- Sector
- Health technology
- Industry
- Medical specialties
- Address
- Seongnam-si South Korea
- IPO Date
- Nov 30, 2021
- Business
- CALTH, Inc. is a South Korea-based biotechnology and medical device company specializing in the research, development, and manufacturing of in vitro diagnostic (IVD) medical devices, point-of-care testing (POCT) platforms, and artificial intelligence-driven diagnostic software. Founded in 2018 and headquartered in Gunpo-si, Gyeonggi-do, South Korea, the company operates within the healthcare and medical technology sector and is publicly traded on the Korea New Exchange (KONEX) under the ticker symbol 402420. CALTH develops rapid, accessible diagnostic solutions designed for hospitals, clinics, diagnostic laboratories, and decentralized healthcare settings worldwide.
The company manufactures and commercializes a diverse portfolio of rapid diagnostic test kits primarily under its proprietary AllCheck brand, alongside digital diagnostic hardware and mobile healthcare solutions. Its core product lines include: respiratory diagnostic kits, such as AllCheck COVID-19 Ag, AllCheck Flu/COVID-19 Ag Combo, and AllCheck Flu/COVID-19 Ag Duo Plus; infectious disease rapid tests, including diagnostic cards for Dengue NS1 and IgG/IgM, Syphilis Anti-TP, Hepatitis B Virus surface antigen (HBsAg) and antibody (Anti-HBs), Hepatitis C Virus (HCV), and Human Immunodeficiency Virus (HIV 1/2); gastrointestinal and preventive screening tests, such as AllCheck Fecal Occult Blood (FOB) cards for colorectal screening and Helicobacter pylori rapid tests; reproductive health and fertility tests, such as AllCheck Human Chorionic Gonadotropin (hCG) pregnancy test cards; and diagnostic instruments and analytical software, including the ALLSIGNAL PLUS lateral flow assay point-of-care reader and deep learning-based diagnostic algorithms (SMARTAI-LFA) that provide automated, high-sensitivity reading and quantitative result analysis.
CALTH supports its product portfolio through proprietary biotechnology platforms, including Engineered Nanotrap sample pre-treatment mechanisms and Ion Concentration Polarization (ICP) technology, which enhance the analytical sensitivity and detection limits of lateral flow immunoassay tests. The company serves domestic and international healthcare markets across the Asia-Pacific region, Latin America, and Europe, maintaining quality management compliance under ISO 13485:2016 and Korea Good Manufacturing Practice (KGMP) standards.
In recent corporate developments, CALTH has advanced its international regulatory positioning by obtaining European Union In Vitro Diagnostic Medical Device Regulation (CE-IVDR) Class C conformity certification for its AllCheck syphilis diagnostic line, alongside acquiring overseas product registrations and manufacturing compliance certifications from Brazil’s ANVISA and Mexican regulatory authorities. Domestically, the company has expanded its commercialization channels through strategic distribution collaborations and supply agreements with prominent pharmaceutical companies, including Daewoong Pharmaceutical and Huons. Additionally, CALTH was selected for the South Korean government’s Ministry of SMEs and Startups Scale-up TIPS program to accelerate next-generation diagnostic R&D, and has completed targeted capital expansion through private placements and convertible debt financing to fund ongoing technological innovation, production scale-up, and global market penetration.