Biomoneta receives US FDA approval for air-decontamination medical device

Biomoneta, a Bengaluru-based healthtech company building advanced air-decontamination technologies, has announced that its flagship product Avata Rx, powered by its proprietary ZeBox® microbicidal technology, has received approval from the United States Food and Drug Administration (US FDA), marking the first time an Indian company has achieved FDA clearance in the air-decontamination category.

Biomoneta enters the global arena at a time when the clean-air and infection-prevention sector is undergoing rapid transformation, with a combined global TAM spanning Healthcare Facilities ($15–20 billion), Consumer/Residential Air Purifiers ($17–20 billion), Commercial & Industrial HVAC Clean-Air systems ($50–60 billion), HVAC OEM clean-air modules ($20–30 billion), and Transportation IAQ solutions ($8–12 billion), and its FDA approval now positions the company to access regulated markets that require clinically validated air-decontamination technologies, unlocking significant global pathways for adoption.

Avata Rx, powered by ZeBox®, delivers broad-spectrum microbicidal action that inactivates airborne bacteria (including multidrug-resistant strains), viruses, fungi, hardy spores, and even Mycobacterium tuberculosis, one of the most difficult airborne pathogens to eliminate and, having been independently validated across multiple testing environments, including a Department of Biotechnology–funded IISc study that demonstrated its ability to destroy over 10 million airborne SARS-CoV-2 viral particles within 5 minutes, it now stands as one of the most scientifically validated air-decontamination technologies globally.