At a Munich cardiology congress, a Korean startup’s ring-shaped monitor drew crowds asking how fast they could buy in bulk.
Ask any startup founder what a good trade show looks like, and most will tell you it is not applause; it is people asking about volume pricing. That is roughly what happened to Sky Labs at the European Society of Cardiology’s 2026 congress in Munich recently, where visitors to the company’s booth kept circling back with a version of the same question: could they buy the company’s blood pressure ring in batches of 100 or 200 units?
Sky Labs makes CART BP pro, a ring worn on the finger that measures blood pressure continuously, without a cuff, without an arm sleeve, without any of the paraphernalia that has made ambulatory blood pressure monitoring, the gold-standard way to catch dangerous swings a single office reading misses, something most patients only tolerate for a day or two at most.
“The discussions we had already been having with global pharmaceutical companies and other global companies have advanced quite a lot,” said Sky Labs CEO Lee Byung-hwan, speaking to Korea Biomedical Review at the congress [1]. “Based on the clinical evidence we have built, conversations have become easier, and I think some of these projects could progress faster than we originally expected.”
Korea as the test kitchen
The company’s confidence traces back to home turf. CART BP pro has already built up a real prescribing track record in Korea, where it earned reimbursement and has since accumulated what Lee describes as a substantial volume of prescriptions in a relatively short window. That real-world data trail, generated even before reimbursement kicked in, is now the evidence base Sky Labs is exporting to the rest of the world.
It also helped move a domestic medical society. The Korean Society of Hypertension this year recommended the use of validated cuffless blood pressure devices, a step Lee called unusually fast by the standards of clinical guideline development, which typically takes years to catch up to new technology. “Even if it does not go all the way into a guideline immediately, a position paper or statement can have a very significant impact,” he said.
Selling into Europe without selling directly
Sky Labs is not handling European retail sales itself. Instead, it has partnered with the German distributor IEM, which received its first shipments earlier this year and expects devices to reach the market in the back half of 2026. Interest at ESC 2026 suggests that rollout could accelerate faster than planned, and feedback IEM’s own distribution partners gave after trying the device firsthand has reportedly been encouraging.
Market entry will not look identical everywhere. In some countries, ambulatory monitoring is already available outside public reimbursement systems, letting private clinics adopt it quickly. In others, adoption hinges on securing formal reimbursement, a process Lee says is moving faster than the company initially expected, with the United Kingdom held up as a case where a substantial private healthcare market can carry early commercial adoption while public reimbursement talks continue in parallel.
The American test comes next
The company has already brought on a contract research organization to run a U.S. clinical study that could start as soon as next month, aiming to wrap enrollment in the first half of next year and move through the FDA’s review process in the back half.
Sky Labs is pursuing the FDA’s de novo pathway, generally reserved for novel device categories without an existing predicate, and Lee said the company does not currently view that route as unusually difficult given the clinical evidence already in hand.
Beyond blood pressure
Longer term, Sky Labs wants CART BP pro to be a beachhead rather than the destination. The company is developing a broader family of ring-based sensors, including CART ON, CART O2 and CART VITAL, aimed at other physiological signals, part of a bet that healthcare monitoring is migrating out of hospitals and into whatever a patient is already wearing.
That migration matters more than it might first appear for anyone tracking healthy aging. Hypertension is one of the single biggest modifiable drivers of cardiovascular disease, stroke and cognitive decline, and yet a huge share of it goes undetected or poorly controlled precisely because office readings capture a single snapshot rather than the fuller pattern of a person’s day.
A device unobtrusive enough that someone will actually wear it for weeks, not just the standard 24-hour monitoring window, could catch the white-coat and masked hypertension that conventional cuffs miss entirely, and catch it early enough for it to matter.
Lee is careful not to oversell the moment. Broader market conditions have made the company’s path to an IPO tougher than once expected, he acknowledged, even as he insisted the underlying growth strategy has not changed.
“The fundamental point is whether the company is heading in the right direction and whether it can show that it is actually getting there,” he said. “We believe we are continuing on that path.”
Photographs courtesy of Sky Labs
[1] https://www.koreabiomed.com/news/articleView.html?idxno=32993
