By Matt Grossman

Beyond Air Inc. said Thursday it no longer expects to commercially launch its LungFit device in the U.S. by the end of the year, citing the regulatory process.

The Garden City, N.J.-based medical-device maker said communications with the U.S. Food and Drug Administration have led it to revise its estimate for when LungFit, intended to treat persistent pulmonary hypertension in newborns, can be rolled out in the U.S.

Beyond Air said it is still on track to receive the CE mark for LungFit in Europe in the first half of next year.

Shares fell as much as 20% in pre-market trading.

Write to Matt Grossman at matt.grossman@wsj.com

(END) Dow Jones Newswires

December 09, 2021 08:56 ET (13:56 GMT)