Icaria Medical was founded in July 2018 as a spin-off of the Polytechnic University of Catalonia (UPC) and in possession of the university's two CardioSense patents. In order to gain medical-product certification, the company needs to pass a first clinical study and a regulatory clinical study, a process that requires three years and three investment rounds of €500,000 (currently underway), €2m and €6–8m, respectively.
The co-founders include Vincent Ribas, an AI PhD holder and a researcher with six patents in medical technologies. He has more than 20 years of experience as an entrepreneur, CEO, and CTO, including at a company focused on blood pressure and electrocardiograms. Co-founder Ignasi Heras is also a veteran entrepreneur in the health sector. One of his startups, Transplant Biomedicals, raised €6m in 2016 – the largest financing round in Spain for a medical equipment startup.
CompassList spoke to the startup's CPO and co-founder Anna Nicolau at this year's 4YFN conference. Nicolau is a young biomedical engineer who also holds a business degree. She has previous experience in startups and in a large medical device company specializing in critically ill hospital patients.
Q: What is the innovation by Icaria Medical?
A: Although there are many players who are trying to create a device to measure blood pressure continuously and non-invasively, no one has really succeeded yet. The only continuous method that exists today is an invasive one: an arterial line catheter, which can be harmful to the patients. We have reasons to believe that our new technological approach will be able to overcome the current limitations in this area.
We are demonstrating that we can track all fluctuations in blood pressure in critical patients. Now, we are working on calibration. With our prototype, only an initial calibration is needed for each patient. This is already a very important milestone, since other devices for continuous blood-pressure measurement need calibration every five to ten minutes. Nevertheless, we are working very hard to eliminate any need for calibration.
We want hospital devices to integrate our technology into monitors in the same way that electrocardiograms or oxygen saturation is monitored today.
How does the device work?
Essentially, two hardware sensors are placed on the patient’s limbs in the form of bracelets. A cable connects them to the monitor. One sensor measures the electrocardiogram and the other measures the pulse wave impedances. The two record cardiovascular signals not previously measured. With these measurements, we obtain real-time blood pressure through neural networks (AI) and you can see continuous systolic, diastolic and average blood pressure readouts on the monitor. We use deep learning for information and data processing.
Who are your competitors?
Continuous blood pressure measurement is a very widespread problem and there are many players. For example, Sotera Wireless in Silicon Valley raised US$100m for a similar product that has not yet reached the market.
Edwards Life Sciences includes a similar device in its portfolio. Several hospitals have it, including here in Barcelona, but it is not used because it is huge and it needs too much calibration according to the doctors.
The competition follows two broad trends: companies that are not in the market due to calibration issues and failure to detect hypotensive periods (blood pressure drops), and companies that have reached the market but whose devices are unreliable. The need for calibration every ten minutes makes it impossible to really measure continuous blood pressure.
What are the next steps to validation?
We have created a functional prototype that has already been tested on 16 patients and so far we are within the range required by the regulations (a mean error of 5.58 mmHg and standard deviation of 8.63 mmHg).
Mobile World Capital Barcelona is one of our shareholders (€50,000), and we are currently looking for a €300,000–500,000 round to conclude a first clinical study at the Intensive Care Unit of the Vall d'Hebron Hospital. This will help us to get clinical validation by comparing our technology with the arterial line catheter.
Once we have the certification, we will have an open route to the hospital market. However, we plan to access a much bigger market because our device can be adapted to any smart box, mobile device or wearable technology.
We have also participated in Horizon 2020 projects and in three accelerator programs: Ship2B Foundation, Barcelona Health Hub, and the EIT Health Headstart Funding Program 2019 (€50,000).
What is your business model?
We intend to establish two business lines: hospitals, and telemedicine.
We are in contact with numerous companies that create and sell hospital devices (Philips, Drager, Siemens) and our objective is to license our technology and distribute the devices together. We have quantified the hospital market at US$5.8bn, including ICUs, operating rooms and early postoperative. An estimated 650 million unstable patients need risk blood-pressure monitoring in hospitals all over the world.
We do not intend to make a new smartwatch, but to license our technology to manufacturers such as Apple and Samsung. In this case, our clients will be companies that produce wearables. For telemedicine, the market skyrockets to US$31bn. There are currently 1.3bn hypertensive people in the world, and only one in five of these is under medical control. Blood pressure variations can cause organ injury and even death.
Would telemedicine include consultations?
Consultations depend on specific country legislation. It would be possible to offer the product together with a consultation service in the US, but it is much more complicated in a public health system such as Spain's. We have studied this possibility.
How much has been invested?
Over 20 years of research have been invested by the Polytechnic University of Catalonia and we have had Mobile World Capital Barcelona support of €50,000. We are currently in a €500,000 seed round to complete our technology clinic validation and build a beta device to start the regulatory clinical study.
What are your projections?
We plan to be on the market in 2022 and exit in 2023 with a potential €200m–250m, depending on other companies in the sector.
