CORDIS - EU research results

SmartNiBP: Non-invasive continuous blood pressure monitoring during surgery

Periodic Reporting for period 1 - SmartNiBP (SmartNiBP: Non-invasive continuous blood pressure monitoring during surgery)

Reporting period: 2017-05-01 to 2017-08-31

There is a major unsolved medical demand for peri-interventional patient monitoring of blood pressure. Currently, 80% of patients do not receive continuous blood pressure monitoring during surgical procedures (225 million worldwide per year). This lack of control increases the peri- and postoperative risk of cardiac arrests and increases by 3.6% the patient's risk of dying within one year after the procedure. To address this problem Impress has developed SmartNiBP. Based on impedance cardiography, SmartNiBP allows for complete non-invasive monitoring of the vital sign blood pressure at any time and in any setting. Our overall objective is to bring SmartNiBP to the industrial stage and commercialize it within the medical device sector in Europe. SmartNiBP will be the best option for non-invasive BP monitoring because: (i) it combines the benefits of invasive and non-invasive BP measurement while avoiding the disadvantages; (ii) it is based on a technology that is inexpensive; (iii) it does not requires specific medical skills.
We have conducted a Feasibility study to guarantee the viability of our project. In the technical plan, we defined the strategy to optimize and industrialize SmartNiBP according to a detailed work plan for Phase2 and a complete evaluation of technical risks. Our commercial plan and a Freedom to Operate Analysis show that SmartNiBP is freely exploitable. Our detailed market analysis showed that our target market, The EU BP monitoring devices market, is expected to grow and reach $1.24 billion in 2021. This and legislative context (with the EC implementing the Health 2020 policy and supporting the Helsinki Declaration on Patient Safety in Anaesthesiology) are expected to favour the deployment of SmartNiBP, for which we prepared a detailed exploitation and dissemination plan. Finally, we prepared a financial plan, in which we conclude that SmartNiBP will allow us to achieve a profit of €19.4 million in 2024.
SmartNiBP will deliver a new medical device that will overcome the limitations of current methods for surgical BP monitoring: 1.) discontinuous arm cuff measurements (80% interventions) and 2.) continuous but risky intra-arterial catheter (20% interventions). Our innovation will have a positive impact on various levels as it will: (1) increase surgery patients survival; (2) allow better monitoring of patient’s status including (3) grant access to neo-natal and paediatrics group; (4) reduce overall Healthcare costs.