CAESAREA, Israel, July 28, 2026
Nitinotes Ltd. has completed the first study procedures at Orlando Health in its pivotal U.S. EASE™ Investigational Device Exemption (IDE) clinical trial evaluating the EndoZip™ Automated Suturing System for Endoscopic Sleeve Gastroplasty (ESG). The milestone expands participation in the multicenter U.S. study and marks further progress in the clinical development of EndoZip, an automated endoluminal suturing technology designed to simplify and standardize ESG for the treatment of obesity. The EASE IDE trial is evaluating the safety and effectiveness of EndoZip and is designed to generate clinical evidence supporting a future U.S. Food and Drug Administration marketing submission. EndoZip is already CE marked in Europe, while its use in the United States remains investigational.
Orlando Health Begins EndoZip Procedures in EASE Trial
The first study procedures at Orlando Health were performed by Andre F. Teixeira, MD, Director of the Orlando Health Weight Loss and Bariatric Surgery Institute, and Manoel Galvao Neto, MD, Director of Bariatric Research at the institute. Their participation adds a center with expertise spanning bariatric surgery, metabolic care and endoscopic obesity treatment to the pivotal study. According to Nitinotes, expanding participation among centers experienced in both surgical and endoscopic approaches is an important part of evaluating the technology in U.S. clinical practice. Endoscopic Sleeve Gastroplasty is a minimally invasive obesity treatment that uses endoscopic suturing to reduce the functional volume of the stomach without conventional bariatric surgery. Nitinotes developed EndoZip with the goal of automating key elements of the suturing process and supporting greater procedural standardization and reproducibility across physicians with different levels of ESG experience.
EASE IDE Trial Evaluates Safety and Effectiveness
The EASE Clinical Trial is a prospective, multicenter, randomized, two-arm, blinded IDE study designed to assess the safety and effectiveness of the EndoZip Automated Suturing System in patients with obesity undergoing Endoscopic Sleeve Gastroplasty. As a pivotal U.S. clinical study, its findings are intended to support a future FDA marketing submission for the system. The addition of Orlando Health represents continued execution of the clinical program as Nitinotes works to establish evidence supporting the device’s potential role in minimally invasive obesity care. Nitinotes CEO Lloyd Diamond said EndoZip was developed to simplify and standardize ESG, potentially making the procedure more reproducible across clinicians, including bariatric surgeons interested in adding endoscopic approaches to their obesity treatment practices. Dr. Teixeira noted that minimally invasive endoscopic procedures are becoming increasingly relevant as obesity care evolves and that technologies capable of simplifying technically demanding procedures could potentially support broader adoption while maintaining procedural consistency.
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EndoZip Targets Automated Endoscopic Obesity Treatment
EndoZip is Nitinotes’ flagship automated endoluminal suturing platform, designed specifically to perform ESG through a standardized automated approach. Rather than requiring traditional surgical incisions, ESG is performed endoscopically, making technologies that improve procedural efficiency and reproducibility potentially important as healthcare systems seek additional minimally invasive options for obesity management. The EndoZip platform has already achieved a major regulatory milestone outside the United States through CE Mark authorization, enabling commercial introduction in the European Union and other markets recognizing CE certification. In the U.S., however, EndoZip remains an investigational device, and the EASE trial will be central to determining whether its clinical performance can support future regulatory review. The Orlando Health milestone also demonstrates Nitinotes’ continued expansion of its U.S. pivotal study among experienced bariatric and endoscopic treatment centers. Successful completion of the EASE IDE trial could provide the clinical evidence required for Nitinotes to pursue FDA marketing authorization and potentially introduce an automated ESG platform into the U.S. obesity treatment landscape. With obesity remaining a major healthcare challenge and demand growing for less invasive treatment approaches, the trial represents an important clinical and regulatory step for Nitinotes as it advances EndoZip toward potential U.S. commercialization.
Source: Nitinotes press release
