EvoEndo’s ultra-slim gastroscope and virtual reality patient distraction Comfort Kit are specifically designed to help physicians provide an unsedated option for upper endoscopy for patients and their families. EvoEndo’s cofounders, physicians at Children’s Hospital of Colorado, identified the clinical need for a safer option for their patients when more frequent sedated endoscopy was needed. They addressed it by developing a single-use gastroscope for pediatric (ages 5+) and adult patients. The EvoEndo Model LE Gastroscope and EvoEndo Controller were cleared by FDA in February 2022. One year later, over 20 hospitals are building their unsedated TNE programs using the EvoEndo System. EvoEndo is committed to providing high-quality single-use endoscopy systems that make unsedated procedures possible and preferable for patients and providers. Our diverse, agile, passionate team is dedicated to creating meaningful solutions to challenging healthcare needs. Indications for Use: The EvoEndo® Model LE Gastroscope is intended for the visualization of the upper digestive tract in patients, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb in patients over the age of five. The gastroscope is a sterile, single-use device and can be inserted orally or transnasally. The EvoEndo® Controller is intended for use with an EvoEndo® Endoscope for endoscopic diagnosis, treatment, and video observation.