IMVARIA’s development of a new test for more accurate malignancy assessment in chest CTs, building on the success of Fibresolve and advancing healthcare AI innovation
IMVARIA Inc., a health tech company pioneering AI-driven digital biomarker solutions, today announced that it has been awarded a Phase I Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH). The funding will support IMVARIA’s development of a new test for more accurate malignancy assessment in chest CTs, building on the success of Fibresolve, its FDA-authorized AI adjunctive diagnostic service in lung disease. This work extends IMVARIA’s AI Platform and algorithms into oncology, leveraging the foundation of healthcare AI innovation that the company has already established since its founding by a team of practicing medical doctors with engineering expertise five years ago.
“IMVARIA was selected for this NIH SBIR grant because of our innovative technology, two prior FDA authorizations, growing commercial traction, a strong interdisciplinary team, and a unique go-to-market strategy. Together, these factors demonstrate scientific credibility and a clear path to enhancing patient care,” said Joshua Reicher, MD, Co-founder and CEO of IMVARIA. “Our Fibresolve AI adjunctive diagnostic service is already making a real difference in patients’ lives, giving us the confidence to apply it to other challenging problems, including oncology assessment.”
More than 1.5 million Americans have an indeterminate pulmonary nodule (IPN) identified on a CT scan each year, according to a study published on the NIH website. Approximately 63,000 of them are estimated each year to receive a diagnosis of lung cancer within two years.
Next Steps on a Path Toward the Clinic
This Phase I NIH SBIR grant expands the IMVARIA Medical AI Platform beyond its first use cases in inflammatory and lung disease into oncology for the first time as a company. IMVARIA has already presented preliminary results at the ATS 2025 conference. Now supported by the grant, the next stage of development is to advance this early work to regulatory-grade performance, so it can then move into clinical studies and, ultimately, into routine clinical use, alongside IMVARIA’s other FDA-authorized AI technologies and services.
“Our long-term goal at IMVARIA is to enable better non-invasive diagnoses and to generate new insights into how patients are assessed and managed across a range of conditions,” said Michael Muelly, MD, Co-founder and CTO of IMVARIA. “This NIH SBIR grant is a meaningful step forward, underscoring recognition that AI can go beyond administrative and backend applications and play a direct, positive role in advancing patient care.”
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 is available through IMVARIA’s centralized service that uses AI to help guide safe, non-invasive diagnoses. 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 is considered one of the most innovative healthcare AI companies,” said Fayez Kheir, MD, a pulmonologist at Massachusetts General Hospital in Boston. “The grant from NIH will accelerate IMVARIA’s work to extend their impressive AI capabilities to a critical sector within the oncology field. I look forward to seeing the outcome from this important work.”
SBIR grants are intended to stimulate technological innovation and encourage small U.S.-based businesses to advance research and development with the potential for commercialization. The objective of phase I grants is to establish the technical merit, feasibility, and commercial potential of a proposed R&D project.