Breath Diagnostics Submits IPO Filing Following FDA Breakthrough Designation for OneBreath™ Platform to Predict Postoperative Pneumonia Risk

Recently, Breath Diagnostics, Inc., a medical technology company dedicated to innovation in respiratory molecular diagnostics, announced that its developedOneBreath™ Respiratory Molecular Diagnostic Platform Successfully Granted “Breakthrough Device Designation” by the U.S. Food and Drug Administration (FDA), to assist in preoperative pneumonia risk assessment.

For patients undergoing cardiac surgery, postoperative pneumonia (POP) is by no means a rare occurrence.

A systematic review and meta-analysis recently published in the Journal of Thoracic Disease revealed that the pooled incidence of postoperative pneumonia among patients undergoing cardiothoracic surgery was as high as 14.8%, with rates of approximately 15.8% following valve surgery and 17.2% after thoracic oncology surgery. Once infections involve multidrug-resistant organisms, patient mortality can surge to 29.79%, accompanied by significant increases in both length of hospital stay and medical costs.

Nomogram for Predicting the Risk of Pneumonia After Cardiac Surgery (Source:Wang K et al., J Cardiothorac Surg, 2024）

Each risk factor corresponds to a specific score; the higher the total score, the greater the risk of postoperative pneumonia.

However, most existing risk assessment methods rely on patients' static medical histories—such as age, history of COPD, and duration of surgery. These indicators have two fundamental limitations:First, they are “past tense,” with a near-total void in genuine preoperative risk prediction; second, they fail to capture the body’s “real-time signals.”。

Studies have shown that surges in postoperative inflammatory cytokines interleukin-6 (IL-6) and interleukin-8 (IL-8) are significantly associated with pulmonary complications; however, by the time these markers are elevated, patients are often already in the ICU, meaning that intervention at this stage has missed the optimal window.

Therefore, there is an urgent clinical need for aEarly, Non-invasive, and Precise Identification of High-risk Populations Preoperativelyinnovative tools. The advent of OneBreath™ is a direct response to this urgent clinical need.

The technological logic of OneBreath™ is built upon a key finding: risk signals for postoperative pneumonia are already present in the breath long before patients enter the operating room.

 OneBreath™System Model Diagram

A 2025 study published in The Journal of Thoracic and Cardiovascular Surgery (JTCVS) by a team from the University of Louisville enrolled 75 patients undergoing cardiac surgery to analyze carbonyl compounds in pre- and post-operative breath samples. The results revealed that four key volatile organic compounds (VOCs)—heptanal, octenone, C12H24O, and acetone—identified from a single pre-operative breath sample could accurately predict the risk of post-operative pneumonia, achieving an area under the curve (AUC) of 0.833.

This means that while patients are still awaiting surgery, a single exhalation can already inform physicians—who requires closer monitoring and who needs preventive intervention.

Although breath analysis is not a new concept, for a long time,How to Achieve Stable and Reproducible Quantitative DetectionThese are the technical challenges facing the field. OneBreath™’s breakthrough technological pathway includes the following components:

● Sampling Revolution: Standardized Quantification with a Single Exhalation

Conventional techniques require patients to exhale continuously for 15–30 minutes to enrich VOCs, yielding results that are at best qualitative. OneBreath™ utilizes patented microreactor technology to complete sampling with a single exhalation, enabling precise quantification in breath analysis for the first time.

● Principle Innovation: Derivatization Technology to Lock in "Metabolic Fingerprints"

Conventional thermal desorption requires heating the sample, which can easily lead to the degradation of biomarkers. The core of OneBreath™ lies in its patented derivatization technology: unstable VOCs are instantly captured and converted into stable cationic adducts, preventing degradation while enhancing detection sensitivity.

● Analytical Method: UHPLC-MS enabled, delivering precise results in 10 minutes

Benefiting from sample stabilization technology, OneBreath™ enables direct analysis via ultra-high-performance liquid chromatography-mass spectrometry (UHPLC-MS), reducing single-test turnaround time to 5–10 minutes—six times faster than traditional GC-MS methods. It is also the first device to apply LC-MS molecular analysis technology to human breath testing and receive FDA Breakthrough Device Designation.

OneBreath™ Testing Process Model Diagram

Therefore, the entire testing workflow of OneBreath™ is designed to be compact and efficient: patients complete a single exhalation in approximately 30 seconds; the sample enters a microreactor for VOC capture and stable conversion; analysis is then performed via UHPLC-MS; and the final results are delivered to the physician. According to the official website, samples can be sent to any laboratory with mass spectrometry capabilities for analysis, offering convenience comparable to that of blood sample processing.

Compared with traditional low-dose CT, the design goals of OneBreath™ include:No radiation exposure, designed to reduce false positives, and expected to lower screening costsThis end-to-end process holds the promise of extending precision screening beyond large hospitals to more community clinics and even pharmacies, truly making screening “within easy reach.”

Previously, OneBreath™ had accumulated the most mature clinical data in the field of lung cancer detection. According to its official website, the technology has achieved a sensitivity of 94% and a specificity of 85% in lung cancer detection. Related studies have covered more than 800 patients, supported by multiple global patents and over 10 peer-reviewed papers.

But the design of OneBreath™ goes beyond that. It is a scalable technology platform—the official website indicates that it is also exploring the detection of other diseases such as pneumonia, tuberculosis, and COVID-19. The FDA’s recent Breakthrough Device designation for preoperative pneumonia risk screening precisely demonstrates the expansion potential of this platform: in the future, simultaneous early warning of risks for multiple diseases may be achieved through a single breath.

It is important to clarify that the clinical application of OneBreast™ adheres to strict medical standards: as an aid in decision-making, it must be used in conjunction with clinical assessments and other diagnostic methods, and operated by professional laboratory personnel. It cannot replace clinical assessment, cannot identify specific pathogens, and cannot be directly used for the diagnosis of pneumonia.

Breath Diagnostics was founded in 2014 and is headquartered in Louisville, Kentucky. The company’s founders and scientific team firmly believe that breath represents the earliest and most dynamic “feedback signal” of the human body’s biological status, and the mission of OneBreath™ is to transform this intangible signal into clinically actionable decision-making evidence.

As outlined in the company’s recent blog post, the future of early detection lies in “multidimensional biology.” The respiratory metabolomics represented by OneBreath™ complements genomics, holding promise to jointly broaden the window for early discovery. The recent FDA Breakthrough Device designation for this technology, marking a shift from “blood-based testing” to “breath-based screening,” serves as an endorsement of its technical approach.

As research advances, a single easy breath may soon help more people avoid disease risks earlier—bringing non-invasive diagnostics to those who need them most.