EASETM is a prospective, randomized IDE study comparing automated ESG to manual suturing, advancing Nitinotes toward U.S. regulatory submission
CAESAREA, Israel, Dec. 10, 2025 /PRNewswire/ -- Nitinotes Ltd., an early commercial stage medical technology company developing fully automated endoluminal suturing solutions for obesity treatment, today announced that the first patient has been treated in its U.S. Investigational Device Exemption (IDE) EASETM Clinical Trial evaluating the EndoZipTM Automated Suturing System for endoscopic sleeve gastroplasty (ESG). The procedure was performed at Lenox Hill Hospital | Northwell Health in New York, NY, the trial's first activated U.S. site.
Obesity affects more than 650 million adults worldwide and remains a leading driver of metabolic diseases, with many patients unable to achieve durable weight loss through lifestyle changes or medical therapy alone. ESG has emerged as an important minimally invasive option, and interest continues to grow in technologies that can enhance usability, standardization and consistency of procedural delivery.
The EASETM Clinical Trial is a prospective, multicenter, randomized, two-arm, blinded pivotal study designed to evaluate the safety and effectiveness of the EndoZipTM automated ESG procedure compared with the manual Apollo OverStitch® ESG procedure. In addition to clinical endpoints, the study will also assess physician-reported outcomes related to procedural experience, including ease of use and workflow efficiency. The study plans to enroll up to 184 patients across up to 10 clinical sites in the United States and Europe, with 12-month follow-up. The IDE study was designed in alignment with FDA guidance and is intended to support a future U.S. regulatory submission.
The first-patient milestone follows the recent CE Mark approval of EndoZipTM, enabling commercial launch in the European Union and other CE Mark-accepting markets.
Dr. Steven Shamah, a lead U.S. investigator for the trial, stated: "Treating the first patient in the EASE trial represents an important milestone for the ESG community. For the first time, a randomized study will compare an automated, single-operator ESG approach to a widely adopted manual suturing technique. There is a significant treatment gap between GLP-1 therapy, which has high dropout rates, and invasive bariatric surgery. ESG offers an important alternative, and rigorously generated clinical evidence will be essential to guide practice and expand treatment options."
"Our mission is to advance the role of automation in obesity treatment by generating high-quality clinical evidence that informs regulatory review and enables broader clinical adoption," added Lloyd Diamond, CEO of Nitinotes. "The first patient treated in the EASE trial is a significant step forward in that mission and builds on the momentum of our recent CE Mark approval. We appreciate Dr. Shamah and the Lenox Hill | Northwell Health team for their leadership as additional U.S. and European sites prepare to initiate enrollment."
Additional clinical sites are expected to initiate enrollment in the coming months.
About the EASETM Clinical Trial
The EASETM Clinical Trial (Endoscopic Automated Sleeve Evaluation) is a prospective, multicenter, randomized, two-arm, blinded IDE study evaluating the safety and effectiveness of the EndoZipTM Automated Suturing System compared with the Apollo OverStitch® ESG procedure.
About Nitinotes
Nitinotes is an early commercial stage, privately held medical device company pioneering automated endoluminal suturing technologies for the treatment of obesity. The company's flagship system, EndoZipTM, is a fully automated ESG platform designed to support a standardized approach to endoluminal suturing. EndoZipTM recently received CE Mark approval, authorizing commercial launch in the European Union and other CE Mark-accepting markets. EndoZipTM is investigational in the United States and is limited by Federal (or United States) law to investigational use.
For more information, visit https://nitinotesurgical.com.
Media Contact:
Offer Nonhoff
Chief Financial Officer
offer@nitinotesurgical.com
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