2025 KOSME U.S. Market Validation Study Program Showcase

Join MATTER and KOSME for the showcase of the 2025 U.S. Market Validation Study Program celebrating six years of partnership supporting Korean healthcare entrepreneurs entering the U.S. market. Through this program, each company engaged in a validation study to gather feedback from healthcare stakeholders and strengthen their market readiness.

The event will open with a fireside chat exploring the role of real-world validation in advancing new technologies and how academic medical centers evaluate and adopt emerging innovations, featuring Dr. Jamie Dwyer, assistant vice president for clinical research and director of the Utah Data Coordinating Center at University of Utah Health, and Sharon Markman, executive director, clinical excellence innovation and engagement at UChicago Medicine.

Following the discussion, Cheolhyeong Jeon, director at KOSME, Global Business Center-Chicago, will share reflections on six years of international collaboration and impact from the MATTER–KOSME partnership. The showcase will then feature five presentations from the Korean companies, sharing how their solutions are addressing unmet clinical needs and advancing healthcare delivery.

Learn more about the 2025 cohort:

DFIX

DFIX Ltd. is a South Korean medical device company founded in 2019, specializing in non-invasive wound closure and catheter securement solutions. Built on real-world clinical experience, DFIX develops and manufactures innovative products such as DIALFIX, DIALFIX PLUS and SDFIX, all designed to improve surgical outcomes and reduce patient discomfort. The company operates a fully integrated in-house system covering R&D, production and export, and its products are already used in over 300 hospitals with more than 100,000 clinical applications. DFIX holds FDA, ISO 13485 and several international certifications. 

Gencurix 

Gencurix, Inc. is a molecular diagnostics company founded in 2011 and listed on KOSDAQ in 2020 through a technology-special listing. The company focuses on precision medicine, offering integrated molecular diagnostic solutions that span the full continuum of cancer care—including prognosis, companion diagnostics, early detection and therapeutic monitoring for solid tumors such as breast, lung and colorectal cancers. Gencurix has established proprietary digital PCR-based liquid biopsy technology for highly sensitive detection of genetic mutations, which differentiates the company in the in vitro diagnostics (IVD) market. 

AIT Studio

AIT Studio provides MEDISTEP M Pro—an iPad-based, markerless gait analysis solution used for rapid screening and follow-up in rehab settings, primary care, senior living/aging services and community fall-prevention programs. In approximately one minute, clinicians receive a full report (22+ metrics including speed, step length, asymmetry, balance) from a single 2D camera with on-device AI—no wearables, no gait lab and minimal training. Accuracy is ≥95% vs. VICON (gold standard); the product is Class I certified in Korea and classified as CDSS in U.S. FDA pre-research, enabling deployment without formal FDA clearance—delivering portable, simple and cost-efficient gait assessment at scale for fall risk, sarcopenia and mobility decline.

Ainex 

Ainex Corporation is a leading medical AI company dedicated to enhancing diagnostic accuracy and safeguarding patient lives through advanced AI technology. Our product, ENAD, is an AI-powered real-time lesion detection and diagnostic support solution for upper and lower GI endoscopy, setting a new standard in endoscopic diagnosis across domestic and global markets. Since its founding in 2019, Ainex has achieved rapid growth — earning Class II MFDS approval for ENAD CADe (ENAD-DET-01) in 2023, adoption by more than 100 medical institutions, and overseas expansion to six countries, including exports to Vietnam, Singapore, and Malaysia. In 2025, ENAD CADx (ENAD-CADx-01) became the first Korean colonoscopy AI solution to receive Class III MFDS approval and enter the national reimbursement process.

Soombit.ai

Soombit.ai, a South Korea–based healthcare AI startup, develops generative intelligence to empower physicians in medical imaging diagnostics. The company’s flagship solution, AIRead-CXR — the world’s first generative AI-based radiology SaMD to receive clinical trial approval from the Korean MFDS — revolutionizes chest X-ray reporting with AI-powered preliminary radiology reports that combine clinical reliability and workflow efficiency. Rooted in innovation and multidisciplinary expertise, Soombit.ai aims to redefine the healthcare ecosystem through intelligent, scalable solutions.

About KOSME

Since our inception in 1979, mandated by the visionary “Small & Medium Enterprises Promotion Act 1978” by the South Korean Congress, we’ve stood as a steadfast beacon of support for Korean Small and Medium-sized Enterprises (SMEs) and Startups. With an annual budget of $8.1 billion, bolstered by our expansive network of 26 global offices, we proudly serve as the catalyst for over 22,000 Korean companies each year. Through our unwavering dedication, we provide not just support, but comprehensive solutions, empowering these enterprises to navigate and conquer the ever-evolving business landscape of today. For more information, visit KOSME.

About MATTER

At MATTER, we believe collaboration is the best way to improve healthcare. The MATTER collaborative includes more than 1,000 current and alumni startups from around the world, working together with dozens of hospitals and health systems, universities and industry-leading companies to build the future of healthcare. Together we are accelerating innovation, advancing care and improving lives. For more information, visit matter.health and follow @MATTERhealth.