Australian regulator approves Beyond Air’s LungFit PH system for marketing

The Australian Therapeutic Goods Administration (TGA) has given the green light for the marketing of Beyond Air’s LungFit PH system, classifying it as a Class IIb medical device. This innovative system, the first in the LungFit therapeutic series, is equipped with the company’s proprietary Ionizer technology.

The LungFit PH operates by delivering a consistent dose of nitric oxide (NO), a vasodilator, directly into the patient’s ventilator circuit. The technology at the core of this device involves a compressor that propels room air through a plasma chamber, where electrical discharge pulses trigger the ionisation of nitrogen and oxygen molecules to generate NO. Additionally, a Smart Filter integrated into the system filters out nitrogen dioxide from the internal circuit. This filter has a lifespan of 12 hours and can be easily replaced.

One of the remarkable features of the LungFit PH is its sustainability aspect. It creates NO from the surrounding air, eliminating the need for tanks or chemicals. This not only makes it efficient in terms of energy consumption but also environmentally friendly. This factor showcases Beyond Air’s commitment to providing cutting-edge medical technology while also considering its impact on the environment.

Beyond Air had previously received approval from the US FDA and European CE Mark for this system, solidifying its position as a leader in innovative medical devices. This recent endorsement from the Australian TGA further highlights the system’s efficacy and safety in delivering nitric oxide therapy to patients undergoing ventilator treatment.

The LungFit PH’s ability to harness NO from ambient air sets it apart from conventional treatment methods that rely on stored gases. This approach not only streamlines the process of treatment but also reduces the logistical challenges associated with managing compressed gas cylinders. Furthermore, the elimination of chemicals from the NO generation process enhances patient safety and minimises potential risks associated with traditional methods of delivery.

The Ionizer technology utilized in the LungFit PH demonstrates Beyond Air’s focus on leveraging advanced scientific principles to develop groundbreaking healthcare solutions. By harnessing the power of electrical discharge to create NO from atmospheric air, the company has developed a system that offers a reliable and sustainable alternative to current treatment modalities.

In conclusion, the Australian TGA’s approval of Beyond Air’s LungFit PH system marks a significant milestone in the field of medical device technology. With its innovative approach to delivering nitric oxide therapy, coupled with its environmentally friendly design, the LungFit PH is poised to revolutionize the landscape of ventilator treatment. Beyond Air continues to set new standards in medical technology, prioritizing patient care, safety, and environmental sustainability in its product development initiatives.