Fully-automated Bronchosolve solution demonstrates major technological advancement in both screening and non-screening cases with suspicious pulmonary nodules; advances on pathway toward clinical use

IMVARIA Inc., a health tech company pioneering AI-driven digital biomarker solutions, today announced that the company’s new platform Bronchosolve, an AI-powered diagnostic solution for assessment of suspicious pulmonary nodules, met the primary endpoints in the pivotal VIRTUAL-BRONCH Study, demonstrating significant improvement in the ability to diagnose lung cancer non-invasively. Key results will be presented at a future scientific conference in 2026. IMVARIA will also be presenting an oral scientific presentation on Bronchosolve at the CHEST conference in Chicago in the session entitled “AI: Cracking the Code in Innovations in Lung Nodule Risk and Diagnosis” at 1:45 pm - 2:30 pm on Tuesday, October 21^st.

The IMVARIA team conducted the pivotal VIRTUAL-BRONCH study of its new Bronchosolve solution to obtain data that underscores efficacy. In this study focused on better non-invasive diagnosis of lung cancer in cases of suspicious pulmonary nodules, topline results showed increased correct cancer classification independently and in combination with expert radiologists and pulmonologists.

“We’re extremely pleased to have taken this significant step forward through our pivotal VIRTUAL-BRONCH Study of our new Bronchosolve solution for suspicious pulmonary nodules. We believe that this new, fully automated solution has the potential to aid diagnoses non-invasively,” said Joshua Reicher, MD, Co-founder and CEO of IMVARIA. “With Bronchosolve, we’re rapidly building on the success that our Fibresolve diagnostic service for pulmonary fibrosis has been having with more than 30 medical institutions around the U.S.”

Bronchosolve is a completely automated, end-to-end platform with a streamlined workflow, eliminating the need for clinicians to do any manual data and imaging manipulation. This solution from IMVARIA is designed to advance a more accurate, non-invasive way to identify lung cancer through cutting-edge AI capabilities uniquely built by medical doctors.

Every two minutes, someone in the U.S. is diagnosed with lung cancer, and every day, lung cancer takes the lives of more than 360 people, according to the American Lung Association. Lung cancer is the leading cause of cancer death worldwide, according to the American Cancer Society. It accounts for 19% of all cancer deaths. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined. The American Cancer Society also reports that, overall, the chance that a man will develop lung cancer in his lifetime is about 1 in 17; for a woman, the risk is about 1 in 18.

These statistics fuel massive efforts in the U.S. and around the world to improve the diagnosis of lung cancer as well as accelerate them through reliable, non-invasive risk assessment.

IMVARIA’s pivotal VIRTUAL-BRONCH study analyzed cases from patients from multiple major cancer centers and health systems in the U.S. The objective was to assess Bronchosolve’s ability to diagnose lung cancer non-invasively through an efficient workflow, in both screening and non-screening cases with suspicious pulmonary nodules. The primary endpoints were met, demonstrating improved accuracy relative to standard clinical assessments.

Michael Muelly, MD, Co-founder and CTO of IMVARIA, said, “The Bronchosolve platform for lung cancer fits well with IMVARIA’s centralized service that uses AI to help guide safe, non-invasive diagnoses, similar to our Fibresolve platform in interstitial lung disease and idiopathic pulmonary fibrosis. We have been successfully able to deliver exactly what clinicians need, and we are doing it yet again with Bronchosolve. We’re making it extremely easy for clinicians to access highly impactful diagnostic solutions from IMVARIA.”

The Next Frontier for the Use of IMVARIA’s AI Innovation Aimed to Improve Patient Outcomes

Led by Stanford School of Medicine-trained practicing doctors who are also trained engineers formerly of Google, IMVARIA is known for its two FDA authorizations for AI-powered tests, growing commercial traction, a strong interdisciplinary team, and a unique go-to-market strategy for AI tests.

As the first FDA-authorized AI diagnostic tool in idiopathic pulmonary fibrosis (IPF), IMVARIA’s Fibresolve was designed to meet the highest medical standards, deliver new insights, and make it easy for clinicians to use AI with confidence and minimal burden.

Fibresolve received FDA authorization in early 2024 for use in suspected interstitial lung disease (ILD), including idiopathic pulmonary fibrosis (IPF), and went through a rigorous process to make it useful and reliable for clinicians. Fibresolve also has the distinction as the first FDA Breakthrough-Designated AI diagnostic tool with simultaneously adopted CPT billing codes by the American Medical Association (AMA) in any disease.

IMVARIA was recently awarded a Phase I Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) for its work on Bronchosolve.

Bronchosolve is an investigational software device and has not been cleared or approved by the U.S. Food and Drug Administration (FDA) for clinical use. It is currently available for research and evaluation purposes only.

For more information about IMVARIA, click here.

About IMVARIA Inc.

IMVARIA is a health tech company pioneering AI-driven solutions that empower clinicians to make accurate diagnoses and prognoses at earlier stages of disease. Founded in 2019 by physician-engineers from Google and Stanford University, the company operates its AI Platform with automated, machine-learning algorithm technology to transform clinical decision-making into data science. IMVARIA is based in Berkeley, CA. For more information, go to www.imvaria.com.

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“The Bronchosolve platform for lung cancer fits well with IMVARIA’s centralized service that uses AI to help guide safe, non-invasive diagnoses" -- Michael Muelly, MD, Co-founder and CTO of IMVARIA