NEBreath™ Receives TFDA Clearance, Advancing Smart Inhalation Therapy from Clinical Settings to Home Care

HSINCHU, TAIWAN – May 19, 2026 – AeproMED Innovation Co., Ltd. (AeproMED), a pioneer in integrated inhalation drug delivery platforms, proudly announces that its flagship product, the NEBreath™ vibrating mesh nebulizer, has officially received medical device clearance from the Taiwan Food and Drug Administration (TFDA) (License No. 008614). This certification confirms that NEBreath™ meets rigorous standards for quality, safety, and regulatory compliance, marking a significant milestone in transitioning professional inhalation therapy from clinical institutions to daily home-care environments.

Redefining Inhalation Efficiency with AFDT™ Technology

Traditional inhalation therapies are often hindered by imprecise dosing, long treatment times, and high drug wastage. NEBreath™ addresses these challenges with AeproMED’s proprietary AFDT™ (Aerosol Fluid Dynamics Technology). This system-level control technology dynamically balances aerosol output and particle size, ensuring stable delivery performance even as the mesh ages or when handling high-viscosity formulations.

In performance benchmarks, NEBreath™ achieves superior efficiency with an average treatment time of just 4.5 minutes for targeted medications. Furthermore, its design significantly reduces residual drug volume compared to competitors, ensuring that patients receive the maximum intended dose with clinical-grade reliability.

Bridging the Translational Gap via AIRHYPER™ Platform

"The TFDA clearance for NEBreath™ is a cornerstone of our AIRHYPER™ Platform strategy," said Vicky Y-T Chang, CEO of AeproMED. "By integrating precision hardware with our DSMT™ (Data Synchronization Monitoring Technology), we are bridging the 'care black box' in home treatment. This platform enables a seamless Device-Drug Co-Validation data chain, shortening the path from pre-clinical R&D to real-world clinical application".

NEBreath™ is engineered for long-term stability and ease of use. Its patented design allows for deep-soak cleaning in hot water to dissolve viscous residues or crystals, preventing the clogging issues common in traditional nebulizers. This reliability is critical for managing chronic conditions such as bronchiectasis and other respiratory infections in a decentralized healthcare model.

Global Expansion and Strategic Vision

Following its TFDA success, AeproMED is accelerating its international roadmap, with US FDA 510(k) review currently in progress. At the BIO Asia-Taiwan exhibition, AeproMED will demonstrate how NEBreath™ functions as a vital link in its "Drug + Device + Data" trifecta, supporting pharmaceutical partners and medical centers in establishing sustainable, data-driven precision medicine for respiratory patients worldwide.

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About AeproMED Founded in 2022 and based in the Hsinchu Biomedical Science Park, AeproMED Innovation Co., Ltd. specializes in advanced inhalation drug delivery systems. With over 30 global patents and an ISO 13485-certified manufacturing facility, the company provides a comprehensive validation platform to reduce development risks and clinical failure rates for global pharmaceutical innovators.

Media Contact: [Sunny Sun] [BU Manager] [Sunnysun@aepromed.com] [+886-3-6676537#21]