MagDI Italian Study

Inclusion Criteria:

1. Between 18-65 years of age, at the time of informed consent. 2. Body Mass Index (BMI) between 30-50 kg/m2. 3. Meets one of the following criteria:

2. Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) or weight regain followingprevious sleeve gastrectomy (≥ 12 months); OR

3. Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) or weight regain followingprevious endoscopic sleeve gastroplasty (≥ 12 months); OR

4. Type 2 Diabetes Mellitus (defined as HbA1c ≥ 6.5%) with a Body Mass Index between 30-35 and without previous sleeve gastrectomy and no plan to perform a concurrentsleeve gastrectomy.

5. Participant agrees to refrain from any type of additional bariatric orreconstructive surgery that would affect body weight for the duration of the study.

6. Participant has been informed of the nature of the study and agrees to itsprovisions, complying with study required testing, medications, follow-up visits,and has provided written informed consent.

Exclusion Criteria:

• 1. Type 1 diabetes. 2. Use of injectable insulin. 3. Uncontrolled Type 2Diabetes Mellitus (T2DM). 4. Investigator plans to perform a sleeve gastrectomywith the duodeno-ileal anastomosis procedure.

5. Uncontrolled hypertension, dyslipidemia or sleep apnea. 6. Prior intestinal,colonic or duodenal surgery (other than bariatric). 7. Prior surgery, trauma,prostheses, disease or genetic expression which prevent or contraindicate theprocedure, including scarring and abnormal anatomy.
6. Refractory gastro-esophageal reflux disease (GERD). 9. Barrett's disease.
7. Helicobacter pylori positive and/or active ulcer disease. 11. Large hiatalhernia. 12. Inflammatory bowel or colonic diverticulitis disease. 13. Anyanomaly precluding orogastric access by gastroscope and catheters, andmanipulation techniques.
8. Any anomaly preventing / contraindicating endoscopic or laparoscopic accessand procedures.
9. Implantable pacemaker or defibrillator. 16. Psychiatric disorder, exceptwell-controlled depression with medication for

• gt; 6 months. 17. History of substance abuse. 18. Pregnant, lactating, orplanning pregnancy during the clinical investigation. Note: Female participants of childbearing age must agree to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants,transdermal patches hormonal vaginal devices, injections with prolonged release).

19. Any comorbidity or current status of participant's physiological fitness that inthe surgeon's or anesthesiologist's opinion represents safety concerns that make theparticipant medically unfit for the procedure, including any significant congenitalor acquired anomalies of the GI tract at or distal to the placement of the Magnets.

20. Unhealed ulcers, bleeding lesions, tumor, or any other lesion at target Magnetdeployment site.

21. Expected need for Magnetic Resonance Imaging (MRI) within the first 2 monthspost-procedure.

22. Any surgical or interventional procedure (including planned and/or scheduled)within the period of 30 days prior to and 30 days following the study procedure.

23. Any stroke/TIA ≤ 6 months prior to consent. 24. Requires chronic anticoagulationtherapy (except aspirin). 25. Active infections requiring antibiotic therapy, unlessresolved before undergoing the study procedure.

24. Recent tobacco or nicotine product cessation ≤ 3 months prior to informedconsent.

25. Known allergies to the device components (including the biofragmentable materialPGLA or similar compounds) or contrast media.

26. Participants with comorbidities that are likely to result in a life expectancyof ≤ 12 months.

27. Currently participating in an investigational drug or another device study thathas not reached its primary endpoint: Note: Studies requiring extended follow-up forproducts that were investigational, but have since become commercially available,are not considered investigational trials.

28. A positive COVID-19 test prior to the study procedure in accordance with localCOVID-19 protocol.

29. Presence of other anatomic or comorbid conditions, or other medical, social orpsychological conditions that, in the investigator's opinion, could limit theparticipant's ability to participate in the clinical investigation or to comply withfollow-up requirements, or impact the scientific soundness of the clinicalinvestigation results.