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Revita-2 study

Fractyl clinical trial to evaluate Revita DMR System

The Revita-2 clinical trial is a randomized, sham-controlled, blinded study performed at multiple centres in Europe and will include three month glycaemic and hepatic endpoints

Fractyl Laboratories has announced that the first patient in Europe has been treated as part of a 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.

Recent discoveries in metabolic science are now demonstrating that lifestyle and diet induced changes to the lining of the first segment of the small intestine (the duodenum) can lead to insulin resistance and are associated with metabolic disorders such as type 2 diabetes and nonalcoholic steatohepatitis (NASH).

“Untreated insulin resistance can lead to more severe diseases including fatty liver disease and NASH,” said Jacques Devière, Head of Gastroenterology at the Hôpital Erasme in Brussels. “The initial clinical data of Revita DMR is encouraging, and there is enormous need for treatments that can change the course of these metabolic diseases.”

The Revita-2 clinical trial is a randomized, sham-controlled, blinded study performed at multiple centres in Europe and will include three month glycaemic and hepatic endpoints. Revita-2 follows the completion of Revita-1, which was an open-label study that enrolled 50 patients across multiple international sites.

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

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.

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

“The clinical data we have gathered to-date suggests Revita DMR may address a significant unmet medical need, which is the underlying insulin resistance in patients with type 2 diabetes who are poorly controlled despite medications,” said Dr Harith Rajagopalan, co-founder and CEO of Fractyl. “We anticipate that the Revita-2 trial will further build the clinical support about the safety and efficacy of the Revita DMR procedure and inform the design of additional clinical trials.”

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