The Hemolung Respiratory Assist System will be exclusively utilized in the 1120-patient study
PITTSBURGH (December 2, 2015) – ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced today its participation in the world’s first and largest pivotal trial of ECCO2R technology. The Hemolung RAS, a minimally invasive artificial lung device which removes CO2 independently of the lungs through a process called Respiratory Dialysis®, has been selected as the exclusive technology for the upcoming UK-based study.
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.
“Reducing ventilator pressures has been one of the most important interventions shown to improve outcomes in these critically ill patients,” said Laura Lund, Ph.D., 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. 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.”
The UK National Institute for Health Research (NIHR) has 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 will be jointly led 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.
ALung will provide Hemolung systems and treatment kits to 40 hospitals participating in the study. “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 Peter DeComo, Chairman and CEO of ALung. “We are honored to have been chosen by the study team as the exclusive technology partner for this very important project and look forward to its commencement next year.”
The Hemolung RAS received European marketing clearance (CE Mark) in 2013 as the world’s first fully integrated Respiratory Dialysis® system. The simplicity, safety and effectiveness of the system have been demonstrated in use at more than 100 hospitals worldwide. The device is approved in 34 countries outside of the US, including Europe, Canada, and Australia.
More information about the REST Trial
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 individual investors and venture firms including Allos Ventures, Birchmere Ventures and West Capital Advisors, LLC.
For more information about ALung and the Hemolung RAS, visit www.alung.com.
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.