Milestone highlights ongoing progress in the firm's key American clinical evaluation of EndoZip for Endoscopic Sleeve Gastroplasty

Nitinotes Ltd., developer of the EndoZip Automated Suturing System for Endoscopic Sleeve Gastroplasty (ESG), has announced completion of the first study procedures at Orlando Health in the Company's pivotal U.S. EASE IDE trial. This step further broadens participation among leading centers focused on bariatric surgery and endoscopic obesity care.

The procedures took place at Orlando Health, a top national site for bariatric surgery and metabolic care. They were carried out by bariatric surgeons Andre F. Teixeira, MD, Director of the Orlando Health Weight Loss and Bariatric Surgery Institute, and Manoel Galvao Neto, MD, Director of Bariatric Research at the same institute and a globally recognized leader in endoscopic bariatric therapies.

The EASE IDE trial assesses the safety and effectiveness of the EndoZip Automated Suturing System for Endoscopic Sleeve Gastroplasty (ESG), a minimally invasive obesity treatment. The multicenter study aims to support a future FDA marketing submission.

Dr. Teixeira and Dr. Galvao Neto rank among leaders advancing minimally invasive obesity care, said Lloyd Diamond, Chief Executive Officer of Nitinotes. Their combined skill in bariatric surgery and endoscopic obesity treatments positions Orlando Health as a strong addition to the EASE IDE trial. EndoZip was built to simplify and standardize ESG, aiming for greater reproducibility among physicians with different levels of ESG experience, including bariatric surgeons adding minimally invasive endoscopic methods to obesity care.

As obesity treatment advances, surgeons are adding minimally invasive endoscopic procedures to full patient care, said Dr. Teixeira. Tools that ease technically challenging procedures like ESG can expand adoption while preserving consistency. We anticipate assessing the EndoZip system in the EASE IDE trial.

EndoZip holds CE mark status in Europe and remains limited to investigational use in the United States.

About the EASE Clinical Trial

The EASE Clinical Trial is a prospective, multicenter, randomized, two-arm, blinded IDE study assessing the safety and effectiveness of the EndoZip Automated Suturing System for Endoscopic Sleeve Gastroplasty in patients with obesity.

About Nitinotes

Nitinotes is a privately held medical device firm pioneering automated endoluminal suturing technologies for obesity treatment. Its flagship system, EndoZip, is a fully automated ESG platform built to enable a standardized approach to endoluminal suturing. EndoZip recently received CE Mark approval, permitting commercial launch in the European Union and other CE Mark-accepting markets.

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SOURCE Nitinotes