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Problem Tech Solves

Tech Brief

IBS is a chronic bowel disorder affecting between 5%-15% of the population, accounting for 12% of primary care visits and exceeding $30 billion in direct and indirect healthcare costs. There is currently no cure for IBS, and less than one-third of IBS patients currently being treated with pharmacotherapy experience symptom relief. Many patients experience ongoing challenges in treating and managing their IBS. CBT is the most rigorously tested psychological treatment for IBS, with more than 20 randomized clinical trials demonstrating its efficacy in the condition. Both the American College of Gastroenterology and the American Gastroenterological Association recommend CBT to treat IBS in clinical guidelines. Unfortunately, access to CBT for individuals diagnosed with IBS has been severely limited due to therapist availability, geography and cost. Mahana IBS is accessible to any individual with IBS in the United States, at a fraction of the cost of in-person CBT.

Tech Differentiators

Our super power is super simple. We digitize known, proven CBT solutions to make them widely accessible at low cost to solve healthcare needs. Mahana IBS is highly differentiated in multiple, meaningful ways that address factors that are critical for success in the emerging digital therapeutics market: - Market need: Noted above. - Accessibility: Mahana IBS delivers gut-directed CBT via patients’ own mobile phone or tablet. - Clinical validation: Unlike other wellness or lifestyle apps, prescription digital therapeutic products such as Mahana IBS must meet FDA standards of evidence and regulatory oversight. Mahana IBS was rigorously tested in a large clinical trial of CBT in IBS patients and validated against the IBS Symptom Severity Scale as a treatment for IBS. - Regulatory clearance: Mahana IBS is FDA cleared and has CE Mark. These regulatory distinctions demonstrate a level of evidence and clinical value that will help drive physician and patient uptake as well as payer reimbursement. - Safety: Mahana IBS has no known side effects and is intended for use with other IBS treatments. - Reimbursement: Mahana is currently pursuing reimbursement with both commercial and government payers. CBT may reduce the downstream costs of IBS by $1,000-2,000/year. We anticipate the cost of Mahana IBS to insurers will be a fraction of the cost of in-person CBT. - Funding and Leadership: Mahana has secured significant investment and we have an impressive, experienced senior leadership team across multiple functions to commercialize our product. We have immediate international market opportunity with regulatory clearance in both UK and U.S.


Mahana IBS demonstrated effectiveness in the largest randomized clinical trial completed to date evaluating CBT in people with IBS. Researchers at King’s College London and the University of Southampton conducted the trial among 558 patients who had ongoing, significant IBS symptoms despite having tried other IBS treatments for at least a year. All patients continued their current IBS treatment. One group added Mahana IBS to their treatment, another group received CBT for IBS via telephone, and the final group continued only with treatment as usual. After three months of treatment, 63% of patients who added Mahana IBS to treatment as usual reported a clinically meaningful improvement in the severity of their IBS symptoms compared to 28% who received treatment as usual alone. IBS symptom severity improvements were maintained to the end of the 12-month study. Improvements with Mahana IBS were also observed in functional impairment and quality of life. Patients using the Mahana IBS program experienced significant clinical improvement in IBS symptom severity, including less abdominal pain, bloating, bowel function dysregulation and adverse impact on daily social activities.

Why Us