REGENSBURG, Germany — numares Health has achieved a significant regional breakthrough after confirming that Malaysia’s Medical Device Authority has approved the use of its AXINON® LDLp Test System, officially opening the company’s entry into Southeast Asia. The approval represents the first regulatory recognition of AXINON® LDLp within ASEAN.
The announcement was accompanied by confirmation of a supply agreement with BioD Medica, which will serve as the system’s distributor in Malaysia and Singapore. The move ensures healthcare organizations across both countries can access advanced cardiovascular diagnostic technology.
numares Health is globally recognised for its metabolomics-driven diagnostic innovations. Through multidimensional biomarker evaluation, the AXINON® platform supports clinicians with deeper insights into disease risk and treatment pathways.
Chief Executive Officer Florian Voss said Malaysia’s adoption highlights its progressive healthcare ecosystem and readiness to embrace precision diagnostics. He added that AXINON® LDLp addresses a critical gap, as conventional lipid testing does not always offer complete clarity, especially for high-risk patients.
Cardiovascular disease remains the leading global cause of mortality, and clinical studies increasingly suggest that assessing LDL particle characteristics — instead of relying solely on cholesterol readings — provides superior accuracy. AXINON® LDLp analyses LDL particle concentration, size and distribution to deliver enhanced clinical value.
Malaysia’s approval is expected to set a precedent for further ASEAN market entry, with numares continuing regulatory processes for additional certified products. The collaboration with BioD Medica will enable efficient clinical rollout, supporting healthcare providers in improving diagnostic precision and patient outcomes.