ALung Technologies, Inc., recently announced that its Hemolung Respiratory Assist System (RAS) has received Expedited Access Pathway (EAP) designation and priority processing status from the U.S. Food and Drug Administration (FDA), as a new technology with the potential to better treat acute exacerbations in chronic obstructive pulmonary disease patients.
The company is a privately held Pittsburgh-based developer and manufacturer of lung assist devices and a provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for patients with acute respiratory failure. Hemolung RAS provides Respiratory Dialysis® by removing carbon dioxide directly from the blood, facilitating lung rest, protection and recovery, the company stated in a release.
With the designation, the FDA recognized the potential of the Hemolung RAS in treating patients with acute respiratory failure due to chronic obstructive pulmonary disease (COPD) and believes the device may provide a clinically meaningful advantage over existing therapies. The Expedited Access Pathway is a new FDA program intended to speed patient access to innovative technologies with the potential to treat or diagnose life-threatening or irreversibly debilitating conditions.
In acute exacerbations, or a sudden worsening of COPD symptoms, high levels of carbon dioxide can result in respiratory failure and necessitate intubation and mechanical ventilation. Mechanical ventilation, however, is associated with damaging side effects and in-hospital mortality as high as 30%, ALung Technologies stated. The Hemolung technology, in aiming to remove carbon dioxide directly from the blood, could treat the exacerbation without either intubation or ventilation.
“This action by the FDA means that the agency recognizes the unmet need for a device such as the Hemolung RAS to help avoid intubation and invasive mechanical ventilation in COPD patients with respiratory failure due to retention of carbon dioxide,” said Nicholas Hill, MD, Chief, Pulmonary & Critical Care and Sleep Division, Tufts Medical Center. “This technology has the potential to manage such patients with fewer complications and more comfort, something that awaits proof in a properly designed clinical trial which the EAP designation will help facilitate.”
EAP status also aids the product in moving more quickly into a clinical trial by dividing part of data collection to the post-market phase.
“The EAP designation further validates that the current standard of care for COPD patients experiencing acute exacerbations can be improved,” said Peter DeComo, Chairman and CEO of ALung. “As one of the first companies selected for this program, we look forward to working with the FDA to make the Hemolung technology available in the United States as soon as possible.”
The Hemolung RAS received European marketing clearance (CE mark) in 2013 as the world’s first fully integrated Respiratory Dialysis® system. The device is approved in 34 countries, including Canada, Australia, and in Europe.