|[February 25, 2013]
ALung Technologies Receives CE Mark Approval for Hemolung Respiratory Assist System
PITTSBURGH --(Business Wire)--
ALung Technologies, Inc., a leading developer of innovative respiratory
assist devices, announced today that it has received CE Mark approval
for its Hemolung Respiratory Assist System (RAS). Receipt of the CE Mark
allows the Hemolung RAS to be sold in the European Union.
The Hemolung RAS provides Respiratory Dialysis® by removing
carbon dioxide and delivering oxygen directly to the blood, allowing a
patient's lungs to rest and heal. The Company completed its
European-based clinical trial of the device in 2011 and has been working
with regulators to secure market clearances. The Company has also been
granted a Health Canada License.
"The Hemolung RAS is the first device to provide simple, efficient,
low-flow extracorporeal carbon dioxide removal for patients with acute
respiratory failure," said Peter DeComo, ALung's Chairman and Chief
Executive Officer. "We are excited to now be able to make this
technology available to European intensive care units."
ALung has been preparing for launch of the Hemolung RAS throughout
Europe, establishing direct operations in Germany and the United
Kingdom, and signing distributors in several other countries. A
controlled launch is planned, with the device initially being made
available to a select group of reference centers. A full commercial
launch is slated for later this year.
The Hemolung RAS offers asimple, minimally invasive approach to
extracorporeal carbon dioxide removal (ECCO2R) through use of
a small venous catheter and techniques similar to renal dialysis. "The
Hemolung approach is really innovative," said Dr. Nicholas Barrett,
Consultant in Critical Care at Guy's and St. Thomas' NHS Foundation
Trust in London. "We see a lot of potential for devices like the
Hemolung RAS in helping patients avoid the deleterious effects of
invasive mechanical ventilation, either by avoidance of intubation or
de-escalation of ventilator settings."
About ALung Technologies
ALung Technologies, Inc. is a Pittsburgh-based developer and
manufacturer of innovative lung assist devices. ALung's Hemolung
Respiratory Assist System (RAS) is a dialysis-like alternative or
supplement to mechanical ventilation originally developed at the
University of Pittsburgh. The Hemolung RAS provides Respiratory
Dialysis® by removing carbon dioxide and delivering oxygen directly to
the blood and is indicated for providing partial extracorporeal
respiratory support in cases of acute hypercapnic respiratory failure,
including acute respiratory distress syndrome (ARDS) and acute
exacerbation of chronic obstructive pulmonary disease (COPD). A simple
extracorporeal circuit, small venous catheter, and techniques similar to
hemodialysis make the Hemolung RAS easy to use.
For additional information, please visit: http://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 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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