Israel-based Nitinotes Surgical has gained a CE mark for EndoZip, enabling the company to launch the automated suturing platform for endoscopic sleeve gastroplasty (ESG) on the European market.
The company’s platform aims to improve on endoscopic sleeve gastroplasty (ESG), a weight-loss procedure that involves reducing the size of the stomach using an endoscope and internal sutures, without any external incisions.
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A minimally invasive form of bariatric surgery, ESG is positioned as an alternative obesity treatment for patients who have not achieved successful weight loss with glucagon-like peptide-1 receptor agonists (GLP-1RAs) but are reluctant to undergo more invasive forms of bariatric surgery. For example, gastric bypass is a more invasive treatment that involves reducing the size of a patient’s stomach and rerouting part of the digestive system to help them achieve weight loss.
EndoZip is claimed to be the first fully automated suturing platform for ESG. According to Nitinotes, the platform stands to reduce procedural times and shorten the learning curve for physicians undertaking the procedure by ideating on the manual suturing process historically used in ESG.
Nitinotes CEO, Lloyd Diamond commented: “With EndoZip, we have the potential to dramatically expand patient access to a safe, durable, minimally invasive obesity treatment while creating significant value for providers and healthcare systems.”
Nitinotes outlined that it initially plans to launch EndoZip in select European “centres of excellence”, while building upon the platform’s clinical adoption and real-world data to support broader market penetration. The company is also preparing to launch a pivotal investigational device exemption (IDE) trial of EndoZip in the US, with the trial’s data intended to support a future regulatory filing with the US Food and Drug Administration (FDA).
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By GlobalDataWith their promise of weight loss via a simple injection, GLP-1RAs have dominated discussions in the obesity treatment space in recent years.
However, research suggests that ESG maintains a role in addressing obesity due to reduced costs and improved health outcomes over time. A study published in JAMA found that the annual US cost of semaglutide would need to be reduced three-fold, from $13,618 to $3591 (prices relevant upon the study’s publication in April 2024), for it to be a cost-competitive alternative. Eli Lilly and Novo Nordisk announced deals with the US Government on 6 November, which will significantly reduce the cost of GLP-1RAs for patients. It therefore remains to be seen how this new pricing model will interplay with weight loss surgeries.
Another study indicates that ESG may function as a more long-lasting weight loss option, finding that patients treated with GLP-1RAs regained up to two-thirds of their weight lost one year after withdrawing from the treatment.
