#United States #New York #ESG #EndoZip #Nitinotes

Nitinotes Launches Pivotal EASE™ Clinical Trial

Nitinotes Ltd., a burgeoning player in the medical technology landscape, has recently announced a significant milestone in its mission to revolutionize obesity treatment. The company successfully treated the first patient under its pivotal EASE™ Clinical Trial, evaluating the innovative EndoZip™ Automated Suturing System for endoscopic sleeve gastroplasty (ESG). The procedure took place at Lenox Hill Hospital, part of Northwell Health, in New York City, marking the activation of the trial's first U.S. site.

Importance of the Innovation

Obesity is a global health crisis affecting over 650 million adults and leading to multiple metabolic diseases. Conventional weight loss methods, such as lifestyle modifications and medical therapy, often fall short in delivering lasting results. ESG has emerged as a minimally invasive intervention providing a viable alternative, making advancements in automated suturing technology all the more crucial. The EASE™ trial aims to further assess the effectiveness and safety of the EndoZip™ system compared to traditional manual suturing methods.

About the EASE™ Clinical Trial

The EASE™ Clinical Trial is a prospective, randomized, multicenter, and blinded pivotal study designed to establish a clear comparison between the EndoZip™ automated ESG procedure and the manual Apollo OverStitch® ESG technique. This trial will include clinical endpoints while also gathering physician-reported outcomes assessing ease of use and workflow efficiency. Over the study's course, up to 184 participants will be recruited from around 10 clinical sites across the United States and Europe, with each participant followed for 12 months. The EASE™ study complies with FDA guidance, serving as a foundational step towards future regulatory submission in the U.S.

Key Remarks from Leadership

Dr. Steven Shamah, one of the principal investigators for the trial, emphasized the significance of this first patient treatment. He highlighted that this randomized study marks a pivotal moment for the ESG community by comparing automated processes with established manual techniques. He pointed out the existing treatment gap between GLP-1 therapies—characterized by high dropout rates—and more invasive bariatric surgery options. The ESG offers vital alternatives, thus generating credible clinical evidence is paramount in guiding practice and broadening treatment avenues.

Lloyd Diamond, CEO of Nitinotes, also conveyed the company’s commitment to enhancing automation in obesity treatment. He remarked, "The first patient treated in the EASE trial is a significant step toward achieving our mission of producing high-quality clinical evidence necessary for regulatory review and wider clinical acceptance."

Recent Milestones

This recent trial initiation follows the CE Mark approval of the EndoZip™, allowing for commercial launches within the European Union and other regions recognizing the CE Mark. As Nitinotes continues to break new ground, the company anticipates that additional clinical sites will commence patient enrollment in the following months, building further momentum for its innovative approaches to obesity treatment.

About Nitinotes

Nitinotes is characterized as an early-stage medical device organization dedicated to pioneering automated endoluminal suturing technologies specifically aimed at obesity management. With EndoZip™ being its flagship system, its development marks a crucial advancement towards standardized endoluminal suturing methods. While the EndoZip™ is currently investigational within the U.S., its CE Mark endorsement signifies positive validation in permissible markets.

For more information about Nitinotes and its innovative solutions, please visit Nitinotes Surgical.