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A NOVEL NON-INVASIVE SOLUTION FOR CONTINUOUS BLOOD PRESSURE MONITORING

Periodic Reporting for period 1 - ICA-100 (A NOVEL NON-INVASIVE SOLUTION FOR CONTINUOUS BLOOD PRESSURE MONITORING)

Reporting period: 2019-06-01 to 2019-11-30

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.
The market size for blood pressure monitoring in hospitals was 1,14 billion euros in 2018 and is projected to expand further at a CAGR of 10.1% from 2019 to 2026, so there is a big market in need of a continuous non-invasive blood pressure monitor. The ICA-100 will have a leading position in the market starting by having a great impact in Intensive Care Units and Operating Rooms. The feasibility study has been key to defining the best channels of distribution for ICARIA, identifying two main ways to bring the solution to the market: a hybrid model based on sales and licenses, which has been validated with relevant distributors in the medical devices field.

Defining the price of the ICA-100 has been extremely important since it is one of the strictest barriers of entry, after a comparison with other devices together with the feedback from hospitals managers we decided a price which will not be a burden for hospitals when deciding to purchase it. Another important barrier of entry is the possibility to integrate the ICA-100 in the existing hemodynamic monitors. We carried out an exhaustive study and found out that, even if a stand-alone and an add-on device would be interesting for the hospital setting, the most interesting and easy to adopt solution would be an integrable one. One last barrier of entry is the accuracy in the measurement and capability to track every fluctuation, for that reason we performed a technical feasibility study that showed great results for the ICA-100.

We also identified the regulatory pathway we have to pursue for obtaining the CE Mark which is mainly all included in the ISO 13 485 for medical devices, and the communications plan both for technical and corporate purposes.
In this project, we have evaluated the clinical relevance of having a non-invasive beat-to-beat blood pressure monitoring device. A very important task for this was to quantify the number of complications that the target patients are having nowadays because of the lack of blood pressure monitoring (Table11). Launching the ICA-100 would decrease this amount on 80%, in other words, it will avoid 122 million complications compared to the current standard of care. Having a huge impact on patients' health.

Another aspect that was extremely important, was to quantify the economic impact ICARIA will have in hospitals. In the European Union, where we are initially focusing our activity, the healthcare systems are mainly public and, accordingly, a product needs to be affordable in order to enter the market, a thorough comparison with the standards of care shows that the ICA-100 represents a huge saving for the hospital.

Once proven the feasibility of the technology and the project, ICARIA's next step is to perform clinical validation of the ICA-100 in order to prove its proper functioning in critical patients and accuracy compared to the arterial line, as well as develop a more detailed commercialization plan for the go-to-market.
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