Fractyl Laboratories, developers of a minimally invasive procedure to resurface the inner linings of the intestine, has raised $55 million to help complete its pivotal clinical trial in Type 2 diabetes.
The study aims to examine the treatment’s effects on blood sugar control and a person’s need for insulin injections. The former Fierce 15 winner’s Revita device has also shown improvements in liver fat, linked to diseases such as nonalcoholic steatohepatitis, or NASH.
“Type 2 diabetes and NAFLD/NASH are eroding our global health and are responsible for a large portion of global healthcare costs,” said Michael Huang, a managing partner at Taiwania, who joined Fractyl’s board of directors after the firm led its series E round.
Other participants included the company’s returning investors Bessemer Venture Partners, General Catalyst, Domain Associates, Mithril Capital Management, Emergent Medical Partners, True Ventures and GV, as well as new backers in Catalio Capital Management, CDIB Venture Capital Corp., and YJ Capital.
Fractyl’s CE-marked Revita device uses water and heat to strip away the mucosal layers inside the duodenum, allowing it to regrow naturally. The company says that lining can thicken after years of exposure to dietary fats, sugars and other foods, upsetting the balance of hormones linked to metabolic pathways, related diseases and resistance to insulin.
The primary endpoint of the U.S. clinical trial set to launch later this year will explore the percentage of participants who can achieve target glycemic control without needing insulin for 24 weeks, compared to a sham treatment.
“Fractyl's founding mission was to find a better way to treat type 2 diabetes by addressing the root cause of disease that can reverse the disease process rather than manage its symptoms,” co-founder and CEO Harith Rajagopalan said. “We now have data from hundreds of patients with type 2 diabetes showing the durable benefits of a single Revita treatment.”