Beyond Air Nabs CE Mark for LungFit PH SystemBeyond Air Nabs CE Mark for LungFit PH System

Beyond Air, a medtech company focused on using nitric oxide (NO), today announced it has received European Union CE Mark approval for the LungFit PH system. The LungFit PH system is the first device in the LungFit therapeutic platform of NO generators and leverages the company’s patented Ionizer technology. The device is also FDA approved for use in the US.

The system is indicated for the treatment of infants ≥ 34 weeks' gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. LungFit PH improves oxygenation and reduces the need for extracorporeal membrane oxygenation, according to Beyond Air.

LungFit PH is also indicated for the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years “in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function,” according to the press release announcing the approval.

Using its Ionizer technology, the device generates unlimited on-demand NO from ambient air and delivers it to a ventilator circuit, regardless of dose or flow. “The device uses a compressor to drive room air through a plasma chamber where pulses of electrical discharge are created between two electrodes,” the release wrote. “The LungFit PH system ionizes the nitrogen and oxygen molecules, forming NO with low levels of nitrogen dioxide (NO₂) created as a byproduct. The gas is then passed through a smart filter, which removes toxic NO₂ from the internal circuit.”

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Of note, the CE Mark triggers a $1 million milestone payment from Getz Healthcare as part of an existing commercialization agreement with the company. Additionally, the company will receive ongoing royalty payments based of LungFit PH net sales. The agreement enables access to hospitals in Australia, New Zealand, Thailand, Philippines, Taiwan, Hong Kong, Malaysia, Pakistan, Singapore, and Vietnam.

The approval comes after a somewhat disappointing 2024 where Beyond Air reduced its headcount by more than 20% and implemented other measures to preserve capital after a slower than expected commercial rollout of LungFit in the US.

In July, BTIG analyst Marie Thibault downgraded the company, citing concerns about its commercial ramp, reduced revenue outlook, lack of progress on profitability metrics, and near-term cash needs. "While [Beyond Air] has demonstrated some initial traction with LungFit — the system has been used in more than 50 hospitals (including trialing) across 10 states to treat over 1,100 patients — the commercial rollout has continued to be slower than expected," she wrote in her report.

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Today, BTIG stood by its previous rating, albeit stating expectations of higher trade share today for the company based on the CE Mark news. “We expect XAIR shares to trade higher today on this news,” according to the analysis. “This regulatory win was on schedule, since management had expected CE Mark by the end of CY24. We had forecasted a small amount of OUS revenue starting in the first quarter of CY25 (Q4 of FY25) and a modest, gradual ramp throughout FY26. We do not make any changes to our model.”