Nitinotes Launches EASE™ IDE Trial with First Procedures at Orlando Health

Nitinotes' First Study Procedures at Orlando Health in EASE™ IDE Trial

Nitinotes Ltd., the innovative company behind the EndoZip™ Automated Suturing System aimed at enhancing Endoscopic Sleeve Gastroplasty (ESG), has made a notable advancement in its pivotal U.S. clinical study. The firm recently completed the initial study procedures at Orlando Health, a leading institution recognized for its expertise in bariatric surgery and metabolic care. This milestone signifies an expansion of the EASE™ Investigational Device Exemption (IDE) trial, which focuses on evaluating the safety and effectiveness of the EndoZip™ system for obesity treatment.

The procedures conducted were overseen by esteemed bariatric surgeons Dr. Andre F. Teixeira and Dr. Manoel Galvao Neto, who lead the Orlando Health Weight Loss and Bariatric Surgery Institute. Dr. Teixeira and Dr. Galvao Neto are renowned for their contributions to advancing minimally invasive obesity treatments. Their involvement enhances the trial's credibility, as both professionals are at the forefront of research and clinical practices in endoscopic bariatric therapies.

The EASE™ IDE trial aims to assess the EndoZip™ Automated Suturing System's capabilities to perform ESG, a minimally invasive procedure that addresses obesity effectively. The multicenter study is designed to support a future submission for marketing authorization to the U.S. Food and Drug Administration (FDA), a crucial step for commercial availability in the United States.

Lloyd Diamond, the CEO of Nitinotes, expressed his enthusiasm about collaborating with leading experts in the field: "Dr. Teixeira and Dr. Galvao Neto are paving the way for minimally invasive obesity treatment. Their expertise significantly enhances the EASE™ IDE trial, which is essential for the future adoption of EndoZip. This system was engineered to streamline and standardize ESG procedures, allowing a wider range of healthcare professionals to utilize it in treating obesity."

The EndoZip™ system, which is already CE marked in Europe, is currently confined to investigational use in the United States until the ongoing trial concludes and regulatory approvals are secured.

About the EASE™ Clinical Trial

The EASE™ clinical study is a rigorously designed trial consisting of a prospective, multicenter, randomized, two-arm, blinded IDE study. It evaluates the safety and effectiveness of the EndoZip™ system in treating patients with obesity, which is a growing concern worldwide. This clinical trial not only represents a significant advancement in medical technology but also emphasizes the commitment of Nitinotes to improve patient outcomes through innovative solutions.

Nitinotes: A Leader in Obesity Treatment Technology

Nitinotes is a privately held medical device company pioneering automated endoluminal suturing technologies specifically designed for obesity treatment. The EndoZip™ is their flagship product, facilitating a standardized approach to endoluminal suturing aimed at simplifying complex procedures like ESG. With its recent CE Mark approval, Nitinotes is poised to expand its reach in the European Union and other markets that accept CE marking.

As the healthcare landscape evolves with increasing prevalence of obesity, Nitinotes’ advancements not only cater to the clinical needs of healthcare providers but also aim at improving the overall patient experience through simplified and effective surgical options.

For further information, please visit Nitinotes' official website.