Coreline Soft has been selected as the lead research and development institution for a national project aimed at obtaining U.S. Food and Drug Administration (FDA) 510(k) clearance for its CT-based artificial intelligence (AI) diagnostic assistance software for lung diseases.

According to a disclosure filed on the 23rd, Coreline Soft was selected for the '2026 1st Multi-Ministerial Advanced Medical Device R&D Project New Support Program,' organized by the Multi-Ministerial Medical Device R&D Project Group, and has signed a corresponding agreement. The date of occurrence was the 10th. The project is titled 'Clinical Trials and U.S. FDA Clearance Acquisition for Safety and Efficacy Verification of Two Types of CT-Based Lung Disease AI Diagnostic Assistance Software Medical Devices.'

• *[Project Core Summary]**
• R&D Period: April 1, 2026 – December 31, 2028 (33 months total)
• Total R&D Budget: KRW 2.94 billion (KRW 2.2 billion in government funding, KRW 740 million in company contribution)
• Government Funding Ratio: 12.11% of the company's equity capital

The final goal of this project is to conduct local clinical trials in the United States for Coreline Soft's medical image analysis software, 'AVIEW Lung Nodule CAD (AVIEW IPN)' and 'AVIEW Lung Metrics,' and to obtain FDA 510(k) clearance. Additionally, the company plans to pursue the publication of one paper in an international academic journal.

• *[Target Software and Implementation Plan]**
• AVIEW Lung Nodule CAD (AVIEW IPN): An AI software for the automatic detection of lung nodules based on coronary CT angiography (CCTA) and chest CT images. Following the verification of the safety and efficacy of AI-based diagnostic assistance technology in addressing the problem of missed incidental pulmonary nodule (IPN) detections through multi-center clinical trials in the U.S., the company will pursue FDA clearance.
• AVIEW Lung Metrics: A general-purpose lung quantitative analysis software based on chest CT scans. Through joint research with U.S. researchers, the company aims to verify the accuracy of automated analysis of lung quantitative biomarkers, obtain FDA 510(k) clearance, and publish an academic paper.

Coreline Soft's policy is to secure clinical evidence and regulatory approval foundations for entry into the U.S. market through this national project, further strengthening the global competitiveness of its AI-based lung disease diagnostic solutions.

※ Note: This disclosure does not indicate that the products have already obtained FDA clearance; rather, it reports the company's selection for a national project that 'aims' to conduct U.S. clinical trials and obtain FDA 510(k) clearance.