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Revita DMR data

One-year Revita DMR data presented at EASD

A single DMR procedure produced sustained reductions in HbA1c, fasting glucose, and markers of insulin resistance out to at least 12 months

Fractyl Laboratories and clinical investigators for the Revita-1 clinical trial have report one-year data from the study showing sustained improvement in glycaemic parameters following a single treatment with Revita DMR in patients with type 2 diabetes (T2D). The data was presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Lisbon, Portugal.

“This is the first presentation of one-year data on the durability of the Revita DMR procedure in type 2 diabetes. The Revita DMR procedure was well tolerated, and no serious adverse events related to the device or procedure were reported through one-year of follow up,” said Dr Harith Rajagopalan, cofounder and CEO of Fractyl. “Additional data on the durability of this intervention’s effects on liver measures in patients with type 2 diabetes will also be presented at AASLD later this year.”

Revita DMR is a minimally invasive, therapeutic procedure designed to rejuvenate the duodenum. It is intended as an outpatient therapy to be performed in less than one hour and allow patients to resume normal activities the following day. By rejuvenating the surface of the duodenum, Revita DMR is designed to address insulin resistance directly and help improve the management of type 2 diabetes.

Figure 1: The Revita device allows physicians to easily separate the mucosal layer of the duodenum from the sub-muscosa

Figure 2: After the mucosal layer is separated, the ablation balloon catheter is delivered into the duodenum

The data from Revita-1, a single arm, open label, multi-centre study, reports that a single DMR procedure produced sustained reductions in HbA1c, fasting glucose, and markers of insulin resistance (HOMA-IR) out to at least 12 months. A larger, randomized, multi-centre, sham-controlled, blinded study is currently underway in Europe to further evaluate the safety and efficacy of the Revita DMR System in orally-treated type 2 diabetes patients with poorly controlled disease.

“While there are an increasing number of pharmacological treatments for type 2 diabetes, these have little impact on the natural history of the disease and create a significant treatment burden for the patient,” said Dr David Hopkins, director of the Institute of Diabetes, Endocrinology, and Obesity at King’s Health Partners, London, UK. “These data, showing durable improvements in insulin resistance (HOMA-IR) and glycaemic control observed over a year, demonstrate the potential for Revita DMR to impact the mechanisms underlying type 2 diabetes through a single same-day procedure indicating considerable potential as an alternative approach to escalating drug treatment."

Fractyl is currently enrolling patients in Europe in a multi-centre clinical trial called Revita-2. The trial is designed to evaluate the safety and efficacy of the Revita DMR System in orally-treated type 2 diabetes patients with poorly controlled disease.  

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