Biomoneta Becomes the First Indian Health-Tech Firms to Earn US-FDA Class II Clearance for Medical Air Cleaners

Bengaluru, Dec 2: Biomoneta Research Private Limited, a Bengaluru-based healthtech company, announces it has received US Food and Drug Administration (FDA) 510(k) Class II clearance for the Biomoneta® Avata Rx Medical Recirculating Air Cleaner. The clearance marks a major milestone in the company’s decade-long R&D journey and enables Biomoneta to enter the US and healthcare market with its globally patented ZeBox technology.

The Avata Rx system is built on Biomoneta’s proprietary ZeBox platform, which represents a fundamentally different approach to air decontamination compared to conventional systems. Instead of relying on HEPA filters, UV radiation, or ozone-based chemical processes, ZeBox employs nanomaterials and advanced power electronics to extract naturally charged microbes from the air through a non-ionizing electric field. These microbes are then captured on engineered microbicidal surfaces, where they are eliminated. Independent third party laboratory testing and published research have demonstrated more than 99.9999 percent efficacy 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;

said Dr. Arindam Ghatak, Co-founder and CEO, Biomoneta Research. “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.”.

Following this FDA milestone, Biomoneta was recently recognized as 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, the company is developing qAMI (Quantitative Airborne Microbial Index), an AI/ML-enabled technology that integrates advanced analytics with microbiological detection to quantify airborne pathogens in real time. This platform aims to strengthen infection-control systems and address the growing challenge of antimicrobial resistance in healthcare environments.

“Biomoneta has been a pioneering company in the field of air health, employing its most advanced technology to support patients in hospitals and in homes. This US FDA clearance represents a significant achievement and will accelerate the global dissemination of this innovation.It stands as a testament to the growing impact of India’s biotechnology and medical-technology ecosystem. At C-CAMP, we are immensely proud of Biomoneta’s accomplishments and the societal value their work delivers,” said Dr. Taslimarif Saiyed, CEO and Director, Centre for Cellular and Molecular Platforms a Government of India’s premier life-science innovation hub, enabling cutting-edge research, deep-tech startups, and biotech entrepreneurship.

“This is just the beginning,” Dr. Ghatak emphasized. “Infection prevention remains a critical challenge worldwide, and wherever vulnerable patients need protection from airborne pathogens, Biomoneta’s Avata Rx can make a meaningful difference.”

India faces one of the world’s highest air-pollution burdens, with PM2.5 levels far exceeding WHO limits and reducing average life expectancy by 3.5 years. Polluted air significantly increases the risk of airborne and respiratory diseases, including Tuberculosis (TB), pneumonia, asthma and COPD especially in hospitals and dense indoor environments. This has made indoor air safety a critical public-health priority, driving demand for scientifically validated air-purification solutions beyond conventional filtration.

With ISO 13485:2016 accreditation and a rapidly expanding innovation pipeline, Biomoneta is preparing to scale manufacturing and global distribution of Avata Rx to meet rising demand for clinical-grade air purification. The FDA clearance significantly enhances the company’s market readiness and opens new opportunities in the US and global healthcare ecosystem, where hospital-acquired infections continue to affect millions of patients each year. The company’s focus now is on accelerating deployment across critical care environments and supporting hospitals in improving air hygiene standards worldwide.