Beyond Air Gains CE Mark for LungFit PH System Advancements

Beyond Air Achieves CE Mark Approval for LungFit PH

Beyond Air, Inc. (NASDAQ: XAIR), a noteworthy player in the medical device and biopharmaceutical industry, has exciting news to share. The company has received CE mark approval for its innovative LungFit® PH system, making it accessible for treatment within Europe and other regions recognizing this certification. This milestone highlights Beyond Air's commitment to leveraging nitric oxide (NO) technology in medical applications, particularly for patients with critical respiratory issues.

Empowering Treatment for Newborns

The CE mark specifically allows LungFit PH to cater to newborn infants suffering from hypoxic respiratory failure and those in need of peri- and post-operative care for pulmonary hypertension. This approval is particularly significant because it aims to enhance right ventricular function during heart surgeries, dramatically improving patient outcomes in vulnerable populations.

Milestone Partnership Announcement

In conjunction with the CE mark approval, Beyond Air is set to benefit from a $1 million milestone payment from its Asia-Pacific partner, Getz Healthcare. Steve Lisi, the CEO of Beyond Air, expressed pride in the team's efforts over the past months and excitement for initiating shipments to Getz Healthcare and future international collaborations. This partnership enables access to numerous hospitals across various Asian countries.

Innovative Technology at Work

The LungFit PH system stands out due to its unique Ionizer® technology, which transforms ambient air into NO. This conversion process is energy-efficient and environmentally friendly, requiring only as much energy as a standard 60-watt light bulb. By eliminating traditional gas cylinder reliance and transportation emissions, LungFit PH aligns with modern sustainable healthcare practices while offering vital treatment to patients.

Targeted Therapeutic Applications

With the authority of the CE mark, the LungFit PH system specializes in treating two key patient groups: firstly, newborns over 34 weeks gestation facing hypoxic respiratory challenges and, secondly, infants up to 17 years who require pulmonary hypertension management linked to heart surgery. These indications are particularly crucial in settings where timely access to advanced therapeutic options can significantly reduce the need for invasive procedures like extracorporeal membrane oxygenation.

Simple, Safe, and Effective Delivery

The device's design allows for variable NO concentrations, matching the current standard of care. With a straightforward replacement mechanism for Smart Filters lasting up to 12 hours, healthcare providers can maintain high treatment standards without complex protocols. This reliability proves essential in high-demand medical environments.

Continuing Beyond Air’s Mission

Beyond Air remains dedicated to addressing severe lung infections and other critical health challenges through its innovative LungFit systems. Their partnerships aim not only to improve respiratory treatment but also to explore numerous applications in neurological health. The company's ongoing research endeavors, including collaborations with prestigious institutions, position them prominently within the biomedical landscape.

Frequently Asked Questions

What is the LungFit PH system used for?

The LungFit PH system is designed to treat infants with hypoxic respiratory failure and manage pulmonary hypertension during peri- and post-operative heart surgery.

How does LungFit PH generate nitric oxide?

This system utilizes Ionizer technology, converting ambient air into nitric oxide. It efficiently produces the gas without needing traditional gas cylinders, enhancing energy efficiency.

What are the benefits of the new CE mark approval?

The CE mark approval allows Beyond Air to market the LungFit PH system in the EU and other markets, facilitating access to critical treatments for newborns and children.

What impact does this approval have on Beyond Air?

This approval signifies a strong step forward in Beyond Air's commercialization efforts, opening new markets and enhancing partnerships, specifically in Asia-Pacific.

How can potential customers learn more about LungFit PH?

Potential customers can access further information by visiting the LungFit PH website for product details and updates on availability.

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