View details of this raise on Seedstage

Louisville, KY

Advancing a breath-based diagnostic platform to enable earlier, non-invasive detection of lung cancer and other diseases.

• Non-invasive diagnostics: Uses breath analysis to detect disease, avoiding radiation or invasive testing.
• Validated in trials: Technology tested on over 800 patients with strong comparative results against CT scans.
• Patent protection: Intellectual property secured in the US, Europe, Japan, Australia, Canada, and India.
• Broader diagnostic potential: Platform may be extended to identify other diseases like pneumonia and tuberculosis.
• Clinical momentum: Supported by major research institutions and grants from the Gates Foundation and NIH.

Breath Diagnostics is raising funds to further develop its breath-based disease detection platform, focused initially on early lung cancer screening. The company’s patented OneBreath technology identifies volatile organic compounds in a patient’s breath, offering a non-invasive, radiation-free alternative to CT and PET scans. This approach aims to improve diagnostic accuracy and reduce false positives, while addressing accessibility and cost challenges that have historically limited screening compliance. The platform has already been validated in clinical trials with over 800 patients and is supported by peer-reviewed research and intellectual property protections across multiple countries.

Funds from this raise will be used to advance product development, complete regulatory approval processes, and begin commercial scaling of the second-generation diagnostic device. The company sees further opportunity in using its breath-analysis system to detect other diseases, including pneumonia and tuberculosis, potentially expanding its role as a platform diagnostic tool. With prior support from the Gates Foundation and NIH, Breath Diagnostics has built strong foundational research and positioned itself to address unmet needs in the $150 billion global cancer diagnostics market. Management believes their cost-effective and scalable solution could lead to broader adoption in both clinical and consumer settings, and future partnerships or acquisitions could support growth into additional medical applications.

Company Info

Breath Diagnostics develops a patented breath analysis platform for early detection of diseases like lung cancer using non-invasive VOC testing.

Breath Diagnostics is a medical diagnostics company developing a non-invasive breath analysis platform for early disease detection, with an initial focus on lung cancer. Its patented OneBreath technology uses a silicon microreactor to capture and quantify volatile organic compounds (VOCs) in exhaled breath that are linked to disease states. This diagnostic method aims to offer a faster, less invasive, and radiation-free alternative to traditional imaging and biopsy-based cancer screenings. Validated in clinical trials with over 800 patients, the system has demonstrated the ability to detect lung cancer earlier and more accurately than CT scans, and to distinguish between benign and malignant pulmonary nodules.

The technology’s versatility enables potential future applications in detecting other conditions such as pneumonia, tuberculosis, and various cancers. Breath Diagnostics holds multiple patents across major global markets and is preparing its platform for regulatory approval. The company aims to address limitations in current diagnostic methods, including high false positive rates, invasive follow-ups, and access barriers. Through its compact, mail-in diagnostic kit, Breath Diagnostics seeks to expand access to early detection tools while reducing systemic healthcare costs and unnecessary interventions. Its business model targets the global in vitro diagnostics and personalized medicine markets, with a focus on scalability and integration into existing lab and clinical workflows.