FDA Approves LungFit PH to Treat Newborns

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The U.S. Food and Drug Administration (FDA) has approved LungFit PH, Beyond Air‘s device to administer nitric oxide therapy, to treat persistent pulmonary hypertension of the newborn (PPHN).

“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. … I am immensely proud of the Beyond Air team for navigating a multitude of obstacles over the past five years, especially the last 27 months during the global pandemic, to bring this revolutionary device to market,” Steve Lisi, chairman and CEO of Beyond Air, said in a press release.

Beyond Air’s commercial team will be working with select hospitals to make the newly approved device available to them. The company is expecting a broader commercial launch in the U.S. in the first half of 2023. Potential customers can learn more at the LungFit PH website.

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PPHN is characterized by increased pressure in an infant’s blood vessels, which can prevent the baby’s body from getting enough oxygen and may be life-threatening. Nitric oxide, or NO, is a gas used in the treatment of PPHN. NO acts as a vasodilator, decreasing blood pressure by prompting blood vessels to relax and widen.

Traditional setups for using NO involve storing the gas in pressurized cylinders, requiring bulky setups that take up a lot of space. The LungFit PH device uses patented technology to generate NO gas out of the surrounding air. The NO is passed through a filter to remove the toxic gas nitrogen dioxide, and the device is designed to administer the gas at current standard dosages for babies with PPHN. The filters require replacement every 12 hours, regardless of ventilator use.

“As the first and only approved nitric oxide generator and delivery system, LungFit PH empowers healthcare providers to maximize the efficiency of a hospital when treating PPHN by moving beyond their reliance on traditional, inefficient delivery systems and the associated burdensome logistics and safety requirements,” Lisi said.

“The approval of LungFit PH validates our patented Ionizer technology and lays out a premarket approval model for our other LungFit platform devices … 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 added.