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How FDA Approval Puts Biomoneta on the Global Map of Infection-Prevention Tech

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Ghatak also sheds light on investor support from BNV India and Beyond Next Ventures

As hospitals worldwide confront the persistent threat of airborne infections, India’s deep-science ecosystem has delivered a breakthrough with global implications. Bengaluru-based Biomoneta has become the first Indian company to secure US FDA approval for an air-decontamination technology, marking a major milestone for homegrown medical innovation. Its flagship device, Avata Rx, powered by the patented ZeBox microbicidal platform, offers continuous, broad-spectrum pathogen elimination, setting a new benchmark for ICU- and OR-grade air safety.

In this exclusive MedTech Spectrum interview, Arindam Ghatak, co-founder of Biomoneta, discusses the scientific, regulatory, and clinical journey behind this achievement. He explains how ZeBox differs fundamentally from HEPA and UV systems, what hospitals can expect in terms of infection-control outcomes, and how the company plans to scale globally across regulated markets. Ghatak also sheds light on investor support from BNV India and Beyond Next Ventures, and shares his vision for the next decade, one where real-time microbial intelligence and embedded microbicidal systems redefine how healthcare systems manage the air we breathe.

Avata Rx is the first Indian air-decontamination technology to receive US FDA approval. What were the most significant scientific and regulatory challenges Biomoneta had to overcome to achieve this milestone?

Securing US FDA approval for Avata Rx meant overcoming challenges that most air-decontamination technologies never face. Only a handful of accredited labs worldwide can perform true microbial-kill testing in dynamic airflow, so generating FDA-grade data required extensive coordination, custom protocols, and long wait times. The regulatory pathway itself was lengthy and non-standard, because Avata Rx is a microbicidal technology—not just a filter—requiring deeper scrutiny of safety, efficacy, and materials. All of this demanded significant capital investment in R&D, quality systems, and repeated validation cycles. Achieving FDA clearance was therefore not just a scientific milestone, but a demonstration of persistence, infrastructure, and deep-tech commitment.

ZeBox as a microbicidal platform, shows broad-spectrum efficacy, including against MDR bacteria and SARS-CoV-2. Can you explain what differentiates ZeBox from existing HEPA- or UV-based systems in real clinical environments?

ZeBox is a microbicidal air-decontamination technology that uses the natural surface charges of microbes—quantified as their zeta potential—to attract and kill them onto an engineered nano-surface that gets activated under certain electrical conditions. This active mechanism gives ZeBox broad-spectrum efficacy, including against MDR bacteria and SARS-CoV-2.

Unlike HEPA filters, which only trap particles and largely depends on the soze of the particles; UV systems, which need line-of-sight and long exposure and are hazardous to human health; or ozone generators, which cannot be used around people, ZeBox continuously pulls in and kills microbes in real clinical environments. It’s a safe, 24/7 system that eliminates pathogens at their source rather than simply collecting or inactivating them under ideal conditions.

Airborne transmission is a stubborn challenge in ICUs, operating rooms, and procedure areas. What specific outcomes or improvements in infection control can hospitals expect after deploying Avata Rx?

Hospitals deploying Avata Rx typically see rapid and sustained reductions—often over 90 per cent—in airborne bacteria and fungi, including MDR organisms. This leads to fewer contamination events, cleaner surfaces, and a lower risk of procedure- or ICU-associated infections. Clinically, hospitals can expect fewer outbreak interruptions, safer environments for high-risk patients and staff, and measurable improvements in overall infection-control performance.

Biomoneta is entering a global market with a large TAM across healthcare, HVAC, consumer, and transport sectors. What are your immediate go-to-market priorities, and how do you plan to scale in regulated markets like the US, EU, and Japan?

Clean, safe air is a universal need, and our go-to-market strategy reflects that universality. We begin where the impact is most profound—ICUs, NICUs, operating rooms—while partnering with HVAC and infrastructure players to bring microbicidal air systems into the very architecture of buildings.

As we scale into regulated markets like the US, EU, and Japan, we anchor ourselves in strong clinical evidence, rigorous quality systems, and collaborations with local medical and industrial partners. Our philosophy is simple: when air itself becomes safer, every space—hospital, home, aircraft, or factory—becomes a place where people can breathe without fear.

BNV India and Beyond Next Ventures have championed deep-science innovation. How has investor support shaped Biomoneta’s R&D and commercialisation journey?

BNV India and Beyond Next Ventures backed Biomoneta long before deep-science became fashionable. Their support gave us the patience, capital, and strategic guidance to validate a new microbicidal platform, navigate global regulations, and build credible clinical evidence. Just as importantly, they connected us to scale-up partners and early distributors, helping us bridge the gap from breakthrough science to real-world adoption.

With airborne pathogens becoming a central focus post-pandemic, where do you see the future of air-decontamination technologies evolving over the next 5–10 years, especially in hospital-grade infection prevention?

The next decade will redefine how we think about the air around us. Hospitals will move from merely circulating air to actively understanding and eliminating the microbial risks within it. Microbicidal systems like ZeBox will become embedded into HVAC infrastructure, delivering continuous, contact-free protection.

But protection alone will not be enough. Real-time microbial intelligence—through platforms like qAMI (quantitative Airborne Microbial Index)—will become essential, allowing hospitals to see invisible threats, predict outbreaks, and respond before infections occur. qAMI by Biomoneta enables real-time detection, scoring, and trend analysis of viable microbial load in dynamic airflows.

In the future, air-decontamination will be less about machines and more about awareness: a world where we can finally measure, manage, and trust the air we breathe.