Wide ranging talk on Stomaphyx ROSE and Apollo Overstitch

1. New Horizons in Bariatric Surgery – endoluminal treatments for weight regain after gastric bypass: Elliot R Goodman MD Bariatric Surgery Service Beth Israel Medical Center New York, NY

4. Weight loss trajectory after gastric bypass:

7. Endoluminal Gastric Pouch Reduction (EGPR) StomaphyX TM

10. Diagram for fasteners H H H H H H

11. Endoluminal Gastric Pouch Reduction

12. Endoluminal Gastric Pouch Reduction Pre anastomosis Post anastomosis

13. Endoluminal Gastric Pouch Reduction Gastro-esophageal Junction

14. Fluoroscopic evidence of stomal narrowing after EGPR with Stomaphyx: GJ stoma before EGPR Stoma after EGPR

15. Serosa-to-serosa Fusion Full thickness tissue plication and serosa-to-serosa fusion seen in several animal models

16. Beth Israel Medical Center results 2008-9 (N=64) Age (years) 47.5 (24-66) Female / Male 92% female / 8% male Height (inches) 65 Median BMI Pre-Gastric Bypass 48.7 Median BMI Post-Gastric Bypass (nadir) 31.3 Median BMI Post-GB(nadir) 31.3 Median time(years) after Gastric bypass surgery 5 (2-10)

17. Median BMI before StomaphyX 39.85 (25.9-54.9) Median BMI post Stomaphyx 37.75(25.1-55.2) Median follow up(months) 6(1-13) No. Patients Weight loss 43(67%) No. Patients no weight loss 14(21%) No follow up weight available 7(12%)

18. Median weight loss (lbs.) post StomaphyX 15.5(3.3-67) Median OR time 50 (35-130) Median reduction in gastric pouch length 33%(0-67) Median # of fasteners 23(10-40)

25. The ROSE Procedure (by USGI):

26. R epair O f S urgery E ndolumenal-ROSE Repair of Dilated Gastric Pouch and Stoma Post RYGBP Dilated Stoma Post ROSE Procedure

27. ROSE with the USGI IOP Dilated pouch and stoma Stoma restoration: Use EOS to create circumferential folds around stoma Create permanent folds in pouch to reduce volume

31. ROSE Registry | Acute Procedural Success PRE-PROCEDURE 2.6 cm POST-PROCEDURE 0.5 cm INTRA-OP STOMA CHANGE Cases Completed 97% (112/116) Mean Final Stomal Diameter 11.5 mm Mean % Stomal Reduction 50% Mean Final Pouch Length 3.3 cm Mean % Pouch Reduction per Case 44% Mean # Total Anchors per Case 5.9 Mean O.R. Time 87 min

32. Stoma/Pouch Reduction Achieved Cases Completed N=112/116 (97%) Mean Final Stomal Diameter 11.5 mm Mean % Stomal Reduction 50% Mean Final Pouch Length 3.3 cm Mean % Pouch Reduction per Case 44% Mean # Total Anchors per Case 5.9 Mean O.R. Time 87 min

33. Results-6 Month Weight Loss *based on target BMI 25kg/m 2 6 Month Endpoint (N=96) Mean for Total Registry Max for Individual Subject Weight Loss (kg) 6.5kg 30kg %EWL* 18% 84% % Regained Weight Lost (RWL) 32% 300%

34. ROSE WEIGHT LOSS WITH STOMA REDUCTION SUBSET 12 MONTHS N=73 (min, max) 12 MONTHS N=22 (30% of N) (final stoma <10mm) MEAN WEIGHT LOSS (LBS) 12.9 LBS 22.4 LBS MEAN % EWL (BMI25) 14 % 24 % MEAN %TBW Loss 5 % 9%

35. Grouped Variable Analysis 6 month ROSE Data Best Positive Group Predictors for %EWL at 6 months * *using linear regression modeling ¥ p<.05 statistically significant Predictive Grouping P-value ¥ %EWL from original bypass 0.0015 # of total anchors placed 0.0267 Female >50 0.0399 Pre-ROSE procedure pouch length 0.3187

42. Patient Characteristics: Average pre-bypass weight 342.2+/-75.4lbs Average nadir weight 206.23+/-57.6lbs Average weight at suturing 260.0+/-68.6lbs

46. Results: n=18 patients Average weight loss 22.5+/-13.4lbs Average follow-up time 3 months % weight regain loss 60.4% % excess weight loss 21.5%

47. Stoma vs. Pouch: Outlet reduction n=10 Outlet/pouch reduction n=8 Average weight loss 15.6lbs 30.9lbs Average follow-up time 94 days 86 days % weight regain loss 63.2% 66.1% % excess weight loss 16.7% 26.3%