Pittsburgh-based Alung Technologies Inc. has received emergency use authorization from the U.S. FDA for its Hemolung Respiratory Assist System (RAS) to treat lung failure caused by COVID-19. The technology could help to ease demand for ventilators, which have been in short supply in coronavirus hot spots, and provide an alternative for patients who can’t tolerate mechanical ventilation.

Hemolung functions like a dialysis machine, removing carbon dioxide directly from the blood and recirculating it with oxygen. It was originally developed to treat patients with chronic obstructive pulmonary disease (COPD) and acute respiratory distress syndrome (ARDS).

The EUA allows for use of Hemolung RAS to treat lung failure in COVID-19 patients as an “adjunct to noninvasive or invasive mechanical ventilation to reduce hypercapnia and hypercapnic acidosis, and/or to maintain normalized levels of partial pressure of carbon dioxide (PCO2) and pH in patients suffering from acute, reversible respiratory failure for whom ventilation of CO2 cannot be adequately, safely, or tolerably achieved.”

Reduce use of ventilators

“The objective is to avoid mechanical ventilation if possible, minimize mechanical ventilation if needed and protect the lungs while on mechanical ventilation in order to allow them to rest and heal,” Peter DeComo, Alung’s chairman and CEO, told BioWorld.

The surge in COVID-19 patients has led to a nationwide shortage of ventilators, particularly in hot spots of the pandemic, where large numbers of machines are needed to help critically ill patients breathe. In a recent report, William Blair analysts predicted the need for additional units could exceed 150,000. Earlier this week, in an effort to stretch the use of existing ventilators, FDA granted an EUA to Vent Multiplexor LLC for a device that enables individualized support for two adults on a single machine.

Meanwhile, concerns about unusually high death rates for COVID-19 patients on ventilators have prompted a search for alternatives. In a recent study in the Journal of the American Medical Association, researchers reported that at least 80% of coronavirus patients in New York City who were placed on ventilators had died.

U.S. pivotal trial

Hemolung cart. Credit: Alung Technologies Inc.

Hemolung has already been used to treat numerous COVID-19 patients in Europe and the U.S., where it has been on a compassionate-use basis. Available via CE mark in Europe since 2013, it is currently in clinical trials in the U.S.

The VENT-AVOID trial is currently enrolling up to 180 patients at 36 hospitals across the U.S. the prospective, randomized pivotal trial aims to assess the safety and efficacy of Hemolung’s low-flow extracorporeal carbon dioxide removal (EECO2R) as an alternative or adjunct to mechanical ventilation for patients requiring respiratory support due to acute exacerbation of COPD. Patients are randomized to receive Hemolung plus standard-of-care mechanical ventilation or mechanical ventilation alone.

The study had been slated for conclusion in late 2021, but DeComo said the pandemic has now made a timeline for the trial and final FDA approval uncertain. “Like many clinical trials, enrollment has slowed as a result of COVID-19.

Hemolung and EECO2R were also evaluated in the just-completed UK REST study, which included 412 patients with moderate to severe ARDS. Those results have not yet been released.

To support its request for emergency use authorization of Hemolung in the current crisis, Alung submitted in vitro and in vivo data from the VENT-AVOID trial, along with information on the device’s use outside the U.S. and results from biocompatibility, cytotoxicity and performance tests.

“We are pleased with the FDA’s recognition that the Hemolung may be beneficial in the treatment of COVID-19 by removal of CO2 directly from the blood during extracorporeal therapy,” said DeComo.

Series D underway

Spun out of the University of Pittsburgh in 1997, Alung has raised a total of $100 million in more than eight rounds – the most recent being a series D that picked up $5 million in January 2019. The company previously scooped up $36 million in a series C financing led by Royal Philips NV and UPMC, through its innovation and commercialization arm UPMC Enterprises, which was used to kick start its U.S. pivotal trial.

DeComo said Alung is currently targeting a $30 million in new series D financing.

Asked about the company’s capacity to ramp up production in the current crisis, he responded, “I have no idea at this point what type of demand we will see. We are a small company, but we will do our best where and when we can to assist hospitals and physicians in treating COVID-19 patients.”

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