It doesn’t need recalibrating often.
The Aktiia optical blood pressure monitor was tested in six healthy volunteers and agreed with a traditional inflating-cuff blood pressure monitor (Omron M6) two months after the initial calibration. The experimental data of this initial study showed error figures within 1 ± 7 mmHg, which are smaller than the threshold of 5 ± 8 mmHg typically accepted in clinical investigations. Aktiia will reveal the full results of their study at the 41st IEEE International Engineering in Medicine and Biology Conference in Berlin, Germany at the end of July. They have now initiated a clinical trial for 30 ICU patients to compare readings with those obtained from invasive arterial lines (NCT03837769).
The Aktiia Blood Pressure Monitor is a wrist worn bracelet that analyzes pulse wave velocities and reflections to measure blood pressures. The device is initially calibrated once to readings from a traditional inflating-cuff blood pressure monitor, then optically measures blood pressures of the wearer at regular intervals. It could greatly improve the comfort and frequency of monitoring patients with high blood pressures.
We checked in with Josep Sola, CTO and co-founder of the company, and Elisa Olivero, Product Manager at Aktiia, to learn more about their developments.
Ben Ouyang, Medgadget: What has been done with Aktiia and Blood Pressure Monitor since we spoke in September last year?
Josep Sola, Aktiia CTO: When we last discussed, Mattia and myself (Aktiia co-founders) were at the point of leaving a Swiss research institute called CSEM (www.csem.ch) in which we had been working for more than 15 years carrying research in the field of cuffles blood pressure. We had explored a large range of solutions, and we failed for a lot of them. However, one particular solution had appeared to be adequate for the complete monitoring of blood pressure day and night. We had called this technology OBPM – for Optical Blood Pressure Monitoring, and we wanted to push it to the market with Aktiia.
On July 2018 we started the company being the 2 only employees. Today, 8 months later, Aktiia counts a team of 13 highly-qualified people going from algorithm, electronics, mechanics engineers, software engineers, and business developers, and we are located in Switzerland, Serbia and the US.
Our work of these last 8 months has been exclusively focused on preparing our first product: the Aktiia Blood Pressure Monitor. We like defining our product as the first Complete Blood Pressure monitor: a groundbreaking way to monitor blood pressure through a cuffless bracelet that people will love to wear. The Aktiia Blood Pressure Monitor will let you monitor your blood pressure 24/7 without ever having to stop what you are doing to take a measurement. Our breakthrough method uses the sensors in existing wearables for heart rate monitoring, and reads information from vessels under the skin of your wrist. The data will be turned into a precise record of your blood pressure, day and night.
After these intense 8 months of works, we are now collecting the first results:
- we have now functional prototypes of the bracelet that we are already using day and night in our lifes,
- we have Swissmedic-approved prototypes that we are putting in clinical trials in Intensive Care Units,
- and we have already deployed a backend server that is gathering optical and physiological data from beta-testers of our prototypes around the globe
In addition to that, during these last 8 months we have also spent countless nights in enlarging our patent portfolio, and on preparing the manufacturing of the Aktiia Blood Pressure Monitor.
Medgadget: What’s the first patient population you envision your product being used for?
Elisa Olivero, Product Manager: The Aktiia Blood Pressure Monitor has been designed for all individuals willing to monitor their blood pressure closely. This population is composed of both people who suffer from hypertension and want to monitor it closely and people who haven’t been diagnosed but are very health-conscious and want to track their vitals to make sure they are within the recommended range. What people in these two groups have in common is their willingness to take action to live a healthier life, and data collection is the first necessary step in achieving this goal.
We believe Aktiia will help people to better understand their blood pressure variations and the factors that have the highest impact on it (i.e. stress at work, salty food, lack of exercise…) so that they can take action to lower their values and track their progress towards their goal.
We believe this will work because it solves a real need – on one side by providing more actionable data and lighting the burden of blood pressure measurement for the users and on the other side by providing more reliable data to the doctors as the bias introduced by how people measure their BP (i.e. are they measuring only when stressed, are they waiting the recommended 5 minutes before taking the readings etc) is overcome.
Accuracy is our number one priority but I think it is important to note that we are also putting a lot of effort in understanding our future customers and including them in the design process to have a product that can really solve their needs. We should also specify that the product is not a smartwatch – it does not have a screen. We designed it to be inconspicuous and slick so that it can easily blend into people’s life without dragging too much attention.
Medgadget: What questions will you answer in your upcoming clinical trial?
Sola: In a very formal answer, we are assessing the performance of the Aktiia Blood Pressure Monitor in terms of measurement errors in mmHg as compared against reference measurements performed by an invasive radial arterial line. In addition to that, the goal of this additional clinical trial in an ICU environment is to collect high quality optical signals and invasive reference values that will better feed Aktiia’s algorithms.
Medgadget: Could you describe more specifically the patient population you intend to measure in the ICUs? I see your inclusion/exclusion criteria in the clinical trial webpage, but could you describe them in your own words?
Sola: The info we released these last days is two-fold:
- On the one side, Aktiia has been invited to present in a Cuffless Blood Pressure symposium that will be held during the next edition of the IEEE EMBC conference, in Berlin in July 2019. During this symposium, we’ll present the results of a trial we performed internally in Aktiia between December 2018 and January 2019. This trial involved volunteers wearing Aktiia’s bracelet for more than two months, while reference readings of blood pressure were performed at the arm. The results that we collected demonstrate that the blood pressure measurements generated from signals recorded at the wrist by the Aktiia Blood Pressure monitor remain stable still two months after a calibration was performed. This is an outstanding result, overcoming the known state of the art, and that demonstrates the potential of the technology being developed by Aktiia.
- On the other side, in February 2019 Aktiia has initiated an additional clinical trial, now at the Intensive Care Unit of the HNE-Hospital of Neuchâtel. Under the medical direction of Dr. Pellaton, this study evaluates the performances of the Aktiia Blood Pressure Monitor when compared to invasive measurements of blood pressure. The goal of this trial is not to address a particular ICU patient population, but to collect high quality optical signals and invasive reference values that will better feed Aktiia’s algorithms. Any future user of the Aktiia Blood Pressure Monitor (most probably belonging to other population profiles than ICU patients) will also profit of more robust Aktiia algorithms fed with this ICU clinical trial data.
- And of course, we have several other clinical trials in the pipeline… but we’ll communicate about these on the right time. It is important here to highlight the clinical validation is a top priority of Aktiia, and that our mission is to deploy a technology that prevents hypertension saves lives, and reduces healthcare costs worldwide, and is not simply another wearable device.
We at Medgadget are closely following Aktiia to see their developments. Having an optical, non-invasive, and cuffless blood pressure monitoring technology would improve the lives of many patients.
Update April 3, 2019: The initial article said that the Blood Pressure Monitor fit within the 5±8 mmHg AAMI guidelines. However, since the AAMI guidelines only apply for specific criteria, this was misleading and was reworded for 5±8 mmHg as “typically accepted in clinical investigations”.