Nitinotes Receives CE Mark Approval of EndoZip™, the First Fully Automated Suturing System for Endoscopic Sleeve Gastroplasty
CAESAREA, Israel, Nov. 6, 2025 /PRNewswire/ — Nitinotes Ltd., a medical device company transforming the treatment of obesity, today announced it has received CE Mark approval for the EndoZip™ System, the first fully automated suturing platform for endoscopic sleeve gastroplasty (ESG). The milestone clearance enables Nitinotes to begin commercialization across the European Union and other CE Mark-accepting markets.
Obesity is one of the most urgent global health challenges, affecting more than 650 million adults worldwide. Current treatment pathways leave a significant gap between medical management such as GLP-1 therapy and invasive bariatric surgery. ESG is emerging as a minimally invasive alternative, addressing patients with obesity (BMI 30–40 kg/m²) who have not achieved success with conservative measures such as diet, exercise, or medication.
By automating suturing, EndoZip transforms ESG into a scalable, single-physician, fast, outpatient procedure with a short learning curve. Unlike current manual suturing systems that demand two physician operators, longer procedure times, and advanced endoscopic skills, EndoZip delivers unmatched efficiency, reproducibility, and economics – democratizing ESG and expanding access to bariatric surgeons while setting a new standard for care.
