Nitinotes Announces First EASE™ Clinical Trial Procedures at Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Italy

EASE™ expands to Italy with first study procedures evaluating EndoZip™ for Automated Gastric Remodeling

CAESAREA, Israel, Sept. 15, 2026 /PRNewswire/ -- Nitinotes Ltd., developer of the EndoZip™ Automated Suturing System for Endoscopic Sleeve Gastroplasty (ESG), today announced the completion of the first EASE™ clinical trial procedures at Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome, Italy.

Gemelli has been performing commercial EndoZip™ procedures following the system's CE Mark approval and is now participating as a clinical site in the EASE™ study, which is evaluating EndoZip™ in support of Nitinotes' U.S. regulatory pathway.

The procedures were performed by Prof. Ivo Boskoski, MD, PhD, Associate Professor of Gastroenterology & Digestive Endoscopy at Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

The EASE™ study is evaluating the safety and effectiveness of EndoZip™ for Endoscopic Sleeve Gastroplasty, a minimally invasive procedure for the treatment of obesity. EndoZip™ brings automation to gastric remodeling through a single-operator workflow designed to reduce the technical complexity of conventional manual endoscopic suturing and support a more standardized approach to procedure execution.

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

"The first EASE™ procedures at Gemelli represent important progress in the clinical development of EndoZip™," said Lloyd Diamond, Chief Executive Officer of Nitinotes. "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 and its potential role in the evolving obesity treatment continuum between pharmacotherapy and bariatric surgery."

Nitinotes also recognizes Prof. Cristiano Spada and Dr. Vincenzo Bove for their participation and valuable contributions, as well as the broader clinical team at Fondazione Policlinico Universitario Agostino Gemelli IRCCS for their collaboration and support.

About Nitinotes

Nitinotes is a privately held medical device company pioneering automated endoluminal suturing technologies for the treatment of obesity. The company's flagship system, EndoZip™, is an automated ESG platform designed to support a standardized approach to gastric remodeling. EndoZip™ received CE Mark approval in November 2025 and is commercially available in the European Union and other CE Mark–accepting markets.

For more information, visit https://nitinotesurgical.com.

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