Caesarea, Israel, September 15, 2026
Nitinotes has announced the completion of the first EASE™ clinical trial procedures at Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome, Italy. The milestone marks the beginning of clinical evaluation of the company’s EASE Endoscopic Sleeve Gastroplasty (ESG) system, an investigational minimally invasive technology being developed for patients with obesity. The procedures were performed by Professor Giovanni M. G. Tringali, Director of the Digestive Endoscopy Unit at Gemelli Hospital, as part of the company’s European clinical development program. The EASE system is designed to enable physicians to perform endoscopic sleeve gastroplasty without conventional surgery, potentially providing a less invasive approach to weight-management treatment.
EASE System Advances Into Clinical Evaluation
The EASE system is an investigational endoscopic medical device designed to facilitate ESG, a procedure that reduces stomach volume by creating internal sutures through an endoscope. Unlike traditional bariatric surgery, ESG is performed through the gastrointestinal tract and does not require external surgical incisions. The approach is intended to alter the structure of the stomach and restrict the amount of food it can accommodate. Nitinotes developed EASE to simplify and standardize the ESG procedure through a purpose-built endoscopic platform. The company describes the system as a single-use, motorized endoscopic suturing device designed to support the creation of a consistent sleeve-like configuration in the stomach. The technology is intended to help physicians perform the procedure through a streamlined workflow while reducing the technical complexity associated with conventional endoscopic suturing approaches. The initiation of clinical procedures at Gemelli represents an important step because the technology is now being evaluated in a real-world clinical setting under a formal clinical investigation. Data generated during the study will contribute to the assessment of the device’s performance and clinical use in patients undergoing endoscopic treatment for obesity.
European Study Evaluates Safety and Performance
The clinical trial is designed to generate evidence regarding the safety, usability, and performance of the EASE system when used to perform endoscopic sleeve gastroplasty. Conducting the investigation at a major European medical institution provides an opportunity to evaluate the technology within an experienced gastrointestinal endoscopy environment. Professor Tringali and the Gemelli team bring expertise in advanced therapeutic endoscopy, an area that increasingly incorporates minimally invasive techniques for gastrointestinal diseases and metabolic conditions. Nitinotes said the collaboration represents an important component of its European clinical program as the company works toward expanding access to endoscopic obesity interventions. Obesity is a major global health challenge associated with numerous chronic conditions, including type 2 diabetes, cardiovascular disease, hypertension, and metabolic disorders. Endoscopic approaches such as ESG have emerged as alternatives for selected patients who may not undergo or prefer not to undergo conventional bariatric surgery. Technologies designed to improve the consistency and accessibility of these procedures could therefore have an important role in the evolving field of minimally invasive metabolic therapy.
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Advancing Minimally Invasive Obesity Treatment
Nitinotes said the first procedures represent a significant milestone in the development of its EASE technology, bringing the company closer to generating additional clinical evidence for the system. The company is focused on creating technologies that can make endoscopic procedures more accessible and reproducible for physicians. The EASE platform builds on the growing adoption of endoscopic sleeve gastroplasty as a minimally invasive intervention for obesity. By accessing the stomach through an endoscope rather than through abdominal surgery, ESG can potentially reduce the invasiveness associated with traditional surgical approaches. However, the procedure still requires specialized skills and equipment, making device design and procedural standardization important areas of medical-device development.
Clinical evaluation will provide additional information about how the EASE system performs during actual procedures and whether its design can support reliable stomach remodeling. As the clinical program progresses, researchers will be able to assess outcomes and collect evidence relevant to the technology’s future regulatory and commercial development. The first EASE procedures at Fondazione Policlinico Universitario Agostino Gemelli IRCCS therefore represent a notable advancement for Nitinotes’ medical-device program. The milestone highlights continued innovation in endoscopic bariatric procedures, while clinical investigation will determine the safety and effectiveness of the technology and its potential role in the expanding field of minimally invasive obesity treatment.
Source: Nitinotes press release
