Designation will facilitate introduction of breakthrough respiratory technology in the United States
Pittsburgh, PA (November 4, 2015) - ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced today 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). The Hemolung RAS provides Respiratory Dialysis® by removing carbon dioxide directly from the blood, facilitating lung rest, protection, and recovery for patients suffering from acute respiratory failure.
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in the US. Acute exacerbations, defined as a sudden worsening of COPD symptoms, are a major cause of morbidity and mortality in COPD patients. For patients with severe exacerbations, high levels of carbon dioxide can result in respiratory failure and the need for intubation and mechanical ventilation as life saving measures. Unfortunately, mechanical ventilation is associated with many deleterious side effects, and in-hospital mortality remains as high as 30%. The Hemolung technology aims to avoid or reduce the need for intubation and ventilator support by directly removing carbon dioxide from the blood.
The Expedited Access Pathway is a new FDA program aimed to facilitate more rapid patient access to breakthrough technologies intended to treat or diagnose life-threatening or irreversibly debilitating diseases or conditions. To qualify for the program, the device must meet one or more criteria that shows it addresses an unmet clinical need. In its designation of EAP for the Hemolung RAS, the FDA acknowledged that the device may represent a breakthrough technology that provides a clinically meaningful advantage over existing legally marketed technology; the device may offer significant, clinically meaningful advantages over existing legally marketed alternatives; and/or the availability of the device may be in the best interest of patients.
"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."
With EAP designation, the FDA works with device manufacturers to try to reduce the time and cost from the start of product development to marketing approval, without changing the FDA's approval standards. Components of the program, on the part of the FDA, include priority review, more interactive review, senior management involvement, and assignment of a case manager. Additionally, the program facilitates development of a potentially less burdensome premarket clinical trial, shifting a portion of data collection to the post-market phase, while still meeting the statutory standard of reasonable assurance of safety and effectiveness.
“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 simplicity, safety and effectiveness of the system have been demonstrated in use at more than 100 hospitals worldwide. The device is approved in 34 countries outside of the US, including Europe, Canada, and Australia.
About ALung Technologies
ALung Technologies, Inc. is a privately-held Pittsburgh-based developer and manufacturer of innovative lung assist devices. Founded in 1997 as a spin-out of the University of Pittsburgh, ALung has developed the Hemolung RAS as a dialysis-like alternative or supplement to mechanical ventilation. ALung is backed by individual investors and venture firms including Allos Ventures, Birchmere Ventures and West Capital Advisors, LLC.
For more information about ALung and the Hemolung RAS, visit www.alung.com.