Slide 1: Prospective post-market clinical follow-up registry after duodenal mucosal resurfacing in type 2 diabetes
A prospective post-market clinical follow-up registry to evaluate real-world effectiveness and patient satisfaction after duodenal mucosal resurfacing in patients with type 2 diabetes Torsten Beyna, Thomas Veiser, Hui Zhang, Emily Cozzi, Kelly White, Stephan Martin October 5, 2024 1
Slide 2: Disclosure Statements and Revita System Indication for Use
Disclosure Statements and Revita SystemTM Indication for Use Authors: Torsten Beyna is a consultant for Olympus, Boston Scientific, Microtech, and Fractyl Health and received lecture honoraria from Olympus, Boston Scientific, Cook, Fujifilm, Pentax, ERBE, Microtech, Falk Foundation, and Medtronic. S
Slide 3: The Rationale for Duodenal Mucosal Resurfacing (DMR)
The Rationale for Duodenal Mucosal Resurfacing (DMR) Intervening at a potential root cause of type 2 diabetes and obesity High-fat and high- Nutrient-induced Duodenal Impaired nutrient Metabolic sensing and signaling carbohydrate maladaptation Dysfunction Impairment diets Healthy Dysfunctional 1. Ma
Slide 4: Duodenal Mucosal Resurfacing with the Revita System
Duodenal Mucosal Resurfacing with the Revita System Endoscopic procedure targeting dysfunctional duodenal mucosa Revita DMR® is a minimally invasive, endoscopic procedure utilizing hydrothermal ablation to remove potentially dysfunctional duodenal mucosa, allowing for regeneration and return to meta
Slide 5: Intuitive endoscopic procedural workflow
Duodenal Mucosal Resurfacing with the Revita System Intuitive endoscopic procedural workflow Carried out by a trained endoscopist in ~1 hour, progresses in 2 steps: Step 1: circumferential saline injection of the duodenal submucosa to create a protective thermal barrier and uniform ablation surface1
Slide 6: Type 2 Diabetes Clinical Trial Findings to Date
Type 2 Diabetes Clinical Trial Findings to Date Revita DMR improves multiple indices of metabolic function Clinical trials in >300 patients have shown that Revita DMR may safely and durably improve: Glycaemic control & insulin sensitivity β-cell function Hepatic steatosis Weight maintenance Diabetes
Slide 7: Study design: key participant criteria and assessments
Assessing Real-World Effectiveness of Revita DMR Study design: key participant criteria and assessments Ongoing, 5-year, non-interventional, Key Inclusion Criteria prospective, observational study in ≤5 ≥18 years of age German centres BMI of ≤45 kg/m2 HbA1c of ≥7.0 and ≤10.0% HbA1c, FBG, weight loss
Slide 8: Baseline characteristics: participants with inadequately controlled T2D
Assessing Real-World Effectiveness of Revita DMR Baseline characteristics: participants with inadequately controlled T2D Most participants have obesity and Demographic N = 31 longstanding T2D despite treatment with Sex, % male 58 multiple GLAs in the majority of cases Age, years, mean (SD) 61 (7) Ba
Slide 9: Safety: Revita DMR was well tolerated with no serious adverse events
Assessing Real-World Effectiveness of Revita DMR Safety: Revita DMR was well tolerated with no serious adverse events Revita DMR was well tolerated with no Procedural and/or Device N = 31 serious procedural and/or device-related Related Adverse Events adverse events (SAEs), or unanticipated SAE 0 ad
Slide 10: Glycaemia: improvements in HbA1c and FBG were maintained through follow-up
Assessing Real-World Effectiveness of Revita DMR Glycaemia: improvements in HbA1c and FBG were maintained through follow-up A) HbA1c (Mean ± SEM) B) FBG (Mean ± SEM) N=31 n=24 n=18 N=31 n=24 n=18 n=12 n=11 0.0 0 Change from BL (mg/dL) Change from BL (%) -0.5 -20 -34.0 (17.4) -1.0 -40 -1.2% -45.8 (0.
Slide 11: Weight: weight loss was maintained through follow-up
Assessing Real-World Effectiveness of Revita DMR Weight: weight loss was maintained through follow-up A) Body Weight (Mean ± SEM) B) Individual 1-Year Body Weight N=31 n=24 n=18 n=12 1-year post-DMR, nearly all participants lost 0 weight with 42% losing >10% of their body 10 weight* Change from BL (
Slide 12: Medication: majority of participants reduced or stabilized GLA usage
Assessing Real-World Effectiveness of Revita DMR Medication: majority of participants reduced or stabilized GLA usage At 1 year, 83% of participants had stabilized or reduced GLA usage in addition to improvements in glycemia and weight Change in GLA Number (n [%]) Time Period (n) Increased Decreased
Slide 13: PROs: Revita DMR was valued by participants and improved T2D management
Assessing Real-World Effectiveness of Revita DMR PROs: Revita DMR was valued by participants and improved T2D management 3 months 6 months 12 months Patient Reported Outcomes (PROs) (n=24) (n=18) (n=12) Undergo Revita again? (% yes) 92% 89% 100% Recommend Revita to friend/relative with T2D? (% yes)
Slide 14: Summary and conclusions
Assessing Real-World Effectiveness of Revita DMR Summary and conclusions Revita DMR in combination with lifestyle intervention durably improved glycemia, maintained weight loss, improved PROs, and reduced/stabilized GLA usage in inadequately controlled T2D patients Revita DMR was well tolerated with
Slide 15: Thank You Acknowledgments
Thank You Acknowledgments Clinical Study Nurses: Ina Grafflage & Bettina Prete Post-market Registry participants and their families 15 DGVS 2024
Slide 16: Supplementary Data
VISZERAL MEDIZIN ““ DGVS _ Deutsche Gesellschaft fiir Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten Supplementary Data
Slide 17: Glycaemia: HbA1c and FBG were maintained through follow-up
Assessing Real-World Effectiveness of Revita DMR Glycaemia: HbA1c and FBG were maintained through follow-up A) Individual 1-Year HbA1c B) Individual 1-Year FBG 0 0 Change from BL (mg/dL) Change from BL (%) -1 -50 -2 -100 -3 -150 -4 -200 1 2 3 4 5 6 7 8 9 10 11 1 2 3 4 5 6 7 8 9 10 11 12 Participants