Manuscripts & Abstracts Allurion Literature – October 2023 Allurion Literature - Manuscripts Meta-Analyses and Registry Studies Safety and efficacy data from around the world – LATAM Safety and efficacy data from around the world – MEA Safety and efficacy data from around the world - Europe Symptom Management Cost-effectiveness of the Allurion Balloon MANUSCRIPTS Meta-Analyses and Registry Studies (1/2) 3 © 2 0 2 2 ALLURIO N TE C H N O LO GIE S - P RO P RIE TARY IN F O RM ATIO N – C O N F IDE N TIAL Citation Sample size (N) Methods Demographics Results Conclusions Ramai, D., Singh, J., Mohan, B. P., Madedor, O., Brooks, O. W., Barakat, M., Ofosu, A., Khan, S. R., Chandan, S., Dhindsa, B., Dhaliwal, A., Facciorusso, A., McDonough, S., & Adler, D. G. (2021). Influence of the Elipse Intragastric Balloon on Obesity and Metabolic Profile: A Systematic Review and Meta-Analysis. Journal of clinical gastroenterology, 55(10), 836–841. https://doi.org/10.1097/MCG.000 0000000001484 2152 Meta-analysis 7 studies Raftopoulos 2017 Alsabah 2018 Machytka 2017 Jamal 2019 Al-Subaie 2017 Genco 2018 Ienca 2020 Baseline BMI: 32.1 to 38.6 kg/m ² Mean TBWL 12% Early deflation rate 1.8% This meta-analysis demonstrates that the Allurion intragastric balloon is a safe, effective, and tolerable device for weight loss and obesity with a minimal side effect profile Vantanasiri, K., Matar, R., Beran, A., & Jaruvongvanich, V. (2020). The Efficacy and Safety of a Procedureless Gastric Balloon for Weight Loss: a Systematic Review and Meta-Analysis. Obesity surgery, 30(9), 3341–3346. https://doi.org/10.1007/s11695- 020-04522-3 2013 Meta-analysis 6 studies Ienca 2019 Raftopoulos 2019 Espinet 2019 Jamal 2019 Alsabah 2017 Machytka 2016 Baseline BMI: 30.6-36.2 kg/m ² TBWL (4M): 12.75% TBWL (1Y): 10.94% 1 SBO 1 gastric perforation Intolerance requiring balloon removal: 2.3% This meta-analysis demonstrates that the Allurion intragastric balloon is a safe device offering an effective weight loss that warrants further studies for its long- term weight loss outcomes. Severe adverse events are rare, and the rate of early removal is low. Meta-Analyses and Registry Studies (2/2) 4 © 2 0 2 2 ALLURIO N TE C H N O LO GIE S - P RO P RIE TARY IN F O RM ATIO N – C O N F IDE N TIAL Citation Sample size (N) Methods Demographics Results Conclusions Ienca, R., Al Jarallah, M., Caballero, A., Giardiello, C., Rosa, M., Kolmer, S., Sebbag, H., Hansoulle, J., Quartararo, G., Zouaghi, S. A. S., Juneja, G., Murcia, S., Turro, R., Pagan, A., Badiuddin, F., Dargent, J., Urbain, P., Paveliu, S., di Cola, R. S., Selvaggio, C., ... Al Kuwari, M. (2020). The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients. Obesity surgery, 30(9), 3354–3362. https://doi.org/10.1007/s11695- 020-04539-8 1770 19 centers Physical follow-up visits 71% female 29% male Mean age : 38.8 ± 12 years Mean Weight: 94.6 ± 18.9 kg Mean BMI: 34.4 ± 5.3 kg/m ² Mean weight loss : 13.5 ± 5.8 kg TBWL: 14.2 ± 5% Change in BMI : 4.9 ± 2 kg/m ² All metabolic parameters significantly decreased 52 (2.9%) intolerance 11 (0.6%) early deflations 4 (0.2%) were endoscopically removed after discovery of contraindications 3 (0.17%) small bowel obstructions (previous version of Allurion Balloon) 1 (0.06%) gastric dilation The Allurion Balloon demonstrated an excellent safety profile. The balloon also exhibited remarkable efficacy with 14.2% TBWL and improvement across all metabolic parameters Safety and efficacy data from around the world - LATAM 5 © 2 0 2 2 ALLURIO N TE C H N O LO GIE S - P RO P RIE TARY IN F O RM ATIO N – C O N F IDE N TIAL Citation Sample size (N) Methods Demographics Results Conclusions Palermo, M., & Davrieux, C. F. (2023). Swallowable Intragastric Balloon: First Consecutive Experience in Argentina. Journal of laparoendoscopic & advanced surgical techniques. Part A, 33(2), 146–149. https://doi.org/10.1089/lap.2022.0 340 153 Single-center (Argentina) 6 months follow up 78% female 22% male Mean age: 39 years Mean BMI: 29.5 kg/m ² Mean TBWL 12% at 4 months AE reported: abdominal pain, nausea, vomiting, headache, reflux, constipation and diarrhea. Effective, safe, and well tolerated Safety and efficacy data from around the world – MEA (1/2) 6 © 2 0 2 2 ALLURIO N TE C H N O LO GIE S - P RO P RIE TARY IN F O RM ATIO N – C O N F IDE N TIAL Citation Sample size (N) Methods Demographics Results Conclusions Taha, O., Abdelaal, M., Asklany, A., Alaa, M., Belal, S., El Assal, I., Shahin, M., Abubasha, A., & Elbanhawy, D. (2021). Outcomes of a Swallowable Intragastric Balloon (Elipse ™ ) on 96 Overweight and Obese Patients. Obesity surgery, 31(3), 965–969. https://doi.org/10.1007/s11695- 020-05086-y 96 Retrospective analysis Single-center (Egypt) 71% female 29% male Mean age: 28.9 years Mean weight: 92.7 kg Mean BMI: 33.6 kg/m ² TBWL at 16 weeks: 12.1% Improvements in Triglycerides, LDL cholesterol, HbA1c (p<0.0001) Intolerance requiring balloon removal: 3.1% Early balloon deflation (<90 days): 1.1% No SAEs The swallowable gastric balloon can be safely and successfully swallowed, with consistent weight loss and clinical improvement in factors related to metabolic syndrome Jamal, M. H., Almutairi, R., Elabd, R., AlSabah, S. K., Alqattan, H., & Altaweel, T. (2019). The Safety and Efficacy of Procedureless Gastric Balloon: a Study Examining the Effect of Elipse Intragastric Balloon Safety, Short and Medium Term Effects on Weight Loss with 1-Year Follow-Up Post-removal. Obesity surgery, 29(4), 1236–1241. https://doi.org/10.1007/s11695- 018-03671-w 106 Single-center (Kuwait) 1 year post excretion follow-up 77% female 23% male Mean age: 31.3 years Mean weight: 92.2 kg Mean BMI: 34.3 kg/m ² 90/106 patients successfully followed-up (1y) TBWL (3M): 10.9% TBWL (1Y) : 7.9% Change in BMI (3M): 3.7 kg/m ² Change in BMI (1Y): 2.95 kg/m ² 6 removals due to intolerance 1 small bowel obstruction 3 early deflations Allurion IGBs are effective, safe, and feasible non-invasive method for weight loss Safety and efficacy data from around the world – MEA (2/2) 7 © 2 0 2 2 ALLURIO N TE C H N O LO GIE S - P RO P RIE TARY IN F O RM ATIO N – C O N F IDE N TIAL Citation Sample size (N) Methods Demographics Results Conclusions Alsabah, S., Al Haddad, E., Ekrouf, S., Almulla, A., Al-Subaie, S., & Al Kendari, M. (2018). The safety and efficacy of the procedureless intragastric balloon. Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery, 14(3), 311–317. https://doi.org/10.1016/j.soard.201 7.12.001 135 Multicenter (Kuwait) 4 months follow-up 82% female 18% male Mean age: 33.5 years Mean BMI: 33.7 kg/m ² Mean weight: 88.8kg At 4 months: Mean WL: 13kg Mean BMI loss: 4.9 kg/m ² Mean TBWL: 15.1% 1 SBO This study aimed to evaluate the safety and effectiveness of the Allurion Balloon in the largest population studied as of date. It was also able to demonstrate that it swallowed, filled, imaged, and passed. In addition, it effectively aided in weight loss, showing promising results. Al-Subaie, S., Khalifa, S., Buhaimed, W., & Al-Rashidi, S. (2017). A prospective pilot study of the efficacy and safety of Elipse intragastric balloon: A single- center, single-surgeon experience. International journal of surgery (London, England), 48, 16–22. https://doi.org/10.1016/j.ijsu.2017.1 0.001 51 Single-center (Kuwait) 4 months duration 92% female 8% male Mean age: 33.6 (18-65) years Mean WT: 83.9 ± 12.3 kg Mean BMI: 32.1 (27.3- 39.7) kg/m ² Mean WC: 95.3 ± 9.2 cm Total weight loss: 8.84 kg TBWL: 10.44% Change in BMI: 3.42 kg/m ² Total WC reduction: 8.62 cm 5 removals due to intolerance 1 early deflation No SAEs Overall satisfaction above average These data proves that Allurion is safe and effective for weight loss. Nevertheless, some limitations were observed that need to be overcome for better outcomes. Safety and efficacy data from around the world – Europe (1/2) 8 © 2 0 2 2 ALLURIO N TE C H N O LO GIE S - P RO P RIE TARY IN F O RM ATIO N – C O N F IDE N TIAL Citation Sample size (n) Methods Demographics Results Conclusions Jense MTF, Palm-Meinders IH, Sanders B, Boerma EG, Greve JWM. (2023) The Swallowable Intragastric Balloon Combined with Lifestyle Coaching: Short-Term Results of a Safe and Effective Weight Loss Treatment for People Living with Overweight and Obesity. Obes Surg. 2023;33(6):1668-1675. doi:10.1007/s11695-023-06573-8 336 Retrospective 2-centers (Netherlands) 71,7% female Mean age: 45.7 ± 11.7 years Mean weight: 107.54 ± 19.16 kg Mean BMI: 36.1 ± 5.02 kg/m 2 At 1-year: Mean TBWL: 11.0 ± 8.4 % Most common symptoms: nausea and gastric pain; majority resolved within one week Premature deflation: 2.4% Given the low rate of long-term complaints while providing a positive effect on weight loss, we conclude that the swallowable intragastric balloon, combined with lifestyle coaching, is a safe and effective treatment option for patients living with overweight and obesity Ernesti I, Ienca R, Basciani S, Mariani S, Genco A (2018) Effect of A New Swallowable Intragastric Balloon (Elipse ™ ) on Weight Loss and Metabolic Syndrome. J Obes Nutr Disord: JOND-120. DOI: 10.29011/JOND-120.100020 42 Single-center (Italy) Physical follow-up visits 12-month follow up program 69% female 31% male Mean age: 47.2 ± 10.3 years Mean WT: 110.5 ± 21.9 kg Mean BMI: 39.2 ± 6.7 kg/m ² WC: 123.5 ± 16.9 cm Mean weight loss : 12.9 kg TBWL: 11.9% Change in BMI: 4.5 kg/m ² WC: 111 ± 16.2 cm Significant reduction in major comorbidities: blood pressure, WC, triglycerides, blood glucose and HOMA-IR index. No complications The main finding of the present study was a significant BMI reduction and Metabolic syndrome remission rate within 4 months of treatment instead of 6 months, as happens in other balloons Genco, A., Ernesti, I., Ienca, R., Casella, G., Mariani, S., Francomano, D., Soricelli, E., Lorenzo, M., & Monti, M. (2018). Safety and Efficacy of a New Swallowable Intragastric Balloon Not Needing Endoscopy: Early Italian Experience. Obesity surgery, 28(2), 405–409. https://doi.org/10.1007/s11695-017-2877-1 38 Single-center (Italy) Phone follow-up 74% female 26% male Mean age: 46.4 ± 10.6 years Mean WT: 109.7 ± 21.9 kg Mean BMI: 38.6 ± 6.7 kg/m ² Mean weight loss: 12.7 kg TBWL: 11.6% Change in BMI: 4.2 kg/m ² Significant reduction in major comorbidities: blood pressure, WC, triglycerides, blood glucose and HOMA-IR index. No complication during balloon passage. 37 normal stool excretion, 1 endoscopic removal. The results of this study on 38 consecutive patients demonstrate that the Allurion ™ Balloon is safe, effective, and very well accepted by patients. Safety and efficacy data from around the world – Europe (2/2) 9 © 2 0 2 2 ALLURIO N TE C H N O LO GIE S - P RO P RIE TARY IN F O RM ATIO N – C O N F IDE N TIAL Citation Sample size (N) Methods Demographics Results Conclusions Machytka, E., Gaur, S., Chuttani, R., Bojkova, M., Kupka, T., Buzga, M., Giannakou, A., Ioannis, K., Mathus-Vliegen, E., Levy, S., & Raftopoulos, I. (2017). Elipse, the first procedureless gastric balloon for weight loss: a prospective, observational, open- label, multicenter study. Endoscopy, 49(2), 154–160. https://doi.org/10.1055/s-0042- 119296 34 Multicenter (Czech republic & Greece) Follow-up every 2 weeks 68% female 32% male Mean age: 42 (18-59) years Mean BMI: 34.8 kg/m ² (27-40) Mean weight: 101.9 kg (73-134) TBWL: 10.0% BMI Loss: 3.9 kg/m ² WC reduction: 8.4 cm Reduction in HbA1c: 0.16% Mean LDL reduction: 9.7 mg/dL Mean TG reduction: 16.4 mg/dL SBP and DBP reduction: 9.6mmHg and 5.8mmHg Overall quality of life, physical function, self-esteem, sexual life, public distress, and work- related quality of life significantly improved. No SAEs, all AEs were expected and normal These results demonstrate clinically significant weight loss with the Allurion Program, the first procedureless gastric balloon. The weight loss was similar to that seen in previous studies of endoscopically placed balloons. In addition, Allurion therapy led to improvements in waist circumference, several metabolic parameters, and overall quality of life. Raftopoulos, I., & Giannakou, A. (2017). The Elipse Balloon, a swallowable gastric balloon for weight loss not requiring sedation, anesthesia or endoscopy: a pilot study with 12- month outcomes. Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery, 13(7), 1174–1182. https://doi.org/10.1016/j.soard.201 7.02.016 12 Single-center (Athens, Greece) 1Y follow-up 58% female 42% male Mean age: 41 years Mean BMI: 35.9 kg/m ² Mean weight: 103.5 kg Mean WC: 117.6 cm 4 months Mean TBWL: 14.6% 12 months Mean TBWL: 5.9% Quality of life was significantly improved at excretion and 12 months. No SAE reported This study is the first to demonstrate 12-month efficacy and performance outcomes of the Allurion Balloon. Symptom Management 10 © 2 0 2 2 ALLURIO N TE C H N O LO GIE S - P RO P RIE TARY IN F O RM ATIO N – C O N F IDE N TIAL Citation Sample size (N) Methods Demographics Results Conclusions Ienca, R., Giardiello, C., Scozzarro, A., di Cola, R. S., Di Lorenzo, N., Juneja, G., Lopez, G., & Badiuddin, F. (2019). Improving Nausea and Vomiting Post-Elipse Balloon: a Novel Single-Dose Regimen of 300 mg Netupitant/0.5 mg Palonosetron Hydrochloride. Obesity surgery, 29(9), 2952–2956. https://doi.org/10.1007/s11695- 019-03937-x 30 Patients received Akynzeo at placement 70% female 30% male Mean weight: 97.8 kg Mean BMI 34.7 kg/m ² 4/30 (13%) reported vomiting on days 1, 2, and 3; 9/30 (30%) reported nausea higher than score 4 on days 1, 2, and 3; 8/30 (26.6%) reported gastric pain higher than score 4 on days 1, 2, and 3. In our experience, the use of a single-pill netupitant / palonosetron resulted to be very easy to administer and effective in reducing vomiting, nausea, and gastric pain in 87%, 70%, and 73.4% patients respectively, ameliorating the post Allurion ™ placements symptoms safely. Cost-effectiveness of the Allurion Balloon 11 © 2 0 2 2 ALLURIO N TE C H N O LO GIE S - P RO P RIE TARY IN F O RM ATIO N – C O N F IDE N TIAL Citation Sample size (N) Methods Demographics Results Conclusions Mital, S., & Nguyen, H. V. (2021). Cost-effectiveness of procedure- less intragastric balloon therapy as substitute or complement to bariatric surgery. PloS one, 16(7), e0254063. https://doi.org/10.1371/journal.pon e.0254063 NA Practice economics Cost effectiveness comparison of procedureless intragastric balloons (PIGB), gastric bypass/sleeve gastrectomy, Gastric balloon as a bridge to gastric bypass/sleeve gastrectomy and no treatment. NA Gastric balloon as a bridge to bariatric surgery is less costly and more effective than bariatric surgery alone as it helps to achieve a lower post- operative BMI. Of the six strategies, PIGB as a bridge to sleeve gastrectomy is the most cost-effective. While PIGB alone is not cost- effective compared with bariatric surgery, it is cost- effective compared with no treatment. PIGB can yield cost savings and improve health outcomes if used as a bridge to bariatric surgery and is cost-effective as a stand-alone treatment for patients lacking access or unwilling to undergo surgery Allurion Literature - Abstracts Multicenter Studies Demonstrating Safety & Efficacy Allurion Program vs Lifestyle Intervention alone Long Term Weight Maintenance Sequential Allurion Balloon Program Diabetes, Adolescents, Overweight, Severe Obesity Remote Follow-up using Telehealth Combination Therapy Behavioral Science AI and Machine Learning ABSTRACTS Multicenter Studies Demonstrating Safety & Efficacy 13 © 2 0 2 2 ALLURIO N TE C H N O LO GIE S - P RO P RIE TARY IN F O RM ATIO N – C O N F IDE N TIAL Citation Sample size (N) Methods Demographics Results Conclusions Caballero A, Giardiello C, Oyola C, et al. The Swallowable Gastric Balloon: Global Experience in 5003 Consecutive Patients - The Largest Gastric Balloon Study in the World IFSO 2023, Oral-325 5003 Multicenter 26 centers 10 countries 3 continents 4 months follow-up 72% female 28% male Mean age: 42.5 years Mean weight: 95 kg Mean BMI: 34.1 kg/m ² Mean WL: 13.46 kg Mean TBWL: 14.04% Significant improvement in all metabolic parameters AE rate 2.85% SAE rate 0.20% The largest study of the Allurion Gastric Balloon Program with 5003 consecutive patients confirms a TBWL of 14%, significantly improved metabolic parameters, and consistent safety in diverse, global populations. The unique Virtual Care Suite facilitates close follow-up to optimize safety and efficacy. Genco A, Giardiello C, Lucchese M, et al. Effects of New Procedureless Intragastric Balloon (Allurion ®) on Metabolic Syndrome and Pre- Diabetes: Italian Group’s Experience on 324 Patients with Overweight and Obesity. SOARD, 2018, 14, S56-S66 324 Multicenter 59% female 41% male Mean age: 45 years Mean weight: 104 kg Mean BMI: 36.8 kg/m ² Mean WL: 14.3 kg Mean TBWL: 13.75% Positive effect on glucose metabolism No SAEs Allurion is a safe and effective in inducing weight loss and results in a significant reduction in obesity-related metabolic diseases including metabolic syndrome and pre-diabetes Ienca R, Rosa M, Selvaggio C, et al. Expanding the reach of Intragastric Balloons; First multicenter results of Allurion Balloon in non-core user group. SOARD, 2018, 14, S99-S196 64 Multicenter 61% female 39% male Mean age : 45.1 ± 10.7 years Mean BMI: 35 ± 4.6 kg/m ² Mean weight: 101.4 ± 19.6 kg Mean TBWL : 16 ± 6% Change in BMI : 5.7 ± 2.6 kg/m ² TG and LDL significantly decreased 1 balloon removal due to intolerance No SAEs These data demonstrate that the Allurion Balloon, as administered by “non-core” clinicians, is not only safe but can also produce above average efficacy results. The extension of the IGB management to other specialists opens access to a greater number of patients. Allurion Program vs Lifestyle Intervention alone 14 © 2 0 2 2 ALLURIO N TE C H N O LO GIE S - P RO P RIE TARY IN F O RM ATIO N – C O N F IDE N TIAL Citation Sample size (N) Methods Demographics Results Conclusions Raftopoulos Y, Tsechpenakis A, Davidson M E, Chapin K, Reardon C, McMillian U The Swallowable Gastric Balloon Significantly Enhances an Intensive Lifestyle Intervention Program for Weight Loss: Final Short and Long Term Results up to 1 Year after Balloon Placement. ASMBS 2021 553 ILI for both groups included a structured curriculum-based nutritional, exercise and behavior modification program. WL results are recorded every month 1Y follow-up Mean BMI (Allurion): 36.2 ± 5.2 kg/m ² Mean BMI (ILI): 36.8 ± 5 kg/m ² At 4 months, TBWL: Allurion group: 14.9% ILI group: 6.3% At 12 months, TBWL: Allurion group: 16.9% ILI group: 7.9% Percentage of Allurion patients achieving: 5% TBWL (98.1% vs. 29.7%), 10% TBWL (83.4% vs. 8.2%) 20% TBWL (18.3% vs. 0.05%) at 16 weeks were all significantly greater (p<.0001). 94.7%, 71% and 39.5% of Allurion patients maintained a 5%, 10% and 20% TBWL at 52 weeks. Allurion IGB remains an independent and highly significant contributor of weight loss when added to a 1-year intensive lifestyle intervention. Furthermore, even after passage of the Allurion balloon, 93% of weight loss achieved was maintained at 1 year after placement. Long Term Weight Maintenance (1/2) 15 © 2 0 2 2 ALLURIO N TE C H N O LO GIE S - P RO P RIE TARY IN F O RM ATIO N – C O N F IDE N TIAL Citation Sample size (N) Methods Demographics Results Conclusions Ienca R, Giardiello C, Schiano Di Cola R, et al. The Evolution of the Allurion Program for Long-Term Weight Loss: From Virtual Monitoring to a Virtual Care Suite European Congress on Obesity, May 2022 - LBP4.16 522 Multicenter 9 international obesity centers Patients followed for 1 year after balloon passage +VCS 64% female 36% male Mean weight: 101.9 kg Mean BMI 35.9 kg/m ² At 4 months: Mean WL: 14.4 kg Mean TBWL: 13.9% At 1 year after Balloon passage: Mean WL: 14.2 kg Mean TBWL: 13.4% 96% maintenance of %TBWL AE 1.6% SAE 0.2% The Allurion Program with the VCS demonstrated excellent short and long-term efficacy for weight loss with very few adverse events Ernesti I, Formiga A, Giardiello C, Genco A, Sukkar S, Zappa M, Rovati M, Rosa M, Watanabe M Effects of a New Procedureless Intragastric Balloon on Weight Loss and Metabolic Syndrome: Multicenter Registry Experience with 1 Year Follow- up. ASMBS 2021 324 Multicenter 59% female 41% male Mean age: 45 years Mean weight: 104 kg Mean BMI: 36.8 kg/m ² After 16 weeks: Mean WL: 14.3 kg TBWL: 13.75% BMI reduction: 5 kg/m ² At 1 - year follow - up: TBWL : 10.1% BMI reduction : 3.7 kg/m ² The overall incidence of the metabolic syndrome at baseline, 4 months and 1 year after balloon excretion was 43.5%, 15.7% and 17.9% respectively. 73% sustained weight- loss No SAE Allurion, a procedureless intragastric balloon treatment, appears to be safe and effective in inducing TBWL of 13.75% at 4 months that was still maintained at 10.1% one year following balloon excretion (73% sustained weight- loss), without use of the VCS. In addition, there was a significant reduction in obesity- related metabolic syndrome; that reduction persisted a year later. Long Term Weight Maintenance (2/2) 16 © 2 0 2 2 ALLURIO N TE C H N O LO GIE S - P RO P RIE TARY IN F O RM ATIO N – C O N F IDE N TIAL Citation Sample size (N) Methods Demographics Results Conclusions Ienca R., Caballero A., Giardiello C., Pagan A., Rosa M., Badiuddin F., Junejia G., Formiga A., Murcia S. Long-Term Efficacy of the Allurion Gastric Balloon System: An International Multicenter Study TOS Obesity Week 2020 / Oral 068 509 1 year follow-up 9 international obesity centers 63% female 37% male Mean weight: 102.6 ± 21.3 kg Mean BMI: 35.9 ± 5.8 kg/m ² At 4 Months: Weight loss: 14.4 ± 7.7 kg TBWL: 13.9 ± 6.4% BMI loss : 5.1 ± 2.6 g/m ² Metabolic parameters improved significantly At 1 year: Weight loss: 14.1 ± 11.7 kg TBWL: 13.3 ± 9.9% BMI loss: 4.9 ± 4.0 kg/m ² AEs: Intolerance 1.2%, gastric dilation 0.2%, gastritis 0.2% and gastric perforation requiring laparoscopic repair 0.2% AGBS demonstrated excellent short- and long-term weight loss results. Very few adverse events occurred during the treatment. “Virtual follow-up” enhanced weight loss during AGBS treatment. Continued “Virtual follow- up” after balloon passage enabled a significant weight loss maintenance. This resulted in a 13.9% TBWL at 4 months and 13.3% TBWL 1-year after balloon passage, a 95% maintenance of %TBWL. Sequential Allurion Balloon Program 17 © 2 0 2 2 ALLURIO N TE C H N O LO GIE S - P RO P RIE TARY IN F O RM ATIO N – C O N F IDE N TIAL Citation Sample size (N) Methods Demographics Results Conclusions Ienca R., Caballero A., Kolmer S., Juneja G., Murcia S., Al Kuwari M., Quartararo G., Rosa M., Karlson R., Giardiello C. Sequential Allurion Balloon Treatment 1- Year Weight Loss Results Approximate Bariatric Surgery Results. TOS Obesity Week 2020 / Poster 384 42 2 sequential balloons 1 year follow-up 9 international obesity centers 76% female 24% male Mean age: 42.2 ± 11.2 years At 1 st balloon placement: Mean weight: 102.4 ± 19.2 kg Mean BMI: 36.8 ± 5.4 kg/m ² At 2nd balloon placement: Mean weight: 89.1 ± 18.0 kg Mean BMI: 31.9 ± 4.7 kg/m ² At 4 months (1st balloon): Mean weight loss : 14.7 ± 4.4 kg TBWL: 14.4 ± 3.6% Change in BMI : 4.9 ± 2 kg/m ² Sequential balloon resulted in additional: WL: 8.8 ± 5.7 kg TBWL: 10.0 ± 6.5% From baseline: Total WL: 22.0 ± 9.0 kg TBWL: 22.8 ± 8.8% BMI decrease: 8.1 kg/m ² After two sequential balloons, %TBWL ≥10%, ≥20% and ≥30% was achieved in 97.6%, 64.7% and 26.1% of patients. 0 SAE, and one patient had a planned endoscopic balloon removal due to history of appendicitis. Sequential Allurion Balloon treatment is safe and effective if additional weight loss is indicated following the passage of the first Allurion Balloon. The mean TBWL of 22.8% at the end of one-year approaches results seen with weight loss surgery. Diabetes, Adolescents 18 © 2 0 2 2 ALLURIO N TE C H N O LO GIE S - P RO P RIE TARY IN F O RM ATIO N – C O N F IDE N TIAL Citation Sample size (N) Methods Demographics Results Conclusions Bhandari M, Mathur W, Kosta S, Reddy M, Chitale D. Resolution of Diabetes with Swallowable Balloon Therapy IFSO 2023 Oral-246 42 Single center Diabetes remission defined as HbA1c < 6.5% without T2DM medication Diabetic improvement was HbA1c < 7.0% with decreased usage of oral diabetes medications At 6 months: 86.2% achieved diabetes remission or improvement (67.1% remission, 19.1% improvement) TBWL: 14.4% New emerging Allurion swallowable Balloon is an effective tool to reduce HbA1c and put T2DM into remission, and achieve weight loss Ienca R, Rosa M, Pagan Pomar A, Hansoulle J, Caballero A. Emerging Role of the New Swallowable Gastric Balloon in Type 2 Diabetes and Prediabetes Treatment TOS Obesity Week 2021 / Poster 114 226 Multicenter 60% female 40% male 78 with diabetes 148 with pre-diabetes Weight loss 17.7 ± 7.1 kg TBWL 16.2 ± 5.5% BMIL 6.1 ± 2.4 kg/m ² HbA1c values in the diabetes group decreased from 7.0 ± 0.6% to 5.5 ± 1.1% (p<.0001) HbA1c values in the prediabetes group decreased from 6.0 ± 0.2% to 4.9 ± 0.7% (p<.0001) AGBS is safe and effective for patients with overweight and obesity with both Type 2 Diabetes and Prediabetes. Highly significant reduction in HbA1c was achieved in just 4 months of treatment. Average HbA1c in patients with diabetes and prediabetes reverted to normal values. Further studies will determine long-term results. Ienca R., Caballero A., Giardiello C., Schiano di Cola R., Schiavo L., Pagan A., Al Kuwari M., Al Samman Zouaghi S., Turro R., Urritia L., Kayassa A., Al Jarallah M. Innovative Swallowable Gastric Balloon for Weight Loss Studied in Patients Younger Than Eighteen Years: A Multicenter Study. ASMBS 2021 50 Multicenter Age: 13.5-17.5 years Mean weight: 98.8 kg Mean BMI: 35.4 kg/m ² At 4 months: TBWL: 13% Mean WL: 12.9 kg Mean BMI reduction: 4.6 kg/m ² No complications Allurion is safe and effective for the treatment of obesity in patients aged less than 18 years. It may be considered a very useful therapeutic option for this difficult to manage category of patients. Overweight, Severe Obesity 19 © 2 0 2 2 ALLURIO N TE C H N O LO GIE S - P RO P RIE TARY IN F O RM ATIO N – C O N F IDE N TIAL Citation Sample size (N) Methods Demographics Results Conclusions A Novel Swallowable Intragastric Balloon Promotes Safe Weight Loss in Patients with a BMI Less than 27 Obesity Week 2023 114 Multicenter Mean age: 41.6 years Mean weight: 69.3 kg Mean BMI 25.6 kg/m 2 At 4 months: %TBWL: 11.84 ± 3.86 Mean weight: 61.09 ± 5.73 kg Mean BMI: 22.53 ± 1.38 kg/m 2 The less invasive nature and positive safety profile makes this device a suitable option for patients with a BMI < 27 kg/m 2 seeking weight loss treatment Rajkukmar S and Raftopoulos Y. Procedureless Gastric Balloon Experience: A Focused Comparative Analysis on BMI < vs. ≥ 40 Subgroups. ASMBS 2023 232 Single center Mean age: 42.6 years 64% Female Mean BMI 37.6 kg/m 2 BMI ≥ 40 kg/m 2 versus BMI < 40 kg/m 2 At 4 months: %TBWL 17.1 ± 5.1 versus 15.4 ± 4.9 At 6 months: %TBWL 20.5 ± 4.8 versus 17.7 ± 5.3 The Allurion Balloon is safe and effective in patients with a BMI ≥ 40 kg/m 2 , achieving over 20% TBWL at 6 months. It could be considered as a bridge to achieve preoperative weight loss before bariatric surgery or as a stand-alone method. Remote Follow-up using Telehealth 20 © 2 0 2 2 ALLURIO N TE C H N O LO GIE S - P RO P RIE TARY IN F O RM ATIO N – C O N F IDE N TIAL Citation Sample size (N) Methods Demographics Results Conclusions Raftopoulos Y, A Tsechpenakis The Swallowable Gastric Balloon: A Telehealth Approach with Best- in- Class Weight-loss Results. An open randomized trial with remote follow-up through asynchronous or synchronous communication. ASMBS 2021 140 Group A: asynchronous follow- up Group B: synchronous follow-up Patients in both groups were not seen in person (except for placement) Mean BMI: 36.7 kg/m ² TBWL at 16 weeks: 14.9% %TBWL was significantly better in group B at: 16 weeks (15.6 vs. 13.5, p=.004), 20 weeks (18.5 vs 13.6, p=.0003, n=19 vs 47) 24 weeks (18.7 vs 13.5, p=.0001, n=23 vs 39) No SAEs were observed. Allurion’s unique non-invasive profile and its Bluetooth connected scale and smartphone app can achieve safe and effective weight-loss by remote follow-up alone without physical visits. Synchronous patient communication achieved an excellent mean TBWL of 18.7% at 24 weeks

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Jessie Kennelly