Periodic Reporting for period 1 - FuseX (Novel device for simple and effective prevention of post-surgical adhesion build up.)
Período documentado: 2018-08-01 hasta 2018-11-30
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.
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.
EIO Biomedical performed a complete analysis of the technical and business potential for the FuseX and ESC solution. The interest of multiple hospitals, suppliers, and clinical regulatory companies were raised and in certain cases, secured across the EU, allowing EIO to further scale up and prepare for final clinical validation. As a result, EIO have secured a value chain which will be capable of delivering the FuseX and ESC solutions to hospitals and National Blood Services after commercialization of the products. EIO Biomedical also identified the necessary engineering optimizations needed for a safe and effective product to be used in a hospital and clinical setting. From a regulatory perspective, EIO identified the clinical validation activities required to achieve the CE Mark for the FuseX device in Europe, designed a suitable clinical trial for pharmaceutical validation of the ESC, and secured the interest of 2 medical centres to act as recruitment and validation sites during the Phase 2 innovation project. Furthermore, EIO Biomedical calculated detailed five year financial projections for commercialisation and analysed the financial and infrastructure requirements for achieving global sales.
The expected outcome is to finalize the composition of the FuseX device, and perform Phase II clinical validation of the ESC. As a result, the solution will be ready for final Phase III clinical trials to validate the solution as a safe and effective pharmaceutical. The FuseX and ESC will have a significant impact on the lives of millions of patients undergoing general abdominal surgery or gynaecological surgeries who are therefore exposed to a high risk of adhesion formation. The system and solution will also provide substantial savings to both the healthcare providers and patients.