• AXINON® LDLp Test System secures approval from Malaysia’s Medical Device Authority (MDA)
• numares Health designates BioD Medica for local distribution
• Filing for MDA approval of an additional CE-marked product is currently underway

REGENSBURG, Germany, Dec. 17, 2025 — numares Health (“numares”), a transformative metabolomics firm at the forefront of multidimensional biomarker insights that drive clinical pathways for optimal patient care, today reveals its expansion into the ASEAN region. This follows regulatory approval in Malaysia and the securing of its first contract for the AXINON® LDLp Test System (“AXINON“) with BioD Medica, a specialist in introducing medical devices and healthcare technology to Malaysia and Singapore.

Florian Voss, Chief Executive Officer at numares Health said: “Malaysia is a recognized innovation leader in the ASEAN region, and the rapid approval and adoption of the AXINON® LDLp Test System reflect this cutting-edge standing. AXINON aids treatment pathways and preventive strategies by enabling earlier detection of complex conditions through analyses of single biomarkers and complex constellations, delivering multidimensional, personalized disease and drug response insights that significantly enhance sensitivity and specificity. This offers meaningful clinical value to healthcare professionals, and we are eager to extend these benefits to patients in Malaysia and the broader region.”

This marks the first regulatory approval for the AXINON® LDLp Test System in the ASEAN region. Simultaneously, numares has inked its first contract with BioD Medica, which specializes in bringing medical devices and healthcare technology to Malaysia and Singapore, equipping healthcare professionals with accessible, innovative diagnostic tools to improve patient outcomes.

According to the World Health Organization, cardiovascular diseases (CVDs) are the leading global cause of death. Key biomarkers for assessing CVD risk include lipids such as total cholesterol, triglycerides, LDL, and HDL cholesterol. Research shows standard lipid profile tests do not capture all available information, whereas the AXINON® LDLp Test System measures the concentration, size, and distribution of lipoprotein particles (LDL-p)—the cholesterol-carrying particles—to deliver more accurate results, particularly for individuals with comorbidities at higher CVD risk.

About numares Health

numares Health is a pioneering metabolomics platform that provides multidimensional biomarker insights and clinical pathways for optimal patient care. Its highly automated digital conversion of biochemical pathways leverages NMR spectra to simultaneously measure hundreds of biomarkers from a single, minimally processed sample, ensuring precise, consistent, scalable, and streamlined workflows across laboratories, clinical trials/treatment, and regions. With robust standardization, incremental tests can be rapidly processed, even from historically collected spectra, accelerating clinical research. These digital biomarkers enable a seamless transition from lab to bedside without further chemical intervention, drastically reducing costs while boosting accuracy and efficiency.

About the AXINON® System

numares Health’s AXINON® System conducts analyses of single biomarkers and complex constellations, yielding multidimensional, personalized disease and drug response insights that significantly enhance sensitivity and specificity. This supports prognostic clinical utility, guiding treatment pathways and preventive strategies while enabling earlier detection of complex conditions. Historic digital sample data can also be reprocessed for new metabolite analyses to enhance the design, stratification, and monitoring of clinical trials in drug development.

numares Health aims to revolutionize R&D and treatment, much as genomic analyses have transformed cancer care, but with a far broader scope across interconnected disease causes. It seeks to shift medicine from diagnosing/managing symptoms to accurately identifying and treating underlying disease causes.

SOURCE numares Health