Abdominal adhesions are a medical condition where scar tissue forms between the intestine and either the abdominal wall, or with other organs in the abdominal cavity. With approximately 6 million abdominal surgeries per year in the EU alone (1.3 million in the UK), and 93% of them resulting in some form of adhesion, patients are exposed to a multitude of problems such as bowel obstructions, chronic pain, and in many cases, repeat abdominal surgeries. In the current economic climate, European healthcare systems face challenges to reduce the healthcare expenditure in an effort to reduce public sector deficits. Healthcare systems will therefore be willing to adopt our treatment as the FuseX and ESC represent an opportunity to generate new revenue streams, while avoiding the negative repercussions and unnecessary costs associated with existing solutions.
EIO have developed a state of the art system to enable blood banks to produce the ESC spray on demand. The FuseX system works with two components: the reusable FuseX machine and one-time use FuseX kit. The FuseX machine extracts the ESC solution which combines naturally occurring coagulation factors and proteins from donor blood plasma. The blood bank ships the ESC to the hospitals for postoperative surgeon application – just prior to the wound closing. This initiates a very robust but highly localized blood clotting process once in contact with the tissue, which also prevents excess fibrin build up – the root cause of adhesion development.
The objectives of the feasibility study were to evaluate the technical, clinical, and regulatory requirements for the introduction of the FuseX device and ESC solution into the European market, identify and finalize an optimized value chain, and design the clinical validation activities including securing sites for clinical trials, with the ultimate objective to become the industry leader in post-operative adhesion prevention.
