Easy-to-Operate Endoscopic Automatic Gastroplasty Device That Mimics the Effect of Gastric Bypass/Bariatric Surgery for the Treatment of Diabetes and Obesity

Project Summary/Abstract According to the CDC, the prevalence of obesity among US adults 20 and over is 41.9 %. These over 100 million people are at an increased risk for diabetes, coronary heart disease, stroke, sleep apnea, stroke, gall bladder disease, several types of cancer, and certain musculoskeletal disorders. The estimated annual medical cost of obesity in the United States is $173 billion. Obesity leads to over 300,000 premature deaths each year in the US. Obesity is a public health emergency. Operative therapy for obesity is effective but at considerable cost, limited patient applicability, and with substantial risks. Glucagon-like peptide-1 (GLP-1) medications induce initial weight-loss but also at considerable cost and have many adverse effects as well as unknown long-term effects. Specialized endoscopists are now performing highly operator-dependent “freehand” endoscopic sleeve gastroplasty. A new non-surgical/non-pharma-based weight-loss solution that is easy to perform is needed. InTailor Bariatrics, LLC and Edward Lin, DO, Chief of Gastrointestinal & General Surgery at Emory University School of Medicine, have developed a patented technology for endoscopic gastroplasty that requires no surgical cutting and can be completed in a 15-minute outpatient procedure. The technology creates a substantial reinforced circular plication of invaginated tissue within the stomach incorporating the entire circumference of the organ to produce a gastroplasty that reduces the volume of the stomach and creates a restrictive pouch. The circumferential plication features a serosal-to-serosal tissue apposition, creating dense fibrous appositions of the serosal fold, enabling a durable augmentation. The created gastroplasty limits the amount of food a person can consume in one sitting. Weight-loss is achieved without substantial modifications in the anatomy of the alimentary tract. The device’s ease of use enables reproducible results that will foster widespread adoption. In the proposed STTR Phase I project the specific aims of our project are: 1) Validate our next-gen prototype by modeling endoscopic gastroplasty in an animal model 2) Evaluate short-term gastroplasty durability and safety after 30-day survival with endoscopic relook, 3) Conduct post-mortem examination of the gastroplasty structure and tissue integrity. Phase II work will focus on refining the device design, completion of a 6-month animal survival study, and continued communication with the FDA to design and complete a human pilot study.