Breath Diagnostics, Inc said the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its OneBreath platform, a breath-based test designed to help doctors assess pneumonia risk before heart surgery.
The designation covers OneBreath as an in vitro diagnostic that analyzes volatile organic compounds from a single pre-operative breath sample. The test aims to support perioperative risk stratification for adults scheduled for elective cardiac surgery. Specifically, it helps clinicians identify patients who face a higher risk of developing postoperative pneumonia.
Postoperative pneumonia can complicate recovery and increase hospital stays. Consequently, hospitals often rely on a mix of clinical judgment and standard risk tools to estimate danger before surgery. However, those tools do not directly measure molecular signals linked to inflammation or metabolic stress.
The FDA grants Breakthrough Device status to a limited group of technologies. Additionally, the program supports devices that may offer more effective diagnosis or treatment for life-threatening or irreversibly debilitating conditions. Devices in the program receive prioritized communication with regulators. Furthermore, companies gain more structured guidance as they move through development and review.
“We believe this designation marks an important step forward for the OneBreath platform and reflects the emerging role of breath-based molecular diagnostics in addressing unmet clinical needs,” said Ivan Lo, CEO of Breath Diagnostics, Inc.
Breath Diagnostics said the FDA based its decision on preliminary evidence suggesting the platform can identify patients at elevated risk through qualitative molecular analysis of exhaled breath. However, the designation does not guarantee approval or a shorter review timeline.
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Breath is a potential window into human biology
The OneBreath system uses a single-breath sampling design. A patient exhales once into the device, and laboratory staff analyze the captured sample using liquid chromatography–mass spectrometry, or LC-MS. The company said the workflow takes about ten minutes. Consequently, hospitals could integrate the test into pre-surgical routines without slowing operating schedules.
Company executives said researchers have long viewed breath as a potential window into human biology. Additionally, they described a single exhaled breath as fast, simple and non-invasive. They argued that patients may prefer that approach over blood draws or other sample types such as urine or stool.
Unlike blood, which the liver and kidneys filter and process, breath contains volatile organic compounds tied to biological processes. These compounds can reflect inflammation and metabolic activity in real time. Consequently, the company believes breath analysis could enable earlier risk detection and more frequent monitoring.
OneBreath captures what the company calls orthogonal layers of molecular evidence from exhaled compounds. Additionally, the platform assesses signals across a wide dynamic range, rather than focusing on a single marker. Breath Diagnostics said that architecture positions the technology as a scalable platform rather than a one-time assay.
The FDA’s grant letter states that clinicians must use the test alongside standard clinical evaluation and existing risk tools. Furthermore, the device does not diagnose pneumonia or identify specific pathogens. Qualified laboratory personnel must perform the analysis in an appropriately equipped clinical laboratory. The device also requires a prescription.
Breath Diagnostics said it plans to continue working closely with regulators through the Breakthrough Devices Program. Meanwhile, the company will advance the platform through clinical validation and regulatory review.
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joseph@mugglehead.com
