Milestone highlights ongoing progress in the Company's pivotal U.S. clinical study assessing EndoZip for Endoscopic Sleeve Gastroplasty

Nitinotes Ltd., developer of the EndoZip Automated Suturing System for Endoscopic Sleeve Gastroplasty (ESG), today announced completion of the first study procedures at Orlando Health in the Company's pivotal U.S. EASE Investigational Device Exemption (IDE) trial. This step broadens involvement among top centers focused on bariatric surgery and endoscopic obesity treatments.

The procedures took place at Orlando Health, a leading national facility for bariatric surgery and metabolic care. They were carried out by bariatric surgeons 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 same institute and a globally recognized expert in advancing endoscopic bariatric therapies.

The EASE IDE trial assesses the safety and effectiveness of the EndoZip Automated Suturing System in performing Endoscopic Sleeve Gastroplasty (ESG), a minimally invasive obesity treatment. This multicenter study aims to support a future U.S. Food and Drug Administration (FDA) marketing submission.

"Dr. Teixeira and Dr. Galvao Neto rank among the leaders in advancing minimally invasive obesity care," said Lloyd Diamond, Chief Executive Officer of Nitinotes. "Their combined skills in bariatric surgery and endoscopic obesity treatment position Orlando Health as a strong addition to the EASE IDE trial. EndoZip was created to simplify and standardize ESG, aiming to improve reproducibility for physicians with different levels of experience, including bariatric surgeons adding minimally invasive endoscopic methods to obesity management."

"As obesity care advances, surgeons are adding more minimally invasive endoscopic procedures to full patient treatment plans," said Dr. Teixeira. "Tools that ease complex procedures like ESG can expand use while preserving consistency. We anticipate assessing the EndoZip system in the EASE IDE trial."

EndoZip holds CE mark status in Europe and remains limited to investigational use in the United States.

About the EASE Clinical Trial

The EASE Clinical Trial is a prospective, multicenter, randomized, two-arm, blinded IDE study evaluating the safety and effectiveness of the EndoZip Automated Suturing System for Endoscopic Sleeve Gastroplasty in patients with obesity.

About Nitinotes

Nitinotes is a privately held medical device company advancing automated endoluminal suturing technologies for obesity treatment. Its flagship system, EndoZip, offers a fully automated ESG platform to enable a standardized approach to endoluminal suturing. EndoZip has received CE Mark approval for commercial launch in the European Union and other CE Mark-accepting markets.

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