Nitinotes has announced promising interim clinical results for its EndoZip™ automated endoscopic suturing system, showing significant weight loss and improved comorbidities in patients with obesity. The data, presented at the IFSO-EC 2025 Congress in Venice, Italy, demonstrated an average total body weight loss of 11.4% at twelve months in a challenging patient population with multiple health conditions.
Clinical Trial Results
The study, titled "Automatic Endoscopic Gastroplasty for the Treatment of Obesity and Associated Comorbidities: An Interim Analysis of a Prospective Clinical Trial," evaluated twenty patients with class I and II obesity (BMI 30-42 kg/m²) who also had hypertension and/or type 2 diabetes mellitus (T2DM). All participants had previously failed non-invasive weight loss therapies and were deemed suitable for bariatric endoscopy by a multidisciplinary team.
"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," said lead researcher Dr. Maria Valeria Matteo, Gastroenterologist at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS. "This data reinforces EndoZip's™ potential to offer a safe, minimally invasive option for patients struggling with obesity and related conditions."
Comorbidity Improvements
The interim analysis revealed significant improvements in obesity-related health conditions. Among patients with hypertension, 54% showed improvements in blood pressure based on ambulatory monitoring and/or medication reduction. Additionally, 62.5% of patients with T2DM demonstrated improvements in their diabetes health condition, with a trend toward improvement in T2DM outcomes observed despite the limited sample size preventing formal correlation analysis.
The procedure demonstrated a favorable safety profile throughout the study period, according to the researchers.
Technology and Market Position
EndoZip™ is designed as a fully automated endoscopic sleeve gastroplasty (ESG) suturing system that aims to provide a minimally invasive treatment option for patients with class I and II obesity. The system is engineered to reduce operator dependency and procedural complexity commonly associated with endoscopic gastroplasty procedures.
"This is the latest example of leading bariatric experts evaluating our system in real-world clinical settings," said Lloyd Diamond, CEO of Nitinotes. "We believe EndoZip™ offers a much-needed alternative in the market. It is safe, quick, consistent, and designed for long-term sustainability in obesity care."
Regulatory Status and Future Plans
EndoZip™ remains an investigational device and is not yet approved for commercial use. However, Nitinotes anticipates CE mark approval soon and is currently in ongoing discussions with the FDA for potential approval in the United States market.
The interim results presented represent data from one of several participating clinical sites in a multicenter study. Comprehensive findings from all sites will be shared in an upcoming publication, providing a more complete picture of the system's efficacy and safety profile across multiple clinical settings.
The clinical research has been presented at several leading international medical conferences, including ESGE Days 2025, FISMAD 2025, Digestive Disease Week (DDW) 2025, and IFSO 2025, highlighting the growing interest in automated endoscopic approaches to obesity treatment within the medical community.
