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™ IBS is the first digital therapeutic cleared by the U.S. FDA to reduce the severity of symptoms of irritable bowel syndrome (IBS), a condition that affects one in 10 people worldwide.
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 IBS is a regulated medical device in accordance with applicable laws.
Mahana IBS is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy for adults aged 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Mahana IBS is indicated as a 3-month treatment for patients with IBS. Mahana IBS treats IBS by reducing the severity of symptoms and is intended to be used together with other IBS treatments.
For more details, please refer to:
Mahana IBS Patient Information Sheet
Mahana IBS Clinician Information Sheet
CAUTION Federal law restricts this device to sale by or on the order of a Physician
Mahana Therapeutics, Inc.
505 Montgomery St.
11th Floor
San Francisco, CA 94111
USA
Made in the U.S.A.
(01) 00860006172015
(10) v1.0
(17) 260721
English
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