ALung Technologies said it’s pursuing approval from Chinese regulatory authorities for its Hemolung respiratory assist system.
The Pittsburgh-based medical device company said it inked a deal with Curative Medical to seek approval for the Hemolung device from the China Food & Drug Administration.
Curative will oversee a clinical trial of the device in the People’s Republic, with ALung providing medical equipment and support. The trial will examine Hemolung’s performance in patients with acute respiratory failure.
ALung won Canadian and European marketing licensees for Hemolung, which it developed through a series of funding rounds in 2010. Curative manufactures non-invasive ventilation devices in China.
"There is a clear clinical need for the Hemolung RAS in China," ALung CEO Peter DeComo said in prepared remarks. "Over 65 million Chinese suffer from chronic obstructive pulmonary disease, primarily due to high rates of tobacco use."