Pivotal Trial of ALung’s Artificial Lung Technology Reaches Record Enrollment
Sep. 04, 2018
PITTSBURGH--(BUSINESS WIRE)--Sep 4, 2018--ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO 2 R) technologies for treating patients with acute respiratory failure, announced today that over 250 patients have been enrolled in the UK-based REST Trial, a landmark pivotal study of its Hemolung RAS in patients with acute respiratory distress syndrome (ARDS). The REST Trial is now the largest ever prospective clinical study of extracorporeal lung support. ALung’s Hemolung RAS, a minimally invasive artificial lung device which removes carbon dioxide independently of the lungs, is the exclusive ECCO 2 R technology being used in the trial.
The global incidence of acute respiratory failure exceeds 1 million cases per year. Many patients with respiratory failure require the assistance of a ventilator to provide life sustaining oxygenation and carbon dioxide removal. Unfortunately, the injured lung is susceptible to additional damage by the positive pressure exerted by the ventilator, leading to additional injury, complications, and increased mortality.
“In patients with ARDS, it is crucial that ventilator settings be reduced so that the lungs can rest and heal,” noted Dr. Steve Conrad, Medical Director at ALung. “The REST Trial is important because it will provide definitive evidence as to the ability of extracorporeal carbon dioxide removal to facilitate potentially safer mechanical ventilation in these critically ill patients.”
The UK National Institute for Health Research (NIHR) funded the 1120-patient study entitled “pRotective vEntilation with veno-venouS lung assisT in respiratory failure - The REST Trial” with £2.1 million. The research is jointly led by Queen’s University and Belfast Health and Social Services Trust under the direction of investigators Professor Danny McAuley and Dr. James McNamee of the Centre for Experimental Medicine at Queen’s University Belfast. ALung is providing Hemolung systems and treatment kits to more than 40 hospitals participating in the study.
“We are very excited to see the REST Trial reach this important enrollment milestone,” said Peter DeComo, Chairman and CEO of ALung. “ALung is committed to generating high-quality clinical evidence for ECCO2R, and I would like to thank the trial leadership team for all their hard work and dedication to this effort.”
The Hemolung RAS received European marketing clearance (CE Mark) in 2013 as the world’s first fully integrated Respiratory Dialysis® system. In addition to the REST Trial, ALung is conducting the US-based VENT-AVOID Trial, a pivotal trial of the Hemolung RAS in patients with severe acute exacerbations of chronic obstructive pulmonary disease. ALung is the only company pursuing two major pivotal trials to validate the safety and efficacy of extracorporeal carbon dioxide removal therapy.
More information about the REST Trial
This project ‘REST’ was funded by the NIHR HTA programme (Project Number: 13/143/02)
About ALung Technologies
ALung Technologies, Inc. is a privately-held Pittsburgh-based developer and manufacturer of innovative lung assist devices. Founded in 1997 as a spin-out of the University of Pittsburgh, ALung has developed the Hemolung RAS as a dialysis-like alternative or supplement to mechanical ventilation. ALung is backed by Philips, UPMC Enterprises, Abiomed, The Accelerator Fund, Allos Ventures, Birchmere Ventures, Blue Tree Ventures, Eagle Ventures, Riverfront Ventures, West Capital Advisors, and other individual investors.
For more information about ALung and the Hemolung RAS, visit www.alung.com.
The Hemolung RAS is an Investigational Device and limited by United States law to investigational use.
This press release may contain forward-looking statements, which, if not based on historical facts, involve current assumptions and forecasts as well as risks and uncertainties. Our actual results may differ materially from the results or events stated in the forward-looking statements, including, but not limited to, certain events not within the Company’s control. Events that could cause results to differ include failure to meet ongoing developmental and manufacturing timelines, changing GMP requirements, the need for additional capital requirements, risks associated with regulatory approval processes, adverse changes to reimbursement for the Company’s products/services, and delays with respect to market acceptance of new products/services and technologies. Other risks may be detailed from time to time, but the Company does not attempt to revise or update its forward-looking statements even if future experience or changes make it evident that any projected events or results expressed or implied therein will not be realized.
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CONTACT: ALung Technologies, Inc.
Scott Morley, +1-412-697-3370 ext. 208
Senior Vice President of Market Development
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SOURCE: ALung Technologies, Inc.
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PUB: 09/04/2018 10:33 AM/DISC: 09/04/2018 10:33 AM