Beyond Air Pushes Back Projection for Lung-Device Launch in U.S.
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
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 firstname.lastname@example.org
(END) Dow Jones Newswires
December 09, 2021 08:56 ET (13:56 GMT)
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