Interim Clinical Results for EndoZip™ Presented at IFSO-EC 2025 Congress Show Promising Safety Profile and Potential Benefits for Patients With Comorbidities
Automated Endoscopic Approach Evaluated for Patients with Obesity, Hypertension, and Type 2 Diabetes
CAESAREA, Israel, May 16, 2025 /PRNewswire/ -- Nitinotes, developer of EndoZip™, a fully automated endoscopic suturing system aimed at treating obesity, announced that new interim clinical data was presented at the IFSO-EC 2025 Congress (International Federation for the Surgery of Obesity and Metabolic Disorders) in Venice, Italy.
The interim results reflect data from one of several participating clinical sites in a multicenter study. Comprehensive findings from all sites will be shared in an upcoming publication. These results highlight the use of the EndoZip™ system to support weight loss and improve outcomes for patients with obesity and related conditions such as hypertension and type 2 diabetes mellitus (T2DM).
"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 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 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 favorable safety profile.
While the sample size limited formal correlation analysis, a trend toward improvement in T2DM outcomes was observed.
"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."
EndoZip™ is designed to provide a minimally invasive alternative for patients with obesity, reducing operator dependency and procedural complexity commonly associated with endoscopic gastroplasty. 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.
About Nitinotes
Nitinotes is a pioneer in medical technology, focusing on an innovative solution for obesity treatment. The company's flagship product, EndoZip™, offers a minimally invasive approach for obesity class I & II patients, ensuring consistent, safe suturing with the press of a button, representing a significant advancement in the field. For more information, visit https://nitinotesurgical.com.
Media Contact:
Ellie Hanson
FINN Partners for Nitinotes
ellie.hanson@finnpartners.com
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