ALung Technologies has been working for a decade on its Hemolung Respiratory Assist System, starting its development in 2005. The device offers a sort of respiratory dialysis in which carbon dioxide is removed from the blood and oxygen is delivered back to it. The idea is to enable patients in respiratory distress to ease the burden on their lungs while they heal.
|Hemolung--Courtesy of ALung Technologies|
Just last month, the FDA granted the system its coveted Expedited Access Pathway Designation. The device nabbed a CE mark in 2013. Now the National Institute for Health Research (NIHR), the research arm of the U.K.'s National Health Service (NHS), is funding a 1,120-patient, 40-hospital study of the Hemolung device for respiratory failure that's dubbed REST.
This pivotal trial is the largest to date of the low-flow extracorporeal carbon dioxide removal (ECCO2R) technology used in Hemolung, according to the company.
"This broad implementation of extracorporeal CO2 removal in support of the study is possible because, unlike other technologies, the Hemolung RAS has been specifically designed to provide highly effective support, in a minimally invasive manner, with a degree of safety and simplicity that allows it to be used in a general medical ICU," said ALung chairman and CEO Peter DeComo in a statement.
NIHR is supporting the trial to the tune of £2.1 million ($3.2 million). It's slated to start in March 2016. The research will be led jointly by Queen's University and Belfast Health and Social Services Trust under the direction of principal investigator Professor Danny McAuley, Professor of Intensive Care Medicine at the Centre for Infection and Immunity at Queen's University Belfast.
The Hemolung is the first fully integrated respiratory dialysis system, the company said. It's approved for use in 34 countries outside of the U.S., including in Europe, Canada and Australia. The device is in use at more than 100 hospitals globally.
The randomized controlled REST trial is tasked with determining if the treatment "really works or not," stated an NIHR description of the trial. It will examine a control group of patients receiving the standard care in the ICU as defined under current NHS guidelines, with a treatment group on Hemolung. Data isn't expected to be published until February 2022.
In February, ALung launched a next-gen version of the device, which removes about 30% to 50% of metabolically produced CO2; the company said the device has twice the rate of carbon dioxide removal of other approaches. It works via a venous catheter.
"Reducing ventilator pressures has been one of the most important interventions shown to improve outcomes in these critically ill patients," said Laura Lund, VP of Clinical and Scientific Affairs at ALung. "Use of these lung-protective ventilation strategies, however, leads to a critical accumulation of carbon dioxide in the blood."
She continued, "Carbon dioxide can be removed from the blood independently of the failing lungs with an extracorporeal device in a manner similar to kidney dialysis, thus enabling implementation of safer mechanical ventilation settings. We have shown through several pilot studies that the Hemolung RAS can safely and effectively meet this clinical need, and are very excited to embark on this pivotal study to determine the impact of this strategy on patient outcomes."
- here is the announcement
- here is the NIHR study description