CAESAREA, Israel, August 13, 2026
Nitinotes Ltd., a medical device company developing automated endoluminal suturing technologies for obesity treatment, has announced the activation of Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center as clinical sites in its pivotal U.S. EASE™ Investigational Device Exemption (IDE) trial. The milestone strengthens the company’s clinical development program for EndoZip™, an automated suturing system designed to support Endoscopic Sleeve Gastroplasty (ESG), a minimally invasive endoscopic procedure for obesity. The first study procedure at the newly activated sites was performed by Reem Z. Sharaiha, MD, Professor of Medicine at Weill Cornell Medicine and Director of Endoscopy at Weill Cornell and NewYork-Presbyterian/Weill Cornell Medical Center.
Weill Cornell Joins Pivotal EASE™ IDE Trial
The activation of the two institutions represents an important expansion of the EASE™ IDE clinical trial, which is evaluating the safety and effectiveness of the EndoZip™ Automated Suturing System in patients undergoing Endoscopic Sleeve Gastroplasty. The prospective, multicenter, randomized, two-arm, blinded study is designed to generate clinical evidence that could support a future U.S. Food and Drug Administration (FDA) marketing submission. With Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center now participating, Nitinotes is expanding enrollment across leading U.S. medical centers with expertise in advanced endoscopy and obesity care. The addition of a major academic medical center may also strengthen the trial’s ability to evaluate a standardized approach to endoscopic suturing in clinical practice.
EndoZip Targets Minimally Invasive Obesity Treatment
EndoZip™ is designed to automate the suturing process used during Endoscopic Sleeve Gastroplasty, with the goal of supporting a simpler and more reproducible procedure. ESG is performed through an endoscope rather than conventional open or laparoscopic surgery, making minimally invasive approaches an important area of innovation in obesity care. According to Nitinotes, the EASE™ study is intended to evaluate whether its automated platform can provide safe and effective clinical performance while supporting greater consistency in endoluminal suturing. Dr. Sharaiha, who also serves on Nitinotes’ Scientific Advisory Board, is leading the study at the Weill Cornell sites. She highlighted the continuing need for minimally invasive treatment options as obesity remains a major health challenge and emphasized the importance of generating clinical evidence for new technologies.
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Clinical Evidence Could Support Future FDA Submission
Nitinotes said the EASE™ IDE trial is being conducted at leading U.S. medical centers and is specifically structured to evaluate the safety and effectiveness of EndoZip™. Successful completion of the clinical development program could provide evidence for a future FDA marketing submission in the United States. The company’s technology already has a CE Mark in Europe, where EndoZip™ is authorized for commercial launch in the European Union and other CE Mark-accepting markets. In the United States, however, the system remains limited to investigational use as part of the clinical development program. The first patient treatment at Weill Cornell therefore marks a significant step in Nitinotes’ efforts to establish clinical evidence for its automated ESG platform and potentially expand access to minimally invasive obesity treatment options.
Nitinotes’ expansion of the EASE™ IDE trial to Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center highlights the growing clinical evaluation of automated technologies for obesity care. As enrollment continues across U.S. clinical centers, the company is focused on demonstrating the safety and effectiveness of EndoZip™ and building the evidence required for potential future FDA review. The trial’s progress will be closely relevant to the development of next-generation endoscopic obesity therapies, particularly technologies aimed at improving procedural consistency and simplifying advanced endoscopic interventions.
Source: Nitinotes press release
