MATTER and KOSME announce 2025 cohort for U.S. Market Validation Study Program for Korean SMEs and startups

CHICAGO, IL, and SEOUL, KR — MATTER, the premier healthcare incubator and innovation hub, in collaboration with the Korea SMEs and Startups Agency (KOSME), is pleased to announce the 2025 cohort for the U.S. Market Validation Study Program. This year, MATTER will support five small and medium enterprises (SMEs) and startups as they work to validate their products and business models for the U.S. healthcare market.

“The KOSME-U.S. Market Validation Study Program turns a complex U.S. healthcare landscape into a clear, actionable path for Korean companies,” said Cheolhyeong Jeon, Director at KOSME, Global Business Center-Chicago. “We are excited to support this year’s innovators as they convert validation into U.S. market traction.”

Over the past five years, MATTER and KOSME have collaborated to help Korean SMEs and startups launch in the U.S., providing guidance on strategy, regulatory considerations, and market entry. The 2025 program will support five companies through a three-month program, combining targeted programming, expert mentorship, and access to validation study partners to strengthen each company’s U.S. business case.

Selected participants will engage in validation studies with University of Chicago Medicine and University of Utah Health. The program also includes one-year membership to MATTER, allowing companies to access a network of healthcare innovators, investors, and industry experts.

Learn more about the 2025 cohort

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.

DFIX Ltd.
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.

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.

Learn more about the U.S. Market Validation Study Program for Korean SMEs and startups program here.

About KOSME
Since their inception in 1979, mandated by the visionary “Small & Medium Enterprises Promotion Act 1978” by the South Korean Congress, they’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, they proudly serve as the catalyst for over 22,000 Korean companies each year. Through their unwavering dedication, they 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.