Cancer fighting biotechnology company, Breath Diagnostics Inc, onboarded a new president and raised USD$1 million in a convertible note financing.
The company announced on Thursday that it had appointed Aaron Roebuck, who brings three decades of experience in respiratory and cardiopulmonary medicine, as well as a background in the development and commercialization of medical devices.
Roebuck most recently served as senior director of Clinical Sciences at Vero Biotech, where he led initiatives in next-generation drug delivery systems. He has excelled in building teams, leading clinical trials, securing funding, and contributing to FDA submissions throughout his career.
This will help when it comes to Breath Diagnostics One Breath system, which can identify disease-specific biomarkers in
Aaron Roebuck, President of Breath Diagnostics. Image courtesy Linkedin.
under a minute from a single breath sample. Studies involving over 800 patients across multiple clinical sites have shown this technology’s promise, particularly in detecting lung cancer.
“Our breath analysis technology, OneBreath, currently in the research and development phase, has demonstrated significant potential in clinical studies focused on the detection of diseases such as lung cancer and pneumonia,” said Ivan Lo, CEO of Breath Diagnostics.
Lo continued in saying that his company is committed to advancing the platform technology with a focus on future commercialization, adding that Aaron’s extensive industry experience will drive efforts to bring OneBreath to market.
“I am honored to join Breath Diagnostics at such a pivotal time,” said Roebuck.
“OneBreath has the potential to significantly improve early detection of diseases like lung cancer and pneumonia. I look forward to helping lead the Company’s efforts as we move toward the ever-important commercialization phase.”
Read more: Breath Diagnostics pioneers novel lung cancer breath test
Read more: Breath Diagnostics takes aim at lung cancer with One Breath
Breath Diagnostics to commercialize its product as lab-developed test
The financing was led by strategic investors, including Lo himself. This financing is for general and administrative operations, and to advance research and development for the OneBreath platform. It is not, however, for the beginning of the FDA approval process.
Instead, the company’s current focus is to commercialize its product as a laboratory-developed test, allowing entry into private markets before pursuing FDA authorization. This approach will enable customers to pay for the product once its results are verified, and Clinical Laboratory Improvement Amendments (CLIA) certification is obtained.
CLIA is a set of regulations in the United States that establish standards for laboratory testing to ensure accuracy, reliability, and timeliness of patient test results.
The company aims to make the product accessible for third-party labs equipped with mass spectrometers, such as those at the Mayo Clinic, to repeat results.
In the interim, Breath Diagnostics plans to build on this framework to launch a National Lung Cancer Screening Trial, which Lo estimates will take two to three years due to the low incidence of lung cancer and the existing standard of care.
Currently, screening relies on low-dose computed tomography (LDCT), which typically requires multiple follow-ups to confirm a diagnosis. Lo intends to start commercialization and the initial phases of the national trial within the next 12 to 18 months.
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