Biomoneta Research Private Limited, a Bengaluru-based health technology company, has achieved a major milestone with U.S. FDA 510(k) Class II clearance for its Biomoneta® Avata Rx Medical Recirculating Air Cleaner. This approval marks a significant step in the company’s decade-long innovation journey and paves the way for market entry into the United States with its patented ZeBox air decontamination technology.
The Avata Rx system operates using Biomoneta’s ZeBox platform, a technology that differs fundamentally from traditional HEPA, UV, or chemical-based purification systems. ZeBox leverages advanced power electronics and nanomaterial engineering to attract naturally charged airborne microbes using a non-ionizing electric field. Once captured on microbicidal surfaces, pathogens are neutralized. Independent laboratory studies and peer-reviewed publications show the technology delivers more than 99.9999% effectiveness against airborne pathogens such as SARS-CoV-2, H1N1, and Mycobacterium tuberculosis.
“This certification represents the culmination of eleven years of work toward enabling infection-free indoor environments,” said Dr Arindam Ghatak, Co-founder and CEO of Biomoneta Research. “With FDA clearance, we can now bring ZeBox-enabled solutions to U.S. hospitals and critical care spaces—helping address the global need for safer medical environments.”
Following its regulatory success, Biomoneta was named one of the nine winners of the C-CAMP AMR Challenge 2024–25, supported by the UK Government’s Global AMR Innovation Fund. Under this program, the company is developing qAMI (Quantitative Airborne Microbial Index), an AI- and machine learning–based platform designed to measure airborne pathogen loads in real time and support antimicrobial resistance mitigation strategies.
“Biomoneta has been at the forefront of air safety innovation,” said Dr Taslimarif Saiyed, CEO & Director of C-CAMP. “This FDA clearance is a milestone for India’s biotech and med-tech ecosystem and will accelerate access to cutting-edge air health solutions globally.” Dr Ghatak added, “This achievement is just the beginning. Wherever vulnerable patients require protection from airborne infections, Avata Rx can make a measurable impact.”
The achievement comes at a time when India continues to battle high levels of air pollution, with PM2.5 concentrations exceeding WHO recommendations and contributing to increased cases of respiratory illnesses such as tuberculosis, pneumonia, COPD, and asthma—particularly in dense indoor environments and hospitals. This growing public health issue has heightened demand for clinically validated air purification technologies beyond conventional filtration.
Biomoneta holds ISO 13485:2016 certification and is preparing to scale manufacturing and international deployment of Avata Rx to support rising global demand for advanced air sanitation systems. With FDA clearance now secured, the company is focusing on partnerships and adoption within critical care environments worldwide.
Founded in 2014 by Dr Arindam Ghatak, Dr Janani Venkatraman, and Dr Santanu Datta, Biomoneta has received support from BIRAC, the Karnataka State Government, and C-CAMP. The company raised its seed round in 2020, led by Beyond Next Ventures (Japan) via the C-CAMP–BNV Innovation Hub, with participation from ArthaVida Ventures, Tranzmute Capital, and additional angel investors.
