Caesarea, Israel – July 2025: Nitinotes has announced that it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). This important milestone allows the company to initiate a pivotal clinical trial in the United States for its innovative EndoZip™ system. The EndoZip™ device is a fully automated endoscopic suturing system specifically developed to perform endoscopic sleeve gastroplasty (ESG), a minimally invasive weight-loss procedure.
About the Clinical Trial.
The upcoming trial will enroll up to 184 patients across as many as ten clinical sites throughout the United States. The study is designed to compare the EndoZip™ system to a currently FDA-cleared device used for ESG. The primary objective is to evaluate the safety and effectiveness of the EndoZip™ system. Enrollment is expected to begin in the third quarter of 2025, with patient follow-up continuing for at least one year.
A Simpler Way to Fight Obesity.
The EndoZip™ system automates the ESG procedure by using a single-use disposable cartridge that performs full-thickness internal sutures. This automation allows a single physician to perform the procedure without needing manual stitching. It is intended to simplify the process, reduce variation between users, and shorten the learning curve for new practitioners. The system targets adults with class I and class II obesity who are seeking effective alternatives to surgery.
Voices from the Team.
Lloyd Diamond, CEO of Nitinotes, described the IDE approval as a “major milestone” in the company’s journey toward U.S. market entry. He emphasized that the EndoZip™ system has the potential to offer a safer, simpler, and more reproducible way to perform ESG. Clinical experts involved in the trial have expressed optimism about its potential to expand the use of ESG among a wider range of healthcare providers.
Promising European Results.
Clinical studies conducted in Europe have already demonstrated the EndoZip™ system’s safety and performance. A recent peer-reviewed article highlighted favorable outcomes from earlier trials, providing strong support for further research. These results play a critical role in building the foundation for future FDA submissions.
Looking Ahead.
This FDA approval marks a critical step forward for Nitinotes as it seeks to enter the U.S. bariatric device market. Simultaneously, the company is preparing to obtain CE mark approval, which would enable commercial entry into the European Union. With its unique approach, the EndoZip™ system could help redefine the future of endoscopic obesity treatment.
