metaMe Health Partners with Indegene to Launch Regulora®, an FDA-Approved Digital Prescription Therapeutic for Adults with Irritable Bowel Syndrome

Indegene Inc

PRINCETON, NJ and CHICAGO, March 22, 2022 (GLOBE NEWSWIRE) — Indegene, a technology-driven global healthcare solutions provider, and metaMe Health, Inc. (metaMe), a Prescription Digital Therapeutics (PDT) company and developer of Regulora®today announced a partnership to commercialize Regulora for the treatment of abdominal pain due to irritable bowel syndrome (IBS).

IBS is a chronic disease that affects 10-15% of adults in the United States. The central symptom is abdominal pain, which is accompanied by diarrhea (IBS-D), constipation (IBS-C) or a mixture of the two (IBS-M). IBS has a significant impact on quality of life. According to a survey of almost 2,000 patients, IBS sufferers say they would spend 25% of their remaining life (an average of 15 years) to live without symptoms.1 The annual cost of treating IBS in the United States has been estimated at $1.7 billion to $10 billion in direct costs, with total indirect costs of $20 billion.2

metaMe Health’s Regulora is the first FDA-cleared PDT specifically for IBS-associated abdominal pain in adults. It provides self-administered Gut-Directed Hypnotherapy (GDH) via a convenient iOS and Android app that can be used at home alongside other IBS treatments. Until now, the availability of GDH has been limited, as it has been provided in person by specialist therapists. “Regulora now makes this treatment available to any adult with IBS through their doctor or gastrointestinal specialist, and also makes it much more convenient as no visit to the therapist is required to receive Regulora,” said Dr. Olafur Palsson, professor of medicine in the Division of Gastroenterology and Hepatology at the University of North Carolina.

Through a multi-year partnership, Indegene will work with metaMe Health to use its flexible, capital-efficient business model to educate healthcare providers, patients and payers on the benefits of this innovative treatment. To help metaMe Health launch Regulora, Indegene brings deep healthcare expertise and advanced omnichannel capabilities powered by artificial intelligence and machine learning. Indegene’s unique co-commercialization model ensures Regulora reaches the right patients while allowing metaMe to focus on its mission of developing innovative digital prescription therapies.

Tim Rudolphi, CEO of metaMe Health, said, “We are thrilled to introduce Regulora as the first FDA-cleared treatment of its kind for IBS in adults. Indegene’s end-to-end commercialization process gives us confidence that this therapy will reach patients and improve their quality of life. It’s great to have a partner like Indegene that we can trust to manage the complexities of bringing our product to market.

Nathan Piland, Vice President at Indegene, adds, “We are proud to enable metaMe Health’s mission to put the power to heal in the hands of patients. With over 30 million patients with symptomatic IBS in the United States alone, we have a great opportunity to make a difference by using our first digital omnichannel approach to bring Regulora to market quickly and at scale.

Prescription Digital Therapeutics provides evidence-based therapeutic interventions through high-quality software programs to prevent, manage, or treat a medical condition or disease. PDTs incorporate state-of-the-art technology, best practices in design, clinical evaluation, usability studies and data safety, and are developed under the same rigorous conditions as pharmaceuticals – with clinical trials , FDA clearance and availability by prescription from a physician.3

PDTs will continue to be a key part of the emerging global digital marketplace. In recent years, more than $12.5 billion has been invested in digital health start-ups. According to one estimate, the value of all digital health start-ups could reach $500 billion by 2025.4

About MetaMe Health, Inc.
metaMe Health, Inc. (metaMe) is an American company that develops Prescription Digital Therapeutics (PDT) for the treatment of common chronic diseases. MetaMe’s first digital solutions aim to relieve the pain and disruptions of daily life experienced by millions of people suffering from gastrointestinal disorders. By allowing patients to be prescribed treatment confidentially and to undergo private treatment at home, metaMe offers non-drug options that provide relief in a familiar and comfortable environment. For more information, visit metaMehealth.com or follow @metaMeHealth on Twitter and metaMe Health on LinkedIn.

About Indegene
Indegene is a technology-driven healthcare solutions provider. It combines deep industry expertise with relevant technology in an agile and scalable operating model. Many of the world’s largest healthcare organizations rely on Indegene to deliver effective and efficient clinical, medical and business outcomes every day. From strategy to execution, Indegene enables healthcare organizations to be ready for the future. To learn more about how Indegene achieves its goal, please visit www.indegene.com

For media inquiries, please contact:

Shefali Kotnala
shefali@spectrummails.com

Dalila Bennett
Communication 3Points
delilah@3ptscomm.com

The references
1 Gastrointestinal Society IBS Global Impact Report 2018 –
https://badgut.org/wp-content/uploads/IBS-Global-Impact-Report.pdf
2 Hulisz, D., J Managed Care Pharm, 2004. PMID 15298528
3 Digital Therapeutic Alliance. Factsheet on the definition and fundamentals of digital therapy. Accessed January 11, 2022.
https://dtxalliance.org/wp-content/uploads/2021/01/DTA_DTx-Definition-and-Core-Principles.pdf
4 McCann C. Realizing the promise of digital prescription therapies. STAT. October 29, 2019. Accessed December 31
2021. https://www.statnews.com/2019/10/29/prescription-digital-therapeutics-realizing-promise/

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