最新临床数据！糖尿病电脉冲治疗或打破针药依赖？

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]