Fractyl Health Presents Clinical Update on Revita German Real-World Registry for Patients With Advanced Type 2 Diabetes (T2D)

First 14 participants with at least six months of follow up continue to demonstrate sustained improvements in blood glucose and weight with reduction in T2D medication utilization after a single Revita treatment

No device- or procedure-related serious adverse events have been observed to date in any registry participant

BURLINGTON, Mass., May 13, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today announced 6-month follow-up data from its enrolling German real-world registry study of Revita for T2D.

The first 14 consented registry participants have now completed at least 6 months of post-Revita follow up. At baseline, prior to Revita, these participants were a median age of 62 years, had a median body weight of 111 kg and advanced T2D with an average of 14 years since diagnosis. Despite using up to three different glucose lowering medications, participants’ T2D remained uncontrolled with a median baseline HbA1c of 9.2%.

These 14 participants underwent Revita and experienced an average total body weight loss of 8.1% at 6 months after the procedure, with generally sustained or improved weight loss from month 1 to month 6. These real-world findings further support the potential of Revita for durable maintenance of weight loss. Fasting blood glucose also improved after the procedure, falling from a baseline median of 153 to 116 mg/dL at 6 months, and HbA1c improved from a median of 9.2 to 7.6%, reflecting better glucose control, despite all patients stabilizing or reducing the number of glucose-lowering medications. No device or procedure-related serious adverse events have been reported to date.

Professor Stephan Martin, Director of the West German Diabetes Center of Excellence offering Revita combined with dietary and lifestyle support in Düsseldorf, Germany recently presented the Revita registry study 3-month follow-up results at the German Diabetes Association (DDG) annual meeting, held in Berlin May 8-11^th.

“Early results from our real-world registry suggest that patients who undergo Revita can experience significant improvement in blood sugar, reduction in body weight, and stabilization or reduction of medication burden,” said Timothy Kieffer, Chief Scientific Officer at Fractyl Health. “These results are particularly impressive considering that most patients in the registry have been struggling with advanced T2D and inadequate control despite treatment with standard-of-care polypharmacy for many years. In particular, the maintenance of body weight loss through 6 months of follow up is a promising indicator for our ongoing clinical development program in weight maintenance through our Remain-1 pivotal study.”