numares Health enters ASEAN region with regulatory approval in Malaysia and first contract win for AXINON ® LDLp Test System

• AXINON® LDLp Test System receives Medical Device Authority (MDA) in Malaysia
• numares Health appoints BioD Medica for local distribution
• MDA filing for additional CE-marked product is currently in progress

Regensburg, Germany, 16 December 2025 – numares Health (“numares”), the transformative metabolomics company pioneering multidimensional biomarker insights that deliver clinical pathways for optimal patient care, today announces the expansion of its global footprint into the ASEAN region having received regulatory approval in Malaysia and subsequently securing its first contract for the AXINON® LDLp Test System (“AXINON”) with BioD Medica, who specialise in introducing medical devices and healthcare technology into Malaysia and Singapore.

Florian Voss, Chief Executive Officer at numares Health said: “Malaysia is a known leader in innovation in the ASEAN region and their swift approval and adoption of the AXINON® LDLp Test System reflects this cutting-edge reputation. AXINON guides treatment pathways and preventive strategies by enabling the earlier detection of complex conditions from the analyses of single biomarkers and complex constellations, delivering multidimensional, personalized disease and drug response insights, dramatically improving sensitivity and specificity. This delivers meaningful clinical utility to healthcare professionals, and we look forward to bringing these benefits to patients in Malaysia and the wider region.”

This is the first regulatory approval in the ASEAN region for the AXINON® LDLp Test System. Concurrently, numares has secured its first contract with BioD Medica, who specialise in introducing medical devices and healthcare technology into Malaysia and Singapore, providing healthcare professionals with accessible and innovative diagnostic devices to transform patient outcomes.

Cardiovascular diseases (CVDs) are the leading cause of death globally according to the World Health Organization. The most important biomarkers for determining CVD risk are lipids, including total cholesterol, triglycerides, LDL and HDL cholesterol. Studies show 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 particles that carry cholesterol – to provide a more accurate result, especially for people with comorbidities who are at higher risk for CVDs.