Magnetic Gastro-Ileal or Gastro-Jejunal Diversion Study ("MGI/MGJ Study")

Inclusion Criteria:

• 18-65 years of age, inclusive, at the time of informed consent

• BMI 30-50 kg/m2, inclusive with either (A) Type 2 Diabetes Mellitus (T2DM), definedas HbA1c ≥ 6.5%, or (B) Weight regain following previous sleeve gastrectomy (>12months) and indicated for a gastro-ileal diversion; OR

• BMI 35-50 kg/m2, inclusive without previous sleeve gastrectomy, and where (A)Gastro-jejunal diversion is indicated for the first stage, of a 2-stage, oneanastomosis gastric bypass (OAGB), or (B) Single anastomosis gastric bypass (SAGB),with the second stage gastric pouch stapling performed >12 months after thegastro-ileal diversion, and not part of the investigational study

• Agrees to refrain from any type of additional bariatric or reconstructive surgerythat would affect body weight for the duration of the study

• If a child-bearing female, subject must commit to not becoming pregnant and agree touse contraception for the duration of the study

• Willing and able to comply with protocol requirements

Exclusion Criteria:

• Type 1 diabetes

• Use of injectable insulin

• Uncontrolled T2DM

• Plan to perform a sleeve gastrectomy and/or hiatal hernia repair and/orcholecystectomy with the investigational study gastro-ileal anastomosis procedure

• Uncontrolled hypertension, dyslipidemia or sleep apnea

• Prior intestinal, colonic or duodenal surgery, other than bariatric

• Prior surgery, trauma, prostheses, disease or genetic expression which prevent orcontra-indicate the procedure, including scarring and abnormal anatomy.

• Refractory gastro-esophageal reflux disease (GERD)

• Barrett's disease

• Helicobacter pylori positive and/or active ulcer disease

• Large hiatal hernia

• Inflammatory bowel or colonic diverticulitis disease

• Any anomaly precluding orogastric access by gastroscope and catheters, andmanipulation techniques.

• Implantable pacemaker or defibrillator

• Psychiatric disorder, except well-controlled depression with medication for > 6months

• History of substance abuse

• Woman who is either pregnant or breast feeding

• Woman of childbearing potential who does not agree to use an effective method ofcontraception.

• Any comorbidity or current status of subject's physiological fitness that in thesurgeon's or anesthesiologist's opinion represents safety concerns that make thesubject medically unfit for the procedure, including any significant congenital oracquired anomalies of the GI tract at or distal to the placement of the magnets.

• Unhealed ulcers, bleeding lesions, tumor, or any other lesion at target magnetdeployment site

• Expected MR imaging within a two-month window following the study procedure

• Any anomaly preventing/contraindicating endoscopic or laparoscopic access andprocedures

• Underwent a surgery/intervention within the 30 days proceeding the study procedure

• Any scheduled surgical or interventional procedure planned within 30 days post-studyprocedure

• Any stroke/TIA within 6 months prior to informed consent

• Requires chronic anticoagulation therapy (except aspirin)

• Active infections requiring antibiotic therapy, unless resolved before undergoingthe study procedure

• Unable to comply with the follow-up schedule and assessments

• Recent tobacco or nicotine product cessation; cessation ≤ 3 months prior to informedconsent

• Known allergies to the device components or contrast media

• Limited life expectancy due to terminal disease

• Currently participating in another clinical research study with an investigationaldrug or medical device

• A positive COVID-19 test prior to the study procedure, where indicated by localCOVID-19 protocols for procedure/surgical clearance

• Any condition that, in the investigator's opinion, may preclude completion offollow-up assessments through Day 360 (e.g., a medical condition that may increasethe risk associated with study participation or may interfere with interpretation ofstudy results, inability to adhere to the visit schedule, or poor compliance withtreatment regimen)