First study patient treated by Dr. Reem Sharaiha at NewYork-Presbyterian/Weill Cornell Medical Center. 

CAESAREA, Israel, Aug. 11, 2026 /PRNewswire/ -- Nitinotes Ltd., developer of the EndoZip™ Automated Suturing System for Endoscopic Sleeve Gastroplasty (ESG), today announced that Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center are now clinical sites in the Company's pivotal U.S. EASE™ Investigational Device Exemption (IDE) trial.  The milestone was marked by the completion of the first study procedure at the institutions by Reem Z. Sharaiha, MD, Professor of Medicine at Weill Cornell Medicine and Director of Endoscopy at Weill Cornell and NewYork-Presbyterian/Weill Cornell Medical Center.

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

"The activation of Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center represents an important milestone in the EASE™ IDE trial," said Lloyd Diamond, Chief Executive Officer of Nitinotes. "We are honored to have Dr. Sharaiha leading the study at one of the nation's premier academic medical centers.  As enrollment expands across leading U.S. medical centers, we are building the clinical evidence needed to support a simpler, more reproducible approach to performing Endoscopic Sleeve Gastroplasty."

"Obesity remains one of today's most pressing health challenges, and there is a growing need for minimally invasive treatment options that expand access to effective care," said Dr. Sharaiha, who also serves on Nitinotes's Scientific Advisory Board.  "The EASE™ IDE trial is designed to generate important clinical evidence that could improve care for our patients, and I am honored to lead the study evaluating the EndoZip™ system."

The EASE™ IDE trial is being conducted at leading U.S. medical centers with expertise in advanced endoscopy and obesity care. The study is designed to evaluate the safety and effectiveness of EndoZip™ and support a future FDA marketing submission.

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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