RegulatoryCompany release

Beyond Air reports record $2.3M quarterly revenue as FDA reviews second-generation LungFit PH

🇺🇸 Beyond Air, Inc. (XAIR) · Fri 13 Nov 2026

The company's PMA supplement for air and ground transport labelling remains under FDA review, with audit readiness expected in mid-December and agency inspections to follow.

Beyond Air, Inc. reported results for the quarter ended 30 September 2026, announcing on 11 November a record revenue of $2.3 million. That is about 28% higher than a year earlier. The company recorded a net loss of $7.8 million for the period.

On the regulatory front, the premarket approval (PMA) supplement for the second-generation LungFit PH nitric oxide system is still being reviewed by the US Food and Drug Administration. The supplement seeks labelling that would cover air and ground transport use. Beyond Air said it expects to be ready for audit in mid-December, with FDA inspections to follow.

The company reaffirmed its revenue guidance of $8 million for 2026 and $16–18 million for 2027. No further detail on the review timetable beyond the audit-readiness milestone was given in the information available.

Beyond Air also noted that LungFit GO has received Breakthrough Device Designation for use in nontuberculous mycobacterial (NTM) pulmonary disease. In addition, it disclosed a deal to sell its controlling stake in NeuroNOS.

What it means for your team

  • The second-generation LungFit PH remains in FDA review; inspections after the mid-December audit-readiness point are the next visible step, and no approval date has been given.
  • Quality teams at device makers can note that a PMA supplement for a labelling expansion, here transport use, can involve FDA inspections as well as document review.
  • Breakthrough Device Designation for LungFit GO in NTM pulmonary disease is a designation for a device in development, not a marketing authorisation.
  • Market-access teams should treat the reaffirmed $8 million (2026) and $16–18 million (2027) revenue guidance as company projections, not confirmed outcomes.

Company's press release (SEC filing): Beyond Air, Inc. ↗

Article written by VigiEye from the official source (Beyond Air, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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