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ALung Technologies Secures CE Mark to Begin European Commercialization


2/26/2013 6:52:22 AM

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 a simple, 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.

Contact:

ALung Technologies, Inc.

Scott Morley, Vice President of Marketing, +1-412-697-3370

smorley@alung.com


Read at BioSpace.com


   

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