Today, patients are searching for treatment that goes beyond the prescription of a drug. Introducing Regulora®, the first and only FDA-cleared GDH prescription digital therapeutic (PDT) indicated for the treatment of abdominal pain due to irritable bowel syndrome (IBS) in adults.1
The American College of Gastroenterology includes clinically administered GDH in its guidelines as a recommended therapy for IBS.2 GDH helps to bridge the mind-gut connection and Regulora is an app that provides a convenient digital implementation of this gold-standard protocol.1,3
Studied across all 3 IBS subtypes (IBS-C, IBS-D, and IBS-M), Regulora is a safe and effective non-pharmacological option for your IBS patients.3
of clinical trial participants would recommend
Regulora to someone else with IBS1
THE REAL COST OF IBS
IBS is a disorder caused in part by the brain and the gut not communicating as they should—resulting in gastrointestinal distress that affects overall quality of life. In one study, a majority of patients indicated they would give up 10-15 years of life expectancy for an instant cure for their condition.2
Abdominal pain is the primary symptom of all IBS subtypes (IBS-C, IBS-D, and IBS-M) and the number-one reason patients seek treatment.2,4
GDH has been helping IBS
patients find relief for nearly
RETHINK IBS PAIN?
Consider a safe and effective
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- Regulora® Instructions for Use for Patients and Physicians. metaMe Health, Inc.; April 2022.
- Lacy BE, Pimentel M, Brenner DM, et al. ACG Clinical Guideline: Management of Irritable Bowel Syndrome. Am J Gastroenterol. 2021;116(1):17-44.
- Data on file. metaMe Health; 2022.
- International Foundation for Gastrointestinal Disorders. What is IBS? Accessed July 29, 2022. https://aboutibs.org/what-is-ibs/facts-about-ibs/
- Digital Therapeutics Alliance. Digital Therapeutics Definition and Core Principles Fact Sheet. Accessed July 29, 2022. https://dtxalliance.org/wp-content/uploads/2021/01/DTA_DTx-Definition-and-Core-Principles.pdf
- Riehl ME. The Emerging Role of Brain-Gut Therapies for Irritable Bowel Syndrome. Gastroenterol Hepatol (N Y). 2018;14(7):436-438.
- Chey WD, Keefer L, Whelan K, Gibson PR. Behavioral and Diet Therapies in Integrated Care for Patients With Irritable Bowel Syndrome. Gastroenterology. 2021;160(1):47-62.
- The Rome Foundation. Brain-Gut Psychotherapy Referral Guide. Accessed July 29, 2022. https://theromefoundation.org/wp-content/uploads/Rome-Foundation_GastroPsych-referral-project.pdf
- Donnet AS, Hasan SS, Whorwell PJ. Hypnotherapy for irritable bowel syndrome: patient expectations and perceptions. Therap Adv Gastroenterol. 2022;15:17562848221074208.
- Miller V, Carruthers HR, Morris J, Hasan SS, Archbold S, Whorwell PJ. Hypnotherapy for irritable bowel syndrome: an audit of one thousand adult patients. Aliment Pharmacol Ther. 2015;41(9):844-855.
Regulora® is a prescription-only digital therapeutic device intended to provide behavioral therapy through gut-directed hypnotherapy for adults 22 years of age and older who have been diagnosed with irritable bowel syndrome (IBS). Regulora is indicated as a 3-month treatment for patients with abdominal pain due to IBS and is intended to be used together with other IBS treatments.
US federal law restricts this mobile application device to sale by or on the order of a physician. Regulora is intended for patients who speak and read English. Regulora may not be appropriate for patients with mental or physical impairment that would prevent interacting with a mobile video application. Regulora may not be appropriate for patients with evidence of intestinal illness that better explains IBS symptoms such as celiac disease or inflammatory bowel disease. Regulora should not be used in lieu of your patient’s current IBS medication or therapy. In a clinical trial of Regulora, side effects were low. About 1% of patients experienced abdominal pain, constipation, fatigue, or headache which was thought to be related to using Regulora.