Gastrointestinal diseases affect more than 70 M of people only in US and many of them, e.g. biliary/pancreatic disorders, can have as a consequence biliary, pancreatic or other duct's narrowing (stenosis). In these cases, there is an urgent need to restore lumen patency and drainage in order to prevent complications (e.g. jaundice, infections, liver disease), and they are often treated long-term by stent placement with an ERCP (Endoscopic Retrograde Cholangio-Pancreatography). However, ERCP stenting (specially for multiple stents) still represents many potential complications, associated with extended procedural times and multiple cannulations, which increases the side-effects of the procedure and the ERCP and post-ERCP costs. EndoGI medical has developed the first patented multi-stent delivery system for treatment of biliary, pancreatic and urologic stenosis that allows the safe insertion of multiple plastic stents (MPS) in a controlled, secure and single step. It enables the insertion of 2 or more plastic stents in the bile, hepatic or urinary ducts at 1 endoscope passage and with securing the guidewire throughout the procedure. EndoGI system can reduce up to 50% the cost of hospitalization/day, up to 80% the cost of hospitalization derived from post-ERCP pancreatitis and up to 20% the costs of hospitalizations by ischemia, which represents a 64% of reduction in comparison with common procedure using MPS and 2 delivery systems. We have built-up a first prototype and preliminary tested it with human phantoms and pig models, and now we aim to optimize the device, completely validate it in clinical settings, obtain regulatory certifications and launch it to market. We will initially penetrate the non-vascular stents market and focus in biliary stenting to offer savings of ˞€330 M/year only in EU. During Phase 1, we will carry out a detailed feasibility study to evaluate the opportunities our innovation has to disrupt the field and boost EndoGI company growth.
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