ALung Technologies said today it submitted an investigational device exemption application to the FDA as it seeks to begin a clinical study of its Hemolung Respiratory Assist System.
The Pittsburgh, Penn.-based company is developing the Hemolung device, an extracorporeal carbon dioxide removal system that works by removing carbon dioxide and delivering oxygen directly to a patient’s blood via a small catheter inserted into the jugular or femoral vein.
“Submission of our IDE is a significant milestone, made possible only through the hard work of our team in close collaboration with the FDA. We look forward to completing the IDE review and beginning the study later this year,” ALung CEO & chair Peter DeComo said in a press release.
The trial will explore the use of the the device in treating patients with severe acute exacerbations of chronic obstructive pulmonary disease, ALung said.
The company said that patients with severe exacerbations of COPD can experience high levels of carbon dioxide, resulting in respiratory failure and the need for intubation and mechanical ventilation. Mechanical ventilation is often associated with side effects and raised in-hospital mortality, the company said.
ALung said it is hopeful that its Hemolung technology will reduce the need for intubation and ventilator support.
Earlier this month, ALung said it closed a $36 million Series C financing round, with funds slated to support a US pivotal trial of its Hemolung respiratory assist system as it pursues FDA approval.