PITTSBURGH–(BUSINESS WIRE)–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 Americans1 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
Contacts
ALung Technologies, Inc.
Peter M. DeComo
Chairman and CEO
+1-412-697-3370
ext. 207
pdecomo@alung.com