Nitinotes Completes First Patient Treatment in Groundbreaking EASE™ Trial for Automated Suturing System
Nitinotes Ltd., a prominent early-stage medical technology firm, is taking groundbreaking steps in the fight against obesity with its innovative EndoZip™ automated suturing system. On December 10, 2025, the company announced a significant milestone: the first patient has been treated in their EASE™ (Endoscopic Automated Sleeve Evaluation) clinical trial. This pivotal study aims to assess the efficacy and safety of the EndoZip™ system in comparison to the manual Apollo OverStitch® technique during endoscopic sleeve gastroplasty (ESG) procedures.
The treatment took place at Lenox Hill Hospital within the Northwell Health network, marking this site as the first fully operational U.S. location for the trial. With obesity affecting over 650 million adults worldwide, the need for effective, minimally invasive treatment solutions has never been more urgent. ESG has emerged as a favored option for those struggling with weight loss, offering a viable alternative to traditional surgical methods. However, many patients still face challenges in achieving sustained results through lifestyle changes or medications alone.
The EASE™ trial is distinguished by its rigorous design: a multicenter, randomized, two-arm, and blinded study that will enroll up to 184 patients across about ten clinical sites in the U.S. and Europe. Participants will be followed for 12 months to gather comprehensive safety and effectiveness data. In addition to clinical outcomes, the study will explore physician-reported metrics concerning procedural experience, which includes evaluations of ease of use and workflow efficiency.
Dr. Steven Shamah, the lead U.S. investigator for the EASE trial, emphasized the significance of this study within the ESG community. Unlike previous research, this trial uniquely compares an automated ESG method to a well-established manual technique. Dr. Shamah remarked that there exists a notable treatment gap between GLP-1 therapies, which are often associated with high dropout rates, and invasive bariatric surgeries. He stated, "ESG presents a crucial alternative for patients, and this trial is essential for generating robust clinical evidence to expand treatment options."
The initiation of the EASE™ trial comes on the heels of Nitinotes securing CE Mark approval for the EndoZip™ system, facilitating its commercial launch in the European Union and other areas acknowledging CE Mark certifications. Lloyd Diamond, CEO of Nitinotes, expressed his optimism regarding the trial’s implications for obesity treatment. He pointed out, "Our goal is to further innovate automation in obesity treatments. The first patient treated in the EASE trial signifies a substantial advancement in our efforts, and the endorsement of our technology is bolstered by our recent CE Mark approval. We commend Dr. Shamah and the Lenox Hill | Northwell Health team for their visionary leadership as we prepare to open additional enrollment sites."
As additional clinical sites gear up for patient enrollment, the industry eagerly anticipates the outcomes of the EASE™ trial. This research may pave the way for an enhanced understanding of automated suturing systems and their applications in treating obesity, potentially transforming the landscape of minimally invasive bariatric procedures.
Nitinotes is a privately held medical device enterprise known for pioneering automated endoluminal suturing technologies aimed at combating obesity. Their flagship product, EndoZip™, is designed to standardize endoluminal suturing procedures. Although currently investigational in the U.S., the technology has shown promise and potential for wider adoption in medical settings.
For more information on Nitinotes and their innovations, visit Nitinotes Surgical.
The treatment took place at Lenox Hill Hospital within the Northwell Health network, marking this site as the first fully operational U.S. location for the trial. With obesity affecting over 650 million adults worldwide, the need for effective, minimally invasive treatment solutions has never been more urgent. ESG has emerged as a favored option for those struggling with weight loss, offering a viable alternative to traditional surgical methods. However, many patients still face challenges in achieving sustained results through lifestyle changes or medications alone.
The EASE™ trial is distinguished by its rigorous design: a multicenter, randomized, two-arm, and blinded study that will enroll up to 184 patients across about ten clinical sites in the U.S. and Europe. Participants will be followed for 12 months to gather comprehensive safety and effectiveness data. In addition to clinical outcomes, the study will explore physician-reported metrics concerning procedural experience, which includes evaluations of ease of use and workflow efficiency.
Dr. Steven Shamah, the lead U.S. investigator for the EASE trial, emphasized the significance of this study within the ESG community. Unlike previous research, this trial uniquely compares an automated ESG method to a well-established manual technique. Dr. Shamah remarked that there exists a notable treatment gap between GLP-1 therapies, which are often associated with high dropout rates, and invasive bariatric surgeries. He stated, "ESG presents a crucial alternative for patients, and this trial is essential for generating robust clinical evidence to expand treatment options."
The initiation of the EASE™ trial comes on the heels of Nitinotes securing CE Mark approval for the EndoZip™ system, facilitating its commercial launch in the European Union and other areas acknowledging CE Mark certifications. Lloyd Diamond, CEO of Nitinotes, expressed his optimism regarding the trial’s implications for obesity treatment. He pointed out, "Our goal is to further innovate automation in obesity treatments. The first patient treated in the EASE trial signifies a substantial advancement in our efforts, and the endorsement of our technology is bolstered by our recent CE Mark approval. We commend Dr. Shamah and the Lenox Hill | Northwell Health team for their visionary leadership as we prepare to open additional enrollment sites."
As additional clinical sites gear up for patient enrollment, the industry eagerly anticipates the outcomes of the EASE™ trial. This research may pave the way for an enhanced understanding of automated suturing systems and their applications in treating obesity, potentially transforming the landscape of minimally invasive bariatric procedures.
About Nitinotes
Nitinotes is a privately held medical device enterprise known for pioneering automated endoluminal suturing technologies aimed at combating obesity. Their flagship product, EndoZip™, is designed to standardize endoluminal suturing procedures. Although currently investigational in the U.S., the technology has shown promise and potential for wider adoption in medical settings.
For more information on Nitinotes and their innovations, visit Nitinotes Surgical.
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