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Press Release

ColonaryConcepts Announces First Patient Enrolled in Landmark Gastroenterologist-Designed Colon-Prep Phase 2 Study

BOSTON, MA--(Marketwired - May 19, 2015) - ColonaryConcepts, LLC, a biotechnology company focused on breakthrough technology platforms that promote gastrointestinal health, announced the first patient enrolled in the landmark gastroenterologist-designed Colon Prep Phase 2 clinical trial.

Colonoscopy is the preferred procedure for screening for colorectal cancer, and a range of gastrointestinal symptoms and conditions, and is undertaken by more than 17.5M patients per year in the US alone. Colonoscopies require patient preparation, and current methods require fasting and the consumption of large volumes of salty, viscous liquids or pills. Studies confirm that patient experience is unsatisfying: patients frequently complain of nausea, vomiting, and bloating, as well as significant hunger and a feeling of fatigue. Many do not complete their prep, jeopardizing the screening. As many as 25M patients avoid the procedure altogether because the prep itself is so unpleasant.

ColonaryConcepts’ technology offers an alternative approach: patients prepare by consuming nutritionally-balanced meals that incorporate polyethylene glycol (PEG-3350), a well-known purgative.

ColonaryConcepts’ landmark Colon Prep Study is a Phase 2, randomized trial designed to evaluate the safety and effectiveness of this new investigational colon prep kit. The kit is a drug and food combination product comprised of nutritionally-balanced food and beverages that incorporate the purgative, and is consumed by the patient during the 24 hours prior to the colonoscopy.

“As gastroenterologists, we realized that current colon preps present a huge barrier for patients -- and we challenged ourselves to create a safe and effective alternative approach,” says Dr. Corey Siegel, a co-founder and gastroenterologist. “Completing the prep is the key to accurate screening and diagnosis,” comments Dr. Joshua Korzenik, co-founder and gastroenterologist, “and we knew that if we could design a palatable experience and eliminate the need for fasting, patient experience would dramatically improve…so we believe more patients will get screened with this innovative approach.”

The study tests three formulations (doses) of the investigational colon prep kit, each containing a range of food, snacks, and beverages. Patients who are scheduled for a colonoscopy and enroll into the study will receive either the investigational colon prep kit, or an FDA-approved colon preparation product prior to their procedure.

The study is being conducted at the Dartmouth-Hitchcock Medical Center and Indiana University Health. Key endpoints for this study are colon visibility, patient tolerability and safety.

The results of this Phase 2 study will be used to plan the Phase 3 program, which is expected to commence in 2016.

Successful Phase 1 study results are being presented in poster form for the first time at the Digestive Disease Week conference starting May 18th, in Washington DC. Principal Investigator L. Campbell Levy, MD, of Dartmouth-Hitchcock Medical Center, is reporting on the results of an early, successful proof-of-concept study.

About ColonaryConcepts, LLC
ColonaryConcepts, LLC is headquartered in Boston MA, and is committed to developing patient-centric innovations that improve gastrointestinal health. Their physician-led product development team includes Board-certified gastroenterologists, food scientists, pharmaceutical development experts, culinary research chefs, and product design strategists. For more information about ColonaryConcepts, LLC, please visit www.colonaryconcepts.com

Certain statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of ColonaryConcepts, LLC to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, that the company will not be able to commercialize its future products, that the FDA will not approve the initiation of the Company's clinical programs or provide market approval of the company's products, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Investor and Media Contacts
Michael Allio
401.865.6372
michael.allio@gmail.com

Herb Stern
401.742.4599
info@colonaryconcepts.com

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