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Regulora™ is a prescription digital therapeutic currently in clinical trials for the treatment of Irritable Bowel Syndrome (IBS).
About
metaMe Health develops digital therapeutics for the treatment of gastrointestinal (GI) conditions. Our lead product is Regulora™, an all-digital implementation of the standardized, fully scripted North Carolina (NC) Protocol, a Gut-Directed Hypnotherapy (GDH) program for the treatment of Irritable Bowel Syndrome (IBS). The NC Protocol is protected by Copyright and is the most widely used form of GDH in the US, comparable in efficacy to any of the $2 billion in IBS prescription drugs sold annually. Despite strong clinical data and a lower cost than prescription drugs, the NC Protocol has remained largely unavailable to IBS patients due to the lack of specialized therapists. metaMe Health provides availability of the NC Protocol to IBS patients through its digital therapeutic product, Regulora™.
Key Benefits
Given the side effects and limited efficacy of IBS pharmaceuticals and the promising outcomes with GDH (Gut-Directed Hypnotherapy) one might ask: Why is GDH not more widespread? The major barrier is patient access. There is a paucity of GDH-trained psychologists and physicians, and those with training are almost exclusively located in academic centers. Regulora™ fills that gap by offering a mechanism very familiar to doctors: writing a prescription. As a digital solution, Regulora™ is limitlessly scalable. Pharmaceutical companies have developed drugs specifically to treat IBS, including Xifaxin, Linzess, Amitiza, Trulance, and Viberzi. Pharmaceuticals are currently the most common treatment, with sales totaling over $2B per year. However, drugs are expensive with frequent adverse effects and poor efficacy against abdominal pain, the primary patient complaint.
Applications
Irritable Bowel Syndrome is a chronic and painful condition that affects 30 million Americans, or about 10% of the US population. This is our target market. Remarkably, IBS is the principal reason for 12% of all primary care visits and 28% of visits to GI doctors.