Publishable Summary
TruVue is a disruptive technology for a haemodynamic monitoring system, to improve the diagnosis and management of cardiac function, fluid delivery and drug administration during surgery and intensive care. Worldwide 234 million patients undergo major surgery annually. One million will die within 30 days. A further 42 million simply die up to 13 years sooner due to complications and 12 million will enter intensive care in the EU and US. Of the adverse events 51% are directly due to inadequate haemodynamic management. Horizon 2020 Phase 1 funding was awarded for this study that has demonstrated the product potential to be over 15m uses annually in the EU and USA. The study objectives were; to establish the feasibility and costs of an observational clinical study; to use a smaller group of centres in the development of a world class graphical user interface (GUI); to assess the market potential; to perform research of future users; assess competition; assess feasibility of the monitor development; and develop a business strategy. The customer response to the observational and GUI studies has been highly supportive. We received confirmation from 27 leading centres with pledges to join the observational study and/or GUI development. Deltex envisages that the clinical trial will generate publications, ‘seed’ early adopters and promote TruVue EU wide and globally. Market potentials by country for surgery and intensive care have been established. Potential competitors have been identified and their strengths and weaknesses assessed. The feasibility of the monitor’s development has been completed. A variety of business models have been assessed and their suitability analysed. The feasibility study has clearly shown that the project should continue and future evolution options have been identified. Use of the system will provide safer haemodynamic diagnosis; safer use of vaso-active and inotropic drugs, guide fluid delivery; reduce complications; reduce unplanned critical care admissions; reduce length of hospital stay; reduce readmissions; reduce mortality; and increase postoperative lifespan for millions of major surgical patients. Hospitals will also benefit from the cost savings resulting from the improvement in care. The impact for Deltex is that it will increase our revenues significantly and grow the company, potentially doubling turnover in less than 3 years. Finally the project acronym has been developed and adopted as the brand and is now TrueVue™.
Objective 1
The ‘Combi Group’ has been re-established for recruitments to a GUI feasibility study and Phase 2 multicentre study at putative sites. 20 centres are required, 54 centres contacted and 27 have been recruited for the study. Prof. A. Mebazaa of Lariboisiere Hospital will be the lead investigator and the EU trial centre will be based in his hospital. Study design is complete and power calculations show that 472 patients will be required. Study centres have confirmed their ability to; recruit patients, have confirmed data recording; and the study has been costed at €943,800.
Objective 2
Market research of user demand has been assessed at 3 promotional events, two events at EBPOM (London) and SFAR (Paris), each gave positive feedback, and clinicians joined the study. Competitors have been analysed in terms of their reaction to TruVue, we do not expect Edwards, LiDCO, Pulsion or Cheetah to be deflected from their current strategy. We will watch Atys in terms of others looking to acquire their technology to copy the system. The potential market has been estimated at 15.3m uses (€1.5bn) annually in UK, Europe, USA, Canada and South Korea. Growth is 5% to 30% depending on sector and country. The economic benefit has been defined by NICE as £1100 per patient. We expect Deltex to double its size in 3 years from £10m to £24.6m. PDR of Cardiff University has been sourced as the designer of a world-class user interface, costings for Phase 2 has been provided. Hardware and software feasibility has identified the requirements for the monitor and user interface. A pay-per-use system and business model have been established using RFID technology. The regulatory plan for CE marking and 510k submittal is complete. Deployment and revenue options have been explored, we favour a “Managed Care Service’ by monitor loan for a fixed annual usage of disposables. We will have to be flexible with State Tenders and distributors.
