Endogenex, a clinical-stage company, has been granted investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin a clinical study of its ReCET system to treat type 2 diabetes in adults inadequately controlled by non-insulin, glucose-lowering medications.

Endogenex是一家临床阶段公司，已获得美国食品和药物管理局（FDA）的研究设备豁免（IDE），开始对其ReCET系统进行临床研究，以治疗非胰岛素降糖药物控制不足的成年人的2型糖尿病。

ReCET is an endoscopic procedure that targets underlying cell pathology in the duodenum that could contribute to type 2 diabetes development and progression. It applied controlled, non-thermal pulsed electric fields to initiate the natural regenerative process, in order to restore correct cell signaling from the duodenum and boost metabolic function—including better blood glucose control. .

ReCET是一种内窥镜手术，针对十二指肠潜在的细胞病理，可能导致2型糖尿病的发展和进展。它应用受控的非热脉冲电场来启动自然再生过程，以恢复十二指肠正确的细胞信号传导并增强代谢功能，包括更好的血糖控制。。。

The clinical study will enroll patients at up to 30 sites in the U.S. and up to 10 sites in Australia.

该临床研究将在美国多达30个地点和澳大利亚多达10个地点招募患者。

'Endogenex is excited to achieve this important clinical milestone,' said Endogenex CEO Stacey Pugh. 'This is a critical next step in advancing the ReCET Procedure as a treatment that addresses the underlying causes of T2D that are not targeted by current diabetes medications.'

Endogenex首席执行官斯泰西·普格（StaceyPugh）说，Endogenex很高兴实现这一重要的临床里程碑这是推进ReCET程序的关键下一步，作为一种治疗方法，可以解决目前糖尿病药物未针对的T2D的根本原因。”

Richard Pratley, MD is co-principal investigator for the ReCET study, as well as the medical director of the Advent Health Diabetes Institute in Orlando, Fla. He explained that many patients with type 2 diabetes have trouble controlling blood sugar levels, even while taking modern glucose lowering medications. .

医学博士Richard Pratley是ReCET研究的联合首席研究员，也是佛罗里达州奥兰多的Advent Health Diabetes Institute的医学主任。他解释说，许多2型糖尿病患者即使服用现代降糖药物，也难以控制血糖水平。。。

'Preliminary results of the ReCET Procedure have been very encouraging, so we look forward to participating in this study and expanding the understanding of how it may fulfill a significant need in the care of this patient population,' he said.

他说：“ReCET程序的初步结果非常令人鼓舞，因此我们期待着参与这项研究，并扩大对它如何满足这一患者群体护理的重大需求的理解。”。

ReCET has been evaluated as part of feasibility clinical studies including REGENT-1 US, REGENT-1 Australia, and EMINENT in the Netherlands. It’s also claimed breakthrough status from the FDA to treat type 2 diabetes patients.

ReCET已被评估为可行性临床研究的一部分，包括REGENT-1 US，REGENT-1 Australia和Excellent in the Netherlands。它还声称FDA在治疗2型糖尿病患者方面取得了突破性进展。