ALung Announces Significant Progress in its Hemolung Clinical Trial Programs
ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced today the achievement of major milestones in its clinical trial programs. In the United States, nearly thirty hospitals have been brought online for ALung’s VENT-AVOID Trial of the Hemolung Respiratory Assist System (RAS), a key milestone in advance of the winter cold and flu season when acute exacerbations of chronic obstruction pulmonary disease (AE-COPD) increase nearly two-fold1. In the United Kingdom, the REST Trial, a landmark pivotal study of the Hemolung RAS in patients with acute respiratory distress syndrome (ARDS), enrolled its 300th patient.
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ALung’s artificial lung technology, the Hemolung RAS, is manufactured in the company’s state-of-the-art facility in Pittsburgh, Pennsylvania. (Photo: Business Wire)
COPD affects 30 million Americans2 and is the third leading cause of death in the United States behind cancer and heart disease.3 Acute exacerbations, defined as a sudden worsening of COPD symptoms, are a major cause of morbidity and mortality in COPD patients. The VENT-AVOID Trial is the world’s first pivotal study of extracorporeal carbon dioxide removal in the AE-COPD population. The study aims to validate the safety and efficacy of the Hemolung RAS for COPD patients experiencing acute exacerbations requiring ventilatory support.
“During the winter months, COPD patients tend to suffer more exacerbations due to the circulation of respiratory viruses and the cold air,” said Peter DeComo, Chairman and CEO of ALung. “It was imperative that we had our study sites online and ready to enroll patients in advance of the season. We are excited to now have nearly thirty prestigious academic medical centers screening patients for the study.” For more information on the VENT-AVOID Trial, and a list of enrolling sites, please visit clinicaltrials.gov.
In the United Kingdom, significant progress continues to be made enrolling patients in the REST Trial. This landmark pivotal study of the Hemolung RAS in patients with acute respiratory distress syndrome was already the largest ever prospective clinical study of extracorporeal lung support. Study enrollment in 2018 has increased by more than 50% over 2017, and three hundred patients have now been recruited. ALung’s Hemolung RAS is the exclusive ECCO2R technology being used in the trial. 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.
The Hemolung RAS has European marketing clearance (CE Mark) and is the world’s only fully integrated Respiratory Dialysis® system. Approximately 900 patients have been treated with the technology worldwide. ALung is the only company pursuing two major pivotal trials to validate the safety and efficacy of extracorporeal carbon dioxide removal therapy.
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.
For more information on the VENT-AVOID trial, and a list of enrolling sites, please visit clinicaltrials.gov.
For more information about the REST Trial, please visit UK National Institute for Health Research (NIHR) – REST Trial Project Website.
CAUTION: 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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