New Weight-Loss Procedure Could Benefit Type 2 Diabetes Patients in France

A new endoscopic weight-loss procedure could improve type 2 diabetes by reducing medication needs and, hypothetically, by enabling type 2 diabetes remission.

Endo Tools Therapeutics (ETT) said that HAS, the French High Authority for Health, has issued a positive opinion to initiate a clinical study of the endomina triangulation platform and the Tapes suturing device within the framework of the Forfait Innovation program. The endomina device is a triangulation platform currently indicated in the European Union to perform endoscopic gastroplasty orally, to reduce the volume of the stomach.

Forfait Innovation provides special temporary reimbursement for medical technologies, in vitro diagnostic devices, or innovative procedures that are in the early diffusion stage, to allow French patients early access to medical innovations. This reimbursement is conditional on the completion of a study prospectively demonstrating the technology's clinical potential. So far, only 14 medical devices have been enrolled in the Forfait Innovation program.

The Gosselies, Belgium-based company said its next step is to enter budget discussions with the French Ministry for Solidarity and Health. Upon completion, ETT plans to work with 12 French study sites and use the Forfait Innovation financing to conduct a clinical study demonstrating the consequence of weight loss on type 2 diabetes. The endomina could be reimbursed in France for use in the clinical study and subsequently, during continued access in the study centers. The endomina device is a triangulation platform currently indicated in the EU to perform endoscopic gastroplasty orally, to reduce the volume of the stomach.

The ESTIME clinical trial would be a prospective, multi-center randomized study on patients with type 2 diabetes and class I obesity, monitoring them over two years for the potential benefit of the procedure in type 2 diabetes. The study will be led by Marc Barthet, gastroenterologist at Assistance-Publique Hôpitaux de Marseille, and Anne-Laure Borel, an endocrinologist at Grenoble University Hospital. The study aims to demonstrate that the minimally invasive endomina device has the potential to improve type 2 diabetes by reducing anti-diabetic medication and even, hypothetically, by delivering type 2 diabetes remission. The study will assess whether the intervention improves a patient’s quality of life and limits their hospital stay to one night, ETT noted.
 
“On approval of the Forfait Innovation funding, we would be able to help patients with type 2 diabetes and class I obesity gain access to a minimally invasive treatment that could improve type 2 diabetes and, we hope, might even lead to remission. If confirmed by the study, this has the potential to become a standard-of-care offered when conventional treatments are not sufficient,” Borel said.

When supported by lifestyle counseling, Barthet said the patient might expect to lose clinically meaningful weight, which in turn could have a positive clinical outcome on the management of the disease.