Regulora™ for IBS
How does a digital therapeutic work for treating IBS?
A digital therapeutic is a software-based product that engages patients, tracks adherence, facilitates clinician engagement, and safely delivers consistent health outcomes in randomized controlled clinical trials. Digital therapeutics are evaluated by the FDA through their medical device clearance pathway and may be designated a prescription-only treatment. Regulora™ is the first digital implementation of Gut-Directed Hypnotherapy (GDH), a behaviorally-focused treatment that addresses the cognitive, behavioral and affective drivers of IBS. Regulora™ is based on the North Carolina Protocol, an IP-protected fully standardized and scripted intervention that has been extensively tested in randomized, controlled trials on hundreds of IBS patients. Regulora™ offers a non-pharmaceutical option that targets the brain-gut axis as a stand-alone treatment or to augment marginally effective medical options.
What is Regulora™?
Regulora consists of seven automated digital sessions administered over 3 months, along with a daily practice exercise. All sessions are delivered via our secure metaMe Connect mobile platform (www.metameconnect.com). The program includes collection of adherence data and patient-reported outcomes using clinically validated survey instruments. We recently completed a Regulora pilot program with Centers of Excellence across the nation, including Northwestern Medicine, Stanford Health Care, Harvard Medical Center, the University of Chicago Medicine, the David Geffen School of Medicine at UCLA and University of Pittsburgh Medical Center. Results show that over 50% of the participants reported clinically significant symptom improvement, consistent with the efficacy reported with in-person sessions. metaMe Health holds worldwide exclusive license for administration of the treatment protocol by any electronic means.