Nitinotes, developer of the EndoZip™ System, a fully automated suturing platform for endoscopic sleeve gastroplasty (ESG), today announced it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a pivotal clinical trial under an Investigational Device Exemption (IDE).

Nitinotes，EndoZip™系统的开发者，这是一个用于内镜袖状胃成形术（ESG）的全自动缝合平台，今天宣布已获得美国食品药品监督管理局（FDA）的批准，可以启动一项关键性临床试验，并获得了研究设备豁免（IDE）。

This prospective, multicenter, randomized controlled trial will evaluate the safety and efficacy of the EndoZip System for the treatment of obesity. Up to 184 patients will be enrolled across as many as 10 U.S. clinical sites, with additional international sites included in accordance with FDA guidelines.

这项前瞻性、多中心、随机对照试验将评估EndoZip系统治疗肥胖症的安全性和有效性。多达184名患者将被招募至美国境内最多10个临床试验点，同时根据FDA指南纳入额外的国际试验点。

As a comparative study against an already FDA-approved device, all participants will receive an active treatment, a design element expected to potentially accelerate enrollment. Patient enrollment is anticipated to begin by the end of Q3 2025, with 12-month patient follow-up projected for completion by mid 2027..

作为与已获FDA批准的设备进行的对比研究，所有参与者都将接受积极治疗，这一设计元素有望加速入组。预计患者招募将于2025年第三季度末开始，并预计在2027年年中完成12个月的患者随访。

'This FDA IDE approval marks a key milestone in our U.S. regulatory strategy and brings us one step closer to commercializing EndoZip™ in this important market,' said Lloyd Diamond, CEO of Nitinotes. 'EndoZip™ represents the next generation of endoscopic bariatric interventions, offering a safe, simpler, and reproducible suturing alternative to existing procedures.

“这一FDA IDE批准标志着我们美国监管策略中的一个关键里程碑，使我们在这一重要市场中向商业化推出EndoZip™更近了一步，” Nitinotes首席执行官Lloyd Diamond表示。“EndoZip™代表了内镜减肥干预的下一代技术，为现有手术提供了一种安全、更简单且可重复的缝合替代方案。”

By reducing the learning curve, it has the potential to democratize access to this treatment and empower a broader range of physicians, including bariatric surgeons.'.

通过降低学习曲线，它有可能使更多医生，包括减重外科医生，更容易掌握这种治疗方法，从而普及治疗的可及性。

The EndoZip™ System is a novel, automated ESG device engineered to standardize endoscopic bariatric procedures. By enabling consistent, full-thickness plications in a single-operator setting, the system aims to reduce procedural complexity and variability. Clinical results from the company's EU pivotal trial, recently published in .

EndoZip™ 系统是一种新型的自动化 ESG 设备，旨在标准化内镜减肥手术。通过在单操作员环境下实现一致的全层折叠，该系统旨在降低手术复杂性和可变性。公司最近在欧盟关键试验中发布的临床结果。

Gastrointestinal Endoscopy

胃肠镜检查

, have demonstrated promising safety and efficacy outcomes in real-world settings.

，在真实世界环境中展示了良好的安全性和有效性结果。

'There is growing demand for less invasive bariatric options for the treatment of obesity and metabolic diseases that help address key barriers to access and adoption,' said

“对于治疗肥胖症和代谢疾病，需求日益增长的微创型减重选择，有助于解决获取和采用的关键障碍，”

Barham Abudayyeh

巴拉姆·阿布达耶ех

, co-principal investigator. 'We are excited to participate in this trial.'

“, 联合首席研究员。‘我们很兴奋能参与这次试验。’”

Christopher Thomspon

克里斯托弗·汤普森

, co-principal investigator, added, 'Standardization is essential to the evolution of ESG. The ability to automate key steps in the procedure may ultimately improve outcomes and enable broader clinical adoption, particularly as we see a growing number of patients coming off GLP-1 therapies and seeking sustainable, minimally invasive weight loss solutions.'.

“, 共同首席研究员补充道：‘标准化对ESG的发展至关重要。自动化处理程序中关键步骤的能力最终可能会改善结果，并推动更广泛的临床应用，特别是随着越来越多的患者停止使用GLP-1类疗法，并寻求可持续的、微创的减重解决方案。’”

This pivotal trial will serve as the foundation for Nitinotes' regulatory submission to the FDA and supports its broader strategy to commercialize EndoZip™ in the U.S. market. In parallel, the company is in the final stages of the CE mark process, with plans for an imminent commercial launch in

这项关键试验将作为Nitinotes向FDA提交监管文件的基础，并支持其在美国市场推广EndoZip™的更广泛战略。与此同时，该公司正处于CE标志流程的最后阶段，并计划即将在相关市场进行商业发布。

About Nitinotes

关于Nitinotes

Nitinotes is a privately held medical device company pioneering an innovative solution for the treatment of obesity. The Company's flagship product, EndoZip™, is a fully automated endoscopic sleeve gastroplasty (ESG) system designed to provide a consistent, reproducible, and minimally invasive alternative to traditional bariatric surgery for patients with class I & II obesity.

Nitinotes是一家私人持有的医疗设备公司，致力于开创一种用于治疗肥胖的创新解决方案。该公司的旗舰产品EndoZip™ 是一个全自动的内镜袖状胃成形术（ESG）系统，旨在为I类和II类肥胖患者提供一种一致、可复制且微创的传统减重手术替代方案。