The LungFit PH system is intended for treating infants over 34 weeks gestation with hypoxic respiratory failure and pulmonary hypertension. Credit: Iryna Inshyna / Shutterstock.

Beyond Air has gained CE mark approval for its LungFit PH system, permitting the marketing of the device within the European Union and other regions, acknowledging the certification.

Said to be the first device in the LungFit therapeutic platform of nitric oxide (NO) generators, LungFit PH utilises the company’s Ionizer technology and has previously obtained the US Food and Drug Administration (FDA) approval.

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Under the commercialisation agreement with Getz Healthcare, Beyond Air is set to obtain a $1m milestone payment following the CE mark certification.

Additionally, Beyond Air is set to benefit from ongoing royalty payments tied to the net sales of LungFit PH.

The partnership with Getz Healthcare extends the device’s reach to hospitals across multiple countries in the Asia-Pacific region.

The CE mark certification for LungFit PH covers two specific indications. The first is for treating infants over 34 weeks gestation with hypoxic respiratory failure and pulmonary hypertension, aimed at improving oxygenation and decreasing the necessity for extracorporeal membrane oxygenation.

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The second indication is for treating pulmonary hypertension associated with heart surgery in individuals ranging from newborns to 17-year-olds, to reduce pulmonary arterial pressure and enhance right ventricular function.

Beyond Air chairman and CEO Steve Lisi said: “We are thrilled to announce the CE mark for LungFit PH, paving the way for commercial sales in Europe and other global regions. In anticipation of this approval, we partnered with Business Asia Consultants to leverage their extensive international distribution network.

“I am incredibly proud of the team that made this happen over the past 30 months and look forward to initiating shipments to our Asia-Pacific partner, Getz Healthcare, and other international partners in 2025.”

The system operates by ionising nitrogen and oxygen molecules in the air through a plasma chamber, producing NO with minimal nitrogen dioxide (NO₂) as a byproduct.

It also includes a ‘Smart Filter’ that removes toxic NO₂. This technology enables the generation of unlimited on-demand NO from ambient air for delivery to a ventilator circuit, adaptable to various doses and flows.