CPAP BreATh Genesis (BAT=Brown Adipose Tissue, Genesis=to form)


Douglas Swain
Lyman Veterinary Clinic LLC
Griswold, IA
The primary aim of the invention is to induce cold thermogenesis, thus leading to increased brown adipose tissue activity and deposition in a comfortable, efficient way, as to increase caloric expenditure, thus aiding weight loss.
A secondary goal is to reduce insulin resistance in Type II Diabetics
The BreATh Genesis Company originated from experiences in my career as a mixed animal veterinarian. The company is dedicated to taking advantage of the human body’s physiologic response to cold therapy by creation of the CPAP BreATh Genesis. The invention reduces body mass and associated co-morbitities by brown fat induction. The methodology/invention encompasses breathing refrigerated air during deep sleep as to not induce a shiver reflex, stimulate BAT deposition/activity, increase caloric expenditure, produce distilled water product for humidification, and decrease condensation in the delivery tubing. The market for anti obesity therapies are widespread since 2/3 of the U.S. population is overweight or obese. Middle aged and African Americans should have the greatest need for a benign system of weight loss. Obesity related dietary supplements and weight loss pharmaceuticals have provided minimal efficacy for the obesity epidemic. Key factors for marketability include the ongoing prevalence of obesity and physicians’ continuing role in preventing disease. The key strategy for implementing this technology is an inability for other technologies to induce BAT comfortably. We will focus on the already established sleep apnea customer base and compare/contrast the widespread benefits to the associated co-morbitities of diabetes and cancer. We will focus on low cost manufacturing options and portray and American image in our company. We will cooperate with institutions for advancing the technology in an evidence-based way. The management will adhere to a honest and professional image and use their prior strengths as successful businessmen to perpetuate the company with a progressive, profit based approach.

The forecast for CPAP BreATh Genesis is encouraging looking at the current market. One should consider the following key factors:
• More than one-third (34.9% or 78.6 million) of U.S. adults are obese.
• Obesity-related conditions include heart disease, type 2 diabetes, and certain types of cancer.
• The estimated annual medical cost of obesity was $147 billion in 2008 dollars; the medical cost for people who are obese were $1,429 higher than those of normal weight.
• Non-Hispanic blacks have the highest age-adjusted rates of obesity (47.8%) followed by Hispanics (42.5%), non-Hispanic whites (32.6%), and non-Hispanic Asians (10.8%).
• Obesity is higher among middle aged adults, 40-59 years old (39.5%) than among younger adults, age 20-39 (30.3%) or adults over 60 or above (35.4%).
• More than 2 in 3 adults are considered to be overweight or obese.
• More than 1 in 20 adults are considered to have extreme obesity.
• 19 active ingredients in common weight loss supplements clinically show modest effects on body weight or decreased weight gain.
• The U.S. is currently the biggest single market for weight loss drugs.
• Even weight loss drugs that have made it to market have not done well.
• IMS Health, which tracks prescriptions, estimates combined sales of obesity drugs last year at only $173 million in the U.S..
• Till date there has been no “silver bullet” remedy for obesity.
• Analysts estimate that the potential market for obesity drugs range from $5-$10 billion in sales in three years.
• When overweight people (with an average weight of 225lbs) lose 7.5 % of their body weight (about 17 pounds or 4 inches of weight size), they improve their HDL “good” cholesterol and LDL “bad” cholesterol levels, blood pressure, and blood sugar levels by 20%. That’s nearly three times the benefit compared to percentage weight loss.
The main driver of growth will be the growing population of overweight and obese individuals needing technological intervention and the subsequent rise in the obesity-related co-morbities to put obesity at the forefront of the medical community.
The second largest driver will be the physicians’ efforts to delay disease progression thru the use of combination therapies. To date, no drug has achieved blockbuster status. This unmet need presents a large opportunity for technological developers to capture an unoccupied market space.

Competitors for brown fat induction:
• Hyperwear Cooling Vest
• Cool Fat Burner Vest
• Potentials such as an endoscopically placed implant, and various drug/stem cell technologies

The product disadvantages are apparent in the following:
All of the cooling vest technologies require the patients to endure cold thermogenesis while awake. This makes this a very unpleasant option. To induce brown fat you are placed in an uncomfortable vest that chills you. They claim that the ability to withstand cold therapy is something you work towards. Unfortunately, most of us are not willing to sacrifice discomfort for extra calorie burn. Secondly, human physiology dictates that appetite is stimulated during cold exposure. What keeps the person from overeating to compensate for the extra calorie burn? In one study, mice were exposed to a cold environment and were offered all the food they wanted; guess what, they showed BAT deposition but did not lose weight. They simply ate to compensate. Other medical devices are undergoing research and many are invasive. Implanting a medical device in your duodenum sounds extreme and unnatural.
CPAP BreATh Genesis will stand out in the market for the following reasons:
1. There is little discomfort in implementing cold thermogenesis because it is administered while sleeping.
2. The methodology is novel. From our independent patent search no identifiable patent described inducing cold thermogenesis by cooling inhalant air.
3. The methodology is non-invasive and will be viewed as natural.
4. The FDA approval shall proceed much more quickly than drug based therapies.

Benefits of CPAP BreATh Genesis

1. Induces cold thermogenesis in a long duration, comfortable fashion, that patients will use.
2. Induces cold thermogenesis without appetite stimulation.
3. Inherently produces distilled water product for end product humidification.
4. Eliminates the necessity to have heated delivery tubing to prevent rainout.
5. Increases BAT deposition/activity
6. Aids weight loss and prevents weight gain by increasing daily caloric expenditures
7. Decreases insulin resistance
With an initial seed start funding, the company will obtain workable prototypes, initiate clinical trials, strive toward FDA approval, and set up appropriate positions to produce and move product sales forward. Cost will always be a primary consideration in our decisions.

The purpose for establishing this business is multifaceted.
1. Establish a more advanced prototype that has dependability in clinical trials
2. Plan and initiate clinical trials to establish an evidence based scaffold to prepare and file for FDA approval.
3. Gain FDA approval for obesity and Type II Diabetes.
4. Establish manufacturing and distribution focusing on low cost production and global marketing.

A utility patent has already been filed and has patent pending status for which the fast review option has been expedited.

I am currently on my 3rd prototype and reducing the size of the hardware. I am using computerized 3D software and 3D printing (material deposition modeling) to create a usable countertop machine. I predict I will have a aesthetic countertop prototype within 1-2 mo. Some of the funds will aid with the development.
I have used my other prototypes for 4 months in conjunction with dietary management and exercise and have lost nearly 70 pounds, improved my hypertension to normal, and lowered my average blood glucose by 25 mg/dl. I urge you to review the brown fat literature; this technological avenue shows a real promise.

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