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COMING SOON

MIND OVER MEDICINE

COMING SOON

MIND OVER MEDICINE

Regulora®, a prescription digital therapeutic (PDT) that is self-administered through Apple or Android devices, is the first and only FDA-authorized treatment for the abdominal pain brought on by irritable bowel syndrome in adults. Regulora has been cleared by the FDA and will be commercially available soon.

By putting the power to heal right in the hands of our patients, millions of IBS sufferers can find relief from abdominal pain.

TREATMENT

BRIDGING THE MIND-BODY CONNECTION

Irritable bowel syndrome (IBS) is a disorder where the brain and the gut don’t communicate as they should, resulting in chronic gastrointestinal distress that affects overall quality of life. One successful treatment for realigning the two is gut-directed hypnotherapy (GDH). Decades of studies show that GDH administered in person by a trained clinician in a medical clinic is effective in treating IBS. However, advancements in technology have now put the power to heal into the hands of millions of IBS sufferers.

HOW REGULORA WORKS

7 individual sessions of hypnotherapy
30 minutes per session
Administered every other week over 12 weeks

THE ABCs OF PDTs

Prescription digital therapeutics (PDTs) operate at the intersection of biology and technology—delivering evidence-based therapeutic interventions through high-quality software programs to prevent, manage, or treat a medical disorder or disease.1 PDTs incorporate advanced technology best practices for design, clinical evaluation, usability, and data security, and are developed under the same rigorous conditions as pharmaceuticals—complete with clinical trials, FDA clearance, and are available only with a physician’s prescription.1

EFFICACY

THE BEST MEDICINE
MAY NOT BE MEDICINE AT ALL

Regulora was evaluated in a multi-site, randomized, controlled, and blinded clinical trial of 362 evaluable subjects.

Two of three analyses of the primary endpoint of abdominal pain achieved clinically significant separation from the control arm. No serious adverse events were associated with Regulora.

68%

reported overall satisfaction with the treatment

87%

would recommend Regulora to someone with IBS

ABOUT IBS

WHAT IS IBS?

Irritable bowel syndrome (IBS) is a disorder where the brain and the gut don’t communicate as they should, resulting in chronic gastrointestinal distress that affects overall quality of life. Abdominal pain is the primary symptom of all IBS subtypes (IBS-C, IBS-D, and IBS-M).

IBS FACTS & FIGURES

Treatment in the United States has been estimated to be between $1.7 billion and $10 billion per year, with total indirect costs of up to $20 billion.2

Abdominal pain is the number one reason patients seek treatment
Accounts for nearly 3.5 million physician visits in the U.S. annually
Is one of the most common diagnoses made by gastroenterologists3
Is common among adults—affecting 10% to 15% of the population
Affects women 2x more than men

JOIN THE REGULORA® REVOLUTION

We’re committed to the innovative use of technology to treat diseases with the human mind. We invite you to join us in reshaping the future of healthcare.

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