IMVARIA Announces FDA De Novo Marketing Authorization of Fibresolve, an AI Biomarker in Lung Fibrosis, and the Adoption of Novel CPT Billing Codes by the American Medical Association

Industry’s first FDA-Authorized Breakthrough AI-based diagnostic tool with integrated billing codes

BERKELEY, Calif.--(BUSINESS WIRE)-- IMVARIA Inc., a health tech company pioneering AI-driven digital biomarker solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the use of Fibresolve, a digital biomarker solution that uses artificial intelligence (AI) to guide safe, non-invasive diagnosis of lung fibrosis with a focus on idiopathic pulmonary fibrosis (IPF). This signifies the first ever FDA authorization of a diagnostic tool of any type in lung fibrosis, and the first FDA Breakthrough-Designated AI diagnostic tool with simultaneously adopted CPT billing codes by the American Medical Association (AMA) in any disease.

“Fibresolve serves as an adjunct to clinicians in assessing patients with suspected lung fibrosis to provide a diagnostic subtype classification, potentially facilitating proper treatments at an earlier stage of the disease process,” said Joshua Reicher, MD, Co-founder and CEO of IMVARIA. “The FDA’s authorization of Fibresolve marks a significant milestone, not only for lung fibrosis patients, but also for the advancement of AI-based healthcare technologies. The medical community, along with health insurance companies, now has a viable, cost-effective option making AI highly practical, useful, and easy to incorporate into medical practice for the thousands of pulmonologists who treat patients with lung disease.”

Lung fibrosis is a life-threatening group of diseases that affect hundreds of thousands of people every year, with IPF the most devastating. Traditionally, existing therapies for this disease are expensive and, if given to the wrong patients, potentially toxic. On average, this condition carries a nearly two-and-a-half-year delay in the diagnosis from the initial manifestation of symptoms. Meanwhile, severe lung impairment and even death can happen within one to two years from the onset of lung fibrosis. To deliver on the promise of AI-driven digital biomarkers to improve the outcomes for patients, IMVARIA developed Fibresolve as a groundbreaking innovation and met stringent regulatory requirements to earn FDA authorization.

The FDA authorization of IMVARIA’s lead product Fibresolve, as a billable digital diagnostic tool for clinicians to use for patients, will expedite the medical community’s access to a non-invasive diagnostic solution using digital biomarkers in a novel way for lung fibrosis. This new authorization builds on the past medical and scientific assessments that the FDA had previously completed in assigning Fibresolve Breakthrough Device Designation.

“It’s important to have new and validated options, such as Fibresolve, for those patients at risk of IPF,” said Joshua Mooney, MD, MS, Clinical Assistant Professor, Medicine – Pulmonary, Allergy & Critical Care at Stanford Medicine, and a board certified pulmonologist and critical care physician who specializes in the care of interstitial lung disease and lung transplant patients. “I look forward to seeing the positive impact of Fibresolve on lung fibrosis patients across the nation.”

“For people living with the rapidly deteriorating symptoms of this rare, yet deadly disease, the FDA authorization of Fibresolve offers real hope, while giving doctors who treat these patients a new, powerful tool that is designed to save lives and reduce suffering at an exponential rate that only AI can deliver,” said Michael Muelly, MD, Co-founder and CTO of IMVARIA. “This truly is a major step forward in advancing digital healthcare through the use of AI in the hands of medical doctors.”

As an option before other more invasive options are considered, data from patients with suspected interstitial lung disease is run through IMVARIA’s AI-trained algorithm to provide non-invasive adjunct information, a diagnostic subtype classification, helping drive diagnosis and setting the patient on a pathway to be given an appropriate treatment on a more timely basis. In addition to the health benefits, this is expected to save thousands of dollars per person for each test, with the cost savings going back into the health system.

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About IMVARIA Inc.

IMVARIA is a health tech company pioneering AI-driven digital biomarker solutions that empower clinicians to make accurate diagnoses and prognoses at earlier stages of disease and reduce the need for invasive biopsy testing. Founded in 2019 by physician-engineers from Google and Stanford University, the company operates its Digital Biomarker Lab 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.

FIBRESOLVE Intended Use

Fibresolve is a software‐only device that receives and analyzes lung computed tomography (CT) imaging data in order to provide a diagnostic subtype classification in suspected cases of interstitial lung disease (ILD). The device supplements the standard‐of‐care workflow by providing a qualitative, diagnostic classification output of imaging findings based on machine learning pattern recognition, in order to provide adjunctive information as part of a referral pathway to an appropriate Multidisciplinary Discussion (MDD) or as part of an MDD. Specifically, the tool is used to serve as an adjunct in the diagnosis of idiopathic pulmonary fibrosis (IPF) prior to invasive testing. The results of Fibresolve are intended to be used only by clinicians qualified in the care of lung disease, specifically in caring for patients with ILD, in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment.

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