RevealDx Announces Distribution Agreement And Investment From 4DMedical

Insider Brief

• RevealDx secured a distribution agreement and a $3.4 million strategic investment from 4DMedical to expand global access to its AI-powered RevealAI-Lung software for assessing lung nodules.
• RevealAI-Lung, which has FDA clearance, MDR certification and TGA approval, has been integrated into 4DMedical’s newly acquired contextflow platform and is already being used at several clinical sites in Europe.
• The software generates an AI-based malignancy score to help radiologists assess lung nodules, has been validated on more than 1,500 patients, and is eligible for Medicare reimbursement in the United States under CPT codes 0721T and 0722T.
• Image: Photo by kalhh

PRESS RELEASE — RevealDx, a leader in AI characterization of lung nodules, announced today, following World Lung Cancer Day, a distribution agreement and strategic investment of $3.4 million by 4DMedical (ASX: 4DX), expanding access to its flagship product, RevealAI-Lung. RevealAI-Lung has received MDR Certification, TGA Approval, and FDA clearance. In the transaction with 4DMedical, Chestnut Partners, Inc. served as the exclusive financial advisor to RevealDx.

This news follows 4DMedical’s recent acquisition of Austrian-based contextflow.  4DMedical, a global medical technology company, is revolutionising respiratory care through advanced imaging and artificial intelligence.  Contextflow offers advanced chest CT technologies that automate the identification of lung nodules.  RevealAI-Lung has been integrated into the contextflow platform and is already operational at several clinical sites across Europe.

The RevealDx technology characterizes incidental lung nodules by producing a Malignancy Similarity Index (mSI™), a score that helps radiologists make more informed follow-up recommendations to assist in cancer diagnosis. The company has validated the software on over 1,500 patients from a variety of cohorts.

The RevealAI-Lung CADx device offers several key capabilities, including:

• Significant improvement in Radiologist reader performance
• Use of real world NLST data as our reference population
• Clinically relevant malignancy scoring 
• First ever integration directly into PACS, vastly improving workflow
• Proven generalizability across exam types and patient populations

“We are excited to announce our new partnership with 4DMedical” said Chris Wood, CEO of RevealDx. “As we recognize World Lung Cancer Day, this milestone underscores our commitment to helping clinicians identify potentially malignant lung nodules earlier and with greater confidence. The incredible team at 4DMedical and the resources they bring will expand our reach and benefit patients.”

Andreas Fouras, Founder and CEO of 4DMedical, said, “For 4DMedical, this is about more than adding products. It is about building a connected ecosystem for cardiopulmonary care. CT:VQ™ gives physicians physiological insight into how the lung is actually functioning. By surrounding that capability with disease detection, and AI-powered risk stratification, we can help health systems identify the right patients earlier and ensure they receive appropriate care. The result is a platform that has the potential to improve outcomes for patients while increasing utilization of advanced functional imaging across vital disease areas.”

In addition to its recent regulatory milestones, RevealAI-Lung is reimbursable by Medicare in the United States under CPT codes 0721T and 0722T, helping to support broader clinical adoption.