Nitinotes Secures FDA IDE Approval for EndoZip™ Trial
On June 24, 2025, Nitinotes announced that it has gained crucial approval from the U.S. Food and Drug Administration (FDA) to commence a pivotal clinical trial for its EndoZip™ System, an innovative automated suturing platform designed for endoscopic sleeve gastroplasty (ESG). This milestone marks a significant step forward in the company’s efforts to introduce a new, minimally invasive solution for obesity treatment.
Trial Overview
The FDA's Investigational Device Exemption (IDE) allows Nitinotes to initiate a multi-center and randomized controlled trial aimed at evaluating the safety and efficacy of the EndoZip System. The trial will enroll up to 184 participants across ten clinical sites in the U.S., with additional international locations to be added in compliance with FDA guidelines. All participants in the study will receive active treatment, as the trial will compare the EndoZip System against an already FDA-approved device, which is expected to accelerate patient enrollment. The recruitment of patients is anticipated to start by the end of the third quarter of 2025, aiming for a 12-month follow-up completion by mid-2027.
What Sets EndoZip Apart?
Lloyd Diamond, CEO of Nitinotes, expressed that this FDA IDE approval is a critical component of their regulatory strategy to promote EndoZip™ within the U.S. market. He highlighted the EndoZip™ System's potential to become a next-generation solution for bariatric interventions, offering a simpler and more reliable suturing alternative than current procedures. This advancement may significantly reduce the learning curve associated with such surgeries, enabling greater accessibility for bariatric surgeons and healthcare practitioners.
The EndoZip™ System represents a pioneering automated ESG tool that seeks to standardize the processes involved in endoscopic bariatric surgeries. By allowing consistent, full-thickness plications while being operated by a single clinician, the system aims to minimize the complexity and variability that often accompany these procedures. Previous clinical outcomes from the company’s pivotal trial in Europe, published in the
Gastrointestinal Endoscopy, have shown promising safety and efficacy results in real-world applications.
Increasing Demand for Less Invasive Solutions
Commenting on the trial, Dr. Barham Abudayyeh, one of the co-principal investigators, noted the rising demand for less invasive options to treat obesity and metabolic disorders. He mentioned that these innovative solutions play a crucial role in removing existing barriers to treatment access and encourage patient adoption.
His sentiments were echoed by Dr. Christopher Thompson, another co-principal investigator, who emphasized the importance of standardization in ESG. He highlighted that automating critical steps within the procedure could pave the way for better clinical outcomes, especially in light of the growing number of patients transitioning off GLP-1 therapies and seeking sustainable, minimally invasive weight-loss options.
Future Prospects
This pivotal trial is crucial for Nitinotes' regulatory submission to the FDA and reinforces its broader strategy to commercialize the EndoZip™ System in the competitive U.S. market. At present, Nitinotes is also reaching the final stages of the CE mark process, gearing up for an impending commercial rollout in Europe.
About Nitinotes
Nitinotes is a pioneering medical device firm focused on creating transformative solutions for obesity management. The EndoZip™ System stands out as the company’s flagship product, intended to deliver a consistent, reproducible, and less invasive alternative to traditional bariatric surgery for individuals with class I and II obesity. Additional details can be explored on their official website at
nitinotesurgical.com.