EndoZip shows promising safety profile and potential benefits for patients with comorbidities

Interim clinical results for EndoZip, a fully automated endoscopic suturing system aimed at treating obesity, reveal it can be used to support weight loss and improve outcomes for patients with obesity and related conditions, such as hypertension and type 2 diabetes mellitus (T2DM).

EndoZip, the system is an automated minimally-invasive suturing system

According to Nitinotes, the developer of the EndoZip, the system is an automated minimally-invasive suturing system, designed to deliver safe and easy delivery of effective restrictive sutures to the stomach wall, whilst reducing operator dependency and procedural complexity commonly associated with endoscopic gastroplasty. It is aimed at providing an effective solution for 85% of the people living with obesity (class 1 and 2 obesity) who do not qualify for bariatric surgery.

The study, ‘Automatic Endoscopic Gastroplasty for the Treatment of Obesity and Associated Comorbidities: An Interim Analysis of a Prospective Clinical Trial’, presented at IFSO-EC 2025 Congress in Venice, Italy, evaluated 20 patients with class I and II obesity (BMI 30-42 kg/m²) who also had hypertension and/or T2DM. All participants had previously failed non-invasive weight loss therapies and were deemed suitable for bariatric endoscopy by a multidisciplinary team.

Highlights from the analysis include:

• An average total body weight loss (%TBWL) of 11.4% ± 1.1 at twelve months.

• 54% of patients with hypertension showed improvements in blood pressure based on ambulatory monitoring and/or medication reduction.

• 62.5% of patients with T2DM demonstrated improvements in their diabetes health condition.

• The procedure demonstrated a favourable safety profile.

• While the sample size limited formal correlation analysis, a trend toward improvement in T2DM outcomes was observed.

"We are pleased to share these encouraging findings with the medical community," said lead researcher, Dr Maria Valeria Matteo, Gastroenterologist at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS. "We observed an average total body weight loss of 11.4% at twelve months in this challenging patient population, alongside meaningful improvements in blood pressure and HbA1C in many patients. This data reinforces EndoZip's potential to offer a safe, minimally invasive option for patients struggling with obesity and related conditions. It's particularly promising to see improvements in comorbidity outcomes alongside meaningful weight loss."

The interim results reflect data from one of several participating clinical sites in a multi-centre study. Comprehensive findings from all sites will be shared in an upcoming publication.

EndoZip is an investigational device and is not yet approved for commercial use. The company anticipates CE mark approval soon and is in ongoing discussions with the FDA.