Korean health care startup Sky Labs aims to launch its Cardio Tracker, or CART, a ring-type wearable device that detects a patient’s heart rhythm 24/7 using internet of things technologies.
“From the beginning, our goal was to penetrate Europe and the US. We will also launch the product in South Korea so we have applied for the Ministry of Food and Drug Safety’s approval, but it is only for limited usage due to government regulations here,” Sky Labs CEO and co-founder Lee Byung-hwan said in a recent interview with The Investor. “We expect to receive marketing approval for CART in Europe before the year-end.”
Sky Labs CEO and co-founder Lee Byung-hwan
CART is mainly used for spotting atrial fibrillation -- an irregular heart rhythm that can cause blood clots and even lead to heart failure or a stroke.
Lee emphasized that the device has lots of potential since it can be used by patients directly as well in conducting drug clinical trials.
“In the past, the pharma industry thought that conducting three stages of clinical trials was enough. But as it sees some side effects and a lack of effectiveness, some agencies including the US Food and Drug Administration are recommending them to present real-world evidence, which is data collected outside of hospitals,” Lee said. “We call this the stage 4 clinical trials and expect to develop our device to be used for this purpose as well.”
According to Lee, the company is currently developing this solution with global pharma companies Bayer and Sanofi.
Established in 2015, Sky Labs first saw its potential in the European market when it was picked at the startup program Grants4Apps Accelerator by German pharma giant Bayer in 2017. Through the program, Sky Labs received 50,000 euros ($59,400) in funding. Lee added that with assistance from Bayer, it has been expanding awareness in Europe.
He also noted that the company is constantly running tests and participating in global conventions to attract more investments.
“To manage a health care startup, we need lots of funding at the early stage,” Lee said. “We especially need lots of money for consulting fees and applying for clinical trials in Europe. Startups that manufacture consumer goods can attract investors with their sales figures, but we cannot do that. So we need to persuade investors with our technology.”
He said that the company showed the potential of its product by sharing data that proves its effectiveness, collected and tested in partnership with Seoul National University Hospital.
In 2018, the company won the top award for the digital health care sector at the European Society of Cardiology Congress, the world’s largest cardiovascular congress.
Lee, who worked as an engineer at Samsung Electronics’ Digital Media and Communications R&D Center, said he started the company and decided to develop the device because he experienced the symptoms of atrial fibrillation.
“I was a workaholic back then, I felt some pain and went for a checkup at the hospital, but they said they could not find anything wrong,” he said.
He noted that this is a common case that many patients with arrhythmia experience, because the disease is often difficult to notice, as it happens inconsistently and at random intervals. “So, unless the pain occurs when the patient is at the hospital, it is very hard to detect the symptoms,” he noted.
Lee believes that with CART, many patients who are suffering will be able to get medical help at an early stage, which is crucial.
Currently, around 150 million people are said to be suffering from atrial fibrillation globally, with one in four people above the age of 40 experiencing early-stage symptoms.
By Song Seung-hyun (firstname.lastname@example.org)