Biomoneta Healthtech Startup Receives US FDA Approval for Air-Decontamination Medical Device

The approval is a major endorsement of Biomoneta’s scientific breakthrough and an important inflection point for Beyond Next Ventures India (BNV India)

Biomoneta, a pioneering healthtech company building advanced air-decontamination technologies, 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.

This milestone is not only a validation of India’s deep-tech innovation capabilities but also reinforces the global urgency for clinically validated solutions that combat airborne pathogens, one of the most persistent sources of healthcare-associated infections (HAIs).

The approval is a major endorsement of Biomoneta’s scientific breakthrough and an important inflection point for Beyond Next Ventures India (BNV India), Japan-based early-stage deep-science fund known for backing transformative research-driven startups. BNV’s investment philosophy centers on supporting technologies rooted in deep science, real-world utility, and global scalability, and Biomoneta’s FDA recognition exemplifies this thesis.

Airborne pathogens including drug-resistant bacteria, fungi, spores, and viruses continue to challenge healthcare systems worldwide. Patient movement, ventilation inefficiencies, and high human activity make clinical spaces such as ICUs, operating rooms, procedure rooms, and labs highly susceptible to contamination. Beyond hospitals, elder-care centers, clinical labs, and home-care environments for immunocompromised individuals require continuous, dependable air-decontamination solutions.

The US FDA’s approval of Avata Rx underscores the global need for technologies that continuously trap and destroy airborne microbes in real time, forming a critical layer of defense in modern infection-control strategies.

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 ($15–20B), Consumer/Residential Air Purifiers ($17–20B), Commercial & Industrial HVAC Clean-Air systems ($50–60B), HVAC OEM clean-air modules ($20–30B), and Transportation IAQ solutions ($8–12B), 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.