Nitinotes Announces FDA IDE Approval to Initiate Pivotal U.S. Trial of the EndoZip™ System for Endoscopic Sleeve Gastroplasty

Advancing Minimally Invasive Obesity Treatment with Automated Suturing Technology

CAESAREA, Israel, June 24, 2025 /PRNewswire/ -- Nitinotes, developer of the EndoZip™ System, a fully automated suturing platform for endoscopic sleeve gastroplasty (ESG), today announced it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a pivotal clinical trial under an Investigational Device Exemption (IDE).

This prospective, multicenter, randomized controlled trial will evaluate the safety and efficacy of the EndoZip System for the treatment of obesity. Up to 184 patients will be enrolled across as many as 10 U.S. clinical sites, with additional international sites included in accordance with FDA guidelines. As a comparative study against an already FDA-approved device, all participants will receive an active treatment, a design element expected to potentially accelerate enrollment. Patient enrollment is anticipated to begin by the end of Q3 2025, with 12-month patient follow-up projected for completion by mid 2027.

"This FDA IDE approval marks a key milestone in our U.S. regulatory strategy and brings us one step closer to commercializing EndoZip™ in this important market," said Lloyd Diamond, CEO of Nitinotes. "EndoZip™ represents the next generation of endoscopic bariatric interventions, offering a safe, simpler, and reproducible suturing alternative to existing procedures. By reducing the learning curve, it has the potential to democratize access to this treatment and empower a broader range of physicians, including bariatric surgeons."

The EndoZip™ System is a novel, automated ESG device engineered to standardize endoscopic bariatric procedures. By enabling consistent, full-thickness plications in a single-operator setting, the system aims to reduce procedural complexity and variability. Clinical results from the company's EU pivotal trial, recently published in Gastrointestinal Endoscopy, have demonstrated promising safety and efficacy outcomes in real-world settings.

"There is growing demand for less invasive bariatric options for the treatment of obesity and metabolic diseases that help address key barriers to access and adoption," said Dr.Barham Abudayyeh, co-principal investigator. "We are excited to participate in this trial."

Dr. Christopher Thomspon, co-principal investigator, added, "Standardization is essential to the evolution of ESG. The ability to automate key steps in the procedure may ultimately improve outcomes and enable broader clinical adoption, particularly as we see a growing number of patients coming off GLP-1 therapies and seeking sustainable, minimally invasive weight loss solutions."

This pivotal trial will serve as the foundation for Nitinotes' regulatory submission to the FDA and supports its broader strategy to commercialize EndoZip™ in the U.S. market. In parallel, the company is in the final stages of the CE mark process, with plans for an imminent commercial launch in Europe.

About Nitinotes
Nitinotes is a privately held medical device company pioneering an innovative solution for the treatment of obesity. The Company's flagship product, EndoZip™, is a fully automated endoscopic sleeve gastroplasty (ESG) system designed to provide a consistent, reproducible, and minimally invasive alternative to traditional bariatric surgery for patients with class I & II obesity. For more information, visit https://nitinotesurgical.com.

Media Contact:
Offer Nonhoff
Chief Financial Officer
offer@nitinotesurgical.com