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ALung Announces that the Independent Data and Safety Monitoring Board (DSMB) Recommends Continuation of VENT-AVOID Trial and Reports that Significant Progress Continues with their Clinical Trial Programs

May 8, 2019

PITTSBURGH--(BUSINESS WIRE)--May 8, 2019--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 a major milestone in its U.S. based VENT-AVOID clinical trial and reports continued progress in its clinical trial programs. The independent Data and Safety Monitoring Board (DSMB) of the VENT-AVOID trial recommended continuation of the trial without modification following its first scheduled review of safety data from the initial 31 subjects enrolled.

COPD affects 30 million Americans 1 and is the third leading cause of death in the United States behind cancer and heart disease. 2 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 ECCO2R in the AE-COPD population. The study aims to validate the safety and efficacy of the Hemolung Respiratory Assist System (RAS) for COPD patients experiencing acute exacerbations requiring ventilatory support. Nearly thirty hospitals have been brought online and are screening patients for ALung’s VENT-AVOID Trial of the Hemolung RAS.

In the United Kingdom, the REST Trial, a landmark pivotal study of the Hemolung RAS in patients with acute respiratory distress syndrome (ARDS), has enrolled greater than 360 patients. Significant progress continues to be made enrolling patients in this landmark pivotal study of the Hemolung RAS in patients with acute respiratory distress syndrome, and it is now the largest prospective clinical study of extracorporeal lung support ever conducted. 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 attainment of this significant VENT-AVOID milestone is gratifying, and we look forward to the continuation of these pivotal trials, both of which hold the promise that the Hemolung RAS and ECCO2R therapy will provide a new tool in the treatment of acute respiratory failure,” stated Peter DeComo, Chairman and CEO of ALung.

The Hemolung RAS has European marketing clearance (CE Mark) and is the world’s only fully integrated Respiratory Dialysis® system. 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.

References
1.  https://www.copdfoundation.org/What-is-COPD/COPD-Facts/Statistics.aspx
2.  http://www.lung.org/assets/documents/research/copd-trend-report.pdf

View source version on businesswire.com:https://www.businesswire.com/news/home/20190508005107/en/

CONTACT: ALung Technologies, Inc.

Peter M. DeComo

Chairman and CEO

+1-412-697-3370 ext. 207

pdecomo@alung.com

KEYWORD: UNITED KINGDOM UNITED STATES EUROPE NORTH AMERICA PENNSYLVANIA IRELAND

INDUSTRY KEYWORD: SURGERY HEALTH BIOTECHNOLOGY CARDIOLOGY CLINICAL TRIALS HOSPITALS MEDICAL DEVICES PROFESSIONAL SERVICES FINANCE MEDICAL SUPPLIES NURSING

SOURCE: ALung Technologies, Inc.

Copyright Business Wire 2019.

PUB: 05/08/2019 09:15 AM/DISC: 05/08/2019 09:15 AM

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