FDA Clearance for Breathe Technologies’ NIOV System for use with Compressed Gas

Breathe Technologies, Inc. has announced that the U.S. FDA has granted a fifth 510(k) clearance for its Non-Invasive Open Ventilation (NIOV) System, opening up the potential for it to be used with a compressed air supply for non-oxygen dependent patients. The previous four FDA clearances cover the use of the Breathe NIOV System with compressed oxygen for home and institutional use, and include invasive and noninvasive patient circuits.


Neuromuscular disorders can ultimately weaken the muscles that are essential for breathing, making it difficult for patients to move air in and out of the lungs effectively. Respiratory failure, often in association with an infection, is a frequent cause of death for people with neuromuscular diseases.

The Breathe NIOV System is a small, non-invasive mechanical ventilator that can be use in homecare and institutional settings. The system utilizes novel venturi principle technology in a comfortable facial interface that can be worn while talking and exercising. The company says its device’s inbuilt technology reduces the overall size of the ventilation system and supports patient mobility and independence.

This is the first and only FDA-cleared, wearable, ventilation system for people with respiratory insufficiency. It provides augmented tidal volume and supplemental oxygen, which reduces the work of breathing for people with respiratory insufficiency caused by chronic obstructive pulmonary disease (COPD), including Alpha-1 Antitrypsin Deficiency. Patients that may receive similar benefits include those with pulmonary fibrosis, interstitial lung disease, cystic fibrosis and most respiratory conditions that result in activity-limiting shortness of breath.

The new FDA clearance for use of the Breathe NIOV System with compressed air allows for the wearable ventilator to be used to assist patients with neuromuscular diseases, such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis. The new clearance also allows for the use of the Breathe NIOV System with compressed air in patients with non-oxygen dependent respiratory diseases such as scoliosis.

The Breathe NIOV System reduces the work of breathing by unloading the ancillary respiratory muscles. Data from the seven studies that support the efficacy of the Breathe NIOV System demonstrate that the device reduces dyspnea, increases oxygenation, enhances exercise endurance, and unloads respiratory muscle activity.

Customer comments

“As neuromuscular diseases progress, patients may need augmented ventilatory support in order to breathe. The Breathe NIOV System offers a lightweight and wearable design that couples the efficacy of mechanical ventilation therapy with the benefits of mobility for spontaneously breathing patients whose muscle strength and overall mobility is compromised. It is also a welcome therapeutic addition for patients with non-oxygen dependent respiratory diseases,” said Robert McCoy, RRT, FAARC, General Manager, ValleyAire Respiratory Services, Apple Valley, Minn.

Company comments

“With five distinct FDA clearances, we have demonstrated that Breathe Technologies’ NIOV System has broad applications to help patients with respiratory insufficiency diseases become more mobile and independent. Our newest clearance allows many patients with neuromuscular disorders to have access to our technology as well,” said Larry Mastrovich, president and CEO of Breathe Technologies.

Source: Breathe Technologies, Inc., PR Newswire

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