Shots:
- Nitinotes has received the FDA’s IDE approval to begin a pivotal trial of its EndoZip System for endoscopic sleeve gastroplasty; enrollment is set to start by Q3’25
- The trial will assess the safety & efficacy of the EndoZip System for obesity pts. (n=184) across up to 10 US and additional international sites. As a comparative study with all participants receiving active treatment, with a 12mFU completed by mid-2027
- The EndoZip System is an automated ESG device that standardizes endoscopic bariatric procedures by enabling consistent, full-thickness plications with a single operator. EU trial results published in Gastrointestinal Endoscopy show promising safety and efficacy in real-world use
Ref: PRNewswire | Image: Nitinotes | Press Release
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