Breath Diagnostics Moves Towards FDA Approval and IPO Plans

Louisville, October 10, 2025

Breath Diagnostics, based in Louisville, has announced plans to complete FDA trials for its non-invasive lung cancer detection test by mid-2026. In addition to pursuing FDA approval, the company plans an IPO to secure funding for expanding its innovative breath analysis technology. Recently, the company raised $10 million in Series B funding, aiming to disrupt the diagnostics industry and improve early lung cancer detection through a simple, at-home screening method. The expansion could also create up to 30 new jobs in Louisville.

Louisville, KY – Breath Diagnostics Advances Toward 2026 FDA Approval and Plans IPO

In a significant step for medical diagnostics innovation, Louisville-based Breath Diagnostics has outlined ambitious plans to complete clinical trials for its non-invasive lung cancer detection test by mid-2026. The company also intends to pursue an initial public offering (IPO) shortly after, aiming to secure the necessary funding and market position to broaden its impact. This announcement comes on the heels of raising $10 million in Series B funding, bolstering the firm’s efforts to bring the breath-based screening technology to patients nationwide.

The core of Breath Diagnostics’ approach lies in its breath analysis device, which detects volatile organic compounds (VOCs) in exhaled air to identify early signs of lung cancer. Unlike traditional methods that rely on invasive procedures such as biopsies or imaging scans, this technology offers a simple, at-home testing option that could significantly improve early detection rates. Early identification is crucial, as lung cancer remains one of the leading causes of cancer-related deaths, often going undiagnosed until advanced stages.

Funding Boost and Investor Confidence

The $10 million raised in Series B funding was secured from a mix of local and regional venture capital firms focused on healthcare and biotechnology. These investors have highlighted the potential of Breath Diagnostics’ platform to disrupt the diagnostics industry by making screening more accessible and cost-effective. The capital infusion will primarily support the ongoing FDA trials, which are a pivotal phase in validating the test’s accuracy and safety for widespread use.

With this financial backing, the company is on track to meet its mid-2026 trial completion goal. The FDA approval process is rigorous, involving multiple stages of clinical evaluation to ensure the technology meets stringent health standards. Successful completion could position Breath Diagnostics as a leader in non-invasive cancer diagnostics, potentially expanding its applications to other diseases detectable through breath analysis.

IPO Strategy and Economic Implications

Following the anticipated FDA milestone, Breath Diagnostics plans to launch an IPO within six months. This move is designed to attract larger-scale investment and fuel further research and development. An IPO would allow the company to tap into public markets, providing the resources needed to scale production and distribution of the breath test kits.

For Louisville’s East End headquarters, the expansion tied to these plans could create up to 30 new jobs. These positions would likely span research, manufacturing, and administrative roles, contributing to the local economy. Kentucky’s growing biotech sector, supported by institutions and incentives, stands to benefit from such developments, reinforcing the region’s reputation as a hub for health innovations.

Background on Breath Diagnostics and the Technology

Breath Diagnostics was founded in Louisville with a mission to leverage breath analysis for early disease detection. The firm’s technology stems from years of research into how specific biomarkers in breath can signal underlying health conditions. Lung cancer screening has been a primary focus due to the disease’s prevalence and the limitations of current detection methods, which often miss early-stage cases.

The non-invasive nature of the test addresses key barriers in healthcare, such as patient discomfort and high costs associated with traditional diagnostics. By enabling quicker and easier screening, the technology could lead to earlier interventions, improving patient outcomes and reducing overall treatment expenses for healthcare systems.

Currently, the company operates from its East End facility, where initial prototypes and early trials have been conducted. The Series B funding marks a critical escalation in resources, allowing for larger participant studies and refined data analysis to meet FDA requirements. As the trials progress, Breath Diagnostics will continue to collaborate with medical experts and regulatory bodies to ensure compliance and efficacy.

This development underscores the evolving landscape of personalized medicine, where simple diagnostic tools can play a transformative role. For patients at risk of lung cancer, particularly smokers or those with genetic predispositions, the potential availability of a breath test by 2026 represents a hopeful advancement in preventive care.

The path to FDA approval is not without challenges, including the need for robust clinical evidence and manufacturing scalability. However, Breath Diagnostics’ progress signals optimism for the biotech community in Louisville and beyond, potentially paving the way for similar innovations in respiratory health diagnostics.

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Author: HERE LOUISVILLE