# Chemical-based Nitric Oxide Gas-generating Drug Device for the Treatment of Pulmonary Hypertension

> **NIH NIH R42** · INOVODEL, INC. · 2023 · $1,467,953

## Abstract

SUMMARY
Patients with pulmonary hypertension (PH) experience low oxygen saturation, shortness of breath, low quality
of life, and a short life span (<10 years) following diagnosis. These patients frequently present to emergency
rooms, and many are admitted to intensive care units (ICUs), straining the health care system. Despite therapy
with phosphodiesterase-5 inhibitors, prostacyclin analogs, and endothelin antagonists, mortality remains high
and quality of life poor. With no specific drug available for curative treatment, inhaled nitric oxide (iNO), a
pulmonary artery-specific vasodilator, is the best option for treating PH without compromising systemic blood
pressure. Current tank-based iNO delivery systems are expensive and available only in operating rooms and
ICUs of established medical centers in developed countries. The need is great for simpler, portable, and less
expensive iNO technologies. During phase 1, a proof-of-concept prototype was developed in partnership with
the University of Alabama at Birmingham. All the proposed goals in phase 1 were met and the technology was
further advanced through several innovations. First, the NO generation method was modified from the original
proposal of producing sustained release NO from its precursor molecule to producing a stock bulk amount in a
single-step chemical reaction to synthesize medical grade NO in a sealed container on demand. This method
will avoid the pitfalls of current NO generation approaches pursued by other companies in which nitrogen dioxide
(NO2, a toxic gas) is converted to NO, or atmospheric air is oxidized to NO by high voltage electric sparks with
subsequent need for extensive purification steps. Second, it is proposed to mix this 100% NO directly with
supplemental oxygen to attain therapeutic doses while reducing co-delivery of NO2 to levels far below FDA safety
limits or diluting NO in inert nitrogen (N2) gas within the device prior to mixing with supplemental oxygen. These
systems avoid the need to dilute NO 1250-fold in N2 gas for storage in compressed cylinders and transport to
hospitals, as is done with current systems. Third, an integrated gas sensor system for NO and NO2 measurement
and electronic control systems for dispensing NO was developed. The assembled prototype is functioning well
and as expected. Based on these encouraging results, iNOvodel, Inc. was formed to license, develop and
commercialize a full-scale product. In Aim 1, focus is centered on developing a fully functional hospital-based
and demonstrating feasibility for a portable iNO devices incorporating an optimized reusable NO-generating
cartridge. Aim 2 seeks to establish the chemical method for generating and storing NO in the cartridge to utilize
on-demand. Aim 3 is directed toward development of noninvasive and invasive interface systems that are
compatible with iNO devices for safe delivery of nitric oxide to patients. Further, the safety of the device to deliver
NO using an in vitro benchto...

## Key facts

- **NIH application ID:** 10611768
- **Project number:** 2R42HL152921-02A1
- **Recipient organization:** INOVODEL, INC.
- **Principal Investigator:** Gary Lessing
- **Activity code:** R42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $1,467,953
- **Award type:** 2
- **Project period:** 2020-08-18 → 2025-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10611768

## Citation

> US National Institutes of Health, RePORTER application 10611768, Chemical-based Nitric Oxide Gas-generating Drug Device for the Treatment of Pulmonary Hypertension (2R42HL152921-02A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10611768. Licensed CC0.

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