FDA-cleared Belun Sleep System may speed up OSA diagnosis for 1 billion population

Belun Technology has just received FDA 510(k) clearance from the US Food and Drug Administration (FDA) for its Belun Sleep System as the World's FIRST wearable ring for obstructive sleep apnea (OSA) & sleep stages using AI. Belun Sleep System, which is comfortable and easy to use, is believed to speed up the diagnosis of 936 million worldwide with moderate to severe OSA¹. It may result in massive savings on medical expenditures for chronic disease management of the aging population.  

Belun's CEO, Dr. Lydia Leung, shared: "we hope to facilitate home sleep tests for identifying undiagnosed OSA. Research shows sleep health is critical for the overall immune system & treatment effectiveness of chronic diseases." The company is expanding towards Preventive Healthcare from the original sleep health. The new direction is an insight found from collaborating with worldwide specialists. Since the launch of our 1st generation Belun^® Ring in 2018, it has been gradually adopted in different research on long-term diseases, including stroke, hypertension, insomnia, dementia, etc. "Our new company direction results from the co-created insights after collaborating with worldwide researchers. Sleep takes up so much human time, but we know little about it. Our vision is to keep people healthy with our preventive healthcare data."

The sedentary lifestyle of people has led to an increasing prevalence of cardiovascular disease, poor sleep patterns, evaluated stress & obesity. OSA is common in patients with high BMI. Therefore, the worldwide obesity epidemic and the aging population demographic will likely contribute to the rising global prevalence of OSA. According to the World Economic Forum, 1 in 3 adults worldwide will suffer from 2 or more chronic conditions, leading to annual healthcare costs with an 80-300% increment². World Health Organization estimates a projected 10 million health workers shortfall by 2030³. Researchers predicted demand for healthcare workers will increase to 80 million by 2030, but supply will only reach 65 million, creating a healthcare worker deficit of 15 million. The anticipated shortage requires some immediate actions, or access to primary healthcare would be at risk. 

Belun's CEO, Lydia Leung, shared: "Belun^® Ring is a user and environmentally friendly PPG-based wearable with medical accuracy. Belun will offer a superb convenient option that may bring disruption to the sleep health market & encourage suspected patients to take action and kick start their treatment journey." According to AASM⁴, "ubiquitous availability of PPG technology may allow for OSA diagnosis at scale." There is "an increased interest in new technologies with therapeutic potential."

Belun is a graduate from the Hong Kong Science and Technology Parks Corporation (HKSTP)’s Incu-Bio Programme. Hong Kong Science Park is home to over 12,000 research professionals and over 1,200 innovation and technology companies focused on biomedical technology, artificial intelligence, robotics, fintech, smart city technologies and more.

Belun's vision is to help people better manage their chronic diseases through artificial intelligence and big data analytics to alleviate medical expenditures due to the aging population. Our solution allows caregivers and patients to follow their treatment effectiveness, select personalized solutions, and enhance treatment compliance. Lydia further shared: "Long-term monitoring using medical-grade wearables can help people to identify abnormalities earlier to achieve preventive healthcare." 

Belun is developing a sleep health index based on its medical-grade wearable, AI, and big data analytics to enhance public awareness and understanding of sleep. People can understand how their sleep quality will be affected by their daily habits, e.g., alcohol intake, exercise, etc., and environment, e.g., air pollution index and medication. Sleep quality is no longer a perception but a quantified index. For example, some senior management may postpone their important decision or meeting if their sleep quality could be better to avoid the wrong decision. "The long-term benefit brought by investment in sleep health is priceless," Lydia concluded."

To cope with the massive market, Belun has teamed up with global partners to customize solutions for local communities in different countries. Some sleep lab groups in the United States will launch the Belun Sleep System to cater to both the OSA & insomnia markets. For the Indian market, Belun will collaborate with renowned neurologists & sleep specialists to tap into the millions of untreated OSA. The two markets have 104 million suspected OSA, according to the Lancet report¹. 

Sources :

1. A.V, Benjafield et al, Lancet Respiratory Medicine, 2019; 2. Susanna Ng et al, PLOS One, 2015

2. https://www.weforum.org/agenda/2017/12/healthcare-future-multiple-chronic-disease-ncd/

3. https://www.who.int/news/item/02-06-2022-global-strategy-on-human-resources-for-health--workforce-2030

4. https://aasm.org/wp-content/uploads/2022/05/Tech-Committee-Report.pdf