Early Feasibility for Safety & Device Functionality of SFM Anastomosis Device Used in 3 Procedures (SNAP-S) or (SNAP-PS) or (J-J)

Inclusion Criteria:

• All Subjects:

1. Age 18-65 years at screening

2. For the primary or post sleeve gastrectomy Anastomosis procedures (SNAP-S/SNAP-PS)- Obesity with Body Mass Index (BMI) ≥ 35 kg/m2 but ≤ 55 kg/m2at time of screening with or without comorbidities at time of screening. Ifsubject has obesity-related comorbidities such as hypertension, dyslipidemia,and sleep apnea, these comorbidities must be well-controlled

3. For the Roux-en-Y gastric bypass jejuno-jejunostomy procedure (J-J) - Obesitywith Body Mass Index (BMI) ≥ 35 kg/m2 but ≤50 kg/m2 with or withoutcomorbidities at time of screening. If subject has obesity-relatedcomorbidities such as hypertension, dyslipidemia, and sleep apnea, thesecomorbidities must be well-controlled.

4. Able to understand and sign informed consent document

5. Patient lives, and intends to remain, within a 150-km radius of study centerfor 12 months

6. Willing to commit to sustained healthy behaviors that include diet, eating andexercise habits for the duration of the trial

7. Willing to refrain from smoking during the study follow-up period

8. If subject is female, she must commit to not becoming pregnant for 12 monthsand agree to use of contraceptives during this period and may not be nursing

Exclusion Criteria:

1. Known or suspected allergy to nickel, titanium or Nitinol

2. Type 1 Diabetes

3. Uncontrolled T2DM Fasting glucose ≥ 200 mg/dl (11.1 mmol/L) and/or hemoglobinA1c >10 or use of injectable insulin

4. Any documented conditions for which endoscopy and/or laparoscopy would becontraindicated or history of previous technically difficult or failedendoscopy

5. Contraindication to general anesthesia

6. Clinically significant finding during procedural endoscopy such as presence ofan unhealed ulcers, bleeding lesions, tumors or ischemic or necrotic tissue attarget magnet deployment site

7. Congenital or acquired anomalies of the GI tract, including atresia, stenosis,prior obstruction or malrotation

8. Presence of a duodenal diverticulum (>10mm)

9. Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding laparoscopically removed gallbladder), pancreas or right colon

10. History of chronic gastrointestinal disease (e.g., cirrhosis, inflammatorybowel disease) that in the opinion of the Investigator may preclude safe andcomplete study participation

11. Uncontrolled severe hypertension (blood pressure >160/100mmHg)

12. Pre-existing severe comorbid cardio-respiratory disease (e.g., congestive heartfailure, uncontrolled cardiac arrhythmia, coronary artery disease, chronicobstructive lung disease requiring supplemental oxygen, pulmonary embolism,Myocardial Infarction with prior 6 months)

13. Liver biochemistries (ALT and AST) ≥ 3 times the upper limit of normal

14. Uncorrectable coagulation disorder (platelets < 100,000, PT >2 seconds aboveupper normal limit or INR >1.5) at time of procedure, Note: management ofanti-platelet medications, when applicable, will follow standard practices ofthe institution

15. Uncorrectable anemia (Hemoglobin < 11 g/dL in women and <12.5 g/dL in men)

16. Specific genetic or hormonal cause of obesity such as Prader -Willi syndrome

17. For females of child-bearing potential: Pregnancy or desire to be pregnantduring the study

18. Concurrent condition anticipated to require MR imaging within the first 2months after the study procedure

19. Diagnosed Bulimia Nervosa or Binge Eating Disorder (using DSM-5 criteria)

20. Physical or mental disability or psychological illness that in the opinion ofthe Investigator would be a contraindication for bariatric surgery

21. Subject is immunocompromised (e.g., active treatment for malignancies,hematologic malignancy, on immunosuppressive therapy, moderate or severeprimary immunodeficiency, advanced or untreated HIV, active treatment withhigh-dose corticosteroids (i.e.,20 or more mg of prednisone or equivalent perday when administered for 2 or more weeks prior to surgery) or otherimmunosuppressive or immunomodulatory agents.

22. Subject has an active or suspected infection at the surgical site or a CDCClass 3/contaminated or Class 4/dirty-infected surgical wound. Subject is notappropriate for inclusion in the clinical trial, per the medical opinion of thePrincipal Investigator"

23. Other prior or concurrent conditions that in the opinion of the Investigatorwould be unlikely to receive clinical benefit from the study procedure orparticipation in the study may compromise patient safety or study objectivessuch as the presence/diagnosis of a severe and evolutive life threateningpathology unrelated to obesity including but not limited to: ongoing infection,chronic pancreatitis, severe hepatic dysfunction, or renal dysfunction (GFR <60mL/min/1.73m2)

24. Any form of substance abuse or psychiatric disorder that in the opinion of theinvestigator could interfere with the conduct of the study

25. (Women only) Pregnancy at screening (+ urine hCG) or unwilling to usecontraception throughout study period