Blood pressure continuous monitoring is essential in managing hemodynamically unstable patients in several hospital areas. In the world, there are 650 million patients in need of continuous monitoring, especially those undergoing surgery, in critical areas or in step-down units. The mercury sphygmomanometer is the most used device for Blood Pressure but it only allows intermittent measurements so it is not enough for unstable patients. Thus, the only continuous method is the invasive arterial line monitoring, which causes severe complications in half of the patients. In the last decade, several attempts have been undertaken to develop an effective, accurate and reliable solution to continuously monitor blood pressure in a non-invasive way. Nevertheless, none of them have solved the medical need for a continuous monitor, mostly due to technological constraints.
ICARIA has developed a medical device for blood pressure monitoring (ICA-100) based on a novel technology approach that allows obtaining a continuous, accurate and reliable blood pressure measurement, by only placing two bracelets in the patient. The ICA-100 solution has already been validated in a relevant environment involving healthy volunteers (TRL5). The technology is protected by means of two international patents, which grant ICARIA freedom-to-operate.
The feasibility study had as the main goal to validate that not only the business idea solves a real problem in the healthcare system, but also that it is coherent with the market. The most important global outcome of the project is a solid plan to face ICARIA’s upcoming stages, in order to transform a proof of concept to a product with a very concrete market fit that truly solves an unmet medical need. More specifically, the aim of Phase 1 was to further develop the marketing strategy and commercial plan. Besides, we assessed thoroughly the relevant regulatory and legal framework for obtaining certification and approval. Following the completion of this feasibility study, we plan to develop a certified commercial product. Solving the unmet medical need of more than 650 million patients in the world by commercializing the ICA-100 implies a potential market of €5.8b.
The feasibility study performed thanks to the SME Instrument phase I grant, allowed ICARIA to conclude that the development of a novel non-invasive solution for continuous blood pressure monitoring is viable and potentially successful. All in all, there is a big unmet medical need in many hospital settings that can be fulfilled with the ICA-100. Through this study, ICARIA has identified the uniqueness of the product in order to enhance the competitive advantages and ensure market adoption. ICARIA’s solution offers an accurate solution, capable to track both hypertensive and hypotensive events, which does not harm the patient and it provides continuous beat-to-beat monitoring. Besides, it is comfortable and cost-effective, with a very competitive price.
