We continue to publish interviews with innovators in blood pressure monitoring. Please meet Mr Jack Lee, the Founder and the CEO of Sky Labs in South Korea. Jack Lee developed CART BP, a smartring that measures blood pressure continuously. Mr Lee has 15+ years of experience developing signal processing systems. Prior to founding Sky Labs, he was a senior R&D engineer at Samsung Electronics R&D headquarters. Mr Lee has kindly agreed to answer our questions about his blood pressure ring.
Q1: Let’s start with a personal story. I was once told by my doctor to do the 24-hours blood pressure monitoring, with a cuff-based device that activated automatically once an hour. In result, I could not sleep at all, and my blood pressure rose significantly, which rendered the results of the 24-hours monitoring useless. Will your ring be able to help in such situations, and how?
People often refer to 24H Ambulatory Blood Pressure Monitoring (ABPM) as a ‘once-in-a-lifetime’ experience because the cuff inflates regularly during sleep, disrupting rest. As you’ve experienced, most patients find it uncomfortable. However, doctors recommend 24H ABPM for a good reason. Checking blood pressure solely in a clinical setting is not sufficient for diagnosing hypertension, a more comprehensive dataset on a patient’s blood pressure throughout the day is preferred.
Unfortunately, 24H ABPM can cause blood pressure to rise upon awakening. As a potential solution, Sky Labs’s ‘CART BP’ offers accurate 24H ABPM monitoring. Designed as a ring-type monitor, it continuously and automatically measures blood pressure without a cuff, providing a more comfortable monitoring experience.
Blood pressure ring: will you feel anything?
Q2: Will the user feel anything when her/his blood pressure is being measured? Why not? If you were to explain how the Sky Labs ring works to a hypertensive patient (not a healthcare professional), how would you do it?
The answer is no, patients won’t feel anything while their blood pressure is being measured with CART BP. There are sensors in the ring, where the signals are collected. The LED emits light to the blood vessels inside the finger and CART BP collects the light signals reflected in the bloodstream. We use our algorithms to analyze the collected data to estimate blood pressure. Blood pressure estimation based on PPG signals is now emerging as a promising candidate for modern blood pressure measurement methods. Patients just need to wear the ring to continuously track and manage their blood pressure levels, day and night, without any required effort on their part. Understanding a patient’s average blood pressure variability can enhance hypertension management, enabling physicians to develop more effective treatment strategies.
Blood pressure ring: validation
Q3. Recently, we have seen quite a few wearless devices, watches, bracelets and even rings, that claim to measure blood pressure. However, their results are often inconsistent and differ significantly from clinically validated blood pressure monitors. What is the way of Sky Labs in validation? Where are you now in this journey and what your intentions are for the EU and the USA?
CART BP is a clinically proven cuffless blood pressure monitor. We have recently completed comparative studies with all existing blood pressure measurement methods. There are currently three main blood pressure measurement methods:
- Auscultatory method in which a cuff-based blood pressure monitor and stethoscope are used in clinics to measure blood pressure.
- Invasive blood pressure measurement method in which a needle or catheter is inserted into an artery (A-line) to measure intra-arterial pressure.
- Ambulatory Blood Pressure Monitoring (ABPM) that measures blood pressure during a 24H period outside clinics by attaching a cuff and monitor to the body.
The last one, which is 24H ABPM comparative study was the world’s first clinical research to reflect the European Society of Hypertension(ESH)’s recommendations for the validation of cuffless blood pressure monitoring devices that were announced in June last year. The research’s significance as announcing a preliminary result for the ‘awake/asleep test,’ which is primary test among the five tests presented by ESH.
How it will help to manage blood pressure
Q4: Let’s take one step further, from tracking to management of high blood pressure. I am interested to know your view on how continuous blood pressure monitoring can help people manage their blood pressure, that is to keep their bp readings in the normal range?
Continuous blood pressure monitoring is paramount for effectively managing hypertension and ensuring blood pressure remains within normal parameters. Notably, nocturnal hypertension has been extensively linked to an elevated risk of heart failure and increased all-cause mortality rates, as supported by various studies on cardiovascular outcomes. 24H continuous blood pressure monitoring provides valuable insights into nocturnal hypertension, enabling timely interventions to mitigate the risk of heart failure and other adverse outcomes.
Blood pressure ring: testing
Q5: I read that currently you are testing the ring on patients in hospital/s in South Korea. Can you confirm these reports? Any results that you can share now? Do you want to do the same in European and American hospitals?
There are few hospitals that are already using ‘CART BP’ for 24H ABPM, even though ‘CART BP’ is not yet locally approved for ‘Fee-for-Service’. According to the hospital, continuous blood pressure measurement was challenging because elderly patients found the device uncomfortable during the traditional 24H monitoring period. The cuff-based blood pressure monitor is difficult to use when a retest is necessary due to its inconvenience in daily life and disturbance of sleep. However, the ring-type blood pressure monitor has overcome these limitations, allowing for the observation of blood pressure during the night as well as during daily activities. This has significantly increased satisfaction levels for both patients and medical staff. Unfortunately, it would be difficult to share results as it is still in too early a stage.
And yes, we are absolutely interested in hospitals in both European and American regions. The upcoming CE-MDR and FDA approval are expected to provide great momentum for ‘CART BP’ to reach patients globally.
Q6: Will you sell directly to consumers in Europe and in the USA?
Yes, we aim to sell our product globally, as long as we obtain CE-MDR and FDA approval. We are diligently working to achieve medical approval from both the US and EU, and we expect to receive CE-MDR within this year. CART BP is a medical device, setting it apart from wellness products. Its guarantee of accuracy makes it especially suitable for patients with hypertension or those in need of blood pressure measurement.
Reference list provided by Skylabs.io
- Yang, W. Y. al al (2019). Association of Office and Ambulatory Blood Pressure With Mortality and Cardiovascular Outcomes. JAMA, 322(5), 409–420.
- Kario, K. at al (2020). Nighttime Blood Pressure Phenotype and Cardiovascular Prognosis: Practitioner-Based Nationwide JAMP Study. Circulation, 142(19), 1810–1820.
