Digital IBS care startup metaMe Health is launching its recently FDA-approved prescription digital therapeutic using a partnership with operations and commercialization company Indegene.
Regulora, which scored an FDA 510(k) late last year, delivers gut-directed hypnotherapy to help alleviate pain associated with IBS in adults. As part of the commercialization deal, Indegene will focus on bringing the prescription digital therapeutic to market and promoting it to providers, payers and patients.
"Indegene’s end-to-end commercialization process gives us confidence that this therapy will reach patients and improve their quality of life. It is great to have a partner like Indegene we can trust to manage the complexities of the process of taking our product to market," metaMe CEO Tim Rudolphi said in a statement.
Around 5% to 7% of the U.S. adult population has been diagnosed with IBS, but the American College of Gastroenterology said more people could be suffering from symptoms without an official diagnosis.
Abdominal pain and cramping are some of the most common symptoms of IBS.
Another digital health company in the gastrointestinal care space is Oshi Health, which recently announced a partnership with virtual care company Firefly Health to be included in its specialty care network. Oshi scooped up $23 million in Series A funding last year.
Earlier this month, Vivante Health, another more general digestive care startup, announced it had scored $16 million in Series A funding.
In the IBS-specific space, Mahana Therapeutics received FDA De Novo clearance in late 2020 for Parallel, a prescription digital therapeutic that provides cognitive behavioral therapy to improve symptoms. London-based Bold Health also offers a CBT-based product.