About Mahana^TM IBS

Overview

Founded in 2018, Mahana Therapeutics is the global leader in prescription digital therapeutics for gastrointestinal conditions. We are guided by a commitment to rigorous clinical evidence and draw from experience as patients ourselves. Our team of experienced entrepreneurs, physicians, psychologists, engineers, and designers are dedicated to using software to treat and manage chronic conditions that affect so many. 

Mahana’s debut product Mahana^TM IBS. Mahana IBS received its UK Conformity Assessment (UKCA) mark on 28 January 2022 and is distributed in the UK by Mahana Therapeutics, Ltd. (CRN 11995982). 

IBS is a disorder of the gut-brain interaction. Mahana IBS is a three-month prescription digital treatment that delivers cognitive behavioral therapy (CBT) for IBS by targeting the gut-brain interaction. It has been clinically proven to reduce the severity of IBS symptoms. Mahana IBS works by helping adults change certain behaviors and thoughts related to IBS symptoms that occur when gut-brain interactions change. Mahana IBS has no known side effects and is intended to be used with other IBS treatments.

Mahana IBS was formerly known as Regul8. Regul8 was originally developed by Rona Moss-Morris Ph.D., Head of Psychology Department, King’s College London (KCL) in collaboration with Trudie Chalder, Ph.D., Professor of Cognitive Behavioural Psychotherapy; Alice Sibelli, Ph.D., KCL; and Dr. Hazel Everitt, Professor of Primary Care Research, University of Southampton. Initial clinical funding support was provided by the UK National Institute for Health Research (NIHR).

Mahana Therapeutics has licensed the use of the Rome Foundation’s Irritable Bowel Syndrome Symptom Severity Scale for Mahana IBS. This is the most frequently used severity measure for evaluating IBS severity. Items relate to pain, bowel dysfunction, and overall well-being. © 1997 Rome Foundation, Inc. All Rights Reserved.‍

Mahana^TM IBS is a regulated medical device in accordance with applicable laws.

For more details, please refer to:

Mahana IBS Patient Manual

Mahana IBS version 1.0

Intended Use

Mahana IBS is intended to provide cognitive behavioural therapy for adults aged 18 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Mahana IBS can be used alongside recommended evidence-based medical treatment for patients suffering from IBS and is indicated as a 12-week (90-day) treatment under the care of your healthcare provider.

It is intended to:

• reduce the severity of IBS symptoms, 
• improve daily functioning and ability to cope with IBS, and
• reduce psychological distress (i.e., anxiety and depression) co-occurring with IBS

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Language

English

Mahana Therapeutics, Inc.

201 Mission Street

Suite 1200

San Francisco, CA 94105

USA

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UKRP

Emergo Consulting (UK) Limited

c/o Cr360 – UL International

Compass House, Vision Park Histon

Cambridge CB24 9BZ

United Kingdom

Made in the U.S.A

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