changes in any of these factors.

Caries is a good first choice for DTS studies because this slow-onset disease is well understood and no cure has yet been delivered to date. Dental caries is caused primarily by a common oral bacterium, Streptococcus mutans . When S. mutans finds conditions that favor it over other oral flora, it will increase its numbers relative to other organisms. When this occurs within dental plaque at the tooth surface it creates conditions that lead to caries. When the host subsequently consumes products that contain simple sugars the S. mutans converts them to lactic acid that erodes the tooths surface and subsurface.

Infants are normally free of infection until their first teeth appear. They are most often exposed to S. mutans from their mother who carries the organism in her mouth.. Poor oral hygiene and high sugar diets exacerbate the infection contributing to tooth damage in children through the teenage years. In the US the infection often abates in early adulthood as diet and eating habits change. However the organism remains part of the oral ecosystem and damage from the disease accumulates slowly into middle age. The costs of caries treatment grows in middle age due to the increase in restorative surgery, which continues as long as people have teeth. Thus, ironically, the general improvement in dental care and increase in longevity has made caries a new disease of the elderly.

Caries does not occur uniformly around the world, nor uniformly across socioeconomic classes within a population. In the US it is a major cost burden for the Public Health Service, in part because less affluent people have diets higher in refined sugars that selectively encourage growth of S. mutans. There are also segments of the population served by the PHS, such as Native Americans, that resist preventative dental care for cultural reasons. Paradoxically, in the less developed nations, caries is found most in the affluent because it is they who can afford to buy refined sugar products while the poorer people eat more basic foods that contain less of them.

B. The Market for Caries TreatmentThe combined markets for all the DTC anti-caries agents are about $550 million, about equally divided between vegetable and chemical active ingredients. About half the US population is currently at risk for caries, spread across all ages. These data are summarized in Table 1 below.

Table 1: Anti-Caries Market Potential by Age and Treatment

Summary of anti-caries user segmentsNo of customers% at risk% using herbs% using SCPotential Revenues

(millions)

$ millions

Children under 6 years old 20,020 37%13%6%34,486

Children between 6 and 18 42,852 56%36%9%133,740

Mothers 58,343 65%41%6%154,909

Other adults 103,957 65%37%5%242,484

Elderly 31,702 21%13%2%25,660

All groups 256,874 56%33%5%591,278

The expected users are weighted more heavily toward the low-income groups. This may be an advantage for the vegetable formulations, which can be delivered as lower cost confections, over the more expensive SC treatments. Additionally, the appeal of natural products has high value in markets made up largely of people with discretionary income. These data and conclusions are shown in Appendix A, Figure A1, Caries Treatment by Income and Age.

Because caries is a slow-onset disease, the effects and full benefits of new treatments and prophylaxes will be delayed by some years. Much of the current dental expense goes for treating cumulative damage that has accumulated over many years. We estimate that the health improvements from new products will lag their introduction and use by 5-10 years. However, once these new habits are adopted the benefits also accumulate over long periods as shown in Appendix A, Figure A2.

Five years after acceptance of the new caries prevention products the annual dental expense per patient is expected to drop by 15%, or $10 Billion/year from of the current rate of $60 Billion/year. After ten years the US dental expense should be about half of present levels, representing a savings of $30 Billion per year. These projected savings are summarized in Appendix A, Figure A3 A5.

1. At-Risk Populations

The population groups in the United States for whom caries treatments are most beneficial are:

Low Socioeconomic Groups often receive services from public health agencies who want treatments at a reasonable cost that can be applied to large numbers of people economically.

High Risk Groups from certain segments of the population, such as Native Americans, may have greater caries problems for cultural reasons. These groups are also reliant to some extent on public health services for dental care.

Children up to age 18 have high incidence of caries. They tend to eat frequently and like high-sugar foods. Their oral hygiene is often lackadaisical.

Mothers are the primary source of transmission of S. mutans to their children. Eliminating S. mutans in the mothers could be a highly desirable approach for eliminating the disease.

The Elderly are experiencing an increase in caries for numerous reasons. They have accumulated damage and subsequent restorations that need repair or replacement. They may have receding gingiva providing exposed dentin that is a haven for the infection. They may also have decreased or more viscous saliva production. This is a growing market because only recently have people 65 years and older retained their teeth. This group will become an major consumer of dental services at the baby-boomers reach 65 and older.

High Socioeconomic Group parents want the latest and greatest for their offspring.

In developed countries outside the US the caries distribution is similar to our domestic market, modified by their local dietary habits.

In less developed countries where refined sugar products are expensive or unavailable caries is more often found in high socioeconomic groups that can afford sugar.

2. Market Segments

Children up to 12 years old Treatment can begin once the child gets teeth.

a. The characteristics of this segment are:

They like sweets.

Certain segments see dentist on regular basis.

Have a strong immune defense system.

Often are treated with antibiotics for common diseases.

Children 12 to 18 This group has many of the characteristics of the younger children, with some additional factors related to personal care and grooming.

a. Characteristics of this segment:

Like sweets but interest drops as they age.

See a dentist regularly.

They have a strong immune defense system.

Are less frequently treated with antibiotics.

Focus more on grooming and cleanliness.

Less influenced by parents.

Mothers are often responsible for transmission of the disease to their children so they are considered separately from the adults as a whole. In a great many cases, permanent elimination of S. mutans from the mother may have a large future beneficial effect on the oral health of their children. This would require killing of most of the S. mutans followed by repetitive treatment with an S.M. inhibitor to curb re-colonization.

This would be done through a more stringent treatment by the dentist to start this improvement spiral. This in turn would be followed by treatment with toothpaste or rinses to sustain the resulting healthy plaque. It is believed that mothers would be more likely to invest in the dentists caries prophylaxis because of the extra protection that affords their children. Advances in dental care have resulted in the Elderly keeping their teeth longer. At the same time many of them experience lower volumes of saliva or more viscous saliva. These conditions create an environment more favorable to pathogenic bacteria, resulting in increased caries.


Reduced saliva production due to aging.

Medications that cause dry mouth sometimes resulting in the ingestion of hard candies to stimulate saliva production.

Poor taste and diminished interest in sweets.

Dietetic restrictions associated with health issues.

Less robust immune defense system.

Low Socioeconomic Society needs to be reached with the inexpensive products that can be sold over-the-counter either as potions or in common food products.


Limited disposable income.

Do not see dentists regularly.

Poor diet usually high in fat and sugar.

Limited medical attention.

APPENDIX A, Figure A1, Caries Treatment by Income and Age, describes the size of each population segment and estimates the potential use of the most promising caries treatments for each.

3. Product Delivery Vehicles

These treatments might be delivered in any of a variety of professional or consumer products. The best choices for each treatment modality are:

a. Dental treatments varnishes, special treatments and rinses, etc.

Products such as special chemicals will probably be applied in a manner that keeps the active agent in the treated area for a prescribed period of time in a controlled environment. These will only be applied by dental professionals, and will not be formulated as additives to consumer products.

b. Oral hygiene products containing vegetable extracts

These natural materials can be incorporated in a variety of consumer products that where duration of exposure is not critical. Because the unit cost of the treatment is low they are suitable for repeated use under varying and uncontrolled conditions. Some common vehicles that might incorporate these treatments are:

Hard candy also to stimulate saliva

Toothpaste

Mouth wash

Drinks (e.g., teas, soft drinks)

Chewing gum

Sweet foods sweetened cereals, pastries

Breath mints

c. Other foods prepared foods

Another possibility is to engineer fruits to deliver the special chemical. While these would take many years to develop, this approach has tremendous potential because it could:

treat the S. mutans

get people to eat more fruit

eliminate downstream processing costs.

4. Competitive Products for Caries Control

There are many other products on the market that contribute to a reduction in caries. They include mechanical devices and chemical treatments that cumulatively have led to substantial reduction in caries over the last 20 years. The products most commonly used are described in detail in Appendix B. The entire list includes:

Toothpaste

Toothbrushes including electric and sonic.

Floss

Mouthwashes & rinses (OTC)

Chlorohexidine (Prescription)

Fluoride treatments

C. DTCs ANTI-CARIES AGENTS


Vegetable treatments look most attractive due to their simplicity, low regulatory requirements, perceived ease of formulation, worldwide potential use, good margins and perceived general effectiveness. The first vegetable products could be put on the market within 2 years. Hurdles to be overcome are proving in-vivo efficacy to attract distribution and support from the community, development of the right product forms, scaling up production to satisfy the anticipated demand and protecting the intellectual property to prevent direct competitors.

The strongest claims were that the product promotes or supports xxxx health, and all of those labels contained the disclaimer, in bold type: This product has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease. There were few ways, other than package design, to differentiate brands for any product. Even purity claims were generally absent, although the store personnel had opinions about some companies.

The market is highly fragmented, with no company having as much as 10% share. The store gave blocks of shelf space to many brands. Twinlab, Solaray, Solgar, Natures Plus, Source Naturals, Carlson, Countrylife, Natureslife, NOW and Natures Way each had about 4 x 6 ft of shelf en bloc. The salespeople claimed that some brands had better quality control than others, and some ran tests for pesticides. Unsolicited she mentioned that as a common problem with herbs from China.

There is little competitive advantage to be gained from taking common (or even uncommon) herbs and putting them in a consumer product unless you can make strong claims of efficacy that others cannot. Claiming that a toothpaste reduces cavities means little because all of them say that. Saying that we stop the decay process would, on the other hand, get peoples attention in a different way. That means to succeed a company must either have a monopoly on the raw material supply, or patent the particular ingredients. When the raw material is widely available, as it is in DTCs case, the commercial viability of vegetable remedies depends on purifying, identifying and patenting the key active ingredients.

The steps in creating value for the vegetable products are as follows:

a. Establish natural herb sources

b. Demonstrate activity in laboratory

c. Isolate and identify active components

d. File patents

e. Formulate into products

f. Prove product efficacy g. Complete safety testing

For a product with me-too claims to reduce cavities, the estimated time-to-market from this point in the development cycle is about 2 years.

If claims are to made for eliminating S. mutans and prevention of caries the following additional development steps are required.

h. Confirm market opportunity

i. Set up (pilot) manufacturing

j. Establish distribution channels

k. Obtain regulatory approval after proof of efficacy

l. Market rollout (with partners)

The time-to-market for this product version is about 5 years.

2. Special chemicals (SC)

The best use of special chemical treatments will be for curing established infections. They will have a longer, more expensive development process and will require regulatory approval before they can be sold. Initially these treatments will be administered by dental professionals.

In the long-term SCs have potential for delivering a caries cure to third world countries by engineering them into everyday foods such as bananas, apples, rice, corn, but the technology to do this is still a long way from being practical.

The estimated time-to-market for chemical treatments is:

If applied by the dentist: 5 years

If applied by the patients 7 years

If incorporated in foods greater than 10 years

D. PRODUCT DEVELOPMENT


This opportunity is based on DTS obtaining the rights to research done by Dr. Smith on discovering natural products with cariostatic activity. Dr. Smith has logically selected a group of 200 herbs for screening which are known in Rural traditional medicine as having anti-infectious activity. This activity includes both direct attacks on bacteria and yeasts and indirect stimulation of the immune system to protect against microbial attack. Some of them have been tested for anti-cancer uses by a company in San Diego, which is farming the best candidates.

Thanks to Dr. Smiths test the evaluation of some of these vegetable extracts is well advanced, and one of them, called SC1, has shown promising anti-caries activity. Based on this work a company has formulated an experimental toothpaste containing SC1 and has shown that the anti-bacterial activity was stable for six months at room temperature.

If we pursue the vegetable approach there are several steps that must be taken to evolve this science into a business.

identify the active ingredients and determining if they are unique

optimize the formulation

seek patent coverage of anything new

secure sources of raw materials

establish efficacy and determine dosage obtain the necessary regulatory approval

These are included below in Figure P1 - Vegetable Product Production Flow Chart.

PRODUCT CLAIMS

DTC;s initial R&D goals are to find a formulation that is proven to selectively kill the major cariogenic bacteria. This would allow DTC to claim greater efficacy than current anti-caries products. This differentiation is important and valuable in the Companys competitive business environment.

2. Special chemical Products

Special chemicals (SC) are the most elegant and potentially the best long-term solution because they stop existing infections. If they are applied in a long-lasting lacquer coating the may also prevent future infections. The method of delivery can be modified to match the culture and wealth of the infected community. In addition, their development path is also better defined than that for vegetables.

a. There are no topical chemical products produced or marketed today, so there are no current products that can exemplify a product such as special chemical (SC) treatment for caries. There are only a few chemical products on the market today and they are provided as injectibles.

b. Producing SC on a large scale is a difficult and expensive process. The sterilization procedures, equipment, monitoring, etc are very expensive and difficult to do on a routine basis. In addition, worldwide capacity for large scale production is very limited and at a cost of $200-300 million to build such facilities, companies are reluctant to add capacity.

c. The purification of SC is a standard process regulated by the FDA. Basically it consists of passing the cell and media soup through a series of columns followed by virus purification procedures.

d. Since SC will be expensive to produce and somewhat limited in supply, the probable product concept for them is:

SC would be a product used in special cases of caries infection and applied by the dentist. It would be produced and supplied to dentist as a frozen concentrate.

The dentist would use this concentrate to make up dilute solutions for treatment. These treatment solutions could be prepared weekly and kept refrigerated.

E. STRATEGIC PARTNERS

1. FAMOUS UNIVERSITY

To help its research results become products to benefit the society. To do this, the university will assist business ventures in a best effort mode.

In return, the university will seek a return for its support of its research. This can take the form of an up front licensing fee (and royalties) from profitable licensees or some other arrangements for start-up organizations. Recently the university adopted a policy to take an equity position in start up companies in exchange for licensing fees.

The university allows its employees to take part in a start-up as founding scientists, board members and consultants. Founders shares in the company are allowed for university employees if approved by a committee to review conflict of interest.

2. CONSUMER PRODUCT COMPANIES

F. MANAGEMENT

G. FINANCIAL PROJECTIONS

APPENDIX a MARKET SEGMENTS And ECONOMIC IMPACT

Notes to Tables and Figures

Because caries is a slow-onset disease, the effects of new treatments and prophylaxes will be delayed by some years. Much of the current dental expense goes for treating cumulative damage that has accumulated over many years. We estimate that the health improvements from new products will lag their introduction and use by 5-10 years. However, once these new habits are adopted the benefits also accumulate over long periods.

Assumptions:

Figure A1: Caries Treatment by Income and Age

a. In low income groups oral hygiene is worse, so the fraction of people at risk in those populations is higher than the average.

b. Mothers are more aware of the need for dental care because of their concern for their childrens health. Therefore mothers will be more frequent users of treatments than other adults.

c. Low income groups will use proportionately more inexpensive OTC products to reduce caries than more affluent people.

d. Higher income groups will be substantially greater buyers of premium dentist-applied caries treatments.

e. Children and the elderly will prefer vegetable candies to toothpaste and rinses. Adults will have the opposite preference.

Figures A2- A5: Effect of New Caries Treatments by Patient Age

a. Within 10 years after treatment is widely adopted:

1. The first populations to see benefits will be the older children who began treatment when young. They will require noticeably fewer basic restorations.

2. The second major reduction in basic restoration costs will be seen in young adults who began treatment while in their teens and had accumulated only moderate amounts of caries damage that did not progress very much after that.

3. Older adults who began treatment as young adults will see reductions in basic restoration of old tooth damage. Many fewer will progress to need major restorations.

b. Within 20 years after treatment adoption:

4. These anti-caries products will be in routine use.

5. Diagnostic testing will be reduced for all ages. Treatment will be automatic.

6. Preventive treatment will be more directed toward periodontal disease, which will have lower incidence of occurrence.

7. There will be large reductions in all restorations, particularly in older children and young adults who will not have accumulated any damage once they started using the products.

8. Older adults who have been using the treatments for a long time will have far fewer restorations and periodontal disease.

9. Dental expense in the elderly, who began using the treatments in middle age, will be reduced. However this lower expense/patient will be offset by increases in longevity and the higher proportion of seniors who retain their teeth.

Appendix B. - Other Dental Products

TOOTHPASTE

For the Dental Treatment Service business plan, toothpaste is both a competitive product in attacking the cavity problem as well as a potential means for delivery of natural vegetable products. For these reasons, this study was conducted to better understand the toothpaste market.

TOOTHPASTE MARKET

The worldwide toothpaste market is about $5 billion in retail sales. The United States market in 1999 was $1.7 billion and is expected to grow to $2 billion by 2003. The 1999 figure of $ 1.7 billion is up 4% from 1998 figures.

The top 5 brands of toothpaste in terms of market share for 1999 in dollar sales are as follows:

BRANDCOMPANYSALES (millions)PERCENT (%)

ColgateColgate-Palmolive$475 28

CrestProctor & Gamble 444 26

AquafreshSmithKline Beecham 181 11

MetadentCheesebrough-Ponds 136 8

Arm & HammerChurch & Dwight 71 4

Other

393 23

Total

1,700100

Colgate and Crest saw sales growth from 1998 of 5.3% and 8.7% respectively. I could not find figures for other toothpaste brands.

The toothpaste market has seen a shift over the last 10 years from standard toothpaste products to premium products that provide tartar control, whitening, gels, desensitizing, antibacterial and all natural ingredients. This has segmented the market and provided the consumer an array of products for specific needs. This has been good for toothpaste sales and, as shown above, sales are on the rise. As a further example of this growth, the largest segment of this premium category, the whitening segment, has seen sales growth since 1996 of 159%. Projections are that toothpaste sales will continue to increase as producers introduce more and more specialty products. Therefore, research and development in the toothpaste business is very aggressive. New, active components for these specialty products are in demand. As an example, competitors are looking for materials that will compete with Colgates new Total containing triclosan. This could be a good opportunity for vegetable based antibacterials particularly for the all natural segment.TOOTHPASTE COMPOSITION

Toothpaste is composed of several ingredients, each of which provides a functional important component to the finished product in its effort to fight cavities and periodontal disease. Below are the various functional component categories with examples of the chemicals used.

1. ABRASIVES & POLISHING AGENTS

Abrasives are added to toothpaste to remove debris, plaque and bacteria from the tooth surface. Polishing agents are added to polish the tooth surface and improve appearance. Often these are the same component. Materials used in toothpaste for these purposes include calcium carbonate, sodium bicarbonate (baking soda), dicalcium phosphate, sodium metaphosphate hydrated aluminum, silica, and sodium pyrophosphate. Natural toothpaste use baking soda or sea salt. Many of these compounds including baking soda have the added feature of neutralizing acids that are produced by cavity forming bacteria.

2. ANTIBACTERIALS AND CAVITY FIGHTERS

These are components added to toothpaste to kill oral bacteria and to reduce the formation of cavities. The leading substance added to toothpaste to do this is fluoride. It is the most effective material as an antibacterial and cavity preventor. It functions topically by inhibiting the growth and acid formation of the bacteria. It functions systemically by becoming part of the tooth enamel making it more resistant to demineralization. It is a proven substance for cavity prevention and is used widely in most toothpastes. It is added as sodium fluoride, stannous fluoride and sodium monofluorophosphate.

Other compounds that fall into this category include sodium dehydroacetate, zinc citrate, sodium lauryl sarcosinate, Neem, tea tree oil, xylitol, chlorine dioxide, myrrh resin, mastic gum, thymol, eugenol, eucalyptal, Echinacea, goldenseal and other natural plant extracts. A recent antibacterial added to toothpaste is triclosan, a broad antibacterial found in soaps. Triclosan is found in a new toothpaste introduced by Colgate called Total.

3. HUMECTANTS

Humectants are materials added to toothpaste to keep it moist. They include compounds like propylene glycol, glycerin, and sorbitol.

4. SWEETENERS & FLAVORS

These are added to improve the flavor of toothpaste. There are many such substances added to toothpaste for this purpose. A few examples are saccharin, sorbitol, peppermint, spearmint, wintergreen, cherry, cinnamon, fennel, ginger, anise, as well as various natural extracts and oils.

5. EMULSIFIERS, STABILIZERS, & FLOW-AGENTS

Subatances in this category provide stability, smoothness and consistency to toothpaste. They are sodium hydroxide, cellulose gums, hydrated silica, carrageenan, and gum tragacanth.

6. DESENSITIZERS

Desensitizers are substances added to toothpaste to make the teeth less sensitive to conditions such as hot, cold, acid, base, etc. Common compounds used in toothpaste for this purpose include potassium nitrate, sodium citrate, and strontium.

7. BINDERS

Binders help hold the toothpaste formulation together. Some examples are sodium alginate, bentonite, and carrageenan.

8. SUDSERS & DETERGENTS

These are added to toothpaste for foaming and cleaning. A common substance used for this is sodium lauryl sulfate (SLS). Natural toothpastes replace SLS with xylitol.

9. LUBRICANTS

Lubricants help toothpaste flow smoothly from the tube and over the teeth. Glycerin is the most widely used compound for this purpose.

10. COLOR

Artificial colors are used to color most toothpastes. Titanium dioxide is added to make the paste opaque and white. Natural colors are used in natural toothpastes and include annatto as well as fruit and vegetable extracts.

11. PRESERVATIVES

Preservatives are added to toothpaste to provide extended shelf life to the product. Common preservatives include p-hydroxybenzoate, methyl paraben, citric acid, and natural extracts.

PREMIUM PRODUCTS (SOME EXAMPLES)

The newest product in this category is Colgates Total containing the antibacterial triclosan. This is a broad spectrum antibacterial that has been used in antibacterial soaps. To use this in their toothpaste, Colgate had to conduct several trials and get FDA approval. Triclosan is a somewhat controversial compound in that many experts warn that its use will only promote strains of microbes that will develop resistance to this antibiotic. Market analysts project that competitors will be introducing similar toothpastes with antibacterial additives.

Gel toothpaste are not new, but were one of the first products to separate themselves from the standard products. Gel toothpastes are offered by all of the major toothpaste producers and are generally promoted as a breath freshenesr. The Aquafresh brand is one that exemplifies this. Mixtures of gels and white toothpaste are also available in unique tubes to deliver both to your toothbrush.

Whitening toothpaste is another premium category that has seen excellent sales growth over the last 6 years. All major toothpaste producers provide whitening formulations in there produce lines. Whitening is promoted through the action of baking soda as an abrasive stain remover coupled with hydrogen peroxide. These products only remove stains from the surface of the teeth and do not penetrate the surface.

Toothpastes are offered that desensitize your teeth to hot, cold, acid, base, etc. A line of such products is offered by Block Drug Company, Inc. under the brand name Sensodyne. The desensitizing is done through the use of nitrate compounds in the toothpaste formulation. Combinations of desensitizing and whitening or gel formulations are available.

Enamelon is a toothpaste introduced in 1998 by a startup company called Enamelon, Inc. This product addresses the issue of repairing cavities through remineralization. The company offers a toothpaste that contains fluoride and proprietary formulations of calcium and phosphate ions such that the saliva concentration of these ions is enhanced to promote repair through remineralization of decay sites. Some of this technology was developed within the company and some was licensed from the American Dental Association Health Foundation. The product and the company are doing very well. They are in the process of offering other toothpaste and dental care products.

A new product from Arm & Hammer addresses nighttime breath. This toothpaste contains zinc citrate that is to inhibit the growth of oral microbe overnight thus preventing nighttime breath.

All natural toothpastes are another premium category that is growing well. There are numerous products on the market from a variety of marketers including Toms of Maine as well as foreign producers. These products usually contain fluoride, baking soda, peroxide and various natural extracts. Vegetable extracts are promoted heavily by this market segment. A product called Enamel Saver markets a sodium lauryl sulfate free toothpaste that contains xylitol in its place. One natural toothpaste offers a product containing aloe vera that is suppose to promote healing of gum and mouth sores.

A unique product is offered by a company named Body Electric of Colville, WA. Their product is called Pristine. This is a tooth cleaning oil made from cold-pressed essential oils of mint and almonds which are known for their antibacterial properties. It does not contain any fluoride, abrasives, foaming agents, sweeteners, emulsifiers or preservatives.

There are many toothpastes offered on the market, but most fit within these categories. The flow of such products is expected to continue as consumers become more educated on dental disease. MOUTHWASH

A. MARKET

Sales of mouthwash in 1999 were $677million. This was up from 1998 by 3.8%. The top 5 leading brands were:

BRANDSALES (millions)

Listerine$293

Private Label 133

Scope 111

Plax 38

Act 19

Other 83

Total 677

The mouthwash market has been growing but not a t the rate of that of toothbrushes and toothpaste.

B. MOUTHWASH COMPOSITION

Mouthwashes contain fewer functional components than toothpaste, but they do have some important key ingredients.

All mouthwashes contain some form of antiseptic or antibacterial. Over the counter products usually contain alcohol, cetylpridinium chloride or methyl salicylate as an antiseptic. They may also contain sodium fluoride. Prescription mouthwash contains the antibacterial chlorohexidine.

Additional functional components in mouthwash are flavorings and colors. Common flavorings include sweetness as saccharin, mint, spearmint, peppermint, thymol, eucalyptol and vegetable extracts.

C. PRODUCTS

Mouthwash products generally fall into one of three categories based on the market they are addressing. These three categories or market needs are breath freshening, teeth whitening and dental hygiene.

In the category of breath freshening, mouthwash is marketed to people seeking a treatment for bad breath. Listerine and Scope are examples of products that address this market. These products contain antiseptics to kill bad breath forming bacteria and a heavy dose of flavoring to temporarily cover bad breath. Research has shown that mouthwashes have an immediate effect on bad breath but long term they are not effective in eliminating the problem.

The mouthwash whitening market is relatively new. Products in this category are SuperSmile mouthwash and products made by Polident. These products contain antiseptics and flavorings but also contain baking soda and peroxide to enhance teeth whitening. Their effectiveness is unproven.

Mouthwashes that attempt to improve dental hygiene are of greatest interest to DTS and its business plan. There are several products on the market that claim to remove plaque, kill oral bacteria, reduce gingivitis and improve overall oral health. PLAX is a mouthwash that is designed for used before brushing to loosen plaque for easier removal on brushing. No information could be found on its special active ingredients. Listerine and other major marketers of mouthwash make a tartar control product that is suppose to reduce the formation of tooth tartar when used regularly. Several natural mouthwashes are sold that contain an array of natural substances such as vitamin C, vitamin E, Aloe vera, witch hazel, tea tree oil (oil form the tree Melaleuca alternitolia) and numerous vegetable extracts. These are claimed to kill bacteria, improve healing, reduce cavities and reduce gum disease. As an example, natural products such as these are available for companies like Toms of Maine.

A few unique antibacterial products are ANTI-OXIDANT and ClosysII. ANTIOXIDANT is a mouthwash marketed as an immune system supplement to boost the immune system to prevent gum disease. It contains vitamin C&E, coenzyme Q, alpha lipoic acid, grape seed extract, selenium, Aloe vera, and a proprietary delivery system. Its effectiveness is unproven. Closys II is a mouthwash that contains chlorine dioxide as an antibacterial. Product claims are that chlorine dioxide is more effective than other antibacterials.

To complete the review of mouthwash products, there are several products marketed that are alcohol free and/or saccharin free. There are also mouthwashes that are two phases to get the desired effect.

In general, OTC mouthwashes have been shown to have little effect on controlling plaque and oral bacteria and they are no substitute for brushing. The one positive in mouthwash is fluoride. A mouthwash that contains fluoride has been shown to be effective in enhancing the protective effects of fluoride in toothpaste.

PAGE \# "'Page: '#''" This sentence adds too much importance to the position of S. mutans relative to the tooths surface. Additionally, it connotes that S. mutans does this willfully. In fact, these are survival strategies evolved over thousands of years and there is no contemplation involved. Id suggest the following:

When conditions in the oral cavity favor S. mutans it may become the dominant species in its biologic niche, Given a suitable metabolic substrate, S. mutans produces lactic acid as a metabolic by-product. This acid attacks the mineral component in tooth structure and may eventually dissolve it sufficiently to cause cavitation.

PAGE \# "'Page: '#''" By definition, if the mother has the organisms she has the infection.

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