The U.S. Food and Drug Administration (FDA) granted approval to the Hemolung Respiratory Support System, an artificial lung device developed by ALung Technologies, a UPMC Enterprises portfolio company.
Last year, ALung Technologies received emergency use authorization for Hemolung to treat COVID-19 patients. While still in clinical trials, the Hemolung has been making a significant difference for hospitalized patients with COVID-19. More than 100 of the sickest patients have been treated with Hemolung Respiratory Support System to control their respiratory and metabolic function, while avoiding ventilator use and further damage to their already stressed lungs.
The new approval allows ALung to market the device in the U.S. for a broader range of conditions, including cystic fibrosis and asthma. ALung’s Chairman and CEO, Peter M. DeComo, is determined to get the device into as many hospitals as possible.
“The beauty of the Hemolung is that it was designed to be simple, safe, and effective,” DeComo said. “It has a much broader application than similar devices that are out there in specialized medical centers. It’s designed for any hospital that has an ICU that has doctors and nurses experienced in taking care of patients on ventilators and kidney dialysis. We have worked with a number of community hospitals that had no previous experienced in extracorporeal therapy and they have done great with the training that we provided.”
According to DeComo, the company has been developing a commercialization plan in anticipation of approval, and they now plan to ramp up production capability.
“We have been in about 50 prestigious medical centers in the U.S. through the process of our clinical trial and our emergency use authorization during the pandemic,” he said. “Many of them are excited about our FDA approval and want to become commercial sites.”