Motus GI Holdings, Inc. announced in collaboration with the Ecuadorian Institute of Digestive Diseases (IECED) initiation of a clinical evaluation of the Pure-Vu Gen 4 Gastro, which is designed for upper gastrointestinal (GI) bleeding procedures - an area of high unmet patient need. This initial clinical evaluation provided excellent insight into the ability of the Pure-Vu Gen 4 Gastro device to navigate and evaluate the entire anatomy in the upper GI tract with usability scores in the very good to excellent range with input from multiple physicians. The procedures in the upper GI tract were efficient for these first time users with the upper procedures averaging only 11 minutes.

Similarly in the colon they were able to improve the average Boston Bowel Prep Scale (BBPS) in 9 patients from 5.9 prior to the use of Pure-Vu to 8.9 after the use of Pure-Vu with total procedure times averaging 24 minutes (note: the BBPS scale ranges from 0 (extremely dirty) to 9 (pristinely clean). Further evaluations of the Pure-Vu Gen 4 system will continue to evaluate its ability in critical indications like upper GI bleeding and in new therapeutic applications, such as underwater endoscopic mucosal resection. The Pure-Vu Gen 4 Gastro builds off the success of the patented and proprietary pulsed vortex irrigation and smart sense suction used in the colon device and has been enhanced to target blood and blood clots in the upper GI tract.

The system has been further streamlined to allow for easy navigation through the GI tract and allows the physician to grip the endoscope directly so that there is virtually no ergonomic impact in performing a procedure. The Company is also leveraging this Gen 4 technology to enhance the Pure-Vu device in the colon. Both the Pure-Vu Gen 4 Gastro and Colon will utilize the same workstation to create an effective platform to improve visualization in both the upper and lower GI tract to facilitate use in multiple indications.

Upper GI bleeds occurred in the U.S. at a rate of approximately 400,000 cases per year in 2019, according to iData Research Inc. The existence of blood and blood clots in these patients can impair a physician's view, making it difficult to identify the bleed source. Believe removing adherent blood clots from the field of view is a significant need in allowing a physician the ability to identify and treat the bleed source. The mortality rate of this condition can reach up to approximately 10%, as noted in Thad Wilkins, MD, et al., American Family Physician (2012).

IECED is recognized as one of the best Endoscopic Ultrasound (EUS) centers in the world based on EURO EUS 2023. Additionally known as the most advanced gastroenterological and endoscopic center in Latin America, which has state-of-the-art equipment, the only ones endorsed in Ecuador by the World Endoscopy Organization (WEO). IECED, with the objective of providing its best service, is constantly updated with the quality certification under the ISO 9001:2015 standard.