# Breath Diagnostics

Companies like Breath Diagnostics and Menssana Research focus on portable sensory systems and proprietary VOC cartridges.

Source: https://en.bioecon.ru/companies/breath-diagnostics/
Updated: 2026-07-02

- Country: United States

## Verifiable facts

| Fact | Value | Source |
| --- | --- | --- |
| Funding | Approximately $7.7 million in prior capital, plus up to $3 million sought in a Reg CF offering starting in May 2025 | https://kingscrowd.com/breath-diagnostics-on-equifund-2025/, https://www.breathdiagnostics.com/investors |
| Revenue | $0 (pre-revenue as of December 31, 2024) | https://kingscrowd.com/breath-diagnostics-on-equifund-2025/, https://www.sec.gov/Archives/edgar/data/2066219/000121390025039119/formc.pdf, https://www.sec.gov/Archives/edgar/data/2066219/000121390026036283/formca.pdf |
| Regulatory approval | OneBreath platform granted FDA Breakthrough Device Designation as of February 2026; no FDA clearance or approval for clinical/commercial use yet | https://www.breathdiagnostics.com/blog/breath-diagnostics-inc-receives-fda-breakthrough-device-designation-for-onebreath-tm-platform-to-aid-pre-operative-pneumonia-risk-assessment, https://www.prnewswire.com/news-releases/breath-diagnostics-inc-receives-fda-breakthrough-device-designation-for-onebreath-platform-to-aid-pre-operative-pneumonia-risk-assessment-302692062.html |
| Headcount | 8 employees | https://www.sec.gov/Archives/edgar/data/2066219/000121390025039119/formc.pdf, https://www.sec.gov/Archives/edgar/data/2066219/000121390026036283/formca.pdf |
| Production site | Laboratories at The University of Louisville, 201 E Jefferson Street, Suite 303, Louisville, Kentucky, USA 40202 | https://www.sec.gov/Archives/edgar/data/2066219/000121390025039119/formc.pdf, https://www.sec.gov/Archives/edgar/data/2066219/000121390026036283/formca.pdf |
| Capacity | None; company is in the late R&D stage and planning for manufacturing setup | https://kingscrowd.com/breath-diagnostics-on-equifund-2025/ |
| Certification | None reported | https://www.prnewswire.com/news-releases/breath-diagnostics-inc-receives-fda-breakthrough-device-designation-for-onebreath-platform-to-aid-pre-operative-pneumonia-risk-assessment-302692062.html |

Independent sources: kingscrowd.com, prnewswire.com, sec.gov

## Technologies

- [Breathomics](https://en.bioecon.ru/technology/breathomics/)