Milestone reflects continued execution of the Company's pivotal U.S. clinical study evaluating EndoZip™ for Endoscopic Sleeve Gastroplasty

CAESAREA, Israel, July 28, 2026 /PRNewswire/ -- 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, further expanding participation among leading centers specializing in both bariatric surgery and endoscopic obesity care.

The procedures were performed at Orlando Health, one of the nation's leading centers for bariatric surgery and metabolic care, 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 Orlando Health Weight Loss and Bariatric Surgery Institute and an internationally recognized pioneer in the development and advancement of endoscopic bariatric therapies.

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

"Dr. Teixeira and Dr. Galvao Neto are among the leaders advancing minimally invasive obesity treatment," said Lloyd Diamond, Chief Executive Officer of Nitinotes. "Their expertise in both bariatric surgery and endoscopic obesity care makes Orlando Health an outstanding addition to the EASE™ IDE trial.  EndoZip™ was designed to simplify and standardize ESG, with the goal of making the procedure more reproducible across physicians with varying levels of ESG experience, including bariatric surgeons seeking to incorporate minimally invasive endoscopic approaches into obesity care."

"As obesity treatment continues to evolve, surgeons are increasingly incorporating minimally invasive endoscopic procedures into comprehensive patient care," said Dr. Teixeira.  "Technologies that simplify technically demanding procedures such as ESG have the potential to broaden adoption while maintaining procedural consistency.  We look forward to evaluating the EndoZip™ system through the EASE™ IDE trial."

EndoZip™ is CE marked in Europe and is 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 pioneering automated endoluminal suturing technologies for the treatment of obesity. The company's flagship system, EndoZip™, is a fully automated ESG platform designed to support a standardized approach to endoluminal suturing. EndoZip™ recently received CE Mark approval, authorizing commercial launch in the European Union and other CE Mark–accepting markets.

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

Media Contact:

Offer Nonhoff

Chief Financial Officer

offer@nitinotesurgical.com

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