Fractyl shows its intestine-resurfacing device for Type 2 diabetes improves insulin resistance, pancreatic function

Fractyl Health posted new data from its device-based, one-time diabetes treatment, showing its approach not only helped lower average blood sugar but also led to improvements in long-term insulin resistance and pancreatic function.

The company’s Revita DMR outpatient procedure runs a water-filled balloon catheter through the initial region of the small intestine known as the duodenum. By applying heat to the intestinal walls, the endoscopic device strips out and helps reset the organ’s mucosal lining, which can thicken over years from dietary fats, sugars and other foods. Those buildups can throw the body’s metabolic hormone production out of balance, which Fractyl believes contributes to the insulin resistance seen in Type 2 diabetes.

The new data, presented during the annual Digestive Disease Week meeting, were gathered from two clinical studies that previously posted benefits in weight loss and glucose level control and also showed some patients could go without insulin doses for at least six months.

Participants completed mixed meal tolerance tests before undergoing the Revita procedure and then again three months afterward. The aim was to examine how much insulin the pancreas produced after consuming a specific blend of fats, protein and carbohydrates. 

Researchers found improvements of about 33% across two measures of insulin resistance—known as HOMA-IR and the Matsuda index—which help evaluate how much insulin the body needs to help keep its blood sugar levels within a healthy range. Both measures are associated with higher risks of progressing to more intensive therapies in Type 2 diabetes.

At the same time, participants showed a 25% gain in insulin secretion rates from the pancreas’s beta cells in response to a meal as well as a 37% improvement in the body’s disposition index, which estimates the ability of the pancreas to correctly counter rising blood glucose.

“The current data suggest that Revita may be the first investigational therapy to offer the potential for improvements in insulin sensitivity and pancreatic beta cell function months after a single minimally invasive, outpatient intervention,” Fractyl Chief Medical Officer Juan Carlos Lopez-Talavera, M.D., Ph.D., said in a statement. 

“These results raise intriguing questions about the potential for therapeutic interventions targeting the duodenum to help address underlying root causes of metabolic dysfunction in people with T2D,” Lopez-Talavera added.

The studies also showed a 0.8% point reduction in HbA1c, down from a baseline of 8.2%, and an average weight loss of 4.3 kilograms.

Last year, Fractyl raised $100 million in venture capital funding to complete the development of its Revita system and secure an FDA approval. The device has already scored a breakthrough designation from the agency as well as a CE mark in Europe.

The former Fierce 15 winner announced last month that the FDA greenlighted a new pivotal study in Type 2 diabetes patients who have not yet begun therapies with insulin. 

The randomized, sham-controlled study is slated to enroll up to 510 participants from around the world to measure changes in HbA1c and see whether a single Revita procedure can prevent the need for future insulin injections. A separate, ongoing pivotal study is set to evaluate up to 420 patients who have already begun insulin treatments.