The digital health company got a green light from the FDA last November for Regulora – which delivers hypnotherapy through an Apple or Android smartphone – as a therapy for abdominal pain associated with all forms of IBS.
Hypnotherapy is a recognised approach to treating pain associated with IBS, which affects 10% to 15% of all adults in the US, but until now has only been available in person through highly specialised therapists, who are in short supply.
Using Regulora, people with IBS receive seven 30-minute sessions of remote behavioural therapy based on gut-directed hypnotherapy (GDH) administered over a period of 12 weeks.
GDH is designed to influence pain sensation and promote healthier control of digestive tract function by addressing a “miscommunication” between the brain and gut. A review of clinical studies published in 2015 found response rates of between 24% and 73% with the technique.
Indegene – an international player in the health tech arena providing technology platforms and commercialisation services to pharmaceutical, biotechnology and medical device companies – will use its network to raise the profile of Regulora among healthcare providers, patients, and payers.
Chicago-based metaMe – which raised $2.2 million last week in a bridge funding round led by Hyde Park Angels – said that the deal would free up time to concentrate on the development of additional prescription DTx products.
That includes products to treat gastro-oesophageal reflux disease (GORD), ulcerative colitis and potentially other chronic conditions like fibromyalgia, cancer pain, migraine and weight loss, according to the company.
“With over 30 million symptomatic IBS patients in the US alone, we have a great opportunity to make a difference using our digital-first omnichannel approach to bring Regulora to market quickly and at scale,” said Nathan Piland, vice president at Indegene.
metaMe’s latest fundraising added to $3.8 million in seed financing in 2019.
The company isn’t alone in taking a digital health approach to IBS. Others operating in this category include Bold Health of the UK, Germany’s Cara Care and San Francisco-based Mahana Therapeutics, whose Parallel prescription DTx was approved by the FDA to reduce the severity of IBS last year.