Background

The DI Biofragmentable Magnet Study ('MagDI Study') is a first-in-human, proof-of-concept/feasibility study of the Magnet System, MagDI System using thebiofragmentable DI Magnet device ('Magnet') as the compression element. This Magnet is a modification to the first-generation device with an all-metalhousing and flange made of titanium alloy material and is swallowable. The aims of the study were safety and efficacy.This procedure was indicated in adults (18 to 65 years of age, inclusive) with obesity (BMI) 30-35 kg/m2 and who have type 2 diabetes mellitus (T2DM defined as HbA1c 6.5%),without previous sleeve gastrectomy, and without a plan to perform a concurrent sleeve gastrectomy.Since Dec 2022, 9 patients were enrolled, and those 6m of f/up had a mean age of 52.2+3.1 and a BMI of 32.4+0.8 kg/m2, 100% had T2DM with preop glucose of 191.2+25.7 mg/dL, and a mean HbA1c of 8.0+0.6. 100% of patients passed their devices at a mean of 23+1.8 days, almost twice as fast as the previous first-generation full-metal device. At 6 months, a total of 12 adverse events were noted, grade I-II Clavien-Dindo Classification. The BMI had dropped to a mean of 28.0 kg/m2, for a %EWL of 64. The mean glucose had a 32 % drop at 129.3 mg/dL and the HbA1c at 6.4.In conclusion, the FIM Side-to-Side Compression Anastomosis Using the Biofragmentable Magnet System to Achieve Duodeno-Ileostomy Diversion with Class I Obesity and T2DM is feasible and safe. Preliminarily results demonstrate an efficient decrease in weight and T2DM parameters.