Periodic Reporting for period 1 - ENDOGI (The first multiple stent delivery system for the treatment of biliary, pancreatic and urologic strictures and stenosis )
Période du rapport: 2019-07-01 au 2019-12-31
In order to treat biliary or pancreatic strictures, physicians usually place biliary or pancreatic plastic stents by performing the ERCP procedure, but it represents potential complications because of prolonged procedure time and multiple cannulations. EndoGI has developed unique minimally invasive medical devices that optimize the stenting placements of one stent or more in a controlled, secure and single cannulation step, providing affordable and safe delivery systems to reduce stenting procedures’ time, cost and risk of complications. Our Multiple Stents Introducer enables the insertion of 2 pre-mounted biliary stents, and we aim to improve its technical features and to adapt it for the pancreatic system. We have made the prototype in a Single Stent Technology enabling the sequential placement of 3 biliary stents and we aim to improve its rapidity and stenting capacity to up to 10 stents, and to also adapt it for the implantation of numerous pancreatic stents.
At the technical level, we worked on defining the main needs to optimize, adapt and validate our delivery systems. We decided to first focus the use of our technologies to deploy gastrointestinal plastic stents and to work, in the future, on developing delivery systems for ureteral stents and for the placement of a single stent. At the commercial level, we searched and identified many potential users, studied the different markets, compare our innovative devices with main competitors and describe EndoGI clinical validators, industrial partners and distributors. Besides, we proposed our commercial strategy, described key regulatory issues and requirements, and completed an FTO study. Financially, we estimated the budget to reach commercialization and make financial projections after market launch.
Patients who are suffering from uncomfortable strictures will have an affordable and successful operation, having fewer complications: EndoGI delivery systems decrease the 20% of potential post-ERCP pancreatitis and 30% of myocardial ischemia. Consequently, physicians will be less afraid about complications because operations will last less time (50%) and they can have more clients and revenues. Hospitals offering EndoGI devices will minimize the frequency of re-hospitalizations and therefore the costs to the healthcare system. The initial market penetration of EndoGI into the biliary and pancreatic multiple stenting markets will offer savings of around ˞€330 M/year only in EU and regarding complications.