Nitinotes gains CE Mark approval for EndoZip fully automated suturing system for ESG

Nitinotes has received CE Mark approval for the EndoZip System, the first fully automated suturing platform for endoscopic sleeve gastroplasty (ESG). The milestone clearance enables the company to begin commercialisation across the European Union and other CE Mark-accepting markets.

Nitinotes will launch EndoZip in select European centres of excellence, building clinical adoption and real-world data to support broader market penetration. In parallel, the company is preparing for its pivotal US IDE trial, which will support FDA submission and entry into the world's largest obesity treatment market.

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.

According to the company, 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 - democratising ESG and expanding access to bariatric surgeons while setting a new standard for care.

Previously, the company has revealed the outcomes from a multi-centre study demonstrated the effectiveness of the EndoZip system in achieving significant weight loss, with an average total body weight loss (TBWL) of 13.21% at 12 months.

The outcomes were published in the paper, ‘Automatic Endoscopic Gastroplasty for the Treatment of Obesity: Results From a Prospective Multicenter Study’, in the journal, GIE: Gastrointestinal Endoscopy. Additionally, the study highlighted notable improvements in metabolic health indicators such as reductions in waist circumference, haemoglobin A1C (HbA1C) and alanine aminotransferase (ALT) levels, which are critical in managing obesity-related comorbidities.

Quality of life improvements were also significant, as measured by the IWQOL questionnaire, underscoring the comprehensive benefits of the procedure beyond just weight reduction. The technical success of the procedure was achieved in all patients, demonstrating its ease of performance, safety, and feasibility, with a low incidence of reported adverse events.

"CE Mark approval of EndoZip is a pivotal milestone for Nitinotes," said Lloyd Diamond, Chief Executive Officer of Nitinotes. "This achievement validates the safety and performance of our technology and paves the way for commercialisation in Europe. With EndoZip, we have the potential to dramatically expand patient access to a safe, durable, minimally invasive obesity treatment while creating significant value for providers and healthcare systems."