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Type 2 diabetes

T2DM: Positive data for Revita DMR procedure

The procedure has the potential to delay the need for insulin therapy and free patients from the burdens associated with managing type 2 diabetes

The first data from clinical studies assessing the non-invasive Revita Duodenal Mucosal Resurfacing (DMR) procedure has reported that the procedure improves glucose control in patients with type 2 diabetes. The DMR procedure, developed by Fractyl Laboratories, is designed to alter the inner surface of the duodenum and change how the body absorbs and processes sugar. The company claims procedure has the potential to delay the need for insulin therapy and free patients from the burdens associated with managing type 2 diabetes, particularly when oral medications have failed.

Professor Francesco Rubino.

“The gastrointestinal tract plays a critical role in the regulation of glucose metabolism,” said Professor Francesco Rubino, Professor and Chair of Bariatric and Metabolic Surgery at King’s College London. “Chronic exposure to food-borne and environmental toxins could cause disruption to gastrointestinal physiology, possibly explaining the link between modern diets and type 2 diabetes. On the other hand, operations used in bariatric surgery, especially those that involve a bypass of the duodenum, are the only type of treatment known to cause complete and long-term remission of diabetes. This knowledge provides a compelling reason to consider the gut as a physiologic and rational target for the development of more effective therapies of type 2 diabetes.”

According to the results of a single-site pilot study performed in Santiago, Chile, the Revita DMR procedure led to a greater than two percentage-point drop in HbA1c levels three months after the procedure with an excellent safety record. The patients in the study who were followed for up to six months maintained their improved HbA1c levels.

Presenting the results at the IFSO World Congress in Montreal, Dr Manoel Galvao Neto, a bariatric surgeon in São Paulo, Brazil, said the outcomes from the company’s proof-of-principal study, demonstrate the safety and effectiveness of the Revita procedure.

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

The Revita DMR procedure is an endoscopic procedure that thermal ablates the duodenal mucosa.  This study included 30 patients (22 male; mean age, 53.7 ± 8.2 years; mean BMI, 31.3 ± 3.5) with uncontrolled diabetes (mean HbA1c, 9.2%; mean diabetes duration, 5.7 ± 3 years) and HbA1c levels averaging 9.2 prior to treatment.

After the mucosal layer is separated, the ablation balloon catheter is delivered into the duodenum.

In the 19 patients who received DMR over several centimetres of their duodenum, HbA1c levels dropped to 7.1, on average, after three months and remained stable six months after the procedure. The treatment effect appears to be dose-dependent, as those patients who received DMR over a shorter segment of their duodenum did not experience as significant of a benefit.

“While early, we believe these results validate our approach and indicate the significant impact that the Revita DMR procedure could have for patients afflicted with type 2 diabetes,” said Dr Harith Rajagopalan, CEO of the company. “We are preparing to launch our multinational study by the end of the year and working towards our clinical development efforts in the US, which we expect to commence during 2016. We are committed to bringing to market an innovative clinical procedure to improve the health of patients with type 2 diabetes.”

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