Breath Diagnostics, Inc. Receives FDA Breakthrough Device Designation for OneBreath™ Platform to Aid Pre-Operative Pneumonia Risk Assessment

Today is a proud and meaningful moment for all of us at Breath Diagnostics, Inc.

The FDA has just granted Breakthrough Device Designation (BDD) to our OneBreath™ platform for the pre-operative assessment of postoperative pneumonia risk in patients undergoing elective cardiac surgery.

To our knowledge, OneBreath™ is the first LC-MS–based molecular breath test to receive Breakthrough Device Designation. That distinction reflects the novelty of bringing laboratory-grade molecular quantification technology into a simple, non-invasive breath test intended for clinical use.

For those who have been part of this journey from the early days, this milestone carries real weight. What started as a bold idea — that a simple breath sample could provide quantitative, molecular insight into serious disease risk — is now advancing within a formal FDA regulatory framework.

The FDA’s Breakthrough Devices Program is reserved for select technologies that meet specific statutory criteria. To qualify, a device must be intended to provide for more effective diagnosis or treatment of a life-threatening or irreversibly debilitating condition, and must also meet additional requirements such as representing breakthrough technology, offering significant advantages over existing alternatives, or addressing an unmet medical need.

We are encouraged that, based on the submitted data and materials, OneBreath™ met the criteria for designation under this program.

Breakthrough Device Designation provides prioritized interaction and more frequent engagement with the FDA as development continues. While this designation is not FDA approval or clearance, it represents an important step forward in our regulatory pathway.

Postoperative pneumonia remains one of the most serious complications following cardiac surgery. Currently, clinicians lack a non-invasive molecular tool to assess risk prior to surgery. OneBreath™ is designed to measure volatile carbonyl metabolites from a single exhaled breath sample using our proprietary microreactor and LC-MS workflow, with the goal of providing additional biological insight to support perioperative risk assessment.

This milestone did not happen overnight. It represents years of research, iteration, clinical collaboration, persistence, and belief in a new category of diagnostics.

Most importantly, it reflects your support.

Whether you invested capital, shared expertise, opened doors, or stood behind our vision during difficult moments, you have helped make this possible. Building a new diagnostic platform requires patience, resilience, and conviction. We are deeply grateful for the trust you have placed in us.

There is still important work ahead, but today marks a meaningful step in our mission to establish breath-based molecular diagnostics as a powerful tool in precision medicine.

Thank you for being part of this journey.