Samay, the maker of a patented, AI-assisted wearable device and platform to monitor lung function, announces impressive results of its trial with more than 100 subjects. Designed for COPD, the wearable device (called “Sylvee”) continuously measures air trapping and other measures of respiratory function in patients at home. This study was conducted in partnership with the Pulmonary, Critical Care & Sleep Disorders Institute of South Florida (PCSI).

In the study, Samay’s platform detected air trapping (RV/TLC) — an early predictor of COPD exacerbations — with 83% accuracy against hospital PFTs (Pulmonary Function Tests), essentially having a small chest wearable (Sylvee) delivering a near equivalence to a hospital-based machine. It also diagnosed COPD with 90% accuracy and registered statistically significant (p <0.05) associations in medication efficacy during pre- and post-bronchodilation PFTs. (Results will be published after securing more patents.)

In the 110-patient study, Samay tested patients with COPD, asthma, and healthy controls using its AI-assisted system. The system includes a prototype wearable device (the Sylvee) to measure lung acoustic resonance, paired with the Sylvee mobile app and a research portal.

Sylvee wearable prototype being synced to tablet

The Sylvee device combines lung physiology, IoT sensors, signal processing, and AI/ML. “Our platform continuously captures pulmonary function data, including early COPD diagnostic biomarkers and predictors of exacerbations,” said Maria Artunduaga, M.D., M.P.H., M.T.M., Samay’s founder and CEO. “Our vision is to enable clinicians to intervene early and monitor frequent exacerbators closely, decreasing hospitalizations.”

According to the World Health Organization, COPD is the third leading cause of death worldwide. In the U.S. in 2020, an estimated 12.5 million people (5% of adults) had COPD and 150,000 people died from it. However, these numbers are likely underestimated, as COPD is unfortunately still underdiagnosed and underreported by 70%.

Air Trapping as a biomarker for exacerbations

When air does not leave the lungs and remains trapped after a patient exhales, the resonance of the lungs changes, similar to a drum. This creates a measurable sound biomarker for air trapping, a finding that has been strongly correlated with COPD exacerbation when patients’ symptoms suddenly worsen. Exacerbation is one of the most serious concerns facing COPD patients.

“Exacerbations or flare-ups of chronic lung conditions cause a major burden on patients, families, and global healthcare systems. They are often diagnosed and treated late, as worsening of respiratory symptoms may be felt well after the biological changes occur,” said Ruth Tal-Singer, Ph.D., former CEO and CSO of the COPD Foundation who sits on the Samay scientific advisory board.

“An effort-independent, simple, non-invasive approach to remotely monitoring, detecting, and reporting early changes in air trapping offers a fantastic opportunity to start treatment and prevent severe outcomes such as hospitalization,” said Tal-Singer.

“Living in poverty or rural areas is a risk factor for COPD. These patients have limited access to healthcare, including specialists, recommended tests, and even pharmacological and non-pharmacological treatments,” said COPD expert, Xavier Soler, M.D., Ph.D., associate professor affiliated at UC San Diego, and global senior medical director of immunology and inflammation at Regeneron Pharmaceuticals.

“Samay’s trial results align with current standards of respiratory measurements of lung function, which is encouraging for such a prevalent disease with a high negative impact on patients and society,” said Soler.[1]

The story behind “Sylvee”

Dr. Artunduaga, Samay’s Colombian-born founder and CEO, named the Sylvee device after her grandmother (Sylvia) who passed away following

complications when her COPD exacerbation initially went undetected. Dr. Artunduaga left her surgical career to create this new, acoustically informed device to predict these events.

“I didn’t want anyone else to suffer the way my grandmother did. Our goal is to measure 10+ pulmonary parameters 24/7 and predict exacerbation events more than five days in advance,” said Artunduaga.

According to the NIH, 20% of patients hospitalized with COPD have to be readmitted within 30 days, making monitoring patients at home — particularly post-hospital discharge — a critical need.

Air trapping theoretically should show up several days before exacerbation symptoms, and Samay’s platform has been assessed to be 83% accurate in detecting this biomarker. Patient-answered questionnaires (CAT assessment) have a sensitivity of 52% and a specificity of 69% to detect a moderate-to-severe exacerbation — the level that requires expensive hospitalizations.

The Sylvee device and accompanying platform cost significantly less than the hospital equipment required to perform in-person spirometry and plethysmography tests or CT scans. Wearing the device and passively measuring air trapping is also easier on patients than at-home spirometers, and more reliable than measuring their respiratory rate.

“It is not easy living with COPD. I am always having to watch for an exacerbation. Something as simple as a cold or sudden shortness of breath can lead to something worse and a trip to the ER. Being able to have an ‘app’ that could allow me to glance at my phone could help me know how I am doing. This is so much better than just guessing. Sign me up! I will be the first in line to have this,” said John Linnell, a patient advocate and Samay advisor.

For more information visit, www.samayhealth.com.

[1] Dr. Xavier Soler is providing an opinion that is personal and does not reflect Regeneron’s point of view.