#Italy #Clinical Trials #Rome #Nitinotes #EndoZip™

Nitinotes Launches EASE™ Clinical Trials in Italy

Nitinotes Ltd., the innovative company behind the EndoZip™ Automated Suturing System for Endoscopic Sleeve Gastroplasty (ESG), has recently announced a significant milestone in its clinical development program. The completion of the first EASE™ clinical trial procedures at Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome, Italy, marks an important step in advancing the technology that aims to address obesity through minimally invasive methods.

Expanding Clinical Horizons

The Fondazione Policlinico Universitario Agostino Gemelli IRCCS is renowned for its research capabilities and has already been performing commercial procedures using the EndoZip™ system since its CE Mark approval. Their participation as a clinical site in the EASE™ study is expected to contribute to a robust evaluation of this innovative technology, which may pave the way for Nitinotes to seek regulatory approval in the U.S.

The procedures during this initial phase were overseen by the esteemed Prof. Ivo Boskoski, MD, PhD, who serves as the Associate Professor of Gastroenterology and Digestive Endoscopy at the facility. His involvement further underlines the clinical pedigree behind the EASE™ study.

What is EASE™?

The EASE™ study is designed to assess the safety and efficacy of the EndoZip™ system, particularly in the context of Endoscopic Sleeve Gastroplasty. This procedure represents a significant leap in bariatric care, focusing on providing a minimally invasive solution for obesity treatment. By automating gastric remodeling into a streamlined workflow suitable for a single operator, the EndoZip™ system is poised to diminish the complexities associated with traditional manual endoscopic suturing methods. This advancement is crucial for fostering a more standardized approach to these procedures.

In a statement about the study, Prof. Boskoski emphasized the commitment of the Gemelli hospital to fostering new treatment methodologies and ensuring patients have access to cutting-edge medical technologies. He expressed enthusiasm for participating in the EASE™ clinical trial, noting its potential impact on the evolution of endobariatric care.

Industry Reactions

Nitinotes’ CEO, Lloyd Diamond, shared his perspective on the progress made in Italy. He highlighted the significance of the procedures conducted at Gemelli, as it encompasses essential steps in developing clinical evidence that supports the concept of Automated Gastric Remodeling. Diamond further pointed out the vital role that expertise from Prof. Boskoski and the entire Gemelli team plays in shaping the future landscape of obesity treatment, especially as it navigates newer pathways between pharmacotherapy and bariatric surgery.

While recognizing the essential input from clinical leaders such as Prof. Cristiano Spada and Dr. Vincenzo Bove, Nitinotes has expressed gratitude for the collaborative efforts of the larger clinical team at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Their contributions are expected to yield valuable insights as the study progresses and more data becomes available.

About Nitinotes

Founded with a vision to revolutionize the management and treatment of obesity, Nitinotes Ltd. is at the forefront of developing automated endoluminal suturing technologies. The flagship product, EndoZip™, which received CE Mark approval in November 2025, has started its journey towards commercial availability across Europe and other CE-marking territories. This innovation aims to deliver a standardized, less complex solution to gastric remodeling, reducing the risks associated with conventional techniques.

For continuous updates and comprehensive details, interested parties are encouraged to visit Nitinotes’ official website. With the EASE™ study underway, the medical community watches attentively as Nitinotes continues to shape the future of obesity treatment through scientific advancements and innovative technologies.