Abstract
Inhaled nitric oxide (iNO) is a critical therapeutic gas with vasodilatory, anti-inflammatory, and antimicrobial properties, used to treat life-threatening conditions like pulmonary hypertension. Previous delivery systems are complex, costly, and restricted to major medical centers. They rely on highly diluted NO in nitrogen or air, require specialized scrubbers for removing toxic nitrogen dioxide (NO₂), frequent consumable changes, and large, non-portable equipment—limiting broader adoption and increasing care complexity. iNOvodel's proprietary system generates highly concentrated (~95%) nitric oxide using safe, low-cost chemical precursors, a rapid, high-velocity gas mixing chamber to minimize harmful NO₂ formation and accurate dosing.
Impact Story
Inhaled nitric oxide (iNO) is a critical therapeutic gas with vasodilatory, anti-inflammatory, and antimicrobial properties, used to treat life-threatening conditions like pulmonary hypertension. Previous delivery systems are complex, costly, and restricted to major medical centers. They rely on highly diluted NO in nitrogen, require specialized scrubbers for toxic NO₂, frequent consumable changes, and large, non-portable equipment—limiting broader adoption and increasing care complexity. iNOvodel's proprietary system generates highly concentrated (~95% pure) nitric oxide using safe, low-cost chemicals and a rapid mixing chamber that minimizes harmful NO₂ formation through high-velocity mixing. The team developed a single-step chemical process capable of generating medical-grade nitric oxide gas at high concentration (~95% or 950,000 ppm) without requiring further purification. This NO can be stored in compact 1–2-pound canisters for convenient shipping and hospital use, significantly reducing both cost and logistical challenges. The next major challenge is to safely mix highly concentrated NO directly with inspired oxygen to achieve therapeutic doses while maintaining toxic nitrogen dioxide (NO₂) levels below 1 ppm. The current technologies rely on highly diluted NO mixtures (0.08%) to minimize the rate of NO reaction with oxygen to generate NO₂. In contrast, we developed a revolutionary technology to mix undiluted or highly concentrated NO while minimizing NO₂ generation to FDA safety levels. Another critical challenge is achieving precise NO delivery of extremely as low as (5 µL/min) volumes for neonatal applications.
These novel technologies for NO synthesis, oxygen mixing, and precision dosing across a broad therapeutic range of 0.5 ppm to 250 ppm at inspired gas flow rates ranging from 2 L/min to 100 L/min, offers several important advantages, including substantially lower cost, device miniaturization, simplified transport, longer dosing duration without cartridge replacement, and compatibility with a broad range of NO doses and carrier gas flow rates. These innovations could expand the use of exogenous NO therapy for pulmonary hypertension, high-altitude hypoxia, respiratory infections, and wound healing in both hospital and non-hospital settings.
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