Breath Diagnostics, Inc. has shared encouraging results from a study published in The Journal of Thoracic and Cardiovascular Surgery. The research shows that their patented OneBreath technology can effectively diagnose and even predict pneumonia in patients who have had elective cardiac surgery. This new method uses a single breath to detect volatile organic compounds (VOCs), providing a safe, non-invasive way to assess risk before symptoms show up. The study included 75 patients and demonstrated that both diagnostic and predictive models, developed using machine learning, performed well with AUROC and PRAUC scores of 0.833 and 0.818, respectively. Notably, the predictive model could identify patients at risk just days before a clinical diagnosis was made, using breath samples collected before surgery.
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Dr. Victor van Berkel, Co-Founder and Chief Medical Officer at Breath Diagnostics, stated that these findings represent a big step forward in handling post-surgical complications. He added that this method could allow doctors to take action earlier, which may help reduce time spent in the ICU, lower hospital costs, and decrease deaths from pneumonia. The breath samples were collected using a Tedlar bag system and analyzed with advanced mass spectrometry tools, combined with AI-based models trained to detect specific carbonyl VOC profiles associated with inflammation and bacterial infection.
Pneumonia is one of the most common and serious complications following cardiac surgery, affecting between 6 to 20 percent of patients. Despite being a leading cause of post-surgical issues, current prevention methods, such as prophylactic antibiotics, often fail to accurately identify patients who are most at risk. The ability to anticipate the onset of pneumonia through exhaled breath analysis presents a new path forward in personalized patient care. This is the first time a study has shown that breath analysis can not only detect disease but also predict its development before any clinical symptoms appear.
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Ivan Lo, CEO of Breath Diagnostics, explained that the OneBreath™ platform is redefining the way breath is used in medical diagnostics. He pointed out that exhaled breath contains a wealth of biological information, yet it has remained underused in clinical settings. According to Lo, the OneBreath™ system, which leverages AI and high-precision analysis, is already proving effective in ICU and surgical environments. It is also one of the most clinically tested breath technologies for early-stage lung cancer, showing 94 percent sensitivity and 85 percent specificity in trials conducted across multiple sites.
Breath Diagnostics plans to further validate its findings through larger, multi-center studies and is working with regulatory agencies to seek approval in the United States and international markets. The company’s long-term goal is to integrate the OneBreath™ platform into hospital workflows to help clinicians make faster, more informed decisions. This could significantly reduce complications, lower healthcare costs, and improve patient outcomes. The technology also holds promise for broader use in detecting other inflammatory or infectious diseases, signaling a new era in predictive, non-invasive healthcare.
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