Beyond Air, a commercial stage medical device and biopharmaceutical company focused on using nitric oxide (NO) to improve patient care, has announced that its LungFit® PH system has received CE mark approval.

This approval enables Beyond Air to market LungFit PH across the European Union and other countries that accept this certification. LungFit PH is the first device in Beyond Air's therapeutic platform for nitric oxide generation and has already received approval from the FDA in the United States.

The CE mark approval opens the way for commercial sales of LungFit PH in Europe and other global regions. In preparation for this, Beyond Air has partnered with Business Asia Consultants, which will help distribute the product internationally through its extensive network. The company is also preparing to begin shipments to its Asia-Pacific partner, Getz Healthcare, and other international partners in 2025.

As part of its ongoing agreement with Getz Healthcare for LungFit PH, Beyond Air will receive a $1 million milestone payment upon receiving the CE mark, along with ongoing royalty payments based on LungFit PH net sales.

This partnership gives Getz Healthcare access to hospitals in Australia, New Zealand, Thailand, the Philippines, Taiwan, Hong Kong, Malaysia, Pakistan, Singapore, and Vietnam.

The LungFit PH system is approved for two main indications:

1. The treatment of infants over 34 weeks gestation with hypoxic respiratory failure and pulmonary hypertension to improve oxygenation and reduce the need for extracorporeal membrane oxygenation.
2. The treatment of pulmonary hypertension in both adults and children (0-17 years) in connection with heart surgery, to decrease pulmonary arterial pressure and improve right ventricular function.

LungFit PH uses Beyond Air’s Ionizer technology to generate NO from ambient air on demand, with the flexibility to adjust dose and flow as needed. The device works by using a compressor to push room air through a plasma chamber, where electrical discharges between two electrodes create NO with minimal nitrogen dioxide (NO2) as a byproduct. A Smart Filter then removes any toxic NO2 from the circuit.

A key feature of the LungFit PH system is its sustainability. By generating NO from ambient air rather than relying on tanks or chemicals, the device is energy-efficient, consuming only as much power as a 60-watt light bulb. This also reduces the environmental impact of hospital operations by eliminating the need for truck transport and cylinder refills, helping hospitals lower their carbon footprint while delivering vital care.

For the approved uses, LungFit PH delivers a NO dosage in line with the current standard of care for ventilated patients, ranging from 0.5 ppm to 80 ppm. The Smart Filter lasts for 12 hours, regardless of ventilator demands, and can be replaced in seconds.

Source: beyondair.net

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