#Israel #Caesarea #Obesity Treatment #EndoZip #Nitinotes

Promising Findings from EndoZip™ Clinical Trials

The latest interim clinical results for EndoZip™, a cutting-edge automated endoscopic suturing system designed to treat patients with obesity, were recently presented at the esteemed IFSO-EC 2025 Congress in Venice, Italy. This technology, developed by Nitinotes, aims to address obesity and related comorbid conditions, providing a minimally invasive solution that could reshape patient outcomes.

Overview of the Study

Nitinotes announced that these interim results emerge from one of several participating clinical sites within a multicenter study. The culmination of data from all sites is set to be elaborated upon in a forthcoming publication. This interim analysis focuses on how the EndoZip™ system has been instrumental in facilitating weight loss and enhancing health metrics for patients struggling with obesity, hypertension, and type 2 diabetes mellitus (T2DM).

Dr. Maria Valeria Matteo, a gastroenterologist from the Fondazione Policlinico Universitario Agostino Gemelli IRCCS and lead researcher on the project, expressed her enthusiasm about the findings: “We noticed a noteworthy average total body weight loss of 11.4% at the twelve-month mark within this challenging demographic. Not only did many patients achieve substantial weight loss, but we also observed significant improvements in blood pressure and HbA1C levels. The results reinforce the idea that EndoZip™ presents a safe and minimally invasive option to help patients with obesity and related ailments.”

Key Findings

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 between 30 and 42 kg/m²) who also had hypertension and/or T2DM. All participants had previously tried non-invasive weight loss methods without success and were deemed suitable for bariatric endoscopy by a comprehensive multidisciplinary team.

Some of the notable highlights from the clinical analysis are:

• - Weight Loss: Participants experienced an impressive average total body weight loss (TBWL) of 11.4% with a variability of ± 1.1 at the twelve-month interval.
• - Improvements in Hypertension: 54% of patients with hypertension reported better blood pressure readings when monitored, including those who had to reduce their medication intake.
• - Diabetes Management: Roughly 62.5% of T2DM patients witnessed improvements in their diabetes health conditions.
• - Safety Profile: The procedure demonstrated a favorable safety profile with no significant complications reported.

Despite the relatively small sample size which limited in-depth correlation analysis, the study revealed a positive trend towards better outcomes for T2DM patients.

Industry Perspectives

Lloyd Diamond, CEO of Nitinotes, remarked on the significance of this study for the obesity treatment landscape. He states, “This latest presentation underscores the real-world application of our system being evaluated by leading bariatric experts. We firmly believe that EndoZip™ fills a significant gap in obesity treatment as it is designed to be a safe, efficient, and consistent option for patients.”

Nitinotes' EndoZip™ system represents a major advancement in obesity care, allowing for a minimal invasion while reducing the complexity and operator dependency often linked to traditional endoscopic procedures.

Future Endeavors

Although EndoZip™ is an investigational device currently not yet available for commercial use, anticipations are set high for its future approval; the company expects to receive the CE mark soon and is actively engaging with the FDA to navigate the regulatory pathways.

For those looking for a more comprehensive and innovative approach to address obesity, EndoZip™ represents a beacon of hope. This technology not only promotes significant weight loss but also aims to mitigate serious health conditions such as hypertension and diabetes, ultimately leading to improved overall health.

For more information regarding Nitinotes and the EndoZip™ system, please visit Nitinotes Surgical.