FDA approves nitric oxide generator to treat neonates with hypoxic respiratory failure
Click Here to Manage Email Alerts
Beyond Air has received FDA approval for its nitric oxide generator and delivery system to treat term and near-term neonates with hypoxic respiratory failure, according to a company press release.
LungFit PH generates on-demand unlimited nitric oxide from ambient air using patented ionizer technology and delivers it to a ventilator circuit, regardless of dose or flow. Using a compressor, LungFit PH drives room air through a plasma chamber of electrical pulses equivalent to a 60 W lightbulb to ionize the nitrogen and oxygen molecules to create nitric oxide, which is then passed through a filter removing the toxic nitrogen dioxide. This platform was designed and built by the inventors who created the first nitric oxide delivery system and subsequent systems currently in use today, according to the release.
“The FDA approval of LungFit PH enables a new era of nitric oxide therapy and marks a pivotal event for Beyond Air as we officially enter the U.S. market,” Steve Lisi, CEO and chairman of Beyond Air, said in the release. “As the first and only approved nitric oxide generator and delivery system, LungFit PH empowers health care providers to maximize the efficiency of a hospital when treating [pulmonary hypertension of the newborn] by moving beyond their reliance on traditional, inefficient delivery systems and the associated burdensome logistics and safety requirements.”
To treat pulmonary hypertension of the newborn, LungFit PH is designed to deliver a nitric oxide dosage to the lungs consistent with the current standard of care for delivery of 20 ppm nitric oxide with a range of 0.5 ppm to 80 ppm for ventilated patients. The filter within the system lasts 12 hours regardless of ventilator demands.
“We believe that LungFit PH is just the first in a series of our medical devices that, if approved, will become available for treating a wide variety of respiratory diseases as we remain dedicated to our mission of harnessing the power of nitric oxide for all who can benefit from this transformational therapy,” Lisi said.
Beyond Air will be working with select hospitals to make LungFit PH available with a broader nationwide launch expected in the first half of 2023.