#Italy #Rome #EndoZip #Nitinotes #EASE™

Nitinotes Initiates EASE™ Clinical Trial Procedures in Italy

Nitinotes Ltd., the company behind the innovative EndoZip™ Automated Suturing System, has announced a significant milestone in its clinical research journey with the commencement of the first EASE™ clinical trial procedures. The event took place at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS located in Rome, Italy. This is a landmark development as it marks the expansion of the EASE™ study, which aims to evaluate the EndoZip™ system for Endoscopic Sleeve Gastroplasty (ESG).

A Pioneering Step in Obesity Treatment

EndoZip™ has been revolutionizing the approach to gastric remodeling, providing a minimally invasive solution aimed at treating obesity. This automated suturing technology streamlines the procedure, allowing for a more standardized method in gastric remodeling while mitigating the technical complexities that often accompany manual suturing techniques.

The first procedures in this new clinical trial were conducted by esteemed gastroenterologist, Prof. Ivo Boskoski, MD, PhD, who serves as the Associate Professor of Gastroenterology & Digestive Endoscopy at the Gemelli Hospital. The hospital has already been utilizing the EndoZip™ system for commercial ESG procedures following its CE Mark approval, thus facilitating their involvement in this pivotal clinical study.

A Commitment to Innovation in Healthcare

The EASE™ clinical study is designed to rigorously evaluate both the safety and effectiveness of the EndoZip™ system when used in ESG. This minimally invasive technique has the potential to significantly affect the obesity treatment landscape by serving as a bridge between pharmacotherapy and bariatric surgery.

Prof. Boskoski expressed the importance of the trial, stating, “As a research hospital, advancing new treatment approaches and providing patients access to innovative technologies are important parts of our mission. We are pleased to participate in the EASE™ clinical trial and contribute to the continued evolution of endobariatric care.”

Leadership and Collaboration

Lloyd Diamond, the CEO of Nitinotes, commented on the significance of this progress, noting, “The first EASE™ procedures at Gemelli represent important progress in the clinical development of EndoZip™. Prof. Boskoski and the team at Gemelli bring extensive expertise in advanced endoscopy, and their participation in EASE™ will contribute to the growing body of clinical evidence supporting Automated Gastric Remodeling.” Moreover, Nitinotes acknowledged the contributions of Prof. Cristiano Spada and Dr. Vincenzo Bove, alongside the wider clinical team at the Fondazione Policlinico Universitario Agostino Gemelli, for their dedication and support in this endeavor.

About Nitinotes

Founded with a vision to transform obesity treatment, Nitinotes is a privately held medical device company that focuses on pioneering automated endoluminal suturing technologies. Their flagship product, the EndoZip™ system, received CE Mark approval in November 2025 and is actively marketed in the European Union and other CE-accepting regions. This clinical trial represents a critical step towards reshaping the landscape of obesity treatments by integrating advanced technology and clinical expertise.

For further insights and updates on Nitinotes and its groundbreaking innovations in medical devices, visit Nitinotes Surgical.