Coreline Soft, a Korean medical AI company, said it has signed a supply agreement with Japan-based contract research organization (CRO) Micron to provide its AI-powered imaging analysis software, AVIEW COPD, as part of its strategic expansion into the Japanese market.

The deal marks a significant step in Coreline Soft’s efforts to diversify beyond its core markets of the U.S. and Europe, as it increasingly targets fast-growing Asian healthcare AI markets. The company recently partnered with China’s Suhai to enhance its presence in China.

Founded in 2005, Micron is Japan’s largest imaging-focused CRO and a subsidiary of CE Holdings, a medical AI company listed on the Tokyo Stock Exchange. In addition to managing clinical trial operations, Micron offers regulatory consulting services, including strategy development for submissions to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), enhancing its ability to navigate Japan’s complex regulatory landscape.

According to Coreline Soft, Micron has delivered imaging services to over 700 local medical institutions and has participated in the development of approximately 100 AI healthcare solutions. Leveraging Micron’s clinical trial expertise and regulatory know-how, the company aims to expedite market entry and product approvals in Japan.

AVIEW COPD is designed to enable early detection of chronic obstructive pulmonary disease through fully automated imaging analysis. The software is currently approved by major global regulatory bodies, including the U.S. FDA, the European CE marking authority, and Japan’s PMDA. It is already being used in hospitals across the U.K., Japan, and Taiwan.

“This agreement with Micron goes beyond simple product distribution. It is a comprehensive partnership covering regulatory strategy and PMDA submission preparation,” Coreline Soft CEO Kim Jin-kook said. “We plan to accelerate our market entry in Japan by jointly developing regulatory strategies and clinical designs with Micron, ultimately broadening product approvals in the region.”

Coreline Soft is executing a full-fledged expansion strategy in Asia, building on its trust and track record in the U.S. and European markets, Kim added.

Kim stressed the company’s expansion into Japan is not a one-off initiative, but a critical step toward sustainable business growth.