# R E G E N T- 1 试验结果：胰岛 功 能与胰 岛素敏感 性持续改善 | 思宇年度活动回顾： 首届全球眼科大会 首届全球骨科大会 首届全球心血管大会 | | --- | | 即将召开： | | 2025年6月12日，首届全球医美科技大会 | | 2025年7月17日，第二届全球医疗科技大会 | | 2025年9月4-5日，第三届全球手术机器人大会 | 近日，美国圣地亚哥举办的消化疾病周（Digestive Disease Week，DDW 2025）上，美国医疗设备公 司 Endogenex 公布其 ReCET系统 在 REGENT-1临床研究 中的 48周随访结果 。该系统通 过一次性内窥镜治疗， 显著改善2型糖尿病患者的胰岛素敏感性和β细胞功能， 且疗效维持近一年，无严重不良事件报告。 REGENT-1是一项在澳大利亚和美国同步进行的临床研究，用于评估ReCET系统在2型糖尿病治疗中的安全性、可行性与代谢效果。在本次DDW会议上， Endogenex披露了澳大利亚队列的48周随访数据 ： 胰岛素敏感性在治疗 12周时即显著提升，至48周仍保持改善状态， 且存在剂量-反应关系； β细胞功能持续 ...

Core Viewpoint - The ReCET system by Endogenex shows promising results in improving insulin sensitivity and beta-cell function in type 2 diabetes patients, with a 100% surgical success rate and no serious adverse events reported over a 48-week follow-up period [1][7][22] Summary by Sections REGENT-1 Trial Results - The REGENT-1 clinical study demonstrated significant improvements in insulin sensitivity at 12 weeks, which was maintained at 48 weeks, indicating a dose-response relationship [3][6] - Beta-cell function showed continuous enhancement, suggesting that duodenal intervention may improve the feedback regulation of the entero-insular axis [6] Rise of Interventional Treatments - The global market for endoscopic treatments of metabolic diseases reached $3.8 billion in 2023 and is expected to exceed $4.9 billion by 2029, highlighting a shift towards non-pharmacological interventions [8] - "Interventional metabolic intervention" is emerging as a new treatment branch, aiming to improve insulin resistance and endocrine dysfunction without increasing the burden of medication [8] Technical Mechanism of ReCET - The ReCET system utilizes non-thermal pulsed electric field (PEF) technology for precise and selective intervention in duodenal tissue, inducing selective apoptosis of abnormal cells while preserving surrounding tissues [11][12] - The procedure is non-implantable and outpatient, with sustained metabolic improvements observed for at least 48 weeks, suggesting potential as a "stage treatment tool" [12] Three Pathways in Interventional Diabetes Treatment - Different companies are developing three technical pathways for metabolic regulation: non-thermal electric field stimulation (Endogenex/ReCET), thermal ablation remodeling (Fractyl/Revita), and physical barrier methods (GI Dynamics/EndoBarrier) [13][14] - Each pathway aims to bypass systemic medication through minimally invasive procedures targeting the upstream metabolic signaling axis [14] Commercialization Pathways and Regulatory Outlook - ReCET has received breakthrough device designation from the FDA, indicating potential for accelerated approval, while Endogenex has completed $88 million in Series C financing to focus on clinical data accumulation [19][20] - Revita has achieved CE certification and is in clinical use in Germany, while EndoBarrier has faced significant safety issues, halting its commercialization path [20] Conclusion - The publication of the 48-week follow-up data for the ReCET system signifies a new approach in treating systemic metabolic diseases through endoscopic intervention [22] - The competition among the three pathways will hinge on the balance of mechanism reconstruction, safety, operational convenience, and cost control, determining the future standard in this field [22]