Nitinotes to initiate US trial of the EndoZip System for endoscopic sleeve gastroplasty

Nitinotes has received approval from the FDA to initiate a pivotal clinical trial of the EndoZip System for endoscopic sleeve gastroplasty (ESG) under an Investigational Device Exemption (IDE). This prospective, multi-centre, randomised 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 ten US clinical sites, with additional international sites included in accordance with FDA guidelines.

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

"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 Dr Barham Abudayyeh, co-principal investigator. "We are excited to participate in this trial."

The EndoZip System is a novel, automated ESG device engineered to standardise 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 Gastrointestinal Endoscopy1, have demonstrated promising safety and efficacy outcomes in real-world settings.

"Standardisation is essential to the evolution of ESG,” added Dr Christopher Thomspon, co-principal investigator. 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."

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 US market. In parallel, the company is in the final stages of the CE mark process, with plans for an imminent commercial launch in Europe.

Reference

1. Boskoski I, Lopez-Nava G, Ravishankar A, Bove V, Matteo MV, De Siena M, Pontecorvi V, Giannetti G, Iaconelli A, Spada C, Shamah SE. Automatic endoscopic gastroplasty for the treatment of obesity: results from a prospective multicenter study (with video). Gastrointest Endosc. 2025 Apr;101(4):818-827. doi: 10.1016/j.gie.2024.09.026. Epub 2024 Sep 21. PMID: 39307402.