metaMe Health partners with Launchit Ventures to market Regulora, an FDA-cleared Prescription Digital Therapeutic for adults with IBS, in Canada

metaMe Health licenses rights to commercialization of Regulora in Canada to Launchit Ventures, Inc. to expedite the availability of Regulora to Irritable Bowel Syndrome (IBS) patients

HAMILTON, Ontario and CHICAGO, Sept. 29, 2022 (GLOBE NEWSWIRE) — Launchit Ventures, Inc., a HealthTech solutions provider and global commercialization partner developing new technology-led business solutions faster and with less risk, and metaMe Health, Inc., a Prescription Digital Therapeutics (PDT) company and developer of Regulora®, today announced a global partnership to bring Regulora® to the Canadian market for the treatment of abdominal pain due to IBS.

IBS is a chronic condition that affects 10-15% of adults in the United States, roughly 25 to 45 million people.¹ Notably, an estimated 13-20% of the population (approximately 5 to 7.5 million people) are living with IBS in Canada.² On average, Canadians with IBS miss an average of 13 days of work per year, leading to $8 billion in lost productivity.² Published data estimates the economic burden of IBS is $6.5 billion annually in Canada.²

metaMe Health’s Regulora® is the first U.S. FDA-authorized PDT specifically for abdominal pain associated with IBS in adults. It provides self-administered Gut-Directed Hypnotherapy (GDH) through a convenient iOS and Android app that can be used at home along with other IBS treatments. Until now, the availability of GDH has been limited, as it required in-person administration by specialized therapists.

Launchit Ventures will work to obtain regulatory authorization in Canada and will develop a commercialization strategy and execution plan to make Regulora® available to patients with IBS in Canada markets.

Tim Rudolphi, CEO at metaMe Health, says, “We’re excited to expand the availability of our first Prescription Digital Therapeutic, Regulora® outside of the U.S. It is great to have a trusted partner like Launchit Ventures to manage the complexities of the Canadian commercialization and regulatory processes required to take Regulora® to market.”

Jamie Harsevoort, CEO at Launchit Ventures, adds, “We are excited to further enable metaMe Health’s mission to provide an innovative treatment option to patients with abdominal pain due to IBS. With an estimated 5 to 7.5 million IBS patients in Canada, we have a tremendous opportunity to make a difference in patients’ lives by providing a proven therapy that they can access easily at home.”

PDTs deliver evidence-based therapeutic interventions through high-quality software programs to prevent, manage, or treat a medical disorder or disease. PDTs incorporate advanced technology, design best practices, clinical evaluation, usability studies, and data security, and are developed under the same rigorous conditions as pharmaceuticals – complete with clinical trials, regulatory clearance, and availability through a physician’s prescription.

PDTs will continue to be a key piece of the emerging global digital market. 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 may reach $500 billion by 2025.³

About metaMe Health, Inc.

metaMe Health, Inc. is a U.S. company that develops Prescription Digital Therapeutics (PDTs) for the treatment of common chronic conditions. metaMe Health’s initial digital solutions aim to relieve the pain and disruption of everyday life experienced by millions suffering from gastrointestinal disorders. By allowing patients to be prescribed treatment confidentially and to undergo treatment privately at home, metaMe Health offers non-drug options that provide relief in a familiar, comfortable environment. For additional information, please visit metamehealth.com or follow @metaMeHealth on Twitter and metaMe Health on LinkedIn.

About Launchit Ventures, Inc.

Launchit Ventures, Inc. is a HealthTech venture studio that offers a new model for entrepreneurship, combining company building with venture funding, to develop new businesses faster and with less risk. Launchit Ventures partners with researchers, entrepreneurs, industry veterans, and others who have great ideas but need support and expertise to commercialize them. The Launchit Ventures team and its partners bridge the gap between a founder with an idea and the actual reality of getting a HealthTech start-up product or service into the market. Learn more at https://launchitventures.com.

MEDIA CONTACTS

Kelsey BaRoss
RoseComm for metaMe Health, Inc.
kbaross@rosecomm.com

Jamie Harsevoort
Launchit Ventures, Inc.
jamie@launchitventures.com

References

1. IBS Facts and Statistics. Accessed September 19, 2022. Learn more: https://aboutibs.org/what-is-ibs/facts-about-ibs/.
2. Gastrointestinal Society and Canadian Society of Intestinal Research. IBS Facts. Accessed September 19, 2022. Learn more: https://badgut.org/information-centre/a-z-digestive-topics/ibs-awareness/
3. McCann C. Realizing the promise of prescription digital therapeutics. STAT. Published October 29, 2019. Accessed September 19, 2022. Learn more: https://www.statnews.com/2019/10/29/prescription-digital-therapeutics-realizing-promise/