Nitinotes Secures FDA Approval for Pivotal Trial of EndoZip™ System for Obesity Treatment

Nitinotes to Launch Pivotal Trial for EndoZip™ System

CAESAREA, Israel — June 24, 2025 — Nitinotes, a cutting-edge medical device company, has just announced that it has received approval from the U.S. Food and Drug Administration (FDA) to commence a pivotal clinical trial for its innovative EndoZip™ System. This approval marks a significant advancement in the field of minimally invasive obesity treatment.

The EndoZip™ System is designed as a fully automated suturing platform specifically tailored for endoscopic sleeve gastroplasty (ESG). This upcoming trial will be crucial in evaluating the safety and effectiveness of the EndoZip System in treating obesity across multiple clinical settings. Envisioned to be a prospective, multicenter, randomized controlled trial, the study aims to enroll up to 184 patients at as many as ten clinical sites throughout the United States. Additionally, international sites may be incorporated in accordance with FDA guidelines.

In this trial, participants will receive active treatment, effectively comparing the EndoZip System against an already existing FDA-approved device. This comparability is expected to expedite patient enrollment, with the recruitment phase anticipated to start by the end of Q3 2025. Completion of the 12-month follow-up for enrolled patients is projected by mid-2027.

A Step Closer to Market Launch

Lloyd Diamond, CEO of Nitinotes, emphasized the significance of this FDA IDE approval, stating, "This marks a crucial milestone in our U.S. regulatory strategy and brings us one step closer to commercializing EndoZip™ in this vital market. The EndoZip™ is pioneering a new generation of endoscopic bariatric interventions, offering a safer, simpler, and more reproducible suturing alternative to existing methods."

He further explained that the system aims to bridge accessibility gaps in bariatric surgery by empowering a diverse range of physicians, including those specializing in bariatric surgery, to utilize this innovative technology.

The EndoZip System is engineered to standardize endoscopic bariatric procedures. It enables consistent, full-thickness plications to be performed by a single operator, effectively minimizing procedural complexity and variability. Clinical outcomes derived from their pivotal trial undertaken in the EU demonstrate promising safety and efficacy indicators in real-world applications.

Addressing Growing Demand

“The increasing demand for less invasive bariatric options to address obesity and metabolic diseases presents an opportunity we need to respond to,” shared Dr. Barham Abudayyeh, co-principal investigator for the trial. “We are thrilled to be part of this crucial study.”

Additionally, Dr. Christopher Thompson, another co-principal investigator, pointed out the importance of standardization in ESG's development. He noted that automating critical steps in the procedure could ultimately refine patient outcomes and encourage broader adoption, especially as an increasing number of patients transition off GLP-1 therapies and seek sustainable alternatives for weight loss.

This pivotal trial lays the groundwork for Nitinotes’ regulatory submission to the FDA and aligns with its global strategy for commercializing EndoZip in the U.S. market. Concurrently, the company is in the final stages of acquiring the CE mark, indicating an imminent commercial launch in Europe.

About Nitinotes

Nitinotes stands at the forefront of innovation in the medical device landscape, focusing on cutting-edge solutions for obesity treatment. Its flagship product, EndoZip™, promises a minimally invasive and reproducible alternative for patients with class I and II obesity, setting a new standard in the field of bariatric surgery. For further details, visit Nitinotes Website.