metaMe Health has received FDA 510(k) clearance for Regulora, a prescription digital therapeutic aimed at treating abdominal pain associated with irritable bowel syndrome in adults.

Regulora is a smartphone app that delivers behavioral therapy based on gut-directed hypnotherapy to alleviate IBS pain.

“The FDA’s clearance of Regulora, our first PDT, is a major achievement for the company,” Tim Rudolphi, CEO of metaMe Health, said in a statement. “We are eager to expand access to this proven therapy to patients with all three subtypes of IBS.”

WHY IT MATTERS

According to the American College of Gastroenterology, about 5% to 7% of the adult population in the U.S. has been diagnosed with IBS, though more may have the condition without a diagnosis. 

Abdominal pain is one of the most common symptoms of IBS, said the Mayo Clinic. Though the precise cause of the disease isn’t known, miscommunication between the nervous and digestive systems could play a role, causing the body to react to normal changes in the digestive process. Stress is also a potential trigger for people with IBS. 

THE LARGER TREND

In 2019, metaMe raised $3.8 million in seed funding to go toward the development of Regulora. 

Other digital health companies that offer tools for treating IBS include London-based Bold Health, Mahana Therapeutics and Berlin-based Cara Care.

In the larger gastrointestinal care space, Vivante Health brought in $5.8 million in early 2020, and Oshi Health raised $23 million in Series A funding in October.