Beyond Air, Inc. (NASDAQ: XAIR) has submitted a premarket approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for its second-generation LungFit PH II system.
The updated device is smaller, lighter, and designed for full compatibility with both air and ground transport.
The company believes FDA approval could transform not only hospital nitric oxide (NO) delivery but also its own market share and logistics efficiency.
TL;DR
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Beyond Air has submitted a premarket approval (PMA) supplement for its LungFit PH II, a second-generation nitric oxide delivery system.
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The new device is lighter, more compact, and compatible with both ground and air transport, addressing one of the biggest barriers in hospital NO therapy logistics.
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Compared to the FDA-approved LungFit PH (2022), the new version adds simplified operation, longer service intervals, and an automated backup system.
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By removing gas cylinders, hospitals gain lower storage needs, improved safety, and reduced costs.
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FDA approval could expand Beyond Air’s market share, reshape hospital NO delivery, and demonstrate how compact device innovations can disrupt long-established treatment practices.
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Beyond Air is also exploring its LungFit platform for viral pneumonia, bronchiolitis, nontuberculous mycobacteria, and even potential home-based nitric oxide therapy.
Improvements Over First-Generation LungFit PH
The LungFit PH II system represents a meaningful advancement over the first-generation device that was approved by the FDA in 2022. While the original model eliminated the need for bulky nitric oxide cylinders, the second-generation version reduces the overall weight and footprint of the system, making it far more portable and suitable for high-demand environments.
It offers simplified operation that requires less staff training, longer service intervals that reduce downtime and maintenance, and a built-in automated backup system that ensures therapy continuity during unexpected technical issues.
By enabling easy compatibility with both ground and air transport, the new system solves one of the biggest logistical barriers in delivering nitric oxide therapy to critically ill patients.
Clinical Role and Patient Benefits
LungFit PH II is intended for treating persistent pulmonary hypertension of the newborn (PPHN), a dangerous condition that occurs when a newborn’s pulmonary arteries fail to open sufficiently after birth. This results in elevated pulmonary vascular resistance, reduced blood flow to the lungs, and dangerously low oxygen levels throughout the body.
Traditional therapies rely on heavy NO cylinders, which complicate storage and transport. The new system generates nitric oxide directly from ambient air using patented Ionizer™ technology, providing continuous and precise dosing from 0.5 ppm to 80 ppm.
Each Smart Filter can deliver up to 12 hours of therapy and is easily replaced in seconds, allowing uninterrupted treatment. For patients, this means faster initiation of therapy, safer hospital transport, and better long-term management of a life-threatening condition.
Impact on the Pharmaceutical Industry
The introduction of LungFit PH II has broader implications for the pharmaceutical and medical technology sectors.
First, it demonstrates how device-based innovation can disrupt long-established hospital practices such as cylinder-based gas delivery, which has dominated nitric oxide therapy for decades.
Second, it validates the potential of combining biotechnology with compact engineering, creating a system that meets both therapeutic and logistical needs.
For the industry, this shift signals new opportunities for companies that can bridge drug therapy with device technology. Analysts expect the approval of LungFit PH II to encourage further investment in respiratory care platforms, expand nitric oxide’s role in other inflammatory and infectious diseases, and set a precedent for rethinking how hospital therapies are delivered.
Final words
CEO Steve Lisi stated that the company expects LungFit PH II to accelerate Beyond Air’s market expansion and establish it as a global leader in nitric oxide delivery.
The company is also exploring additional applications of its LungFit platform, including treatments for severe viral pneumonia, nontuberculous mycobacteria infections, and even future home-based respiratory care.
With FDA approval pending, LungFit PH II could mark the beginning of a new standard for safe, portable, and efficient nitric oxide therapy
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