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Biomoneta Research Private Limited, a Bengaluru-based health-tech innovator, today announced a landmark achievement, securing U.S. Food and Drug Administration (FDA) 510(k) Class II clearance for its Biomoneta® Avata Rx Medical Recirculating Air Cleaner. This pivotal clearance positions Biomoneta as the first Indian health-tech company to receive such critical approval for clean-air solutions, paving the way for its entry into the stringent US healthcare market with its globally patented ZeBox technology. The Avata Rx system represents a significant leap forward in air decontamination. Unlike conventional systems that rely on HEPA filters, UV radiation, or ozone, Biomoneta's proprietary ZeBox platform utilizes advanced nanomaterials and power electronics. This innovative approach extracts naturally charged microbes from the air using a non-ionizing electric field, capturing them on engineered microbicidal surfaces where they are effectively eliminated. Independent third-party laboratory testing and published research have demonstrated an astounding efficacy of more than 99.9999% in eliminating airborne pathogens, including SARS-CoV-2, H1N1, and even Mycobacterium tuberculosis. This FDA clearance validates everything our team has worked toward over the last eleven years, We set out to prevent hospital-acquired infections by creating truly germ-free air zones. This milestone now enables us to bring ZeBox-powered solutions to US hospitals and critical-care environments, addressing a global need for safer, infection-free indoor spaces. Today, the FDA confirms we’ve achieved technology that meets the world’s highest standards. Dr. Arindam Ghatak This significant FDA milestone follows another recent recognition for Biomoneta, as the company was named one of the nine winners of the C-CAMP AMR Challenge 2024-25, supported by the Global AMR Innovation Fund (GAMRIF), Government of the United Kingdom. As part of this initiative, Biomoneta is developing qAMI (Quantitative Airborne Microbial Index), an AI/ML-enabled technology designed to quantify airborne pathogens in real-time by integrating advanced analytics with microbiological detection. This platform aims to bolster infection-control systems and tackle the growing global challenge of antimicrobial resistance in healthcare settings. Read More: Eyestem’s Eyecyte-RPE™ Trial Shows Vision Rescue for Geographic Atrophy Patients India, grappling with one of the world’s highest air-pollution burdens, where PM2.5 levels significantly surpass WHO limits and contribute to a reduction in average life expectancy by 3.5 years, faces an urgent need for advanced air purification. Polluted air dramatically increases the risk of airborne and respiratory diseases, including Tuberculosis (TB), pneumonia, asthma, and COPD – a concern particularly acute in hospitals and dense indoor environments. This has elevated indoor air safety to a critical public-health priority, driving demand for scientifically validated air-purification solutions that go beyond conventional filtration. With ISO 13485:2016 accreditation and a rapidly expanding innovation pipeline, Biomoneta is now poised to scale manufacturing and global distribution of Avata Rx. The FDA clearance significantly enhances the company’s market readiness and unlocks new opportunities within the US and the broader global healthcare ecosystem, where hospital-acquired infections continue to impact millions of patients annually. The company's immediate focus is on accelerating deployment across critical care environments and actively supporting hospitals worldwide in elevating their air hygiene standards. Information: www.biomoneta.com Last Modified:

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Biomoneta Makes History: First Indian Health-Tech Firm to Achieve US-FDA Class II Clearance for Medical Air Cleaners

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