More than 15 million Americans live with chronic obstructive pulmonary disease (COPD), a progressive lung condition that makes it difficult to breathe. But monitoring the often-debilitating condition can be challenging. And when dangerous flare-ups go undetected — something that happens in at least half the cases — the result can be fatal.
Leveraging funding from the National Heart, Lung, and Blood Institute’s (NHLBI) small business program, one medical technology company, Samay, is trying to help solve this detection problem — and so far, the news is looking up.
Based in Mountain View, California, the company has developed a prototype wearable chest patch that could allow patients with COPD to continuously monitor changes in lung function, including the flare-ups that can lead to hospitalizations, and worse. The chest wearable also shows promise for monitoring respiratory changes in other lung-related diseases, including asthma and long-COVID, which together affect millions more people. The company, which started in 2018, developed the device with funding support, in part, from the NHLBI through its Small Business Innovation Research (SBIR) program.
Maria Artunduaga, M.D., M.P.H., M.T.M., the company’s founder and chief executive officer, called the prototype a potential gamechanger in lung care because it is the first to allow real-time monitoring of lung function through a process called acoustic resonance. The device delivers sound into the chest cavity to identify audible changes inside the lung that could correspond to abnormal lung volumes, such as those caused by air trapping — a measure of decline in lung function.
“Our device has the potential to revolutionize respiratory care and management in millions of people worldwide, including those in remote areas with limited access to physicians and hospitals,” Artunduaga said. “If we can start treatments earlier, then we can save lives.”
COPD is usually diagnosed using a device called a spirometer, which requires patients to blow into a tube connected to a small machine to measure how much air they can manage while they breathe out through the device. This gives a measure of COPD severity and can help set treatment goals. Other lung function tests include medical imaging of the lungs (computed tomography, or CT, scans), oximetry (blood oxygen levels), and quality-of-life questionnaires. But these tests, Artunduaga said, can pose multiple challenges for patients and their providers for different reasons: poor correlation to flare-up detection, limited accuracy when moving, high expenses, inconvenience, and, in the case of questionnaires, subjective interpretations.
“We wanted a tool that was as accurate as clinical grade testing but easier-to-use, and more telehealth-friendly than current devices used to monitor lung diseases,” said Artunduaga, a former practicing physician. She was inspired to develop the new device, she said, after the death of her grandmother Sylvia, who passed away nearly a decade ago due to complications from COPD. Artunduaga named the device “Sylvee” in her honor.
Sylvee, which is about the length of a pencil, works like this: The patient temporarily attaches it to the skin above the ribcage and leaves it there from a few days up to a month to allow real-time monitoring of respiratory changes. The device, which is fitted with tiny speakers on one end and microphones on the other, delivers sound into the chest and captures lung resonance or vibrations that indicate lung air volumes. It then sends signals wirelessly to a cell phone where initial machine learning algorithms are applied. Those signals are later uploaded to the cloud where classification and diagnostic algorithms are run in real-time. Healthcare providers have access to the data via a web portal, where they can provide recommendations and quickly deploy an action plan for patients.
Artunduaga compared the device to continuous glucose monitoring skin patches that allow people with diabetes to detect their blood sugar levels without needle sticks — except in this case, it’s levels of air that are being detected. “Our new biomarker is the amount of air trapped in the lungs, a predictive parameter for decline in lung function and death in patients with COPD,” the physician-scientist said. “We are the first wearable company to use air trapping for respiratory diseases, and we are pretty excited about that.”
The battery-operated, rechargeable device is part of a smartphone interface and has its own app. The prototype has been tested so far in about 80 patients — mostly those with COPD — and has resulted in about a 74% accuracy rate for detecting COPD, asthma, or long-COVID. Artunduaga said the goal is to achieve at least a 90% accuracy rate in the next two years.
In the future, Artunduaga plans to incorporate artificial intelligence into the device to enhance the speed and accuracy in identifying respiratory changes. Her company also plans to make the device smaller, thinner, and more lightweight. The company has received four U.S. patents and an additional patent in China for technology related to the device, with eight more patents still pending.
The name of her company has personal meaning: “Samay” means "to breathe deeply" in Quechua, an indigenous language spoken in the Andes. While the company started out with just Artunduaga and a few contractors in 2018, it currently employs about 22 people. Many of the employees are Latinas. Artunduaga herself is originally from a small town in Colombia, and later moved to Bogotá, the capital of her native country, where she received her medical training before relocating to the United States. She said she is particularly excited about the device’s potential impact on women, who are disproportionately underdiagnosed for lung diseases.
Stephanie M. Davis, Ph.D., coordinator of NHLBI’s Small Business Program, said the device could meet a serious yet unmet need for the home monitoring of COPD and other chronic lung conditions. “This unique device not only could help save lives; it could also help reduce the disturbing health disparities associated with lung diseases, including COPD, which is a leading cause of death and disability in the U.S.,” she said. “We look forward to additional testing and validation of the device as it makes its way toward the market.”
Samay (formerly Respira Labs) received an NHLBI STTR grant (1R41HL152769-01A1) and they are also a 2021 awardee through the NHLBI CAPCaT program, which is funded through the NIBIB POCTRN (U54HL143541-02) program. In addition to funding from the NHLBI, the company has been funded by Phase I (Award #1913545) and Phase II (Award # 2112096) SBIR grants from the National Science Foundation.
More about the NHLBI SBIR and STTR programs
The NHLBI Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs support research and development on the next generation of commercially promising technologies and products to prevent, diagnose, and treat heart, lung, blood, and sleep-related diseases and disorders. For more information on NHLBI’s small business programs, visit https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/small-business-program.
Disclaimer
Reference to any specific commercial products, process, service, manufacturer, and/or company does not constitute an endorsement or recommendation by the National Heart, Lung, and Blood Institute (NHLBI), the NHLBI's Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, or any other portion of the U.S. Government.