IMVARIA Announces Presentations at American Thoracic Society International Conference Featuring IMVARIA’s AI-Driven Digital Biomarker Technology

Berkeley, Calif. – April 18, 2023 − IMVARIA Inc., a software-as-medical-device (SaMD) company pioneering AI-driven digital biomarker solutions, today announced that four presentations utilizing the company’s technology will be featured at the upcoming American Thoracic Society 2023 International Conference (ATS 2023),held in Washington, DC from May 19-24.  

“Our vision at IMVARIA is to transform clinical decision-making into data science that can help physicians more accurately and rapidly diagnose patients, and therefore, potentially reduce the need for invasive biopsy testing,” said Joshua Reicher, MD, CEO of IMVARIA, and Michael Muelly, MD, CTO of IMVARIA. “These four presentations at ATS demonstrate our ability to leverage AI, machine learning and deep-learning models in ways that may ultimately help optimize patient outcomes through novel digital biomarkers.”

Details for the four presentations can be found below:

Chest Computed Tomography Machine Learning Classifier for Idiopathic Pulmonary Fibrosis Predicts Mortality in Interstitial Lung Diseases
Oral Presentation
Mini Symposium, Session D91 - Looking for the Crystal Ball: Biomarkers to Predict Disease Progression and Mortality in ILD
May 24, 2023, 12:00 PM - 2:00 PM
Walter E Washington Convention Center, Ballroom A (Level 3)

Development and Validation of a CT-based Deep Learning Algorithm to Augment Non-invasive Diagnosis of Idiopathic Pulmonary Fibrosis
Poster Presentation #812
Poster Discussion, Session A23 - Leveraging Imaging and Biosamples to Improve Diagnosis and Risk Prediction in ILA and ILD
May 21, 2023, 9:00 AM - 11:00 AM
Walter E. Washington Convention Center, Room 209 A-C (Level2)

Predicting Interstitial Pulmonary Fibrosis Using a Machine Learning Classifier in Cases Without Definite or Probable Usual Interstitial Pneumonia Pattern on Computed Tomography
Poster Presentation #P556
Thematic Poster Session C39. Care and Evaluation of Patients with Interstitial Lung Disease
May 23, 2023, 11:30 AM - 1:15 PM
Walter E. Washington Convention Center, Area E, Hall C(Lower Level)

A Machine Learning System to Predict Diagnosis of Idiopathic Pulmonary Fibrosis Non-Invasively in Challenging Cases
Poster Presentation #P557
Thematic Poster Session C39. Care and Evaluation of Patients with Interstitial Lung Disease
May 23, 2023, 11:30 AM - 1:15 PM
Walter E. Washington Convention Center, Area E, Hall C(Lower Level)

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About IMVARIA Inc.

IMVARIA is a software-as-medical-device (SaMD) 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.

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Anthony Petrucci
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anthony@bioscribe.com
512-581-5442

IMVARIA Enters into Know-how Agreement with Mayo Clinic to Improve the Understanding of Cancer through AI Digital Biomarkers

Berkeley, Calif. – November 1, 2023 − IMVARIA Inc., a health tech company pioneering AI-driven digital biomarker solutions, today announced a collaboration through a know-how agreement with Mayo Clinic to develop AI designed to significantly improve the analysis and understanding of cancer, beginning with lung cancer. With its unique platform built by a cohort of co-founders to include former Googlers, engineers, and medical doctors, IMVARIA’s team of experts specializes in developing and advancing digital biomarkers to enable better patient outcomes.

The collaboration brings together IMVARIA’s engineering expertise in digital biomarkers with Mayo Clinic’s know-how and data assets as part of the Validate pillar of Mayo Clinic Platform. The large-scale datasets will allow for comprehensive and reliable training of AI “brains” to discover and validate clinically relevant software-only biomarkers for cancer, analyzing complex text, numeric values, and images. The AI-powered digital biomarkers that result from this joint work, which will analyze a range of medical data types, will help clinicians gain unique insights into making better-informed decisions for treating patients with lung cancer.

Lung cancer is the leading cause of cancer death in the US, accounting for about 1 in 5 of all cancer deaths, according to the American Cancer Society. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined. In 2023, over 125,000 deaths have occurred due lung cancer, and nearly a quarter-of-a-million new lung cancer cases were identified.

“AI biomarkers hold immense promise to unlock a more intricate understanding of many diseases, including cancers, and to advance healthcare with AI-powered precision,” said Joshua Reicher, MD, Co-founder and CEO of IMVARIA. “Our collaboration blends high-quality, big data for digital biomarker development with a strategy to make the new biomarkers available for use within the medical and clinical research community.”

“We’re excited to collaborate with Mayo Clinic to harness big data and AI with the aim to create novel insights that are powered by millions of data points,” said Michael Muelly, MD, CTO of IMVARIA. “Together, we’re helping advance digital healthcare delivery capabilities.”

Mayo Clinic has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education, and research.

About IMVARIA Inc.

IMVARIA is a software-as-medical-device (SaMD) 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.

Media Contact

Anthony Petrucci
Bioscribe
anthony@bioscribe.com
512-581-5442

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. – January 16, 2024 − 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.

About IMVARIA Inc.

IMVARIA is a software-as-medical-device (SaMD) 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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Anthony Petrucci
Bioscribe
anthony@bioscribe.com
512-581-5442

IMVARIA Receives 510(k) Clearance for ScreenDx, a First-of-its-Kind Screening Algorithm to Assess for Interstitial Lung Disease

IMVARIA’s ScreenDx enhances referral pathways by automatically assessing medical data for interstitial lung findings compatible with interstitial lung disease (ILD)

Berkeley, Calif. – January 13, 2025 − IMVARIA Inc., a health tech company pioneering AI-driven digital biomarker solutions, today announced its second FDA authorization, securing 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ScreenDx solution, an AI-powered healthcare tool to assist clinicians in assessing for interstitial lung disease (ILD).

“ScreenDx is a software‐only device leveraging artificial intelligence to analyze CT imaging data for findings suggestive of interstitial lung disease,” said Joshua Reicher, MD, Co-founder and CEO of IMVARIA. “ScreenDx is designed to be supplementary for current standard-of‐care workflows, providing adjunctive information based on pattern recognition, as part of a referral pathway to an appropriate, qualified clinician. This FDA clearance marks another major milestone for IMVARIA, continuing the advancement of AI-based healthcare technologies.”

Patients with ILD suffer from frequent diagnostic delays and often undergo multiple clinical and radiological assessments before getting diagnosed. ScreenDx was developed by IMVARIA to augment referral pathways by automatically assessing for interstitial lung findings compatible with interstitial lung disease, helping flag this deadly disease in a wide range of settings. It is intended as an incidental screening tool to set patients on a path to be given an appropriate diagnosis and treatment on a timely basis.

“With the FDA 510(k) clearance of our ScreenDx digital solution, IMVARIA continues on the quest to make AI highly practical, useful, and easy to incorporate into medical practice for the thousands of pulmonologists who treat patients with lung diseases,” said Michael Muelly, MD, Co-founder and CTO of IMVARIA. “Our ultimate goal is to help patients with serious diseases, like ILD, get identified and placed into the diagnostic pathway as efficiently as possible, regardless of whether they were first seen in emergency, lung cancer screening, or specialty clinical settings. As medical doctors ourselves leading IMVARIA, we are putting another powerful tool into the hands of clinicians to help enhance decision-making.”

This regulatory milestone builds on IMVARIA’s success last year with the FDA’s authorization of IMVARIA’s Fibresolve, an adjunctive diagnostic solution that uses AI to guide safe, non-invasive diagnosis of idiopathic pulmonary fibrosis (IPF). In early 2024, this signified 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.  

In the United States, interstitial lung disease affects approximately 650,000 people and causes between 25,000 and 30,000 deaths every year, according to the JAMA Network. ILD is a type of lung condition that causes inflammation or fibrosis in lung tissue, characterized by shortness of breath and difficulty getting enough oxygen into the bloodstream. ILD is complex, as it can have many causes and vary in treatments. In some cases, ILD can eventually lead to a patient’s need for a lung transplant, if not detected in an early stage and not treated early enough. With ScreenDx helping assess for ILD, and Fibresolve serving as a diagnostic adjunct in IPF, IMVARIA is driving care forward for patients with diffuse lung disease.

For more information about IMVARIA, click www.imvaria.com.

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 and reduce the need for invasive biopsy testing. Founded in 2019 by physician-engineers from Google and Stanford University, the company operates its AI 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.

ScreenDx Use

ScreenDx is a software‐only device that receives and analyzes lung computed tomography (CT) imaging data in order to assess for interstitial lung findings compatible with interstitial lung disease. The device supplements the standard-of‐care workflow by providing a qualitative output of imaging findings based on pattern recognition, in order to provide adjunctive information as part of a referral pathway to an appropriate qualified clinician. Patients with positively identified patterns may undergo assessment for lung fibrosis, but ScreenDx does not replace the current standard of care methods for diagnosis of lung fibrosis and the results of the device are not intended to rule-out or rule-in lung fibrosis. The results of ScreenDx are intended to be used only by clinicians qualified in the care of lung disease, in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment.

Media Contact

Anthony Petrucci
Bioscribe
anthony@bioscribe.com
512-581-5442