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PrepAdd™

PrepAdd  website

A better tasting colonoscopy prep

Dear Website Reader,

We’re all friends here. One day you will need to get a colonoscopy. Everything that you have heard about the prep tasting awful, is true.  At some point in-between drinking the first 1/2 gallon of prep and running to the toilet, you’ll say to yourself,  “why can’t they make this stuff taste better”.  Then, realizing you still have another 1/2 gallon to go,  you’ll swear to any higher power that “you’ll pay anything to make the stuff taste better”. 

Well, we have figured out how to make the stuff taste better. It’s all about increasing the user experience, one rectum at a time.

Background: Colon cancer is bad. It is the third most commonly diagnosed cancer and the second leading cause of cancer deaths in men and women combined in the US. The American Cancer Society estimates 150,000+ people were diagnosed last year and 50,000+ will die from colon cancer. The test to screen is a colonoscopy, which is an endoscopic examination and requires the bowels to be completely cleansed prior to the procedure. A colonoscopy prep is a prescribed oral solution that is an osmotic laxative indicated for cleansing the colon for preparation prior to a colonoscopy procedure. According to a 2015 consensus document for adequate bowel cleansing by the American College of Gastroenterology, American Gastroenterological Association and the American Society for Gastrointestinal Endoscopy, the recommended protocol is fasting for 24 hours and then drinking a split dose of a 1 gallon oral solution of a prescribed polyethylene glycol (PEG3350/Golytely) based chemical. The mixture is extremely salty to taste, smell, somewhat viscous in texture and challenging to fully consume. The powdered prep is supplied with a powdered flavor packet that comes in artificial fruity/sweet flavors, such as, cherry, pineapple or lemon lime. As an alternative, doctors suggest adding Crystal Lite or Gatorade to the prep solution and then chill in the refrigerator, as an attempt to mask the flavor. Whatever flavor you add, it still tastes like you’re consuming a gallon of very sweet ocean salt water. From the patients’ perspective, the unpleasant taste challenges many from fully drinking the volume of solution and completing the protocol. It has been documented that between 20%-25% of all procedures have inadequate bowel preparation and cannot be successfully completed. During the actual scoping process you are peacefully sedated.

Invention: Our innovation, PrepAdd™, embraces the inherent salinity of the PEG3350 solution. We have developed a proprietary flavor profile from a blend of ingredients, that when combined with warm tap water mimics a savory chicken bouillon soup, one of the few food items allowed while fasting. When mixed, it produces a palatable drink and a sense of satiation for the patient. It’s completely vegetarian in composition and made from all natural ingredients that are vegan-based, dairy-free, gluten-free, sugar-free, lactose-free, allergen-free, kosher, halal and with nothing artificial. Can also make it taste like beef, pork or roasted vegetable bouillon soup.

When you first bring the glass to your nose you get a whiff of comforting chicken soup. Upon drinking, you get the warm sensation of nourishment and calming to your stomach.

Packaged separately, you simply add the PrepAdd  into the prep and add warm water. Flavor additive can be fabricated as a powder, self-dissolving tablet or liquid. Testing for palatability and efficacy of bowel cleanse can be accomplished thru a standard IRB study.

Development is complete.

 

 

US Market size:

  • 35 million, age 50+ people annually of whom it is recommended should get a colonoscopy to test for colon cancer
  • Only 50%, age 50+, 17.5 million, get. Most common reason for not – “the taste and challenge of drinking the prep”
  • 22 million, age 45-49 just recommended for screening by American Cancer Society, 5/18
  • 1.5 million people with IBD, inflammatory bowel disease
  • 750,000 with Crohns disease or ulcerative colitis
  • 750,000 with familial hereditary conditions such as, Lynch syndrome
  • Using my personal economic beer rule, I would gladly pay the value of a 6-pack, $9.99 for the flavor. Only a guess on what someone else would pay, but, if you’ve drunk the stuff already, it could be priceless. Potential market: $$$ X 60,000,000
  • 150,000+ diagnosed annually with colon cancer -3rd most diagnosed cancer
  • 50,000+ deaths annually from colon cancer – 2nd leading cause of cancer deaths
  • 20%-25% of all procedures cannot be completed due to inadequate bowel preparation
  • Patients with opioid addictions and obesity are more often constipated and require 2X prep  applications
  • American Cancer Society is trying to promote and get 75% of market tested

Regulatory issues:

  • By not mixing the PrepAdd directly into the prescribed PEG3350 and distributing it in a separate package, it would be classified as a Class 1 device, only requiring registration with the FDA.
  • Can be sold as OTC product
  • No human trials needed

Intellectual property:

  • Patent: filed patent application with USPTO as an invention related to the “Composition of Matter & Method of Usage”
  • Trademark:  Notice of Allowance issued  from USPTO to cover brand, PrepAdd
  • Domain: www.prepadd.com

Accomplishments to date:

  • Have developed proprietary flavor recipe
  • Have filed patent application to protect product, method of consumption and packaging
  • Branding the product: PrepAdd
  • Supply chain; have sourced ingredient suppliers and costed-out recipe for production
  • Located potential partners for licensing product
  • Have performed human trial on-self for recent 10th colonoscopy. It was delicious!

My very clean upper and lower intestine!

Goals:

  • Goal for patient: Increase palatability to enhance user experience and expand potential user base.
  • Goal for doctors: Increase successful screening of patients by expanding adenoma detection rates.
  • Goal for project: Have everyone drinking a better tasting colonoscopy prep for proper bowel cleanse and early cancer detection.

End game:

  • License IP/recipe to an existing FDA approved prep manufacture, or;
  • License IP/recipe to pharmacy chain, or;
  • Bring PrepAdd to market as an aftermarket OTC product, or;
  • Create an online home delivery “care package” service to include; allowable foods during 24 hr. fasting period, PrepAdd™, lots of baby wipes and inspirational messages, and;
  • Donate % of profits to American Cancer Society to assist educational programs to increase the number of people who get colonoscopies.

Principle investigator: Brett Stern, Portland, OR www.brettstern.com

  • As an industrial design consultant, spent 7 years within Pfizer’s Pfresh Tech, an internal think-tank, to invent/develop surgical instruments and implantable medical devices.  Functioned as internal hands-on inventor/entrepreneur. 6 of my 8 utility patents are related to the medical field.
  • Was the creator/founder of Beer Chips® – potato chips made with beer snack foods, where I figured out how to put beer into potato chips without making then soggy. Developed & sourced all of the flavor profiles of product line. Brought product to market in a self-funded entrepreneurial fashion. Project was successful that a national snack food company purchased assets, recipes and IP within 4 years of introduction.
  • My father survived colon cancer, my brother did not. Recently, had my 10th colonoscopy with 2 benign polyps removed. I am highly motivated to bring this product to market.

More info: Want to know more or have an upcoming colonoscopy and want to try some PrepAdd™?

Contact our friendly Bowel Support team

BowelSupport@prepadd.com